2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home...

2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home (CAHSAH)

Integration of Compliance Management into Organizational Performance

Deborah Randall, [email protected]

www.deborahrandallconsulting.com


I. Why Develop An Internal Corporate

Compliance Program?


At present, only HMO’s, publicly traded companies, and some states are required to have compliance programs — so why develop an internal compliance program that meets federal sentencing guidelines?

The Patient Protection and Affordable Care Act of 2010 “ACA” requires it for all providers by Jan 2011

Because OIG underscores the savings from its investigations --$4 Billion in 2009($492 Million in audits) and OIG at $3 Billion mid-way in 2010.


IS IT JUST PHARMA?

AVENTIS Pharmaceuticals to pay $95.5 million to federal government, State Medicaid programs and other federal insurers for misstating Medicaid price base for drugs sold


No---November 2009

Kaiser Foundation Hospitals - Kaiser Sunnyside Medical Center, Kaiser Foundation Health Plan of the Northwest and Northwest Permanente P.C., Physicians & Surgeons agreed to pay $1,830,322.41 in False Claims Act liability services billed hospice w/o written certifications of terminal illness 2000-4


Word from the Top

JUNE 2010 OBAMA WHITE HOUSE ANNOUNCES

THERE WILL BE A FUTURE “DO NOT PAY” LIST. Joint Letter of Department of Justice and Office of the Inspector General about intentions to intensify fraud enforcement.


A. Preventative Medicine

Implement procedures and systems to ensure compliance with and avert violations of federal, state, and local laws regulating hospice providers


B. Insurance Policy in the Event the Agency Is Investigated or Prosecuted

1. Can persuade enforcement authorities to rely on less draconian remedies than criminal prosecution and/or exclusion from government programs

2. Can mitigate corporate penalties otherwise mandated under the Federal Sentencing Guidelines


C. Commercial Advantage

Positions the hospice positively for acquisition, merger, networking, affiliation, managed care contracts, and relations with physicians, hospitals, and consumers


D. Medicaid LawAs of Jan 1, 2007, the DRA requires entities with $5 million or more in Medicaid revenues in a federal year to:1.Create policies and systems informing employees and contractors about fraud laws, compliance and whistleblower protections2.Include similar information in employee manuals.


E. New Hospice Conditions of Participation

Hospice COPs effective year- end 2008 and February 2009 change relationships between Hospices and Nursing Facilities Hospice COPs alter the role of

physicians in hospice care delivery

Hospice quality of care is a COP focus; failure = ?? unbillable claims


F. Changes in HIPAA

Breach – access, acquisition, use, disclosure

What is a discovery and when does it occur – when it would be found if the business used ‘care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances.’


New HIPAA Regulation about Security Measures;Business

Associates Have you identified the e-PHI that you

create, receive, maintain or transmit? What are the external sources of e-PHI? For example, do vendors or consultants create, receive, maintain or transmit e-PHI? The human, natural, and environmental threats to information systems that contain e-PHI?


G. Medicare, Medicaid, PPACA 2010 Integrity Provisions

Sec. 6401. Provider screening/enrollment requirements.[Debt; compliance programs]

Sec. 6402. Enhanced Medicare and Medicaid program integrity provisions.

Sec. 6404. Maximum time to submit Medicare claims not >12 mo from service


INTEGRITY continued

Sec. 6406. Physician documentation on referrals @ high risk of waste/abuse.

Sec. 6407. Face to face encounter with patient required if physicians certify HHA;? MORE service lines possible

Sec. 6408. Enhanced penalties.


INTEGRITY continued

Sec. 6409. Medicare self-referral disclosure protocol.

Sec. 6411. Recovery Audit Contractor (RAC) program extended to Medicaid.

Sec. 6501. Termination of provider participation under Medicaid if terminated in Medicare or State plan.


INTEGRITY continued

Sec. 6502. Medicaid exclusion from participation relating to certain control, ownership, and management affiliations.

Sec. 6601. Prohibition on false statements and representations.

Sec. 6604. Applicability of State law to combat fraud and abuse.


Overpayment Reporting (Sections 6402(a) and 6506)

Affirmative obligation for any provider, supplier, Medicaid managed care organization, MA organization, or PDP sponsor that has received an overpayment to report and return the overpayment to the Secretary, state, intermediary, carrier, or contractor along with a written notification of the reason for the overpayment.

Deadline for reporting and returning such overpayments is the later of 60 days after identified or the date that any corresponding cost report is due.

False Claims Act liability ALREADY EXISTS for knowingly concealing or knowingly and improperly avoiding an “obligation” to pay money to the government.

Overpayments retained beyond the deadline become actionable under the False Claims Act.


PPACA Hospice Target After 1/1/2011, a hospice physician or nurse

practitioner must have a face-to-face encounter with each hospice patient to determine continued eligibility prior to the 180th-day recertification & thereafter. Section 3132(b)(2) PPACA

Attestation of visit

HHS medical review of certain patients in hospices with high percentages of long-stay patients—Congress allows CMS to set the %


II. Government Agencies Involved With

Compliance Audits


Where are Certs/ReCerts Going? New CMS Regulation

180day face to face no more than 15 days before 180th day and before subsequent 60 day recerts.

Narrative from medical director addt’lDating documents by named physicianALL CERTs/RECERTs affectedDates of Certification Period required


Office of the Inspector General (OIG)Region 9 has 2 OIG offices; all other regions have 1 OIG

officeDepartment of Justice: US Attorney & FBIState Medicaid Fraud Control Units (MFCU)Fiscal Intermediaries (FI’s), now MACs &

Enforcement: Medicare PSCs, RACs, ZPIC Audits, Fiscal Audits, CERT; Referral to OIG

State Survey and Certification AgenciesOffice of Civil Rights (HIPAA)


New Fraud Focus at CMSMedicare and Medicaid Program Integrity

groups now linked in Center for Program Integrity headed by Peter Budetti, MD, JD Visiting Professor for Health Care Fraud at the National

Association of Insurance Commissioners last year

Counsel to the U.S. House Subcommittee on Health and the Environment under Chairman Henry Waxman

Chair of the Board of Taxpayers Against Fraud (TAF): The False Claims Act Legal Center, a nonprofit, public interest organization


Department of Justice Letter 6/8/10

Obama directs 50% decrease in overpayment situations that lead to fraud

Fraud prevention Summits regionally: LA, Vegas, Detroit, Boston, NYC, Philadelphia

Fraud task forces every US Attorney areaDouble Senior Medicare Patrol on fraudCMS and Aging Ad’mn educating seniors


OIG Work Plan 2010

Hospice-Nursing Home relationshipsPhysician billing and ? double billing

for hospice patients by attending physicians and hospices

Trends in Hospice growthPart D duplicate billing -

pharmaceuticals


OIG Reports on Hospice and Nursing

FacilitiesSept. 2009 – OIG found 82% of claims

for hospice/NF residents lacked one or more coverage requirements

Second OIG Report was statistical and gave the intensity and frequency of NF-based hospice care….suggesting CMS might want to consider implications


New State Operations Manual Section 2085 - Operation of Hospice

Across State LinesSOM section now states that when a hospice

provides services across state lines, the involved states must have a written reciprocal agreement permitting the hospice to provide services in this manner. This is a consistent position of CMS BUT no effort is made to bring States to the table to make such agreements ‘expected behavior.’


Freeze in Transaction in Homecare for agencies less than 3 years old or sold within 3 yrs (aka “the 36-month rule)

Indicates huge fraud concern in home health field and rampant related agency fraud schemes

Where growth in hospice industry has been noteworthy, CMS simply allowing Regional Offices to stall and delay processing of 855s for providers


Medicaid Integrity Program

In fiscal year 2007, there were roughly $627 million in overpayments, $568 million in recovered payments, and total recoveries of $1.3 billion. Overall, state program integrity initiatives cost $181 million.

Testimony of MIP executive to Congress, October 2009


III. A Very Broad Risk of Liability and Sanctions

Exists for Hospice Providers


A. Hospice Provider Must Know the Law

Six laws are particularly important to health care providers

Qui Tam lawsuit = whistleblower lawsuit


1. Federal False Claims a. Criminal

— May result in monetary penalties

— May result in jail sentence

b. Civil— U.S. and/or private party

— civil action; multiple monetary damages

— persons who “knowingly” make false or fraudulent claims OR false statements in support of claims against the U.S.


1. False Claims continued

False = Intentional or = “Reckless Disregard” for whether true/accurate or = Intentional Ignorance

c. False Claims in Medicare or State HealthPrograms-other laws

d. Per Service, episode, cost report


2009 Fraud Enforcement ActMay 20, 2009 Federal Enforcement and

Recovery Act signed by Obama Indirect submissions to government Intentional retention of funds “Material” False statements/documents Whistle-blower protection for

independent contractors/contractors More subpoena power


Odyssey CaseOdyssey HealthCare paid the United States

$12.9 million to settle a qui tam false claims case \ VP got $2.3 million award

Allegations that patients were not terminally illThe settlement covers a period from 2001 \

2005Odyssey HealthCare also entered into a

Corporate Integrity Agreement (CIA) with the HHS/OIG


Faith Hospice

Faith Hospice, Inc. allegations of fraudulent claims to Medicare/Medicaid

Sample of medical records: 50% ineligible

Forfeited approximately $599,000; half seized by civil forfeiture action


Home Hospice of North Texas

Misrepresented condition of patientsMisinformed physicians of patient

dataHalf million $ paybackCorporate Integrity AgreementCompliance program within 90 daysFalse Claims Act; May 29, 2008


SouthernCare

Hospice organization agreed to pay $24.7 million

Five year Corporate Integrity Agreement with the Office of the Inspector General

Alleged inappropriate admissions and LOS issues

Extensive press coverage in Home Health Line


California Criminal Hospice Case

May 2009 family run hospice paid outside person to be ”capper” and refer patients

$500 per referral with continuing paymentsPatients paid $200 to agree to be “terminal”Physicians paid for sign-offsSignificant sentences


Investigations Announced

Large, for-profit hospice organizations have announced new or renewed DOJ investigations

Subpoena are being issuedFocus of investigations now length of

stay as well as terminal condition at time of admission; nursing home focus


2. Mail or Wire Fraud

a. Electronic Billing

b. Cost Reports and Claims

c. Fraudulent Back-up Documentation Mailed to Payors


3. False Statements

• Making an untrue statement

• Filing an inaccurate CAP report

• Nurses altering notes during QA or in response to ADR

• Is an untrue certification = false statement?


4. Concealing or Failing to Disclose Overpayments

Knowingly concealing, or failing to disclose occurrence of an event affecting right to payment

• Overpayment• Duplicative billings • Outcome of internal audits


5. Medicare - Medicaid Anti-Kickback Statute • Remuneration: In cash or in kind; direct

or indirect; cross referral arrangements may be illegal

• Referring a patient, arranging service or recommending a provider

• Giver and receiver of kickback are liable

• Inducement of a beneficiary is a kickback


OIG ALERTS

Nursing Homes And Hospice = 2

Joint Ventures

Contractual Joint Ventures


OIG opinions www.oig.hhs.gov Hospice of Martin and St. LucieLucie

/fraud/docs/advisoryopinions/2000/ao00_3.htmContracting with Nursing Homes /2001/ao01-20.pdfFundraising solicitations /2001/ao01-02.pdfPatient monitoring systems /2003/ao0304.pdfPre-hospitalization assessments /2006/AdvOpn06-01A.pdf

Foundations giving free drugs /2008 /AdvOpn08-17.pdf ;

2010/AdvOpn 10-06Patient bonuses for referrals to Independent Lvg

2010/AdvOpn10-05


6. “Stark” Law

Does not apply to hospices directly — but affects other relationships among health providers, so hospices within health systems should review their physicians’ relationship with affiliated institutions, such as hospitals and home health agencies of the system

All financial relationships with Physicians are affected for Designated Health Services “DHS”


7. Other Statutes

a. Conspiracy to Defraud the United States b. Theft, embezzlement, conversion of public

monies c. Theft or bribery concerning programs

receiving federal funds d. Obstruction

- of agency proceedings - of criminal investigations - of a federal audit

e. Money laundering


8. State Statutes

a. Theft, larceny, false instruments

b. Medicaid false claims [Attn! DRA]

States with their own Federal False Claims Act to combat Medicaid fraud and abuse:

CA, DEL, D.C., FL, HA, IL., IN., LA, MA,

MI, MT, N.H., N.M., NV, NY,TN, TX, VA

c. Health care false claims


B. Administrative Remedies – OIG Goes after the “Little Guys”

1. Civil Money Penalties [“CMP”]

3x Error plus >$11,000 for each claim

“Know or should know” were not provided as claimed, or were false or fraudulent

Exclusions in administrative proceeding for Medicare or Medicaid claims

Beneficiary “inducement” is CMP


2. CMS may refuse to enter or refuse to renew*, provider agreement for not complying

a. With the statute or regulations or

b. With the “requirements to be a hospice”**

* 855 to be submitted every three years

** QAPI as the new standard in Hospice Conditions of Participation


3. Suspension of payments for: Suspected overpayments, or if the

FI has reliable evidence that the overpayment is a result of fraud or willful misrepresentation, without prior notice.


4. State administrative sanctions:

May be suspended from participation upon indictment, or some finding by an administrative agency prior to any hearing on the underlying facts. Suspension by state may trigger exclusion by the OIG and hence government wide exclusion.


IV. Essentials of Compliance Planning for Hospices


A. WHY?

1. Prevention

2. Insurance

3. Business

4. Medicaid Law for $5 million in revenue entities


B. WHEN?

1. Before a corporate integrity agreement “CIA” is imposed by the government, with harder terms and mandated reports to OIG

2. After a vote by Board of Directors/ Officers


C. WHAT?

A RISK ASSESSMENT FOLLOWED BY:

Seven Essential Elements of an Effective Compliance Plan


Hospice Risk Areas In OIG 1999 Compliance Guidance

http://www.oig.hhs.gov/authorities/docs/hospice

Prime Focus:* Admitting patients to hospice care who are not

terminally ill* Under‑utilization* Falsified medical records or plans of care* Untimely and/or forged physician certifications or

plans of care * Knowingly billing for substandard care


OIG 1999 Guidance for Hospice Billing higher level of care than substantiated Incentives to potential referral sources (physicians, nursing

homes, hospitals, assisted living, patients) that may violate the anti‑kickback statute: focus on nursing homes

www.oig.hhs.gov/fraud/docs/alertsandbulletins/hospice www.oig.hhs.gov/fraud/docs/alertsandbulletins/ SFANursingFacilities


OIG FOCUS TODAY?? Inflating general inpatient or continuous care:

Higher reimbursement by “promising” NFs or hospitals a certain number of inpatient days

or transferring patients to continuous care, to lower hospital LOS

Using inpatient facilities owned by the hospice whose medical director is “controlled”

Gaming the CAP


Where is OIG Focusing… Improper marketing for admissions

(versus allowable incentives to W-2 staff)

“Joint Ventures” that are kickbacks; Nursing Homes

Underserving and therefore delivering poor quality of care — judged by visit #, length, cost

Unnecessary additional Medical Directors


Narratives for Physician Certification; Visit Billing IntegrityCR #6540 (re-issued on 12/23/09) speaks to

the hospice reporting requirements for the attending physician and the physician certifying the terminal illness in written form

CMS issued a clarification to CR6440 when rounding for the 15 minute increments in time reporting for all claims. 0 to 14 minutes=1 unit


The 180 Day Physician Visit

New regulation to be issued this week; posted last week. Short comment period.

<15days pre-180th day and <15 every following cert period.

In person, face to face [no telehealth] nurse practioner can inform the physician but attestation, in writing and specifics


Compliance and the New COPsPatients’ Rights; participation in care planningQuality as underlying the value of careRole of the Medical Director; suggestion that >

1 is not what CMS expectsCredentials; Multiple Site Hospices Validation through documentationSignaturesMore…………


What are the Patient’s Rights? Effective Pain management Involvement in Care Plan Development Information on coverage, scope, limitations Refusing care or treatment Choosing the attending Confidential patient record, access/release HIPAA Freedom from mistreatment, neglect, abuse,

property misappropriation, injuries of unknown source


Failures in COPs affect BillingGovernment theory is that really poor care

means a bill should not be sentIf you bill a claim when you know or should

know the quality was inadequate, this could be a “False Claim”. Federal and State false claims act [FCA] cases growing

Billing a claim without documentation to prove care, level of care, or terminal status could also be a “False Claim”


Assessments of Patients Initial 48 hour window; Comprehensive within 5

calendar days of NOE; q. 15 days = updated assessment

Signed and dated Election = ImportanceContent: the clinical presenting picture; the

functional status and patient participation in care; risk factors in care planning; imminence of death; Drug Profiling; bereavement needs; Referral Needs=> “Amalgam of documents” risks


Assessment of Patients: Update

IDG and “collaboration of the attending”How do you document/ proveProgress =>desired outcomes; response

to care; did you ask patients?Uniform data outcomes measures Data systematic, retrievable for

individual care planning and larger QAPI work


The Right Services from the Right People at the Right TimeCredentialingTraining and competenciesSupervisionCore Services from Hospice Employees or

Contractors when permittedWaivers of Required ServicesRole of Personal Care Workers and NF

employees as “Family-equivalents”


418.56 Interdisciplinary Group: IDGRN IDG member must coordinate care and ensure

“continuous assessment” of patient and family needs

IDG must “work together”, “provide the care” “meet the needs” & reassess every 15 days

Must have a “Super IDG” to set policies on day to day care, if >1 IDG in the hospice

IDG must document patient’s understanding, involvement and agreement w care planning


Hospice Aide SupervisionIn-person: RN with the patient in the home

every 14 days [no aide present]In-person with the aide to observe aide’s

services with a patient = 1 time per yearNo therapist, and no LPN, can satisfy the

supervision requirementWhat mechanisms to ensure compliance

through what RN “observes” of patient?


Background ChecksNot “credentialed” if behavior or

background do not meet standards418.114(d) criminal background checks all

who do patient care or affect patient record/billing. State law as guidance.

Affirmative obligation to come forward?OIG and GSA exclusions list more than

criminal activities; all claims un-billable


Hospice Medical Director If there is only one physician connected to the hospice,

this physician is “expected to provide direct patient care to each patient.”

Medical Director [MDir] provides “overall medical leadership” in the hospice.

Numerous physicians in the MDir role “would likely result in inconsistent care and decreased accountability.”

Certifications depend on information= review of DX, current medical findings, meds and treatments 418.102 (a) and (b)


418.112: Patients Residing in Nursing Facilities

Legally binding, written arrangement Designated liaison for both providersPrimacy of the hospice in care decisions —

”full responsibility”Mandated strong communication and

coordination — in written terms 112(e)(3)Absent revised SNF regulations, however,

how will it “work”?


Special Requirements: Patients Residing in Nursing Facilities

NF’s continue to provide services as before / room & board & support

Core services = the hospice providesUse of the NF personnelPlan of Care planning, sharing, role of each

provider, consistencySpecific IDG member deals with NF coord’n


Nursing Facility Contracts

Hospice must ensure NF staff trainedOffer of bereavement services to facility

staff goes in contract = 418.112(c)??Hospices can use some of its own staff

for NF staffing, if it is in the contract.Single, identified NF staff as liaison


Surveyors & QAPI

Will access aggregated data and analysisWill access QAPI plan, minutes and notesWill access “individuals responsible”Will match data w actual experiences of

employees/ patients to see if QAPI is “prevalent” and “positively influencing patient care”


V. Seven Essential Elements of An Effective

Compliance Plan


Seven Essential Elements of an Effective Compliance Plan

The degree of formality depends on the size and complexity of the organization \ OIG rejects “canned” plans

Begins with a statement of corporate philosophy, a code of conduct and an employee manual

If the Compliance Plan is not “effective” and “robust” OIG will ignore it


#1 Compliance Standards and Procedures that are reasonably capable of reducing

the prospect of criminal conduct.


#2 Steps to Prevent and Detect Offenses which may occur in an organization engaged in this particular type of business.


#3 Compliance Oversight with the standards and procedures assigned to a specific individual within the high-level personnel of the organization.

• Essential qualities: effective, compelling, autonomous (reports to Board of Directors), unimpeachable integrity, holds confidence of senior management, respected by peers, approachable


#4 Substantial Discretionary Authority Is Not Given to individuals whom the organization knew, or should have known through the exercise of due diligence, had a propensity to engage in illegal activities.

• Background and criminal records checks within the state law limits.

• OIG and GAO exclusion lists MANDATORY


#5 Effective Communication of Standards

• Through understandable documents

• Thorough, regular and repeated training


#6 Monitoring to Achieve Compliance

• OIG guidelines called for baseline audits

but many providers installed programs without this

• Internal monitoring and auditing, penalty free reporting and confidential reporting mechanism (hotline)


#7 Effective Enforcement, all the way up the ladder.

Responses That Are Reasonable, appropriate, prompt and effective to

remedy problems, including modifying the compliance plan which must be

a “living document.” Feedback is essential.


D. HOW? The On-Site Process: Start with the OIG Guidance and

Attachment III – G, H, I and J and review all the following:a. Corporate organization, structure

b. Corporate related organizations, e.g., pharmacy/ infusion, durable medical equipment suppliers, management holding companies, subsidiaries, etc.

These are matrix documents for subsequent internal audits, plus medical records and billing records.


1. Before On-Site Process

a. Contracts with independent contractors, managed care organizations, physicians, referral sources, vendors

b. Position descriptions

c. Policy and procedure manuals with particular focus on trouble areas in hospice

d. Employee manuals


1. Before On-Site Process (continued)

e. Orientation and training materialsf. Financial statementsg. Cost reports h. Internal and external audit reportsi. Survey and certification reviewsj. Outside survey and accreditation reports

k. Election, informed consent and DNR


2. Process

•Systems/operations review

•Interviews of employees

•“Spot-check review” by outside counsel


E. WHO?

All Company StaffContractors for Services (Clinical,

Billing, etc.)


Some Legal Issues in Today’s Strategies for Hospice

Contracting and Joint Venturing Expanding Geographically Adding Medical Directors/consultants –

Documentation model: Attachment III-M Adding a physical facility; leasing offices near

or in medical complexes Changed documentation protocols; software Exploring telehealth How to handle an outside investigation


Compliance Officer ToolsOIG website resourcesOIG exclusion and GSA exclusion listsHCCA website information: www.hcca-

info.orgFI training and updates, for example:

https://www.cahabagba.com/part_a/education_and_outreach/newsletter/index.htm

NHPCO website materials


Websites for Exclusion Review

http://oig.hhs.gov/fraud/exclusions/databa se.html#1

http://oig.hhs.gov/fraud/exclusions/database.html#2

http://exclusions.oig.hhs.gov/search.html

Basic download instructions:

http://oig.hhs.gov/fraud/exclusions/instructions.html


Thank You!

Deborah Randall JD and ConsultantLaw Office of Deborah [email protected] 202-257-7073www.deborahrandallconsulting.com

2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home...

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Transcript of 2010 © Arent Fox PLLC, Washington, D.C. 2010 © California Association for Health Services at Home...