Navigating Telemedicine Requirements for Licensing, Scope...

111
The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10. Presenting a live 90-minute webinar with interactive Q&A Navigating Telemedicine Requirements for Licensing, Scope of Practice and Reimbursement Overcoming Multi-State Regulatory Hurdles for Healthcare Providers and Facilities Today’s faculty features: 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific TUESDAY, NOVEMBER 22, 2016 Joseph P. McMenamin, Principal, McMenamin Law Offices, Richmond, Va. René Y. Quashie, Member, Cozen O'Connor, Washington, D.C. Richard K. Rifenbark, Partner, Foley & Lardner, Los Angeles

Transcript of Navigating Telemedicine Requirements for Licensing, Scope...

Page 1: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

The audio portion of the conference may be accessed via the telephone or by using your computers

speakers Please refer to the instructions emailed to registrants for additional information If you

have any questions please contact Customer Service at 1-800-926-7926 ext 10

Presenting a live 90-minute webinar with interactive QampA

Navigating Telemedicine Requirements for

Licensing Scope of Practice and Reimbursement Overcoming Multi-State Regulatory Hurdles for Healthcare Providers and Facilities

Todayrsquos faculty features

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

TUESDAY NOVEMBER 22 2016

Joseph P McMenamin Principal McMenamin Law Offices Richmond Va

Reneacute Y Quashie Member Cozen OConnor Washington DC

Richard K Rifenbark Partner Foley amp Lardner Los Angeles

Tips for Optimal Quality

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FOR LIVE EVENT ONLY

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participation in this webinar by completing and submitting the Attendance

AffirmationEvaluation after the webinar

A link to the Attendance AffirmationEvaluation will be in the thank you email

that you will receive immediately following the program

For additional information about continuing education call us at 1-800-926-7926

ext 35

FOR LIVE EVENT ONLY

Program Materials

If you have not printed the conference materials for this program please

complete the following steps

bull Click on the ^ symbol next to ldquoConference Materialsrdquo in the middle of the left-

hand column on your screen

bull Click on the tab labeled ldquoHandoutsrdquo that appears and there you will see a

PDF of the slides for todays program

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FOR LIVE EVENT ONLY

copy2016 Foley amp Lardner LLP bull Attorney Advertising bull Prior results do not guarantee a similar outcome bull Models used are not clients but may be representative of clients bull 555 South Flower Street Suite 3500 Los Angeles CA 90071-2411 bull 2139724500

Rick Rifenbark

Telehealth Licensing amp

Scope of Practice Issues

5

213-972-4813

rrifenbarkfoleycom

wwwfoleycomtelemedicine

copy2016 Foley amp Lardner LLP

The Practice of Medicine

What is the practice of medicine minus Holding oneself out as a doctor to the public (ie

advertising it on an app)

minus Charging for the medical services

minus Making a medical consult

minus Issuing a diagnosis

minus Making treatment recommendations

minus Issuing orders (lab diagnostics)

minus Writing prescriptions

minus Performing treatmentssurgery

6

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

A physician offering care via telemedicine is subject to licensure rules of

The state in which the patient is physically located at the time of the consult

The state where the physician is locatedlicensed

Depending on the technology platform this could result in the physician practicing medicine in all states

7

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

Regarding medical practice rules it is generally accepted that the law that governs the consult is the state where the patient is located at the time of the consult

minus Some states explicitly address this in law or guidance

minus Some states indirectly address this by including diagnosing or rendering treatment through ldquoelectronic or other meansrdquo as part of the practice of medicine

minus Other states are silent

8

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 2: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Tips for Optimal Quality

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FOR LIVE EVENT ONLY

Continuing Education Credits

In order for us to process your continuing education credit you must confirm your

participation in this webinar by completing and submitting the Attendance

AffirmationEvaluation after the webinar

A link to the Attendance AffirmationEvaluation will be in the thank you email

that you will receive immediately following the program

For additional information about continuing education call us at 1-800-926-7926

ext 35

FOR LIVE EVENT ONLY

Program Materials

If you have not printed the conference materials for this program please

complete the following steps

bull Click on the ^ symbol next to ldquoConference Materialsrdquo in the middle of the left-

hand column on your screen

bull Click on the tab labeled ldquoHandoutsrdquo that appears and there you will see a

PDF of the slides for todays program

bull Double click on the PDF and a separate page will open

bull Print the slides by clicking on the printer icon

FOR LIVE EVENT ONLY

copy2016 Foley amp Lardner LLP bull Attorney Advertising bull Prior results do not guarantee a similar outcome bull Models used are not clients but may be representative of clients bull 555 South Flower Street Suite 3500 Los Angeles CA 90071-2411 bull 2139724500

Rick Rifenbark

Telehealth Licensing amp

Scope of Practice Issues

5

213-972-4813

rrifenbarkfoleycom

wwwfoleycomtelemedicine

copy2016 Foley amp Lardner LLP

The Practice of Medicine

What is the practice of medicine minus Holding oneself out as a doctor to the public (ie

advertising it on an app)

minus Charging for the medical services

minus Making a medical consult

minus Issuing a diagnosis

minus Making treatment recommendations

minus Issuing orders (lab diagnostics)

minus Writing prescriptions

minus Performing treatmentssurgery

6

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

A physician offering care via telemedicine is subject to licensure rules of

The state in which the patient is physically located at the time of the consult

The state where the physician is locatedlicensed

Depending on the technology platform this could result in the physician practicing medicine in all states

7

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

Regarding medical practice rules it is generally accepted that the law that governs the consult is the state where the patient is located at the time of the consult

minus Some states explicitly address this in law or guidance

minus Some states indirectly address this by including diagnosing or rendering treatment through ldquoelectronic or other meansrdquo as part of the practice of medicine

minus Other states are silent

8

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 3: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Continuing Education Credits

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participation in this webinar by completing and submitting the Attendance

AffirmationEvaluation after the webinar

A link to the Attendance AffirmationEvaluation will be in the thank you email

that you will receive immediately following the program

For additional information about continuing education call us at 1-800-926-7926

ext 35

FOR LIVE EVENT ONLY

Program Materials

If you have not printed the conference materials for this program please

complete the following steps

bull Click on the ^ symbol next to ldquoConference Materialsrdquo in the middle of the left-

hand column on your screen

bull Click on the tab labeled ldquoHandoutsrdquo that appears and there you will see a

PDF of the slides for todays program

bull Double click on the PDF and a separate page will open

bull Print the slides by clicking on the printer icon

FOR LIVE EVENT ONLY

copy2016 Foley amp Lardner LLP bull Attorney Advertising bull Prior results do not guarantee a similar outcome bull Models used are not clients but may be representative of clients bull 555 South Flower Street Suite 3500 Los Angeles CA 90071-2411 bull 2139724500

Rick Rifenbark

Telehealth Licensing amp

Scope of Practice Issues

5

213-972-4813

rrifenbarkfoleycom

wwwfoleycomtelemedicine

copy2016 Foley amp Lardner LLP

The Practice of Medicine

What is the practice of medicine minus Holding oneself out as a doctor to the public (ie

advertising it on an app)

minus Charging for the medical services

minus Making a medical consult

minus Issuing a diagnosis

minus Making treatment recommendations

minus Issuing orders (lab diagnostics)

minus Writing prescriptions

minus Performing treatmentssurgery

6

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

A physician offering care via telemedicine is subject to licensure rules of

The state in which the patient is physically located at the time of the consult

The state where the physician is locatedlicensed

Depending on the technology platform this could result in the physician practicing medicine in all states

7

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

Regarding medical practice rules it is generally accepted that the law that governs the consult is the state where the patient is located at the time of the consult

minus Some states explicitly address this in law or guidance

minus Some states indirectly address this by including diagnosing or rendering treatment through ldquoelectronic or other meansrdquo as part of the practice of medicine

minus Other states are silent

8

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 4: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Program Materials

If you have not printed the conference materials for this program please

complete the following steps

bull Click on the ^ symbol next to ldquoConference Materialsrdquo in the middle of the left-

hand column on your screen

bull Click on the tab labeled ldquoHandoutsrdquo that appears and there you will see a

PDF of the slides for todays program

bull Double click on the PDF and a separate page will open

bull Print the slides by clicking on the printer icon

FOR LIVE EVENT ONLY

copy2016 Foley amp Lardner LLP bull Attorney Advertising bull Prior results do not guarantee a similar outcome bull Models used are not clients but may be representative of clients bull 555 South Flower Street Suite 3500 Los Angeles CA 90071-2411 bull 2139724500

Rick Rifenbark

Telehealth Licensing amp

Scope of Practice Issues

5

213-972-4813

rrifenbarkfoleycom

wwwfoleycomtelemedicine

copy2016 Foley amp Lardner LLP

The Practice of Medicine

What is the practice of medicine minus Holding oneself out as a doctor to the public (ie

advertising it on an app)

minus Charging for the medical services

minus Making a medical consult

minus Issuing a diagnosis

minus Making treatment recommendations

minus Issuing orders (lab diagnostics)

minus Writing prescriptions

minus Performing treatmentssurgery

6

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

A physician offering care via telemedicine is subject to licensure rules of

The state in which the patient is physically located at the time of the consult

The state where the physician is locatedlicensed

Depending on the technology platform this could result in the physician practicing medicine in all states

7

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

Regarding medical practice rules it is generally accepted that the law that governs the consult is the state where the patient is located at the time of the consult

minus Some states explicitly address this in law or guidance

minus Some states indirectly address this by including diagnosing or rendering treatment through ldquoelectronic or other meansrdquo as part of the practice of medicine

minus Other states are silent

8

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 5: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP bull Attorney Advertising bull Prior results do not guarantee a similar outcome bull Models used are not clients but may be representative of clients bull 555 South Flower Street Suite 3500 Los Angeles CA 90071-2411 bull 2139724500

Rick Rifenbark

Telehealth Licensing amp

Scope of Practice Issues

5

213-972-4813

rrifenbarkfoleycom

wwwfoleycomtelemedicine

copy2016 Foley amp Lardner LLP

The Practice of Medicine

What is the practice of medicine minus Holding oneself out as a doctor to the public (ie

advertising it on an app)

minus Charging for the medical services

minus Making a medical consult

minus Issuing a diagnosis

minus Making treatment recommendations

minus Issuing orders (lab diagnostics)

minus Writing prescriptions

minus Performing treatmentssurgery

6

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

A physician offering care via telemedicine is subject to licensure rules of

The state in which the patient is physically located at the time of the consult

The state where the physician is locatedlicensed

Depending on the technology platform this could result in the physician practicing medicine in all states

7

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

Regarding medical practice rules it is generally accepted that the law that governs the consult is the state where the patient is located at the time of the consult

minus Some states explicitly address this in law or guidance

minus Some states indirectly address this by including diagnosing or rendering treatment through ldquoelectronic or other meansrdquo as part of the practice of medicine

minus Other states are silent

8

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 6: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

The Practice of Medicine

What is the practice of medicine minus Holding oneself out as a doctor to the public (ie

advertising it on an app)

minus Charging for the medical services

minus Making a medical consult

minus Issuing a diagnosis

minus Making treatment recommendations

minus Issuing orders (lab diagnostics)

minus Writing prescriptions

minus Performing treatmentssurgery

6

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

A physician offering care via telemedicine is subject to licensure rules of

The state in which the patient is physically located at the time of the consult

The state where the physician is locatedlicensed

Depending on the technology platform this could result in the physician practicing medicine in all states

7

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

Regarding medical practice rules it is generally accepted that the law that governs the consult is the state where the patient is located at the time of the consult

minus Some states explicitly address this in law or guidance

minus Some states indirectly address this by including diagnosing or rendering treatment through ldquoelectronic or other meansrdquo as part of the practice of medicine

minus Other states are silent

8

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 7: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

A physician offering care via telemedicine is subject to licensure rules of

The state in which the patient is physically located at the time of the consult

The state where the physician is locatedlicensed

Depending on the technology platform this could result in the physician practicing medicine in all states

7

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

Regarding medical practice rules it is generally accepted that the law that governs the consult is the state where the patient is located at the time of the consult

minus Some states explicitly address this in law or guidance

minus Some states indirectly address this by including diagnosing or rendering treatment through ldquoelectronic or other meansrdquo as part of the practice of medicine

minus Other states are silent

8

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 8: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Telemedicine and Licensing

Regarding medical practice rules it is generally accepted that the law that governs the consult is the state where the patient is located at the time of the consult

minus Some states explicitly address this in law or guidance

minus Some states indirectly address this by including diagnosing or rendering treatment through ldquoelectronic or other meansrdquo as part of the practice of medicine

minus Other states are silent

8

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 9: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Select Physician Licensing Exceptions

Consultation

bullAllows unlicensed physician to practice medicine in peer to peer consultation with a physician licensed in the state

bullAvailable in most states but significant variances in scope

bullRequires state-by-state understanding

Bordering State

bullAllows practice of medicine by out-of-state physicians who are licensed in a bordering state

bullOnly a few states offer this

Special License or Registration

bullAbbreviated license or registration for telemedicine-only care

bullOffered in several states

Follow-Up Care

bullAllows physician to provide follow-up care to hisher patient (eg post-operation)

bullOnly a few states have this

Endorsement

bullPhysician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

9

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 10: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Consultation Exception

Allows unlicensed physician to practice medicine in peer-to-peer consultation with a physician licensed in the state

Peer-to-peer local physician retains ultimate authority over treatment and diagnosis

Example Arizona minus ldquoThis [licensing statute] does not apply tohellip (1) A doctor

of medicine residing in another jurisdiction who is authorized to practice medicine in that jurisdiction if the doctor engages in actual single or infrequent consultation with a doctor of medicine licensed in this state and if the consultation regards a specific patient or patientsrdquo Ariz Rev Stat sect 32-1421

10

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 11: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Consultation Exception

Significant variances regarding

minus Frequency of consults

minus Primary vs secondary diagnosis

minus Free vs for compensation

minus Contractual arrangement or regular contacts

minus In-state office or location to meet

11

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 12: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Bordering State Exception

Allows practice of medicine by out-of-state physicians who are licensed in a bordering state

Example Maryland minus ldquoSubject to the rules regulations and orders of the Board

the following individuals may practice medicine without a licensehellip A physician who resides in and is authorized to practice medicine by any state adjoining this State and whose practice extends into this State if (i) The physician does not have an office or other

regularly appointed place in this State to meet patients and

(ii) The same privileges are extended to licensed physicians of this State by the adjoining staterdquo Md Health Occ Code sect 14-302

12

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 13: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Special Telehealth License

Abbreviated license or registration for telemedicine-only care provided to residents in the state

Nine states have special telehealth licenses Example Minnesota

minus ldquo(a) A physician not licensed to practice medicine in this state may provide medical services to a patient located in this state through interstate telemedicine if the following conditions are met (1) the physician is licensed without restriction to practice medicine in the

state from which the physician provides telemedicine services (2) the physician has not had a license to practice medicine revoked or

restricted in any state or jurisdiction (3) the physician does not open an office in this state does not meet with

patients in this state and does not receive calls in this state from patients and

(4) the physician annually registers with the board on a form provided by the boardrdquo Minn Stat Ann sect 147032

13

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 14: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Follow-Up Care Exception

Allows physician to provide follow-up care to hisher patient (eg post-operation)

Example Indiana

minus ldquoIn addition to the exceptions described in section 2 [IC 25-225-1-2] of this chapter a nonresident physician who is located outside Indiana does not practice medicine or osteopathy in Indiana by providing hellip treatment services to a patient in Indiana following medical care originally provided to the patient while outside Indianardquo Ind Code Ann sect 25-225-1-11

14

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 15: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Endorsement

Physician licensed in another state can more quickly obtain in-state license based on the out-of-state credentials

Example New Mexico minus ldquoThe board may grant a license by endorsement to an applicant

who (1) has graduated from an accredited United States or Canadian medical school (2) is board certified in a specialty recognized by the American board of medical specialties (3) has been a licensed physician in the United States or Canada and has practiced medicine in the United States or Canada immediately preceding the application for at least three years (4) holds an unrestricted license in another state or Canada and (5) was not the subject of a disciplinary action in a state or provincerdquo NM Stat Ann sect 61-6-13

15

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 16: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Licensing Compacts

Interstate Medical License Compact

Nurse Licensure Compact and APRN Compact

Psychology Interjurisdictional Compact

Physical Therapy Licensure Compact

16

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 17: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Interstate Medical License Compact

Additional licensure approach for physicians in Compact-participating states

Physician licensure portability and practice of cross-border services

Complements existing licensing and regulatory authority of state medical boards

Eighteen states have joined the Compact (as of November 2016)

17

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 18: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Nurse Licensure Compact

Permits nurses to practice in own state as well as other Compact states

If a Compact state is the primary state of residence the license automatically becomes a Compactmultistate license

25 states have adopted the Nurse Licensure Compact to date

APRN Compact also approved May 4 2015 by National Council for State Boards of Nursing

18

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 19: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Psychology Interjurisdictional Compact

Approved by the Association of State and Provincial Psychology Boards in February 2015

Goal is to facilitate telehealth and temporary in-person face-to-face practice of psychology across state lines

Becomes operative when seven states adopt the Compact

19

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 20: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Physical Therapy Licensure Compact

Developed by the Federation of State Boards of Physical Therapy

10 states must adopt the physical therapy licensure compact for it to become effective

To date at least four states have adopted the Compact

20

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 21: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Adopted in 2014

Provides guidance to state medical boards regarding telemedicine

Covers various topics including minus Physician licensure

minus Establishment of physician-patient relationship

minus Evaluation and treatment of patient

minus Informed consent

minus Continuity of care

21

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 22: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Federation of State Medical Boards

Telemedicine Policy

Covers various topics including

minus Referrals for emergency services

minus Medical records

minus Privacy and security

minus Disclosures and functionality of online services

minus Prescribing

22

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 23: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Telehealth Informed Consent

Approximately 29 states require informed consent for telehealth services

Example California

ldquoPrior to the delivery of health care via telehealth the health care provider initiating the use of telehealth shall inform the patient about the use of telehealth and obtain verbal or written consent from the patient for the use of telehealth as an acceptable mode of delivering health care services and public health The consent shall be documentedrdquo Cal Bus amp Prof Code 22905(b)

23

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 24: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Telehealth Malpractice Considerations

Tort liability for telehealth is rooted in negligence

Providers should adhere to the same standard of care in telehealth settings as they would when delivering care in person

Less is known of telehealth lawsuits than is known about those arising in an in-person setting because only a fraction of the total malpractice claims involve telehealth

24

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 25: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Telemedicine Credentialing

CMS Conditions of Participation for Hospitals minus A hospital is required to have a credentialing and

privileging process for physicians and practitioners providing services to the hospitalrsquos patients including those who provide services via telehealth

minus CMS permits the hospital receiving the telehealth services to rely on the privileging and credentialing decisions made by the hospital or entity providing the telehealth services provided certain requirements are met

minus A hospital must have a written agreement in place with the distant-site hospitaltelehealth entity

minus 42 CFR 48212(a)(8) (a)(9)

25

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 26: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

copy2016 Foley amp Lardner LLP

Speaker Information

Rick Rifenbark Foley amp Lardner LLP

213-972-4813

rrifenbarkfoleycom

Special thanks to

Nathaniel Lacktman Foley amp Lardner LLP

813-225-4127

nlacktmanfoleycom

wwwfoleycomnlacktman

26

News amp Resources wwwfoleycomtelemedicine

wwwhealthcarelawtodaycom

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 27: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

NAVIGATING TELEMEDICINE REQUIREMENTS FOR LICENSING SCOPE OF

PRACTICE AND REIMBURSEMENT

THE REIMBURSEMENT LANDSCAPE

Reneacute Quashie Esq

Partner

Cozen OrsquoConnor

rquashiecozencom

202-912-4884

27

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 28: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

OverviewBackground

28

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 29: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Terms amp Definitions

American Telemedicine Association

Telemedicine The use of medical information

exchanged from one site to another via electronic

communications to improve patients health status

Medicaid

Telemedicine The use of telecommunications and information technology to provide access to health assessment diagnosis

intervention consultation supervision and information

across distance

Medicare

Telehealth Two-way real-time interactive communications between originating site and

distant site physicians to deliver health services

Maryland

Telemedicine Practice of medicine from a distance in which intervention

and treatment decisions and recommendations are based on

clinical data documents and information transmitted through

telecommunications systems

World Health Organization (WHO)

Telemedicine Delivery of health care services at a distance using information and communication

technologies for the exchange of valid information for diagnosis

treatment prevention research and continuing education

Center for Connected Health Policy

Telehealth Collection of means or methods for enhancing health care public health and health education delivery and support

using telecommunications technologies

29

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 30: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Benefits of Telehealth

30

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 31: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Telehealth and US Health Care Landscape

The US health care landscape is transitioning from fee-for-service to pay-for-performance (eg outcomes quality)

Increased use of integrated delivery models such as Accountable Care Organizations bundled payments medical homes and readmissions reduction initiatives

Growing consumer demand for in-home care modalities

Telehealth viewed as an efficient and cost-effective care delivery vehicle

Availability accessibility and ubiquity of telehealth technologies

31

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 32: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

bull 365 million population by 2030

bull 65 and over 19 of population 2030

Increasing Aging Population

bull Shortfall of 130000 physicians by 2025

bull Similar shortages for nurses Fewer Physicians

bull Driven by increased patient costs and post-acute care strategies designed to reduce readmissions

Payment for Value Outcomes

Ubiquity of Telehealth Technology

Use of Telehealth Outside the US

Other Telehealth Drivers

32

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 33: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Patient Trends

Anthem

bull 74 of US consumers indicated that they would use telehealth services (and the number is expected to grow)

Cisco

bull 76 of patients choosing access to care over human interaction with their care provider

bull 70 are comfortable communicating with doctors via text email video instead of seeing them in person

Telehealth amp eHealth Journal

Study

bull 75 of respondents said they would not use telehealth unless it was covered by their insurance

33

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 34: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Stakeholders Affecting Adoption (Advisory Board)

34

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 35: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

2016-2020 Trends

Impact of International

Telehealth

Rise of Virtual Medical Centers

Sophisticated Technology

bull Wearables

bull Medical device innovation (like the physioglove)

bull EHR integration and analytics

bull Expansion of EHR-integrated applications

Emergence of Remote

Specialist Care

35

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 36: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Projections

36

Increased movement away from conventional reimbursement models

Growing health plan demand

Growing consumer demand

Growing large employer demand

Telemedicine becoming the standard of care

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 37: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare

37

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 38: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Coverage and Reimbursement ndash Medicare

Limited Coverage

Beneficiaries must be present and encounters must involve interactive audio and video

telecommunications providing real-time communication

between the practitioner and the beneficiary

Beneficiaries must be seen at certain identified originating sites (eg hospitals physiciansrsquo offices FQHCs)

bull In very rural counties

Encounters may be performed at distant sites only by certain identified

practitioners (eg physicians NPs PAs)

Only certain CPT codes reimbursed

Medicare beneficiaries are responsible for co-

insurance and deductible payments

38

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 39: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Overview

Last meaningful expansion in 2001

Mostly for rural beneficiaries

Limited number of services covered

Live interactive audiovideo (no coverage for asynchronous store-and-forward communication in most cases)

Only $14 million paid out for telehealth services (2014)

bull $615 billion paid out for all Medicare programsservices

39

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 40: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Definition

Interactive audio and video

telecommunications system that permits real-

time communication between beneficiary and

distant site provider

Asynchronous ldquostore and forwardrdquo technology is

permitted only in Federal telemedicine

demonstration programs in Alaska or Hawaii

40

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 41: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Coverage for Professional Fees

Beneficiary must present in an

ldquooriginating siterdquo located in

Rural HPSA located outside an MSA or in a rural census tract or

County outside of a Metropolitan

Statistical Area

Beneficiary can also present at an entity participating in a

federal telemedicine demonstration project in

Alaska and Hawaii

Demonstration projects can use asynchronous communication

Interactive live audio and video telecommunications

provided in real-time communication between the practitioner and beneficiary

41

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 42: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Coverage for Professional Fees

bull Beneficiary must present at one of the following ldquooriginating sitesrdquo1

bull If beneficiary does not present at one of these sites no Medicare

coverage for telehealth 1Even though the beneficiary is at these sites there is no requirement that a billing professional be in attendance

with the beneficiary unless it is medically necessary as determined by the practitioner at the distant site Note that a

beneficiaryrsquos home cannot be an originating site

Physicianrsquos office Critical access hospital

Hospital Skilled nursing facility

Hospital-basedcritical access

hospital-based renal dialysis

center

Rural health clinic

Federally Qualified Health

Center

Community mental health

center

42

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 43: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Coverage for Professional Fees

bull Professional services must be performed at a distant site by only one of the following billing professionals1

bull There is no location requirement for the distant site (where the practitioner delivering the service is located at the time the service is provided via a telecommunications system)

Physician Nurse midwife

Clinical psychologist Clinical social worker

Registered dietitian or nutritional

professional

Physician assistant

Clinical nurse specialist Nurse practitioner

43

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 44: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Coverage for Professional

Fees

bull ESRD related services

bull Individual and group kidney disease education

bull Smoking cessation

bull Individual psychotherapy

bull Psychiatric diagnostic interview examination

bull Depression screening

bull High-intensity behavioral counseling to prevent sexually transmitted infection

bull Intensive behavioral therapy for cardiovascular disease

bull Annual wellness visit

Only certain CPT

codes are

covered

44

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 45: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Coverage for Professional Fees

2017 Physician

Fee Schedule

bull End-stage renal disease related services for dialysis less than a full month of service per day (90967-90970)

bull Advance care planning including the explanation and discussion of advance directives by the physician or other qualified health care professional (99497-99498)

bull Critical care consultation services remotely to critically ill patients (GTTT1-GTTT2)

45

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 46: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Payment for Telehealth Services

Distant site practitioners are paid under the Medicare Physician Fee Schedule for covered telehealth services

Practitioners must use the appropriate code for the professional service along with the telehealth modifier GT (ldquovia interactive audio and video telecommunications systemsrdquo)

bull GT modifier certifies that the beneficiary was present at an eligible originating site when the telehealth service was furnished

bull For ESRD-related services GT modifier certifies that one visit per month was furnished ldquohands onrdquo to examine the vascular access site

46

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 47: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Coverage for Facility Fees

Originating sites are paid an originating site facility fee for telehealth services

Separately billable Part B payment

47

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 48: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Telehealth Benefit Will Be Difficult

to Expand

HHS not persuaded by clinical efficacy of telehealth for many indications bullMost covered CPT codes involve counseling mentalbehavioral health consultation

Bias towards keeping

telehealth benefit only available for

rural beneficiaries in areas with shortage of health care

professionals

Need for telehealth in urban contexts not fully

understood

Fear of increased costs to

Medicare program

with expansion

of telehealth

benefit

Privacy and security

concerns

Many studies have

been inconclusive

regarding efficiency

cost savings

preventable hospitalizations from the

use of telehealth services

48

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 49: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Opportunities for Medicare Telehealth Expansion

Significant telehealth coverage in other

government programs (ie Veterans Administration

Medicaid)

Increased coverage of telehealth data

monitoring approved by health care reform

initiatives (ie CMMI)

Promoted for use in Medicare Shared

Savings Program even though coverage is

limited to the narrow Medicare fee-for-

service coverage rules for telehealth

Focus on preventing rehospitalizations forcing CMS to look at treatment modality alternatives

49

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 50: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Opportunities for Medicare Telehealth Expansion

Number of newer private studies showing the

efficiency cost-saving potential of

telehealth

Many telehealth initiatives underway with private health plans

bull Potential to yield persuasive cost and other data

Potentially covered by Medicare

Advantage

50

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 51: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicare Developments

Various Congressional bills

MACRA

bull Merit-Based Incentive Payment Systems (MIPS)

bull Alternative Payment Model (APM)

bull 5 annual payment bonus for physicians who participate in APMs

bull Exempts physicians from participating in MIPS

bull Telemedicine and RPM APMs may cover (even if those services not reimbursed under traditional Medicare)

51

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 52: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicaid

52

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 53: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Coverage and Reimbursement ndash Medicaid

States have the option flexibility to determine whether to

cover telemedicine services and what types of

services to cover

To date 48 states and

DC provide at least some coverage of

and reimb for telemedicine

services

States not required to submit a

separate SPA for coverage of or reimb

for telemedicine services if

they reimburse for telemedicine services in

the same way amount they do for face-to-face services

visits consultations

States are responsible for ensuring access and

covering face-to-face

visits examinations

by ldquorecognizedrdquo practitioners providers in those parts of the state

where telemedicine services are not available

53

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 54: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicaid Overview

States and DC Medicaid programs cover telemedicine in some form

bull The most predominantly reimbursed form of telehealth is live video

with almost every state offering some type of live video reimbursement in their Medicaid program

States specify list of sites that can serve as an originating site for a telehealth encounter

States and DC do not specify the type of healthcare provider allowed to provide telemedicine as a condition of payment

States cover store and forward services

States cover remote patient monitoring

States reimburse a transmission facility fee

States require informed consent

54

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 55: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicaid Coverage

55

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 56: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicaid Managed Care

In 2014 the OIG issued a report evaluating the adequacy of access to care for enrollees in managed care

The Report found

bull 35 of providers were not located at the location listed on the plan

bull 8 of providers were at the location but were not participating in the plan

bull 8 of providers were not accepting new patients

bull Primary care providers were less likely to offer appointments than specialists

bull Specialists tend to have longer waits

bull Median wait time among providers who offered appointments 2 weeks

bull Over frac14 of providers had wait times of more than 1 month

bull 10 of providers had wait times of longer than 2 months

56

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 57: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Medicaid Managed Care

Federal regulations from April 2016 overhauled Medicaid

managed care requirements

States required to develop and make publicly available time and

distance network adequacy standards for primary care and several specialties behavioral

health and dental care hospital care

Includes factors states should consider in setting standards

including the use of telemedicine e-visits andor other evolving and innovative

technological solutions

57

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 58: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Private Payers

58

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 59: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Coverage and Reimbursement ndash

Private Payers

Many leading private insurers

provide coverage and reimbursement for telemedicine services although these policies

vary

bull Private pay ldquopioneersrdquo include

bull Blue Cross Blue Shield

bull CIGNA

bull United Healthcare

A growing number of states (almost 35 states and DC) have or are in the process of enacting so-called

ldquoparityrdquo laws

bull Generally require health insurers to cover and provide reimbursement for services provided via telemedicine ldquoin a comparable mannerrdquo to how the payer would for the same services provided in person

bull Over 30 states and counting (eg CA GA HI MD MI OR VA)

59

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 60: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Parity Laws - Definitions

State parity laws also define ldquotelehealthrdquo and

ldquotelemedicinerdquo

Maryland Parity Law Telemedicine Use of interactive

audio video or other telecommunications or electronic

technology by a provider to deliver health care services at a site other than the site at which the patient is

located

DC Parity Law

Telehealth Use of interactive audio video or other electronic media used for the purpose of

diagnosis consultation or treatment

Virginia Parity Law Telemedicine Use of electronic technology or media including

interactive audio or video for the purpose of diagnosing or treating a

patient or consulting with other health care providers regarding a patients

diagnosis or treatment

60

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 61: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Federal Legislative Efforts

61

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 62: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Telehealth Federal Legislative Efforts

CONNECT for Health Act (S2484)

Gives providers flexibility to

experiment with telehealth in alternative

payment models (ie MACRA)

Makes telehealth a basic benefit

under Medicare Advantage

Telehealth Enhancement

Act (HR 2066)

Would promote and expand the application of

telehealth under the Medicare and

other federal health care programs

Medicare Telehealth

Parity Act (HR 2948)

Expands Medicare telehealth

coverage in three phases

62

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 63: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Telemedicine Business

Issues Strafford Webinar

November 22 2016

Joseph P McMenamin MD JD

McMenamin Law Offices

8049214856

mcmenaminmedicalawfirmcom

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 64: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Disclaimers The views offered are my own and not necessarily

those of any client of McMenamin Law Offices or of my

consultancy MDJD LLC

The information presented is intended to be

educational but is not intended to nor does it create an

attorney-client relationship between me and anyone

else

ldquoMDrdquo here means ldquophysicianrdquo including DOs

64

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 65: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

65

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 66: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Corporate Practice of Medicine

(ldquoCPMrdquo) Policy Considerations

Tension

Corporate focus achieve and increase profits

Professionrsquos focus patient care

Concern If corporations get involved in the practice of

medicine and control physicians compensation that

could harm patient care

So prevent unlicensed persons from interfering with or

influencing MDs judgment

66

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 67: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Policy Considerations 2

Corporate employment of a licensed professional is prohibited because such a relationship

ldquo[T]ends to the commercialization and debasement of [the] professionrdquo Barton v Codington Country 2 NW 2d 337 343 (SD 1942)

Undermines MD-patient relationship and MDrsquos exercise of independent medical judgment in the sole interest of the patient Garcia v Texas State Bd of Med Examrsquors 384 F Supp 434 437 (WD Tex 1974)

Lets corporate entities not licensed and so not subject to the same professional standards or regulatory control as licensed entities intrude into medical practice

See eg State v Boren 219 P2d 566 568-69 (Wash 1950) Funk Jewelry Co v State ex rel La Prade 50 P2d 945 945-47 (Ariz 1935)

67

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 68: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Policy 3 Dangers of lay control over professional judgment division

of MDrsquos loyalty between patient and profit-making employer

and commercialization of profession Berlin v Sarah Bush

Lincoln Health Ctr 688 NE2d 106 (Ill 1997)

But see Carter-Shields v Alton Health Inst 201 Ill 2d 441 777

NE2d 948 2002 Ill LEXIS 622 268 Ill Dec 25 19 IER Cas

(BNA) 139 147 Lab Cas (CCH) P59660 (Ill 2002)(FPrsquos

employment agreement with non-licensed not-for-profit non-

hospital corporation violated prohibition against corporate

practice and was therefore void from its inception so its

restrictive covenant was unenforceable)

68

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 69: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

History of the CPM Doctrine MDs fought control by nonprofessional organizations

Prevent formation of corporations offering medical services

Discourage quackery

Early 20th C AMA got state legislatures to adopt CPM laws

Advent of large private and governmental health insurance

programs attempts to rein in costs defeated AMArsquos efforts to

resist external controls

End-20th C most states ignored or repealed the laws or

enacted laws enabling managed care plans to structure

themselves as corporations

69

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 70: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

CPM Enforcement Cal Tex

Ohio Col Ia Ill NY NJ

Corporation may not practice medicine or employ MD to provide professional medical services

Licensee to make ldquobusiness or management decisions control practice

Own patient records including content determination

Select hirefire (as it relates to clinical competency) MDs allied staff medical assistants

Set contract parameters between MD and payers

Decide coding and billing procedures

Select medical equipment and supplies

70

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 71: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

California Medical Practice Act

Business and Professions Code

Any person who practices or attempts to practice or who

holds himself or herself out as practicing[medicine]

without having at the time of so doing a valid unrevoked

or unsuspended certificateis guilty of a public offenserdquo

sect 2052

Corporations and other artificial entities shall have no

professional rights privileges or powersrdquo sect 2400

Mere potential for control may suffice for violation

See Marik v Superior Court 191 Cal App 3d 1136 (Cal Ct

App 1987)

71

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 72: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Prohibited in California Non-physicians owning or operating a business that

offers patient evaluation dx care andor treatment

MD(s) operating a practice as an LLC LLP or a general

corporation

Management service organizations arranging for

advertising or providing medical services rather than

providing administrative staff and services only

Non-MD exercising controls over practice even where

MDs own and operate the business

Non-owner MD acting as medical directorrdquo

See 65 OpAttyGen 223 4-7-82 and 11 OpAttyGen 236

72

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 73: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Unauthorized Practice

(Cal Examples)

Selecting diagnostic tests for a particular problem

Determining need for consults with another MD

Responsibility for ultimate overall care of patient

including treatment options

Determining how many patients a physician must see

in a given period of time or how many hours a

physician must work

See also Staley v Board of Medical Examiners 109 Cal App 2d 1 240 P2d 61 1952 Cal App LEXIS 1790 (Cal App 1952)

73

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 74: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Characteristic Prohibitions

Practice of medicine without a license

Sharing of fees between licensed and unlicensed

individuals or business entities

Ownership of medical practices

Employment of professionals by

Nonprofessionals

Business entities

74

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 75: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Characteristic Requirements Licensed physicians to own and operate entities that

provide medical services

Management fees stated within management services

agreements set at fair market value

75

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 76: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Exceptions Certain corporate employers OK (NY NJ Col Ill)

Hospitals

NY hospitals and other licensed facilities may employ MDs to render medical services to hospitalrsquos patients People v John H Woodbury Dermatological Inst 192 NY 454 (NY 1908)

HMOs Md Code Ann Health-Gen sect 19-704

Professional corporations

Med school as part of its mission to promote medical science and instruction Albany Med Coll v McShane 104 AD2d 119 (NY App Div 1984) affrsquod 489 NE2d 1278 (NY 1985)

School health programs NY Educ Law sectsect 901 et seq

Partnerships PCs professional service LLCs and registered LLPs comprising physicians and certain other licensed professionals exclusively NY Educ Law sect 6531

76

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 77: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Where the Hospital Exception

NA California Cal Bus Prof Code Sec 2052

But see Op Cal Atty Gen 8-803 for exceptions (narcotic programs public hospitals)

Iowa Iowa Statutes Sec 1481

Iowa hospitals may employ pathologists and radiologists

Texas Tex Health amp Safety Code Stat 311062

Texas public hospitals and California teaching hospitals

may employ physicians

77

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 78: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Application of CPM Doctrine

to Telemedicine Telephysicians may not share compensation for patient

services with other providers in-state or out-of-state

Enforcement State AG or medical board

MDs may not be employedmdashexcept by an entity comprising

MDs onlymdashto provide telemedicine services

Prohibitions vary state to state

May hinder practices wishing to operate nationally

Rx organize the practice as a physician-only LLC LLP etc

Some states non-MDs may provide management services

78

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 79: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Management Services

Agreements

Company does management functions for practice

Day-to-day administrative functions

Non-professional operations

Bookkeeping budgeting supply purchasing HR

Company incurs all practice costs except physiciansrsquo

compensation benefits malpractice premiums

FMV must dictate management fees

Ow practice gains inequitable surplus income after the

deduction for management fees

By charging sub-FMV fees management company may be

able to improperly influence how MDs provide care 79

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 80: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Complying with CPM Law Determine if the doctrine applies in relevant state

If so examine statutes regulations common law

Consider each states exceptions

Management services agreement

Consider hiring 3d-party expert to opine on whether

agreement reflects FMV

80

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 81: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and self-referral

81

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 82: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

1997 Balanced Budget Act

Required Fee Splitting Medicare reimbursement has always been limited

1997 BBA 100 of Medicare payment went to the

remote consulting practitioner

Consultant (remote site) had to pass 25 of the

payment to referring practitioner (originating site)

Accounting problems full amount was reported to IRS

as income to the consultant even though for one-fourth

of the payment he was but a conduit

82

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 83: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

BIPA 42 USC 1395m Pub L

106-554 sect 223(m)(2)(c) Medicare Medicaid and SCHIP Benefits Improvement and

Protection Act of 2000 42 USC sect 1395m

Consultant receives entire Medicare payment in an amount equal to the amount thathellippractitioner would have been paid under Medicare had the service been furnished without the use of a telecommunications systemrdquo

Referring physician could bill Medicare for any services he provided to the patient on day of telehealth service

Referring physicians site may also receive a facility feerdquo Originally $20

Now 80 of the lesser of the actual charge or $2493

83

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 84: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Minn Stat sect 147091 The boardhellipmay refuse to grant registration to perform

interstate telemedicine serviceshellipagainst any physician The following conduct is prohibited and is grounds for disciplinary actionhellip

(p) Fee splitting including without limitation

hellip

(2) dividing fees with another physician or a professional corporation unless the division is in proportion to the services provided and the responsibility assumed by each professional and the physician has disclosed the terms of the divisionhellip

84

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 85: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Vine Street Clinic v HealthLink

856 NE2d 422 426 (Ill 2006) Through Ks with MDs and payors D created networks to

be ldquoavailable to members ofhellipplansrdquo

HCPs agreed to serve members at a discount

HealthLink processed claims sent them to payors ldquofor

benefit determination and paymentrdquo

Each MD had to pay ldquoan administrative fee equal to 5 of

the amount allowed in HealthLinks rate schedule for services

provided to members by the physicianrdquo

Later charged fixed flat fee based on the specialty and

volume of HealthLink claims submitted

MDs sought refunds alleged improper fee-splitting

85

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 86: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Vine Street Clinic v HealthLink 2 Ill Medical Practice Act 225 Ill Comp Stat 6022 lets Dept of Professional

Regulation discipline MDs who divide ldquowith anyone other than physicians with whom the licensee practices any feehellipfor any professional services not actually and personally renderedrdquo

Intermediate appellate court

Both percentage fee and flat fee were for referral of patients

Fee requirement violated the Act and public policy

Illinois Supreme Court

Upheld prohibition on percentage-based fee

BUT flat fee OK ldquonot based or linked to revenue gross receipts or billings collectedrdquo but ldquoon the volume and complexity of the administrative services providedrdquo if doctorslsquorevenue increased would not increase automatically

Therefore no fee-sharing

86

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 87: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

87

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 88: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

42 USC 1320a-7b

MedicareMedicaid Pt Protection Act

(AKS) Criminal statute makes unlawful any arrangement where 1

purpose is to offer solicit or pay anything of value in return for a referral for treatment or services provided to Medicare Medicaid and state program patients

Mens rea intent

Safe harbors narrow but provide immunity from prosecution

42 CFR sect 1001952

Violations Fine le$25000 imprisonment le5 years or both

88

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 89: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

History Enacted 1972 Misdemeanor to solicit offer or receive ldquoany

kickback or bribe in connection withrdquo furnishing covered goods or services or referring a patient to a provider

1977 Congress

Prohibited solicitation or receipt of ldquoany remuneration (including any kickback bribe or rebate)rdquo in return for referrals

Prohibited offer or payment of remuneration to induce referrals

Made violation of the statutes a felony

1980Congress added knowing and willful requirement

1987 Congress combined Medicare and Medicaid statutes into one

Authorized OIG to exclude from Medicare and Medicaid individuals and entities that violated the statutes

89

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 90: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

United States v Greber

760 F2d 68 (3rd Cir 1985)

Doc convicted of Medicare fraud for paying illegal

remuneration to other physicians in return for referring

patients to his company Cardio-Med Inc for

diagnostic services

Cardio-Med provided cardiac monitoring Data were

stored in a device while the patient was wearing it

uploaded to a computer and interpreted by MD at

Cardio-Med

90

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 91: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

United States v Polin

194 F3d 863 (7th Cir 1999)

MD convicted of Medicare fraud for paying illegal

remuneration to a cardiac device sales rep in return

for referring patients to MDrsquos cardiac pacemaker

monitoring company

Court monitoring services could be performed by the

monitoring physician while in direct contact with the

patient or remotely using appropriate technology

91

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 92: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

AKS Proving a Violation Government must show

ldquo(1) that the defendant knowingly and willfully solicited or received remuneration directly or indirectly overtly or covertly

(2) that in return the D referred individuals to a person or entity for furnishing or arranging the furnishing of services

(3) that payment for the individuals services was made in whole or in part under a Federal health care programrdquo

US v Patel 12 CR 491-5 2014 WL 642199 (ND Ill 2014)

Kickback need not be made from the federal funds United States v Ruttenberg 625 F2d 173 176 (7th Cir 1980)

Sufficient payment ldquoto one in control of federal funds ie one in a position to open up or control a source of incomerdquo Bethune Plaza Inc v State Deprsquot of Pub Aid 90 Ill App 3d 1133

1139 414 NE 2d 183 188 (1980) citing Ruttenberg

92

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 93: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

AKS Analysis Does provider have any remunerative relationship

between itself and persons or entities in a position to generate Federal health care program business for the provider directly or indirectly

Could one purpose of the remuneration be to induce or reward the referral or recommendation of business payable in whole or in part by a Federal health care program

93

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 94: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

AKS Analysis Additional

Considerations

Does the arrangement or practice

Have potential to interfere with or skew clinical decision-making

Have potential to increase costs to Federal health care programs

Have potential to increase risk of overutilization or inappropriate utilization

Raise patient safety or quality of care concerns

94

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 95: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Safe Harbors - Equipment rental

- Personal services and management contracts

- Electronic prescribing items and services

- Electronic health records items and services - Investment interests

- Space rental

- Sale of practice

- Referral services

- Warranties

- Discounts

- Employment relationships

- Waiver of beneficiaryrsquos co-insurance deductible

- Group purchasing organizations

95

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 96: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Safe Harbors - Increased coverage or reduced cost sharing under a

risk-basis or prepaid plan

- Price reduction agreements with health plans

- Practitioner recruitment

- Obstetrical malpractice insurance subsidies

- Investments in group practices

- Cooperative hospital service organizations

- ASCs

- Referral arrangements for specialty services

- Price reductions for eligible managed care organizations

- Price reductions offered by contractors with substantial financial risk to managed care organizations

- Ambulance replenishing

- Health centers

96

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 97: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

AKS Safe Harbors Must analyze any telemedicine arrangement from each

partyrsquos perspective and what benefits either party

may receive in return for inducing referrals

Safe harbor is remuneration-specific and does not

globally protect an arrangement

97

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 98: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

AKS and Telestroke

Advisory Opinion No 11-12

Proposal emergency protocols and TM consults with stroke neurologists for community hospitals

Telemedicine hardware software audio-visual

Clinical consults 247365

Acceptance of transfers

Protocols training and medical education

Participating hospitals

Not to participate in any other neuro emergency telemedicine service without systemrsquos prior OK for length of agreement 2y anticipated

Marketing Grant system a limited license to use participating hospitalsrsquo trademarks and service marks

OIG

Deal could potentially generate illegal remuneration under federal AKS

But no sanctions because safeguards suffice to reduce risk of improper payments for referrals

98

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 99: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

No 11-12 Safeguards System unlikely to generate many referrals

Neither participating hospitals nor their MDs required or encouraged to refer to system

No additional compensation for EP

Initially participation offered only to hospitals the system already had a clinical affiliation with

Both participating hospitals and system might benefit from deal but primary beneficiaries would be patients who could be treated at the participating hospitalsrsquoEDs

Deal would afford system and hospitals opportunity to engage in marketing using each otherrsquos marks but

Neither would be required to engage in marketing

Each party would pay its own marketing costs

Unlikely to result in increased costs System certified that few if any consults would be billable to Medicare

What if Medicare coverage expands 99

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 100: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

AKS and Grant-Supported

Rural TM Network Op 99-14 Federal grant supported a rural TM network

Possible fraud exposure upon expiration

Given clear Congressional intent that network support continue beyond grantrsquos term systemrsquos ongoing financial support of equipment provided to rural HCPs OK

Still any HCP that stood to profit from the TM network should share the appropriate costs borne by the health system to maintain the TM infrastructure

99 Op Off Inspector Gen 14 (1999)

100

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 101: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Ad Services Facilitating

Telemedicine Advis Op 02-12 Party requesting opinion ldquocertified that it would comply with the

Health on the Net Foundation Code of Conducthelliprdquo

Entailed ensuring ldquothat the visitor-web site relationship support and not replace the patient-physician relationshiprdquo

ldquoThrough the use of identifying words design or placementrdquo advertiser to make clear that it provides commercial advertising

Disclaimer ldquohellipthat the inclusion of such ads does not constitute a guarantee endorsement or recommendation of the products services or companies appearing in such ads or accessible through such hyperlinksrdquo

May help leave the design of ads up to advertising docs

Goal Make clear to reader that site is providing no medical advice nor is it in some special position to do so

101

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 102: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Potential AKS Safe Harbors 1994 OIG special fraud alert re clinical lab services

If clinical labs provide free computers or fax machines to MDs could be illegal remuneration unless MD

(1) Used the equipment exclusively to coordinate lab services

(2) Equipment was integral to MDrsquos use of labrsquos services

OIG SFA 59 Fed Reg 65372 65377 (Dec 19 1994)

MD access to hospital TM equipment could implicate AKS unless hospital takes precautions to make sure equipment and services are used for hospital patients only

Charge MD FMV for any additional use

bull MD receives free electronic prescribing technology or training

bull 42 CFR sect 1001952(x)

Free EHR software information technology or training

42 CFR sect 1001952 (y)

102

Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

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Telemedicine Equipment Leases

Medical Staff Incidental Benefit

(i) Written lease signed by the parties

(ii) Lease specifies the equipment covered

(iii) Lease provides lessee with use of equipment for

periodic intervals not full-time for lease term

For the intervals lease specifies schedule length rent

(iv) Term is for at least 1 year

(v) Aggregate rent set in advance cw FMV

Not influenced by volume or value of any referrals

42 CFR Section 1001952(c)

OIG Advisory Opinion No 98-18 (optometrist) 103

Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

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Provision of Subsidized

or Free Equipment

By virtue of their interconnectedness telemedicine

partners may be incentivized to refer to each other

Is subsidy of systemrsquos capital or operating costs

intended to lock in a referral stream to the host

Risk proportional to the extent that

Host bears most of the cost

Remote MD access to host results in referrals and vice-

versa

104

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 105: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Outline A Corporate practice of medicine

B Fee splitting

C Anti-Kickback Statute and Self-Referral

105

Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

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Self-Referral Stark

42 USC sect 1395nn

For designated health services reimbursable by Medicare MD may not refer Medicare beneficiaries to an entity MD has a financial interest in

Prohibition is narrower in its scope than AKS but it is a strict liability offensemdashdoes NOT require intent

Complying with Stark exception protects MD

42 CFR sectsect 411355 ndash 411357

357 held invalid in Council for Urological Interests v Burwell 790 F3d 212 (DC Cir 2015)(MD owner leasing equipment to hospital to which he refers cases using equipment) but amended made retroactively effective 3716

ldquoFinancial interestrdquo Though it provides numerous exceptions definition includes almost any arrangement in which a physician receives something of value from an entity he refers to

42 CFR sectsect 411354-411357

106

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 107: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Stark and Telemedicine Federal restrictions not major concern apply only

when the payor is a federal health care program

Medicare and Medicaid cover telemedicine services to

but a limited extent

State regulations many apply regardless of payor

Telemedicine provider may need to structure its business

model accordingly

May have to refrain from offering participating MDs equity

or other financial incentives that induce referrals

107

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 108: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Caution Under Stark Free telemedicine equipment or services

Volume discounts

ldquoPer-clickrdquo payments or ads on physician websites

Joint ventures with telemedicine tech monitoring or networking companies

Telemedicine network to facilitate patient consultations MD may wish to be financially independent

Practitioner could invest in a comprehensive hospital or health system not a discrete telemedicine subsection of that hospital or health system

108

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 109: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Caution Under Stark MD may invest in

Well-capitalized telemedicine services company or

One that provides or manufactures telemedicine

technology

42 USC sect 1395nn(d)(3) (2002)

Riskier telemedicine start-ups

109

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 110: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

110

Telemedicine Self-Referral

Exceptions Free e-prescribing technology or training or free EHR software IT

or training (through 2021)

Hospitals may fund up to 85 of docsrsquo EHR costs 42 CFR sect 411357(v) (w)

Community-wide health information systems For patients served by community providers MDs may refer Medicare

patients to entities MD has received IT equipment or services from that allow MD access to and sharing of EHR if certain conditions are met

42 CFR sect 411357(u)

Referrals to a rural provider MD has a financial interest in Rural provider any entity that furnishes at least 75 of the DHS that it

furnishes to residents of a rural area

42 CFR sect 411356(c)(1) sect 1395nn(d)(2)

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111

Page 111: Navigating Telemedicine Requirements for Licensing, Scope ...media.straffordpub.com/products/navigating-telemedicine-requireme… · Navigating Telemedicine Requirements for Licensing,

Questions Comments Joseph P McMenamin MD JD

McMenamin Law Offices PLLC

8049214856

mcmenaminmedicalawfirmcom

111