Becky Sutherland Cornett,

Volume SevenNumber Eight

August 2005Published Monthly

BeckySutherland

Cornett,Ph.D., CHC

2PHYSICIAN PRACTICE

COMPLIANCE

CONFERENCES

September 8 & 9

October 6 & 7

For more information see page 2

2 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org

Health Care Compliance Association

presents

PHYSICIAN PRACTICE COMPLIANCE CONFERENCES

22The Health Care Compliance Association (HCCA) will hold its 2005 Physician Practice ComplianceConference twice this year; in San Francisco, September 8 & 9 and in New York, October 6 & 7. Theconference will provide physicians, practice managers, and compliance officers with the most currentinformation and compliance strategies for physician practices.

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CMS■ CMS Offers New Option for Physicians Who Administer

Drugs in Their Offices http://www.cms.hhs.gov/media/press/

release.asp?Counter=1490

■ CMS Announces Medicare Demonstration for Day Care

Services Under the Home Health Benefit http://www.cms.

hhs.gov/media/press/release.asp?Counter=1488

■ CMS Open Door Forum Schedule

http://www.cms.hhs.gov/opendoor/schedule.asp

DOJ■ Health Care Fraud and Abuse Control Program Annual Report

for FY 2003 http://www.usdoj.gov/dag/pubdoc/hcfacre-

port2003.htm

GAO■ Identity Theft: Some Outreach Efforts to Promote Awareness of

New Consumer Rights Are Under Way

http://www.gao.gov/new.items/d05710.pdf

■ Medicare: Drug Purchase Prices for CMS Consideration in

Hospital Outpatient Rate-Setting

http://www.gao.gov/new.items/d05581r.pdf

■ Medicaid Financing: States' Use of Contingency-Fee Consultants

to Maximize Federal Reimbursements Highlights Need for

Improved Federal Oversight http://www.gao.gov/new.items

/d05748.pdf

■ Medicaid Fraud and Abuse: CMS's Commitment to Helping

States Safeguard Prog

ram Dollars Is Limited

http://www.gao.gov/

new.items/d05855t.pdf

■ JCAHO Behavioral

Health Care New

Standards

http://www.jcaho.org/

accredited+organiza-

tions/behavioral+

health+care/stan-

dards/new+stan-

dards/new_stds.htm ■

3August 2005

HCCA • 888-580-8373 • www.hcca-info.org

R E S O U R C E S

T H E C A L E N D A RONON

HCCAHCCA

2005 CONFERENCES:(See page 5 for upcoming audioconferences)

Los Angeles, CA■ SCCE WorkshopNovember 10

San Francisco, CA■ Physician Practice

Compliance ConferenceSeptember 8-9

Denver, CO■ Mountain Area MeetingAugust 26

Buena Vista, FL■ Compliance AcademyNovember 7-10

Atlanta, GA■ SCCE WorkshopDecember 1

Chicago, IL■ SCCE's Compliance & Ethics

InstituteSeptember 12-14■ North Central MeetingOctober 7

Baltimore, MD■ Fraud & Compliance ForumSeptember 25-27

Boston, MA■ New England Area MeetingSeptember 9

Minneapolis, MN■ Upper Midwest Area MeetingSeptember 16

Kansas City, MO■ Midwest Area MeetingAugust 5

Las Vegas, NV■ Advanced AcademyOctober 24-28■ Desert Southwest MeetingNovember 4

New York, NY■ Physicians Practice

Compliance ConferenceOctober 6-7

Philadelphia, PA■ Northeast Meeting September 30

Houston, TX■ SCCE WorkshopDecember 2

Seattle, WA■ SCCE WorkshopNovember 11

2006 Conferences:

Los Angeles, CA■ Compliance AcademyFebruary 6-10

For more information about

resources, go to the HCCA

Website, http://www.hcca-

info.org or call 888/580-8373.

■ The HIPAA Security Rule

■ The Health Care Compliance

Professional’s Manual

■ Monitoring & Auditing

Practices for Effective

Compliance

■ HCCA’s Guide to Resident

Compliance Training

■ Compliance 101

■ Compliance, Conscience,

and Conduct™, a video-based

training program

■ Privacy Matters,

A video-based HIPAA

Training Program

■ Corporate Compliance &

Ethics: Guidance for

Engaging Your Board

Volume 1: The Board’s

Perspective ■

WEBLINKSWEBLINKS

INSIDEOn the CalendarWeblinksAnti-Kickback Statuterejected in Federal CourtInvesting in complianceMiddle management &complianceThe slippery slope of healthindustry fraudMeet Becky SutherlandCornettCEO’s letterClinical trials: A compliance primer forphysician practices

334

79

12

14

1820

INSIDE

4August 2005

Health Care Compliance Association • 888-580-8373 • www.hcca-info.org

Editor's note: Gabriel L. Imperato is

the Managing Partner of the Fort

Lauderdale office of Broad and

Cassel. He is certified as a specialist

in health law and was admitted to

the Florida Bar in 1977. Mr.

Imperato represents individuals and

organizations accused of criminal or

civil health care fraud and handles

compliance matters for health care

organizations. He can be reached by

calling 954/745-5223 or by email at

[email protected].

he recent acquittal of eight

sales representatives for a

large pharmaceutical manu-

facturer has thrown into doubt whether

the Federal Anti-Kickback Statute's pro-

hibition against providing trips and gifts

to physicians who may prescribe a phar-

maceutical company's products is an

appropriate application of the law. The

irony of this acquittal is that the compa-

ny itself, TAP Pharmaceutical Products,

Inc. (TAP or the Company), in 2001,

agreed to pay $875 million dollars to

settle criminal and civil charges that it

inflated prices and bribed doctors to

prescribe its top selling prostate cancer

drug, Lupron. The Company agreed to

plea to a criminal conspiracy to violate

the Prescription Drug Marketing Act

(PDMA), based on the very same prac-

tices that its sales personnel were acquit-

ted of after this recent Federal trial

against the individual defendants who

allegedly participated in these activities.

The criminal indictment against the

Company named six marketing repre-

sentatives of the drug company and one

physician/urologist. This criminal indict-

ment came after four other physicians

around the country had already pled

guilty (but were not adjudicated guilty)

to criminal charges involving their pay-

ment relationships with TAP. These

cases involved the misconduct of the

pharmaceutical manufacturer, but also

the willingness of physicians to witting-

ly or unwittingly receive remuneration

in return for the ordering of the specific

drug (Lupron) manufactured by TAP.

The Medicare program has generally not

paid for prescription drugs for Medicare

beneficiaries, unless it must be injected

under the supervision of a physician.

The prostate cancer drugs, Lupron and

Zoledex, are administered to patients

under the supervision of physicians.

Under these circumstances and during

the time period in question, Medicare

paid for eighty percent (80%) of the

urologist's charge for Lupron, or the

average wholesale price (AWP) reported

by the pharmaceutical company. The

government alleged, in the case against

the Company, that the AWP reported by

TAP was significantly higher than the

average sales price (ASP), which TAP

offered to its affiliated physicians and

other customers for Lupron.

The government's complaint against TAP

further alleged that it marketed the

spread between its discounted prices

paid by physicians and the significantly

higher Medicare reimbursement based

on the AWP as an inducement to physi-

cians to order Lupron for their patients.

The government further alleged that TAP

also concealed the true discounted prices

paid by physicians from the Medicare

Program and falsely advised physicians

to report the higher AWP, rather than

their real discounted price for the drug.

This opportunity to bill the Medicare

Program an amount greater than the

price actually paid by physicians and the

opportunity to obtain reimbursement

revenue because of this price spread was

alleged to be an item of value in return

for ordering the specific drug Lupron (as

opposed to any of its competitor drug

products, such as Zoledex).

The case also identified other practices,

which the government characterized as

inducements to physicians, which violat-

ed the Federal Anti-Kickback Statute,

such as free products (including free

By Gabriel L. Imperato

T

Continued on page 6

GA

BR

IEL

L.IM

PE

RAT

O

HCCA Audio ConferencesJoin us for the following

HCCA Audio Conferences are a fast and easy way to aquire HCCB CEUs!

Get the latest “how-to” information–tools and advice you can use daily without even leaving your office! Register on theHCCA Website–www.hcca-info.org. You will receive an email afew days before the conference with any conference handouts,and dial-in information and instructions.

➤ ➤ Enterprise Compliance: How to Ensure Quality Careand Reduce Risk throughout Your OrganizationSpeakers: D. Scott Jones, CHC and Cathy Boerner, JDJuly 27, 2005

➤ ➤ Compliance Assessments: How to Ensure ComplianceProgram EffectivenessSpeakers: Lisa Eggleston, CHC, Cathy Boerner, JD, andD. Scott Jones, CHCJuly 28, 2005

➤ ➤ Compliance Program 'Month End' Strategies forOrganizational AccountabilitySpeakers: John Steiner, Jr., Esq., CHC and EmmaWollschlager, MHAAugust 17, 2005

➤ ➤ Quality of Care Issues and How They Are Perceived bythe EnforcersSpeakers: Sheryl Vacca, CHC and Dr. StephenMorrealeAugust 18, 2005

➤ ➤ HCCA-AHIA Auditing and Monitoring Focus GroupSpeakers: Debi Weatherford, Kathleen Thomas, GlenMueller and Randall BrownAugust 23 and 30, 2005

➤ ➤ HCCA/HFMA Revenue Cycle and Compliance:Where do they begin and end?" September 14, 2005

➤ ➤ Auditing Your AuditSpeaker: Theresa BivensSeptember 21, 2005

*Audio CDs are available for all past audio conferences.

Health Care Compliance Association • 888-580-8373 • www.hcca-info.org 5

6August 2005


samples of Lupron which the physicians

could dispense and then also bill to the

Medicare Program); free consulting serv-

ices; trips to expensive golf and ski

resorts; money disguised as "educational

grants, but which were, in fact, intend-

ed to be used for any purpose, includ-

ing, but not limited to, parties, medical

equipment, travel expenses for urolo-

gists and their staff; and discounts on

Lupron sold to treat endometriosis in

women to effect a lower price on

Lupron used in the treatment of men

with prostate cancer.

The case against the Company was orig-

inally brought by a whistleblower, who

was a marketing and sales representa-

tive of TAP, because of his concerns

about the illegal marketing activities by

TAP and its employees. There was also

a cooperating witness, who was a

physician for a university medical plan,

who was offered an "educational grant"

if he would reverse a decision made on

behalf of the university health plan to

use only the less expensive drug

Zoledex, instead of Lupron, for prostate

cancer patients.

The Federal prosecutors, in the recent

kickback case against the individual

defendants, accused the employees of

"marketing the spread" between the

Company's discounted prices actually

paid by physicians for Lupron and the

higher Medicare reimbursement rate; of

concealing the discount to physicians by

advising the physicians to report the

higher AWP, rather than the actual sales

price to physicians; and of offering inflat-

ed consulting fees, resort trips under the

guise of continuing education, and "edu-

cational grants", along with free drug

samples, in exchange for physicians'

agreements to prescribe its prostate can-

cer drug, Lupron, instead of a competi-

tor's product. The basic defense in the

case was that the sales employees

offered drug samples to promote the

drugs and other practices that were legal

and standard in the industry for promot-

ing the sales of new pharmaceuticals.

The judge and the jury apparently

agreed and acquitted all of the parties.

There were other aspects of this prose-

cution which are noteworthy for future

cases involving the application of the

Federal Anti-Kickback Statute:

1. A sales manager was acquitted by the

court (before the case went to the

jury) because an "educational grant"

provided to a health maintenance

organization (HMO) was determined

to be a payment made pursuant to a

"written agreement" to an HMO (and

not a physician) and, therefore, was

within the "managed care" safe har-

bor provision for discount arrange-

ments with managed care organiza-

tions and, therefore, did not violate

the Federal Anti-Kickback Statute.

2. The defense position in the trial, that

many of the practices of the sales

managers were "standard in the indus-

try", was apparently convincing

enough for the jury in this case and

perhaps even the Judge. Accordingly,

the defense that "everybody was doing

it" is not quite dead yet, despite the

views of many Federal prosecutors.

3. There was sufficient evidence of

record that the facts did not necessar-

ily bear out true violations of the

Federal Anti-Kickback Statute and

that the government's case was more

dependent on a theory of the appli-

cation of law than what the proven

facts would have supported in the

case. This may suggest that aggres-

sive criminal prosecution in the

health care fraud area should be

undertaken more carefully and with

more sufficient and thorough consid-

eration of alternative civil and admin-

istrative remedies.

4. An organization which agrees to

plead guilty to a criminal charge and

to civil damages and penalties, based

on evidence which the government

may not be able to successfully

prove at trial, does so at the risk of

encouraging the government to

become more aggressive and careless

in future prosecutions.

This case may not be reflective of the

Department of Justice's nationwide

approach with respect to health care

fraud prosecutions, but it does, at least,

send a signal that cases involving an

individual's freedom should be investi-

gated and prosecuted more carefully,

especially when considering novel

applications of a well documented

ambiguous statute. Nevertheless, the set-

tlement of criminal and civil fraud

charges against TAP, in connection with

fraudulent drug pricing and marketing

conduct related to the sale of Lupron,

should send a clear signal to business

organizations, with relationships with

health care professionals and physi-

cians, to be especially careful in their

payment and referral relationships.

The moral of the story for physicians, as

well as marketing and sales representa-

tives of health care companies, is that

these types of arrangements can, and

will, be the subject of whistleblower

complaints and criminal and civil fraud

investigations by Federal and state gov-

violations of Anti-Kickback ...continued from page 4

Continued on page 11

Editor's note: Steve Lefar is President

of MediRegs, Inc. He may be reached

by email at 800/808- 6800 x 4.

he primary mission of every

health care organization is to

provide high-quality, cost-

effective services to patients, families,

members, clinicians and communities. To

accomplish this mission, many organiza-

tions view regulatory compliance as a

necessary evil imposed on them by fed-

eral and state governments. Most organi-

zations operate with high integrity and

some, perhaps, may view their compli-

ance obligations as a burden that they

must bear in order to protect the world

against a few bad apples. Stress imposed

by today's regulatory environment tends

to promote a "comply-or-see yourselves-

on-the-evening-news" mentality. And this,

in turn, may fuel resentment among sen-

ior leaders who regard compliance as an

obligation rather than a valuable asset.

Nevertheless, the OIG and the

Department of Justice expect health care

organizations to maintain compliance

programs, and recent changes to the fed-

eral sentencing guidelines reinforce that

requirement. Therefore, the quality of an

organization's compliance program can

make the difference between a mistake

and reckless disregard, which could lead

to massive fines and even criminal prose-

cution. With Medicare and Medicaid pro-

grams in difficult financial straits, govern-

mental scrutiny will not abate. Whether

or not such scrutiny is justifiable, it is

here to stay, and there is simply no hid-

ing from it.

The state of health care compliance Compliance programs in health care

have evolved in response to develop-

ments in the OIG's Compliance Program

Guidance, federal sentencing guidelines,

and certain financial-control elements of

the Sarbanes-Oxley Act. Most compliance

programs consist of seven elements:

■ high-level oversight

■ written standards of conduct,

policies, and procedures

■ education and training

■ auditing and monitoring

■ a communication process

■ a disciplinary process

■ a process for responding to detected

offenses

Furthermore, federal sentencing guide-

lines now recommend implementation

of annual risk assessments that cover all

areas of the organization. All this, in

combination with the thousands of new

regulations issued each year, means that

without extraordinarily effective tools,

there is no way even a large compli-

ance team can focus on effecting

change, conducting oversight activities

and keeping up to date.

Making matters worse, compliance offi-

cers have constructed their own regula-

tory compendia of conflicting govern-

ment transmittals, newsletters, and

guides. These same compliance officers

also rely on costly outside resources

and homegrown tools. These resources

do help and could be considered valu-

able, but they are not enough for the

day-to-day management of the compli-

ance program; and they certainly do not

integrate comprehension, experience,

and knowledge into the daily process.

The emergence of evidence-basedcomplianceThe world of compliance, however, is

changing. Yes, there are those who

believe that ignorance is bliss and that

compliance for external and internal

"optics" is a viable strategy. Even in the

current environment, there are some -

and this is rare - who absolutely believe

that their biggest risk is to build a pro-

gram and find things that they would

rather not uncover as if somehow that

provides protection.

Rather, it appears that most manage-

ment teams are embracing compliance

as they have Six Sigma quality method-

ologies. They are discovering that com-

pliance is good for operational out-

comes and, furthermore, consistent and

institutionalized compliance has a posi-

tive impact on business processes,

accountability, governance, and the bot-

tom line. And in the event of a mistak—

or worse yet, a bad apple—a well-

developed compliance program enables

the organization, along with its manage-

ment team and board, to withstand the

7August 2005


Continued on page 8

By Steve Lefar

T

STE

VE

LE

FAR

8 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org

heat of an investigation.

In today's ever-changing regulatory envi-

ronment, however, an effective compli-

ance solution means a system within

which regulations and business process-

es are integrated with risk assessment,

management, and tracking tools to drive

evidence-based compliance.

Modeled on evidence-based medicine,

evidence-based compliance integrates

regulations, generally accepted business

practices, organizational wisdom, and

process management software to deliver

a best-practice model for compliance. It

embeds compliance into daily practice,

providing the management team and

board with a black-and-white picture

that clearly delineates the status of com-

pliance within the organization. Most

importantly, with evidence-based com-

pliance programs, compliance becomes

part of the culture.

Independent of the systems or mecha-

nisms that are deployed to manage a

compliance program, there are a number

of elements that make it evidence-based.

■ The program must be designed to

involve all areas of the organization

at the department, topic, and process

levels.

■ Risk assessment tools and questions

are clearly and directly linked to the

specific regulatory citations or source

material from which the questions

are derived. This demonstrates the

basis and the necessity of managing

the risk area.

■ Work plans are driven specifically

from the risk assessment. The OIG

work plan varies from year to year

and suggests areas of focus; it does

not, however, cover all aspects of the

regulations and issues with which

organizations are supposed to com-

ply or should monitor.

■ Compliance plans should be pushed

into the daily workflow through e-

mail reminders, task management

tools and reporting.

■ Communications management and

tracking tools such as hotlines, letters,

phone calls, and conversations are inte-

grated into tools for education tracking,

disciplinary action management and

auditing for a closed-loop system.

■ Billing and reimbursement compliance

tools, such as tracking Fiscal

Intermediary correspondence, and

integrated coding tools such as

eCodebooks, pricing calculators,

LCDs/NCDs, fee schedules, crosswalks

and similar capabilities, are in place.

■ Regulatory, reimbursement, and

legal-content databases and tools are

integrated with the compliance plat-

form to support daily alerts, accurate

billing, auditing, and oversight of the

program.

■ A maintainable, repeatable and inter-

nally located (not necessarily devel-

oped or owned) technology platform

that maintains attorney-client privi-

lege where invoked, and ensures

software access over the long term.

An evidence-based compliance program

can improve processes, reduce risk, and

improve the bottom line of any organi-

zation.

The value of an evidence-based com-pliance programThere are many ways to build a pro-

gram and there are a variety of models

ranging from 100% homegrown to

licensed software, rented software, con-

sultants, lawyers and anything in

between. All are valid approaches.

Regardless of how you get there, the

value of evidence-based compliance is

real and delivers a compelling return on

investment. Other tangible benefits

include the following:

■ Increased employees' productivity

■ Streamlined external review costs

■ Reduction in risk through a more

comprehensive risk assessment

■ Quantifiable compliance improve-

ment plan for your board

■ Institutionalized compliance plans,

documents, communications, audits,

education, and FI communications

■ Faster regulatory and reimbursement

research time

August 2005

investing in compliance...continued from page 7

Automate Risk Assessments and Compliance Work Plan

Board Insight

Enterprise Engagement

Education Management

Communications Management

Email Reminders

Secure Paper Trai

Automated Updates

Personalized Alerts

Comprehensive Research Tools

Improved Workflow

Enterprise Oversight

Customized Reports

Local Software Control

WorkflowSoftware

Evidence-Based

Compliance

YourTeam's

Expertise

Federaland StateRules and

RegulationsFully Integrated

Audit and Investigations

Agency Interaction

Evidence compliance model


Figure 1

Editor's note: Eric W. Klavetter is

Compliance & Privacy Officer with

the Mayo Clinic, Office of

Compliance, in Rochester, MN. He

may be reached by telephone at

507/266-0195.

Adam T. Brase is a Communication

Consultant for Mayo Clinic in

Rochester. He may be reached by

telephone at 507/266-2641.

he "tone at the top" is often a

concept that gets a great deal

of attention when implement-

ing new initiatives within organizations.

However, it is often more important to

monitor the tone "in the middle." In

terms of compliance, one essential

group whom compliance professionals

must engage is middle management. By

observing the traits of middle managers

in an organization, compliance profes-

sionals can anticipate obstacles to

implementation and plan accordingly

when implementing new initiatives.

As professionals, we shouldn't forget to

monitor the tone at the top, comprised

of our board and c-level professionals

(CEO, COO, CFO, etc), but we should

learn to focus on a second population

that is often unassessed, and is often at

the center of compliance issues. This

"hub" directs and manages any imple-

mentation strategy. They interpret the

tone at the top and work to direct imple-

mentation of that tone. Middle managers

can be that neglected compliance hub.

The thrust behind this group is often

difficult to define, but presents an enor-

mous opportunity. Middle management

is often "caught in the middle" while

trying to "get things done" with incom-

plete facts, and trying to maintain their

integrity at the same time.

In order for compliance professionals to

develop and maintain effective pro-

grams, they need to understand and col-

laborate with the middle manager. One

approach for the compliance profession-

al is to define the attitude and aptitude

(profile) of their institution's middle

management. Specifically, are they coop-

erators, free-riders, or reciprocators?

The science of complianceIn a recent publication by Robert

Kurzban and Daniel Houser called

"Experiments Investigating Cooperative

Types in Humans," the two studied a

number of participants who played a

"public-good game," involving four par-

ticipants who had never met and inter-

acted via computer.

They were given tokens and could

invest to benefit themselves or the

group as a whole. Each player was

given a choice of investing all or none

of their tokens. If they invested on

behalf of the group, the pool was dou-

bled and dispersed equally. If they kept

their tokens, the amount was not

changed. Simply put, the more every-

one put together, the more the group

had to gain. At the conclusion of the

study, they devided the participant's

behavior into the following groups:

1) Cooperators - those who contribute

to generating groups benefits at a

potential cost to themselves

2) Free-riders - those who contribute to

generating group benefits but are

unwilling to incur any cost to them-

selves

3) Reciprocators - those who respond to

others' behavior by using a condi-

tional strategy (i.e. wait and see how

much you put in before I risk any-

thing)

This classification had also been studied

by social psychologists and economists

and is cross-walked in Figure 1 below

to show how other areas of study are

assessing this same topic.

But there is a fourth biological group

called the "floater," which has not been

studied or well-defined. This proposed

fourth category would be a potential

mixture of all three, depending on the

issue and/or topic. For example, when

9August 2005


By Eric W. Klavetter and Adam T. Brase

T

Biology Social Psychology Economics

Cooperative Cooperators Altruistic

Free Riders Competitors Spiteful

Cat

ego

ry

Reciprocators Individualistic Payoff -maximizing

Field of Study

Figure 1

asked to volunteer for the community,

the manager may exhibit an altruistic,

cooperative nature, but when asked to

change a process that will lessen the

revenue of their department; they may

become competitive and spiteful.

Depending on the issue, their "profile

may float" from one style to another.

In their study, Kurzban & Houser noted

that when reciprocators are paired with a

cooperator, the group can expect to earn

40% more than if the reciprocators are

paired with a free-rider. This doesn't mean

that free-riders do not add value, but it

does point out that the "tone of the team"

is vital to determine the team's effective-

ness. The challenge for compliance pro-

fessionals, when managing expectations

and mitigating risk, is to determine into

which category the middle manager they

are collaborating with falls.

To begin to define the "Middle

Management Profile" we can ask:

■ How do middle managers allocate

resources for compliance issues?

■ How do middle managers engage

when a compliance issue is identified

in their line of business?

■ Are middle managers rewarded for

resolving compliance issues?

■ Have they been promoted when they

find revenue opportunities?

■ How do they communicate compli-

ance risks to their staff?

■ To their leadership?

Once the compliance professional starts

answering these questions and estab-

lishes a Middle Management Profile, the

rules of engagement become clearer.

These questions allow us to answer

"how" middle managers participate.

The reality of complianceAs we work through the above exer-

cise, middle managers can be defined

as cooperators, free-riders and/or recip-

rocators. This analysis can be invaluable

when facilitating or coordinating issues.

In order to increase odds of success

dealing with the issue, compliance pro-

fessionals need to understand the

dynamics and effectiveness of the team

in order to properly manage outcomes

and expectations.

To truly manage compliance, under-

standing middle management will

empower compliance professionals to

understand the "economics of sharing"

within their organization. Kurzban &

Houser focused on why people engage

in an exercise that will benefit the

group and themselves. Mr. Yochai

Benkler in the Yale Law Journal

focused on a different set of attributes

that affect information sharing.

The example repeatedly cited by Mr.

Benkler to illustrate this concept was

"open source" software, where the soft-

ware code is not owned by anyone but

can be improved, utilized, and distrib-

uted by anyone. By being available to

everyone, the quality improves and the

cost is decreased. Some reasons why

"open source" has been successful is the

ability of the contributing person to

increase "one's prestige," gain experi-

ence, or have fun. Mr. Benkler notes

that outside "open source" software is

the exception, while the norm is that

most people would rather improve an

existing process than develop one.

ConclusionSo how does "Economics of Sharing" or

"open source" software impact compli-

ance? Understanding why people engage

and not how they engage is just as

important. While middle managers might

be cooperators (how), they may do it

out of fear of non-compliance (why).

They may free-ride (how) because they

have very little expertise in the area

(why). They may reciprocate (how)

because they want to be recognized for

their contribution to the organization.

In a recent article in Strategic Finance,

titled, "Self-Interest vs. Concern for Others,"

Michal Shaub, Frank Collins, Oscar

Holzman and Suzanne Lowenhn provide a

few suggested questions that might help

you assess the "why?" profile of the middle

management at your institution:

1) Will they do whatever it takes to

enhance their:

a. Job security?

b. Reputation with their Leadership?

c. Promotion potential?

d. Pay?

2) Do they value the relationship with

other patients, peers and subordi-

nates?

3) Are they sensitive to the pain and

suffering of their patients, peers and

subordinates?

4) Do they listen closely when interacting

with patients, peers and subordinates?

5) Do they openly share thoughts, ideas

and information with peers and sub-

ordinates?

6) Do they routinely tell the truth?

7) Do they routinely "spin the story" to

patients, peers and subordinates?

By answering both sets of the above

questions, we can understand the how

and why of the middle manager profile,

meaning compliance professionals are

able to better manage risk, outcomes

and expectations. ■

10August 2005


■ Enterprise-wide access to appropriate

resources

■ Access to updates that can impact your

reimbursement levels

■ Instant notification of compliances that require

immediate attention

■ Optimization of reimbursement and related

processes

ConclusionEvidence-based compliance, which is emerging as a

best practice for compliance programs, does more than

provide a protective paper trail. It gives companies and

their officers the tools and processes for creating a cul-

ture of compliance. Rather than making do with a vari-

ety of mismatched and costly resources, companies

can streamline day-to-day management and safeguard

their compliance program from future risk.

Just as evidence-based medicine brought a system of

checks and balances to the health care field and

gave providers a system upon which they can make

effective decisions, evidence-based compliance can

do the same for health care companies looking to

take the guesswork out of compliance. ■

ernments. Accordingly, it is recommended that par-

ties review their payment and referral relationships

with any health care organization and engage in

such conduct only after competent advice and assur-

ances that it will be free from this risk of liability. ■

violations of Anti-Kickback

...continued from page 6

investing in compliance

...continued from page 8

11August 2005

Health Care Compliance Association • www.hcca-info.org

CERTIF IED INHEALTHCARECOMPLIANCECHCCHC

The Healthcare Compliance Certification

Board (HCCB) compliance certification

examination is available in all 50 States.

Join your peers and become Certified in

Healthcare Compliance (CHC).

CHC certification benefits:

■ Enhances the credibility of the com-

pliance practitioner

■ Enhances the credibility of the com-

pliance programs staffed by these

certified professionals

■ Assures that each certified compli-

ance practitioner has the broad

knowledge base necessary to per-

form the compliance function

■ Establishes professional standards

and status for compliance professionals

■ Facilitates compliance work for compliance practitioners in dealing

with other professionals in the industry, such as physicians and

attorneys

■ Demonstrates the hard work and dedication necessary to perform

the compliance task

CHC Certification, developed and managed by HCCB, became avail-

able June 26, 2000. Since that time, hundreds of your colleagues have

become Certified in Healthcare Compliance. Linda Wolverton, CHC,

Director, Compliance, Triad Hospitals, Inc. says that she sought CHC

Certification because “...many knowledgeable people work in compli-

ance, and I wanted my peers to recognize me as ‘one of their own’”.

With certification she is “recognized as having taken the profession

seriously, having met the national professional standard.”

For more information on how you can become CHC Certified,

please call 888/580-8373, email [email protected], or visit the HCCA

Website: http://www.hcca-

info.org/Template.cfm?section=HCCB_Certification

The Compliance Professional’s Certification

Congratulations on achieving CHC status! The Health care

Compliance Certification Boardannounces that the following

individuals have recently successfully completed the

Certified in HealthcareCompliance (CHC) examination,

earning CHC designation:

Donna Bernardi

Susan Clark

John Landreth

Kenneth Nunez

Monica Sattler

Joan Taylor

HCCA's Compliance TodayThe Health Care Compliance Association (HCCA)

is seeking authors for upcoming issues of

Compliance Today. We welcome all who wish to

propose health care compliance-related topics and

write articles.

Anyone interested in submitting an article for pub-

lication in Compliance Today should send an

email to [email protected]

12August 2005


Editor's note: David S. Barmak, the

principal of a law office in Skillman,

is a transactional and litigation

lawyer who exclusively represents

health-related companies, including

physician practice groups, skilled

nursing homes, outpatient rehabili-

tation clinics, home health care

agencies and medical equipment

distributors. He is on the board of

directors of the NJSBA Health and

Hospital Section, is an associate

member on the executive board for

the Health Care Association of New

Jersey, and he is a member of HCCA.

Reprinted with the permission of New

Jersey Lawyer ©, February 21, 2005

e hear so much about

what constitutes health

care fraud: false billing,

upcoding, unbundling, kickbacks, self-

referrals, substandard care, etc.

How does fraud begin? What is its origin?

Do we really have an industry of greedy

professionals as the media would have us

believe? Do we really have an industry

comprised of dishonest human beings or

of uninformed health care practitioners

making choices considered fraudulent? To

hear the media speak of it, the entire

health care industry is corrupt, just wait-

ing for opportunities to rip off the system.

Does the public think health care practi-

tioners are spending time and money

with their lawyers, dreaming up new

ways to maneuver around fraud and

abuse laws and regulations, in an effort to

maintain high profit margins? I think not.

True fraud, as distinguished from acci-

dental mistakes, starts and grows within

a particular type of corporate environ-

ment—one that can be found through-

out the health provider field: physician

office, long-term care nursing facility,

sub-acute facility, hospital, home health

care agency, surgicenter, out-patient

rehab facility, etc.

Let's illustrate with a long-term care nurs-

ing facility in New Jersey. This particular

home has successfully and quickly grown

into diversified areas, including sub-acute

and outpatient rehabilitation. All this was

initiated and neared completion under the

old Medicare cost-based reimbursement

system. Everything has been going great;

this nursing home even has a history of

state Department of Health deficiency-free

surveys for two consecutive years. There

is, however, a problem. The Balanced

Budget Act of 1997 is law, and this nurs-

ing home is faced with severe cutbacks

based on the prospective payment system

(PPS). Ill-prepared for this, the administra-

tor begins to worry about the impact PPS

- coupled with Medicaid cutbacks - will

have on cash flow and continued diversi-

fication projects. The administrator, how-

ever, has difficulty explaining these con-

cerns to the board of directors, comprised

primarily of owners familiar neither with

the industry nor its day-to-day operations.

As a result, there's a mismatch of expec-

tations. The board continues to expect

growth and positive cash flow. The

administrator, however, sees those are

not likely to continue, at least for a few

years. For the first time in years, the

administrator is facing the real possibili-

ty of failing to meet board expectations.

To make matters worse, the directors

have clearly communicated to the

administrator that its expectations must

be realized—Or else!

Experienced health care administrators

would recognize that this nursing home

must suck in its breath, tighten its belt,

dig into cash reserves and expand its rev-

enue source to include managed care

payers. Experienced administrators would

anticipate that Congress's initial overreac-

tion in the Balanced Budget Act would

be met a year or two down the road by

a second overreaction, but in the oppo-

site direction in the form of relief, which

is exactly what has happened. But this

nursing home doesn't have an experi-

enced administrator. She's terrified she

won't be able to meet her directors'

expectations. In fact, the board is pressur-

ing her even harder to grow revenues,

add a new wing and increase cash flow.

The administrator worries about failing.

We now have a corporate environment

that includes intense pressure, aggressive

growth targets, and a clear message that

those targets must be reached. The

administrator realizes the targets won't

be reached—no way, no how. Medicare

reimbursement simply won't be there, at

least over the next few years. Added

competition from assisted-living facilities

has increased the difficulty in filling beds

and admitting sicker patients who cost

more to care for. Staff already has been

reduced as much as possible. Group

purchasing opportunities, too, have been

maximized. What else can be done?

The choices

By David S. Barmak, Esq.

W

Health Care Compliance Association • 888-580-8373 • www.hcca-info.orgAugust 2005

13

The administrator has two choices. The

first choice is to notify the board that

she anticipates failing to achieve its

goals. This is, of course, totally unpalat-

able, especially after the success she's

enjoyed. The other alternative is to

fudge the financials just a bit to make it

look like-for this financial quarter only-

the home will meet its goals. She

chooses the latter option.

But how does she do this? She decides to

meet with her rehab director to ensure

that the resource utilization groups

(RUGs) categories are being maximized

for billing purposes. After all, doesn't the

nursing home have a new group of ther-

apists? The previous therapists who had

worked for a national company were not

rehired when their employer was fired

last year. PPS had certainly brought about

a lot of changes. Perhaps these new ther-

apists, many of whom are recent gradu-

ates, aren't really skillful enough in maxi-

mizing legitimate opportunities to bill

through the RUGs program. The rehab

director gets the message loud and clear:

If in doubt, record the patient in the

higher RUGs category. We'll work out the

supporting documentation later, if neces-

sary. This seems to work. Invoices show

increased charges, and the nursing home

population, when looked at from a RUGs

category perspective, appears to be get-

ting the amount of therapy it deserves.

The administrator is pleased because the

board is pleased.

This approach appears to work for the

first quarter. In fact, what started as a

strategy for one quarter has spread into

the second and third quarters. The

administrator found it difficult to rescind

her directive to the rehab director once

the increased revenues begin arriving.

The administrator also thought the other

strategies, including increasing revenue

from managed-care payers, would have

worked by now. The other strategies

have not worked. Unfortunately,

because of PPS - something beyond the

administrator's control - cash flow con-

tinues to weaken, albeit at a slower rate

had the administrator not taken her

extraordinary steps. So, despite increas-

es in RUGS categories, PPS continues to

have its effect. But now, not only is

there the anticipated decreased cash

flow, there also is a new problem in

having inappropriately increased the

RUGS categories.

Problems compound The administrator begins to worry. How

likely is it that OIG will knock on the

door during this, the fourth quarter? Or

ever, for that matter? She did hear, how-

ever, that a nursing home in North Jersey

was recently visited by OIG and the

investigation wasn't pretty. Nevertheless,

she decides her more immediate concern

is meeting the board's expectations. But

revenues continue to drop despite her

best efforts and, as she now admits to

herself, her unlawful strategy of increas-

ing RUGS categories.

The administrator further becomes

alarmed by her suspicion that the thera-

pists have stopped struggling with the

question of what is the proper RUGS cate-

gory to use, and instead, are automatically

upgrading them one full classification.

Now, nearly one year after the adminis-

trator began to fudge the financials just a

bit, she's panicking over facing continued

cash flow declines and possible patterns

of intentional misrepresentations in the

therapy department. To make matters

worse, outside accounting auditors are

due soon for the annual cost reports.

Surely they'll see what's happened. She

finds herself instructing the rehab director

to change patients' rehab records to sup-

port the higher RUGS categories. More

and more, the administrator feels as if

she's on a treadmill, having to run faster

and faster just to stay in place. What

started as just the administrator's efforts to

maximize billing during the first quarter

now includes fraudulent participation by

the rehab department and, unknowingly,

by the accounting department. The nurs-

ing facility is ripe for a qui tam (whistle-

blower) action to be filed or, with more

immediate and severe consequences, a

telephone call to be made directly by an

anxious employee to the OIG. Therapists

misrepresenting the proper RUGS cate-

gories and the rehab director all know

that they're doing something wrong.

They're anxious about the pressure

they're under to continue their patterns of

fraud, and yet, are even more anxious

about getting caught.

What began as a way to help the admin-

istrator and the nursing home has turned

into serious issues of potential civil and

criminal liability. Unfortunately, these

employees have now participated in

what will clearly be considered fraud.

They're in too far to extricate themselves.

Had a corporate compliance program

been in place, one of two elements

would have prevented, or at least limit-

ed, this fraudulent behavior: first, an

auditing system to review and compare

medical records and billing statements;

second, the availability of a corporate

compliance officer to whom these anx-

ious employees could turn regarding


14August 2005


Editor's note: This interview with

Becky Sutherland Cornett was con-

ducted in June by Julene Brown

CHC, HCCA Secretary and Billing

Compliance Manager for MeritCare

Health System. Becky may be

reached by telephone at 614/293-

5937 and by email at

[email protected]

JB: Becky, please tell me about your

background and the work that you do.

How did you get into Compliance?

BC: I have been a compliance pro-

fessional for over five years; after a

career in clinical practice, academia,

association management, and health

care operations management. During

my years of operations management at

The Ohio State University Medical

Center, I was fortunate to serve on sev-

eral special task forces (operations

improvement, re-engineering, etc.) and

was also a surveyor for CARF- The

Rehabilitation Accreditation

Commission. I had also been an assis-

tant director in health care financing

for the American Speech-Language-

Hearing Association in Rockville, MD

(DC area) in the 1980s. Further, my

Ph.D. coursework included a number of

courses in health policy, health care

financing, management, and health law.

These experiences helped shape my

interest in serving in a broader capacity.

Our administration had the foresight to

realize that our compliance administra-

tors (the chief medical officer and the

attorney who serves as compliance

director) needed someone with a clini-

cal background and operations manage-

ment experience, who could help make

compliance part of everyday life within

the organization. After joining the com-

pliance program, I attended the first-

ever HCCA Compliance Academy in

1999 and was among the first group to

earn the CHC in 2000.

As the operations person in the

compliance program, my role is to help

make regulations, standards, values and

principles "happen" in the organization.

We have an overall Integrity Program

Compliance Plan and three sub-plans

(clinical laboratories, medical informa-

tion management, and finance) to

implement. Our work must be integrat-

ed with clinical operations initiatives

and activities, the very strong safety,

quality, and performance program, and

internal audit efforts.

JB: What do you find most challeng-

ing about your job?

BC: We've been able to get most peo-

ple beyond the notion that compliance is

a necessary evil or a nuisance. Now, we

are challenged to demonstrate that "com-

pliance" is really a set of standards that

should provide an infrastructure for doing

business. More importantly, compliance

standards provide a guidepost for fulfill-

ing our mission. We have to keep that in

front of our administrators and staff mem-

bers. Compliance should be part of our

performance strategy.

JB: How do you keep yourself up-

to-date in the compliance field?

BC: Earning and maintaining the

Certified in Health Care Compliance

(CHC) designation has been a great way

to "keep up" with laws, regulations,

issues, and trends. In addition, prepar-

ing articles and presentations requires a

thorough knowledge of the topic area -

so my interest in publishing and pre-

senting forces me to focus intensively

on a variety of compliance issues.

JB: How is your compliance program

featureMeet Becky Cornett, Ph.D., CHC

Associate Compliance Director,The Ohio State University Medical Center

article

15August 2005


at Ohio State University Medical Center

organized?

BC: We have a Medical Center com-

pliance committee chaired by our chief

medical officer and associate vice presi-

dent, which regularly communicates

with the medical center's board. Our

compliance director is an attorney who

also has credentials in nursing and pro-

fessional coding. As associate compli-

ance director, I facilitate implementation

of components of the overall compli-

ance plan and program as well as sub-

committees and task forces. Business

unit leaders serve as compliance offi-

cers in their respective areas. We also

have compliance officers for health

information management, billing, and

clinical laboratories, and other liaisons

that address issues in various business

units (health system hospitals and

physician networks).

JB: In your opinion, what is the most

important part of a compliance pro-

gram?

BC: I don't think there is one "most

important" component; all of the ele-

ments work together to form a whole.

Certainly the importance of "tone at the

top" cannot be overstated - the chief

executive must set the expectation that

a culture of compliance and ethical

behavior is integral to achieving the

organization's mission and vision. One

of our medical center values is integrity,

so we continuously define, refine, and

keep that value in front of us everyday.

JB: How do you prioritize what is

most important in your work?

BC: The compliance director and I

work as a team to accomplish long-

and short-range objectives. We prioritize

in two ways: things that we can address

or "fix" immediately, and high-risk areas

or issues that will take a team effort

over the long-term. As we all know, the

best laid plans can be quickly dissolved

for a variety of reasons, but we try not

to let our goals get set aside by the

small concerns that can eat up one's

day quickly.

JB: How is your internal audit pro-

gram structured? Is it part of the compli-

ance program or separate?

BC: Internal Audit is a department of

The Ohio State University, that reports

to the senior vice-president for business

and finance. Their services include

auditing, surveying, liaison, special serv-

ices (e.g., investigations, department

reorganizations, IT systems consulting),

and internal controls consultation and

monitoring. IA audit reports go to the

university president, and the Board of

Trustees. IA has an audit unit assigned

to the medical center. We work closely

with our colleagues on a number of

projects related to the compliance hot-

line, the OIG's LEIE, and internal con-

trols issues. We exchange information

regularly to achieve mutual goals.

JB: Compliance and quality: do they

play a role together, or individually?

BC: I am a big advocate for integrat-

ing patient safety, quality manage-

ment/performance improvement, com-

pliance, and accreditation activities. I

don't think the oversight of these areas

can be separate anymore, particularly as

public reporting of specific quality indi-

cators have been linked with Medicare

payments and Quality Improvement

Organizations (QIO) have "beefed up"

the Hospital Payment Monitoring

Program (HPMP) with the Program for

Evaluating Payment Patterns Electronic

Report (PEPPER). PEPPER indicators are

based on clinical level of care, utiliza-

tion patterns, and coding integrity -

quality issues that have become compli-

ance issues. CMS is concerned about

the basis for payment - were the servic-

es clinically appropriate and document-

ed accurately?

I have made it a priority to work

with our quality and operations

improvement administrators and man-

agers on a variety of projects, including

co-authoring articles and presenting

together at conferences on issues such

as JCAHO [Joint Commission on

Accreditation of Healthcare

Organizations] tracer methodology,

quality initiatives and indicators, quality

as a compliance issue, and PEPPER.

However, the hospital industry, as

a whole, has a long way to go in inte-

grating accreditation, compliance, risk

management, and quality activities. We

still keep some things secret, duplicate

efforts, miss important information, and

even work at cross-purposes.

Professionals in these areas need to "get

over" concerns about "knowledge is

power," and competition. I think we

need to catch-up internally with the

movement toward public disclosure -

many people would not have thought

that hospital quality data would ever be

posted on a website such as Hospital

Compare. We used to hide that informa-

tion in notebooks that had to be turned

in at the end of meetings. Now, anyone

who accesses the website can compare

hospitals' ability to give something as

simple as an aspirin in the ED.

JB: How do you keep compliance

education/training interesting, motivat-

ing, and effective? Continued on page 16

16August 2005


BC: It's a tall order. One ongoing

program I'm proud of is our Patient

Care Compliance Forum (PCCF). The

PCCF is a monthly forum comprised of

administrators and directors of clinical

departments (nursing, rehabilitation

therapies, respiratory therapy, nutrition

services, pharmacy, clinical laboratories,

behavioral health, etc.). Our purpose is

to provide information and an opportu-

nity to discuss regulatory, legal, and

professional issues as they relate to clin-

ical practice. We have a presentation

and follow-up discussion that lasts one

hour. We've met since September 2000

and we're still going strong. Some of

the topics discussed include: business

ethics, patient safety, the clinician's role

in revenue cycle management, HIPAA,

JCAHO tracer methodology, discharge

planning and case management issues,

Hospital CAHPS, the Medicare Cost

Report, risk management trends, and

malpractice litigation. This type of

forum, although labor-intensive, is a

great way to keep compliance and relat-

ed issues in front of operations person-

nel in a familiar format that helps them

in "everyday life."

JB: What do you consider important

information to give to the board of

directors?

BC: Compliance officers are experi-

encing pressure for increased accounta-

bility as corporate boards across the

United States are going through their

own trial by fire in the wake of the epi-

demic of corporate scandals. We need

to think beyond giving "information" to

the board, and form a triumvirate rela-

tionship among the board, the chief

compliance officer, and the organiza-

tion's executives. Gary Thompson, JD,

wrote one of the best articles I've found

on this topic for the Bureau of National

Affairs (BNA) in the Prevention of

Corporate Liability Current Report

series. The title is "Multifaceted

Approach to Corporate Governance

Reform: The Role of Corporate

Compliance Programs & Officers" (vol.

11, No. 8, 9/15/03). Here's the conclud-

ing statement: "in the end, given that

ultimately her (the compliance officer's)

loyalty should lie with the corporate

entity and not the particular manage-

ment or board members of the organi-

zation, she can help keep both manage-

ment and the board honest with each

other regarding the status of corporate

governance reform measures, which in

and of itself is a critical component of

good corporate governance." So, our

role with the board must be multifac-

eted, not just presenting reports on the

traditional seven elements of a compli-

ance program. The compliance officer's

primary resource for developing our

relationship with the board is the docu-

ment Corporate Responsibility and

Corporate Compliance: A Resource for

Health Care Boards of Directors (DHHS

OIG and American Health Lawyers

Association, undated).

I also recommend that all compli-

ance officers read Hospital Governing

Boards and Quality of Care: A Call to

Responsibility (National Quality Forum,

2005)-access at www.qualityforum.org.

The Call contends that boards should:

take concrete steps to fulfill their role in

ensuring quality; enable effective evalu-

ation of their own role in enhancing

quality; develop "quality literacy"

regarding patient safety, clinical care,

and health care outcomes; and oversee

and be accountable for their institutions'

participation and performance in nation-

al quality measurement efforts and sub-

sequent quality improvement activities.

Quality has become a compliance issue.

We should be helping the board to

incorporate the traditional "compliance"

effort with the "quality" effort in overall

corporate oversight.

JB: You have written a number of

articles and presented frequently on rev-

enue cycle management and quality

improvement trends. Why do you think

these areas are so important and of

such interest to you?

BC: I think the two areas - revenue

cycle management and quality/safety

are key risk areas and key components

of hospital operations. It's important for

the compliance officer to understand

thoroughly what's going on in health

care operations for these reasons: to

know where the risks are, how to help

facilitate problem resolution; and how

to make compliance standards part of

infrastructure. I am much more credible

to operations management when I can

speak their language. I enjoy writing,

and I learn best by having to research

topics and tell somebody else about

them. Plus, it's kind of a hobby for me,

too. I am fascinated by this stuff,

strange as that may seem.

JB: What do you see in the future for

the compliance field?

BC: HCCA's broadening scope and

activities reflect the field as a whole.

The HCCA Key Priorities to "establish

and enhance compliance as a profes-

sion" "broaden the HCCA vision" and

"broaden and enhance external relation-

ships" are crucial to our future growth

and success as professionals. The term

"profession" gets overused (traditionally

the only true professions have been

medicine, law, and clergy). Compliance

Becky Sutherland Cornett

Health Care Compliance Association • 888-580-8373 • www.hcca-info.org 17August 2005

"professionals" have come from many

different fields and have largely learned

on-the-job or in continuing education

activities through HCCA and other

organizations. Now, a major university

offers a graduate certification program

in health care corporate compliance and

other formal academic programs are

evolving. We'll need to formalize our

knowledge bases and determine what

specific skill sets are needed for suc-

cessful compliance officers (we've

already read good articles on these top-

ics: see Effectively Managing

Compliance Requires 10 Key Traits by

A. Frink in JHCC, Sept./Oct., 2001; Roy

Snell's interview with Steve Ortquist -

How the Compliance Profession Has

Changed Since the Mid-90s in JHCC,

March/April 2005; and Compliance

Officer: Who Are You? By J. Passey in

Compliance Today, May 2005). Of

course, Sheryl Vacca was ahead of her

time when she said, "compliance offi-

cers need to be viewed as problem-

solvers, not whistleblowers" in The

Transitioning Role of the Compliance

Officer (JHCC, March/April 2000). There

are still probably too many compliance

officers who continue to be frustrated

FBI agents or U.S. Attorney "groupies"

instead of professionals who strive to

integrate compliance standards and ethi-

cal principles into an organization's

business culture and operation. I like

HCCA's vision statement: "the vision of

HCCA is to be the preeminent compli-

ance and ethics association promoting

lasting success and integrity of organiza-

tions worldwide." The key is promoting

the link between the organization's

integrity and its success as a business.

Health care compliance profession-

als are beginning to join forces with

compliance officers in other business

sectors. We know we can learn a great

deal from individuals who have been-

there-and done-that in energy, aero-

space, manufacturing, banking, and

other industries. Likewise, health care

quality professionals are learning from

quality managers in other businesses

particularly about safety management

and error reduction. We've found that

acceptable health care error rates are

way above those tolerated in other

industries.

We'll also likely be focusing a lot

more on compliance best practices - the

Health Ethics Trust (a division of the

Council of Ethical Organizations) has a

Best Compliance Practices Forum annu-

ally. Best practices topics and criteria

are developed, and individuals and

organizations can compete for awards

in those areas. Let's collaborate with

others to expand best practices topics,

criteria, and resources.

JB: What advice do you have for

other compliance professionals?

BC: Here's my list:

■ Don't assume anything.

■ Build strong working relationships

with operations management, but

remain objective and independent -

walk shoulder-to-shoulder, not arm-

in-arm.

■ Learn about the nooks and crannies

of the operation - there you will find

the most interesting problems.

■ Listen very carefully.

■ Be very accessible.

■ Provide accurate and timely informa-

tion; offer solutions and alternatives..

■ Learn all you can about finance and

revenue cycle management; accredi-

tation standards; quality improvement

and safety management; ethics; and

internal controls.

■ Don't agree with operations person-

nel that the regulations are "dumb,"

but we have to follow them anyway.

■ Know what you're talking about - all

you have is your credibility.

■ "Trust, but verify" (with apologies to

President Reagan). ■

Full Name:

Title:

Organization:

Address:

City/State/Zip:

Telephone:

Fax:

E-mail:

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18August 2005


The following excerpts were

taken from an article that I

discussed with Jim Sheehan,

DOJ, Eastern District of

Pennsylvania. Jim felt it was an interesting example of a com-

pliance problem. The text comes from a BNA [Bureau of

National Affairs] article. I have selected two pieces of the arti-

cle to make an observation.

"………Hospital denies any

intentional wrongdoing in

the disputed claims," …

said in a statement. "The

mistakes made were the

result of human error in a

complex billing system that

includes tens of thousands

of billing codes, with com-

plicated and ambiguous

guidelines."

From a legal perspective, denials must be important because

they are in most every settlement statement. However, I am

not so sure that denials help from a compliance perspective.

What message does it send to the staff? We always deny

wrongdoing. It's always someone else's fault. Part of the spirit

of compliance is facing up to your mistakes, as opposed to

denying and pointing fingers, intentional or not. I think the

word that helps make the denial have some degree of integri-

ty is "Intentional." I guess you can't argue with denying

"intentional wrongdoing" unless you have proof that the

problem was done intentionally. The article went on to

state…

“The same billing problems were discovered by

Pennsylvania officials in a Medicaid audit and were

called to the hospital's attention in 1993. This should

have alerted the hospital to the likelihood of similar fail-

ings in its Medicare billings for outpatient laboratory

services, the government alleged.”

I am not a big fan of spinning. I am passionate. I am enthusi-

astic. I probably spin a little now and then. But there is a

limit to how much I can do.

Where I draw the line is

when it involves serious

issues in which the spinning

could have negative side

effects or lack integrity. I

must admit that it is a judg-

ment call and is different for

everyone, but I feel good

about my approach. At the

end of the day, that's all you

have… your own judgement

and can you live with yourself?

Compliance is about finding and fixing problems. To get peo-

ple to fix problems, it helps a little if you admit you have a

problem. It seems to me, if we would just spin a little less,

we may get health care out of the enforcement communities’

bull’s-eye. My guess is that for every time we deny wrongdo-

ing, we get another week at the top of the investigatory

charts. Isn't that what we are ultimately shooting for? To get

healthcare out of the bulls eye?

By the way, I deny any wrongdoing with regard to the com-

ments made in this article. ■

Roy Snell

We deny anywrongdoing…

“Compliance is about finding

and fixing problems. To get

people to fix problems, it

helps a little if you admit you

have a problem.”

19Health Care Compliance Association • 888-580-8373 • www.hcca-info.orgAugust 2005

Share Compliance Documents With Other HCCA Members...

And win one of 12 Portable DVD PlayersCourtesy of:

Each time you add a compliance doc-ument to the HCCA Website you willhave an additional chance to win aPolaroid Portable DVD Player,* **courtesy of Brown

McCarroll L.L.P. Add 30documents and you will

have 30 chances to wineach month for a period of

12 months– November 2004 to October 2005. OnePortable DVD Player willbe given away eachmonth for 12 months.Any non-copyrightedcompliance document willcount; such as policies, proce-dures, forms, memos, presentations,educational tools, government documents,articles, white papers, or miscellaneousdocuments. Just visit eCommunities onthe HCCA Website:

www.hcca-info.org*No repeat winners.**HCCA staff members are not eligible.

Announcing

July’s winner:

TOBI TANZER

Editor's note: Gregg D. Reisman, Esq.

and Lara Jean Ancona are attorneys

in the New York Garfunkel, Wild &

Travis, P.C. Gregg may be reached

by telephone at 516/393-2294 or by

email [email protected] and

Lara may be reached by telephone at

516/393-2245 or by email

[email protected]

he conduct of human research,

including clinical trial research;

involving drugs, biologicals

and devices; requires an understanding

of, and compliance with, extensive and

complicated federal and state laws, rules,

and regulations. Traditionally, manufac-

turers have focused upon institutions,

such as community hospitals and aca-

demic medical centers, to act as the sites

for the conduct of their research. These

institutions typically have substantial

administrative infrastructure, often have

long standing experience in conducting

research, and many times even have their

own institutional review boards (IRB).

Therefore, these institutions are generally

well equipped to handle the significant

responsibility relating to the performance

of clinical trials. This is often not the case

for private practice physicians performing

research in their private offices.

Because manufacturers are increasingly

turning to physician offices as clinical

trial sites, more and more physicians,

who have little or no experience with

clinical trials, or who have historically

only acted as principal investigators

under the watchful guidance and over-

sight of a hospital, are now being faced

with significant responsibility for which

they may be unprepared. Physicians

should carefully consider the capabili-

ties of their office and their staff, and

the obligations created by performing

clinical research in their offices, prior to

agreeing to act as a clinical trial site.

Failure to properly conduct research in

compliance with the requirements of

the applicable laws, rules and regula-

tions, can result in serious conse-

quences, including placing patients at

risk, lawsuits, FDA enforcement actions

and even licensure issues. This article

will review certain of the considerations

and concerns relating to the responsibil-

ities of the physician conducting FDA

related research in his or her office.

Overview of research obligationsPrior to agreeing to perform human

research in his or her office, a physician

and the staff of the office should be

prepared to:

1. Adopt research policies and procedures;

2. Engage and communicate with an IRB;

3. Contract with a research sponsor;

4. Recruit subjects and obtain informed

consents;

5. Comply with Form 1572 and the

rules of Good Clinical Practice;

6. Comply with the applicable research

protocol and maintain research records;

7. Report adverse events and maintain

control of investigational drugs;

8. Train staff; and

9. Ensure that the human research is

conducted in compliance with all

applicable laws, rules and regulations,

including FDA regulations and HIPAA.

Policies and proceduresAll necessary research policies and pro-

cedures should be written, adopted and

implemented by the principal investiga-

tor and his or her office prior to con-

ducting human research. The policies

and procedures should address:

1. Compliance with the FDA and good

clinical practice rules;

2. The process for reviewing and evalu-

ating research protocols;

3. Relationship with an IRB, including

appointing officials to interact with

the IRB;

4. Creation of informed consent and

implementation of an informed con-

sent process;

5. Monitoring procedures to ensure that

the policies and procedures are fol-

lowed and oversight activities are

documented;

6. Reporting procedures for responding

to adverse events and non-compli-

ance and follow-up measures to deal

with such reports;

7. Procedures for maintenance of

research records;

8. Procedures to avoid the appearance

or existence of a conflict of interest;

9. Procedures for use, storage and over-

sight of research drugs; and

10.Internal audit or self-assessment pro-

cedures in connection with FDA

inspections or audits.

All research policies and procedures

should then be made available to the

personnel of the physician’s office who

are involved in conducting research,

and all staff involved in research should

20August 2005


By Gregg D. Reisman, Esq. and Lara Jean Ancona, Esq.

T

21August 2005


be required to comply with the policies

and procedures. The personnel involved

in performance of research must be

trained in the policies and procedures

for, and the process of, conducting

research at the physician office.

Institutional review boardWith few exceptions, all research must

be conducted under the oversight and

approval of an IRB. Traditionally, where

a physician conducts hospital based

research, the hospital’s IRB is used. The

principal investigator conducting human

research at his or her office is responsi-

ble for locating and engaging an appro-

priate IRB. If the principal investigator is

affiliated with a hospital, the hospital’s

IRB may be available. Hospital IRBs are

often amenable to reviewing human

research performed by members of the

hospital’s medical staff, even when the

research in not conducted at the hospi-

tal. If a hospital IRB is not available, the

principal investigator will have to

engage an independent or non-institu-

tional IRB. The process of engaging an

IRB often involves contracting with the

IRB and ensuring that the IRB is duly

constituted and capable of providing

review and continuing oversight of

research involving human subjects.

Once an IRB reviews and approves or

disapproves proposed research, it will

report such approval or disapproval to

the principal investigator. Such approval

will involve review of the protocol,

informed consent, HIPAA authorization,

investigator’s brochure, proof of qualifi-

cations of researcher, and proposed

advertising. Subsequently, the principal

investigator will be responsible for con-

tinuing communication with the IRB,

reporting protocol changes and obtain-

ing continuing IRB review of the

research (required not less than once

per year). The physician’s office is also

required to maintain adequate docu-

mentation of IRB activities, although

such documentation can be maintained

by the IRB on behalf of the physician’s

office. The documentation should

include copies of all research proposals

reviewed by the IRB, minutes of IRB

meetings, records of continuing review

activities, copies of all correspondence

between the IRB and investigators, and

statements of significant new findings

provided to research subjects.

Contracting with the sponsorA sponsor of research, such as a pharma-

ceutical company or device manufacturer,

will usually require the physician’s office

(and often the physician acting as principal

investigator for the research) to enter into a

“clinical trial agreement.” This Agreement is

a legal document which places responsibil-

ities for the research upon the physician’s

office (as the trial site) and the principal

investigator (in conducting the trial) and

the sponsor. The clinical trial agreement

will also address (i) indemnification, if any,

of the physician’s office and principal

investigator, in the event of subject’s injury

or death resulting from participation in the

research; (ii) the budget for the reimburse-

ment the physician will receive for con-

ducting the clinical trial; (iii) the reporting

requirements the physician must comply

with; (iv) insurance requirements; (v) qual-

ifications the investigators must meet; and

(vi) termination rights.

Overall, it is important that the physi-

cian review and understand this

Agreement before entering into it.

Generally, the sponsor will provide the

physician with a form of Agreement that

is beneficial to the sponsor. The physi-

cian may, therefore, find it necessary to

negotiate certain of the terms contained

in the Agreement and the budget

and/or obtain counsel to complete this

step in the process.

In negotiating this Agreement, the

physician (and/or his or her counsel)

must also ensure that neither the terms

of the Agreement, or the research

process, violates any federal or state

fraud or abuse statutes, regulations or

rules. The agreement must be for bona

fide research; the payments being made

by the sponsor must be fair market

value for the services rendered by the

principal investigator; and the payments

cannot be in exchange for referrals from

the principal investigator. A principal

investigator has to be particularly care-

ful in relation to these issues when

entering into agreements to conduct

post-marketing studies.

Informed consent and subject recruitmentOnce research is approved by the IRB

and a clinical trial agreement is execut-

ed, conduct of the research can begin.

Initially, the principal investigator will

need to recruit research subjects and

ensure such recruitment is conducted in

accordance with the requirements of the

FDA regulations and the regulations

under the Health Insurance Portability

and Accountability Act of 1996 and

related regulations (“HIPAA”). He or she

will also be responsible for ensuring

each research subject signs an appropri-

ate informed consent prior to any par-

ticipation in the clinical trial. Typically,

the sponsor will provide an informed

consent to be used. The IRB may

require modifications to the form pro-


22August 2005


vided by the sponsor.

The process of obtaining informed con-

sent from a research subject does not

only involve ensuring that the research

subject signs an IRB approved and appro-

priate informed consent. Rather, the

signed informed consent is considered

documented evidence of the entire

informed consent process, e.g., the

process of discussing the research with

the subject to educate them regarding

terms of the research and ensure that they

understand the research purpose, risks,

duration, procedures, alternatives and

benefits. It is important that the informed

consent form and the educational process

be done in a manner that is understand-

able to the subject, e.g., in layman terms.

Under the FDA regulations, both the

informed consent form and the informed

consent process must contain/involve

specific statements and discussions. There

are at least 13 points that must be

addressed in writing in the informed con-

sent form and the entire form should be

discussed with the subject during the

informed consent process. The principal

investigator should ensure that the

process is completed correctly and that all

subjects are given an opportunity to ask

questions before entering into the

research. The FDA website provides

access to the regulations governing

informed consent at http://www.access-

data.fda.gov/scripts/cdrh/cfdocs/cfcfr/C

FRSearch.cfm?CFRPart=50 and pro-

vides guidance regarding the informed

consent process at http://www.fda.gov/

oc/ohrt/irbs/informedconsent.html#model

In addition to the informed consent, the

principal investigator shall ensure that

each subject executes a HIPAA compliant

authorization. A sample authorization

form and further information regarding

this form can be obtained at http://priva-

cyruleandresearch.nih.gov/authorization.as

p. This form lets the research subject

know how his or her protected health

information will be used and disclosed

and the circumstances under which his or

her protected health information will

remain confidential and those under

which it will not.

Complying with Form 1572 and therules of good clinical practiceIn connection with FDA related

research, the principal investigator is

required to complete a Form 1572. By

signing this Form the principal investiga-

tor is agreeing, among other things to:

1. Conduct the study in accordance

with the applicable research protocol;

2. Personally conduct or supervise the

research;

3. Complete the informed consent process;

4. Report adverse events to the sponsor;

5. Read and understand the investigator

brochure;

6. Maintain adequate records;

7. Comply with FDA regulations and rules

and rules of good clinical practice;

8. Obtain IRB approval of the trial and

informed consent; and

9. Ensure that all other investigators are

informed of, and comply with, these

requirements.

A copy of the form can be obtained at:

www.fda.gov/opacom/morechoices/f

daforms/default.html.

Additionally, all research must be con-

ducted in compliance with the rules of

good clinical practice. These rules

require principal investigators (and all

other investigators involved in a clinical

trial) to (i) comply with the general fed-

eral regulations, (ii) control the investi-

gational drug; (iii) create and retain

records, (iv) create reports, and (v)

obtain appropriate IRB review. Guidance

regarding the rules of good clinical prac-

tice can also be obtained on the FDA

website at http://www.fda.gov/

cder/guidance/959fnl.pdf.

Complying with the research protocoland maintaining recordsThe principal investigator is responsible

for ensuring that the research proceeds

in compliance with the applicable

research protocol. The protocol contains

the criteria for admitting subjects into

the study, the procedure for administer-

ing the study drug or device, detail

regarding testing of each study subject

and all follow up tests required for each

study subject. Failure to strictly follow

the protocol can result in sanction by

both the study sponsor and the FDA.

Moreover, once a protocol has been

approved by an IRB, an investigator

cannot make changes to such protocol

without the IRB approving changes.

Moreover, often times, the research

sponsor will require its approval of all

changes as well.

Further, the actual conduct of the clini-

cal trial will require the creation and

maintenance of research records as set

forth in the protocol and FDA regula-

tions. These records shall include

records of disposition of drugs or the

device, case histories, regulatory corre-

spondence, and a delegation log indi-

cating responsibilities of all those

involved in the research. Even following

completion of the trial, the principal

investigator will often be required to

maintain certain records and conduct

certain follow up activities.

Clinical trials ...continued from page 21

23August 2005


their concerns. However, in this illustra-

tion, there is no system or officer

because there is no corporate compli-

ance plan. The board earlier declined to

put such a plan in place because it

believed it had an honest staff. But now,

the administrator seeks an exit strategy.

The administrator calls a health care

attorney who specializes in developing

and implementing corporate compliance

programs. She explains briefly and des-

perately that the nursing facility pro-

vides good care and is run by honest

people, but she nevertheless recognizes

the need for a corporate compliance

program should OIG ever come calling.

She confirms with the attorney that such

a compliance program, if effective, may

minimize any civil and criminal penal-

ties should the government impose

them. The attorney agrees to begin

work immediately. However, before the

assignment can begin, the dam breaks.

Word gets out to OIG that something's

wrong and that altered documents are

about to be destroyed. The administrator

is faced early one morning with FBI

agents brandishing guns, holding search-

and-seizure warrants for all patient data.

Computers are loaded into trucks. Filing

cabinets are carted off. Medical records

are taken away. Anything of question-

able value to the investigation is taken.

The nursing home is left in a complete

financial and clinical shambles. The attor-

ney hired to begin a compliance pro-

gram is standing at the front door, help-

less to intercede and realizing the admin-

istrator's effort to initiate a corporate

compliance program was too little, too

late. Things to remember about fraud:

■ It doesn't start with dishonesty

■ It starts with pressure

■ It starts one small step at a time

■ It starts with what might be consid-

ered "gray" areas

■ It increases in complexity and scope

over a long period

■ It locks in its participants so there's

no escape

The solution Fraud starts with good intentions: to con-

tinue building the organization and to

continue providing jobs for employees.

But the slope is slippery from there. What

often begins as a one-person effort even-

tually involves many. A corporate compli-

ance program, seriously initiated, imple-

mented and maintained, is the only way

to ensure that nascent fraud does not

begin and spread throughout an organiza-

tion. Once that happens, often the only

option available for an otherwise honest

organization, without a corporate compli-

ance program, is to confess. The organi-

zation must seriously consider approach-

ing OIG before it and/or the Justice

Department approaches the organization. ■

health industry fraud ...continued from page 13

Reporting adverse events and main-taining control of investigational drugA principal investigator is responsible

for reviewing and understanding the

applicable FDA regulations and for

reporting all adverse results of the study

to the proper individuals at the IRB and

sponsor. The principal investigator must

strictly monitor all study subject reaction

to participation in the study and report,

in a very timely manner, an adverse

response of such study subject. The

principal investigator will also be

responsible for making all progress

reports, safety reports, final reports, der-

ivation reports, financial disclosures,

reports on changes in research activities

and reports on unanticipated problems

involving risks to subjects to the IRB,

sponsor and FDA. Further the principal

investigator will be responsible for

keeping accurate records of the use,

storage and disposal of any study drug

used in the research.

ConclusionAs noted above, failure to properly con-

duct research in compliance with the

requirements of the applicable laws, rules

and regulations, can result in serious con-

sequence to the physician and staff con-

ducting the research. As part of its moni-

toring and oversight responsibilities, the

FDA conducts periodic audits of research

sites. Should a FDA audit result in the

FDA’s determining that the research site

is not operating in accordance with appli-

cable laws, rules and regulations, the

FDA may issue a Warning Letter to the

researchers or the research site regarding

their failures. All Warning Letters issued

by the FDA are posted on the FDA web-

site and are publicly available at

http://www.fda.gov/foi/warning.htm.

Failure to timely and satisfactorily

respond to an FDA Warning Letter can

lead to more significant consequences

such as FDA enforcement actions. To

avoid the consequences, it is very impor-

tant that any physician interested in con-

ducting research in his or her office

understand the requirements and obliga-

tions surrounding such research before

moving forward. ■

24August 2005


The Health Care Compliance

Association welcomes the following

new members and organizations (States

Iowa - Montana). Member contact infor-

mation is available on the HCCA web-

site in the Members Only section -

http://www.hcca-info.org. Please

update any contact information using

the HCCA Website or email April Kiel

([email protected]) with

changes or corrections to your member-

ship information.

Iowa■ Janice Balmer, BS, RHIA, Skiff

Medical Center

■ D. Michelle Burford, Fort Madison

Community Hospital

■ Jerald Ness, Wellmark BCBS

■ Renee A. Rasmussen, CPA, Allen

Health System

■ Jeff Rissman, MD, Iowa Pathology

Assoc

■ Tina Sullivan, RN, Mercy Hospital

■ Sharon Taylor, RN, MS, Burgess

Health Center

Kanasas■ Janine Colson, Citizens Medical

Center, Inc.

■ Cheryl Daly, Mt Carmel Regional

Medical Ctr

■ Sonja Fiechtl, Family Med Centers

■ Stacy Kratz, Crawford County Mental

Health

■ Larisa Nightingale, VA Eastern KS HCS

■ Sara Powers, Via Christi Regional

Med Ctr

■ Nancy Roht, CHCA

■ Tammi Schaper, Physicians Business

Network

Kentucky■ Beth Baker, Jane Todd Crawford

Hospital

■ Carolyn Graves, Univ of Louisville

HSPPO

■ Richard J. Huck, BA, MA,

Marymount Medical Ctr

■ Gloria Luber, Humana Inc.

■ Sherri A. Matthews, Univ of

Louisville

■ Christy M. Mattingly, St Joseph

Healthcare, Inc

■ Ricky Neeck

■ Tonya Peters

■ Carolyn Prater, Our Lady of the Way

Hosp

■ John Sass, Norton Healthcare

■ C Alex Smith, MPH, Family Health

Centers, Inc

■ Chris Wooldridge, Murray-Calloway

County Hospital

Louisana■ Eden Ezell, JD, LHC Group, Inc.

■ Glenda Folse, Tulane University

■ Kimberly Hibbard, CPA, General

Health System

■ Edie Kearley, Our Lady of the Lake

RMC

■ Christopher Martin, Ochsner Clinic

Foundation

■ Jarvis Morgan, MHA, W Jefferson

Med Ctr

■ Kenneth Roark, Huey P Long

Medical Ctr

■ Judy Stromme, Lindy Boggs Medical

Ctr

■ Aimee E. Troxclair, MBA, MHA,

Synergy Healthcare Group, Inc

■ Robert Erik Watts, LJ Chabert

Medical Cntr

■ Madeline West, City of New Orleans

Maine■ Janet Berkel, Eastern Maine Medical Ctr

Maryland■ Deborah Bell, CPC, Medical

Reimbursement Resource

■ Danna R. Brooks, APWU Health

Plan

■ Sharon Davis, Sheppard Pratt Health

System

■ Fernando Fleites, Holy Cross

Hospital

■ Susan L. Glover, RN, MHA, Adventist

Hlthcare

■ Paul W. Kim, Ober Kaler

■ Ken Kradel, CareFirst BCBS

■ Karen Lucien, Harbor Hospital Ctr -

Medstar Hlth

■ Nancy Miller, Suburban Hosp

Healthcare System

■ Pamela Owens, Esq., State of

Maryland

■ Gwyn Pasquale, CMS

■ Christine Perenich, CMS

■ James W. Pryde, Jr, Erickson

Retirement Communities

■ Barbara Reiber, RN, St. Joseph

Medical Center

■ Michelle Rice, Sibley-Suburban

Home Health Agency

■ Ms. Marianne Spevak,

■ Thomas Staffa, Johns Hopkins

Health System

Massachusetts■ Brad Boyd, Hayes Management

Consulting

■ Lorraine A. Brue, Hallmark Health

System Inc.

■ Audra Eames, Fallon Community

Health Plan

■ Maura I. Early, JD, MA, Youville

Hosp

■ Paula Kaminow, JD, Great Brook

Valley Health Center

■ David Levenstein, JD, Baystate

Health System

25August 2005


■ Katherine McGrath, Network Health

■ Louise Morse, Baystate Health

System

■ Lois B. Trusten, APRN, BC, Erich

Lindemann MHC

■ Maryann Volz, RN, OIG

■ Andrea Williams, Caritas Christi

Health Care System

■ David M. Yarin, Navigant Consulting

Michigan■ Carol S. Allis, JD, Hackley Health

■ Marci Beneson,

■ Cheryl Britcher, Priority Health

■ Elizabeth Callahan-Morris, JD, Hall

Render Killian Health & Lyman, PLLC

■ Elle Candela, Advantage Health

■ Tracy Coleman, PhysicianLinx

■ Sara Desmond, Community Health

Center of Branch Co

■ Daniel Gillett, Visiting Nurse Svcs of

MI

■ Robert Gunn, Mercy Hospital

■ Susan Hyde, HealthPlus of Michigan

Inc

■ Jacklyn Isham, Sparrow Health

System

■ Kevin R. Kalinowski, MBA, PHR,

Community Hosp

■ Harriett Kinney, Trinity Health

■ Marquita Kiss, University of

Michigan

■ Greg Loomis, Mercy General Health

Partners

■ Veronica A. Marsich, Smith Haughey

Rice & Roegge

■ Rhonda Mathis,

PricewaterhouseCoopers

■ Andrea Merritt, CHAN Healthcare

Auditors

■ James Miller, Saint Mary's Health

Care

■ Edward Montgomery, Henry Ford

Hospital

■ Camille L. Orso, Trinity Health

■ Kathleen Raftery, RN, Huron

Medical Ctr

■ Angela Rewa, Spectrum Health

■ Donna Saffioti, Iron Mountain VA

Medical Center

■ Rebecca Simpkins, VA Medical Ctr

■ Beverly Singleton, Lutheran Social

Srvs of MI

■ Cheryl Sullivan, CPA, Munson

Healthcare

■ Jean C. VanDine, Monroe CMHA

■ Nancy M. Vannest, Physicians Health

Plan of S MI

Minneasota■ Molly Andresen, Halleland Lewis

Nilan & Johnson

■ Karen Boyle, Twin Cities

Orthopedics

■ Lee S. Broadston, BCS, Incorporated

■ Jackie Dolentz, MS, SMDC Health

System

■ Nancy Dvorak, Parker Hughes

■ Tom M. Feldhege, CentraCare Clinic

■ Scott A. Gifford, Mayo Clinic -

Rochester

■ Lee D. Harness, Reprodutive

Medicine & Infertility Association

■ Adam Jones, Smiths Medical MD Inc

■ Angela Kaiser, Metropolitan Health

Plan

■ Mia King, The King Firm

■ William Michael, Jr., Lindquist &

Vennum, PLLP

■ Gary A. Nelson, Medtronic

■ Mona Peterson Rosow, Halleland

Lewis Nilan Sipkins & Johnson

■ Margaret Price, Smiths Medical MD

Inc

■ Valerie H. Ruttenberg, Prime

Therapeutics, LLC

■ Janette Setterquist, RN, Fond Du Lac

Human Svcs Division

■ Hilary Smith, Prime Therapeutics

■ Marjore Thompson, MA, Community

Univ Health

■ Fatih Uckun, MD, Parker Hughes

Clinics

■ Laura Wolfe, Prime Therapeutics,

LLC

■ Mary Zilinski, Medica

Mississippi■ Randy Belton, Magnolia

Management

■ Janet V. Gallaspy, BS, RN, Forrest

General Hospital

■ David Scott Grizzard, Natchez

Community Hosp

■ Joey Havens, CPA, Horne LLP

■ Judy McAlister, AAPC, CPC,

Hattiesburg Clinic

■ Robert M. Newell, HCM, Inc

■ Susan Riley, Magnolia Management

■ Michael Villalonga, MBA, MPH,

Hattiesburg Radiology Group

Missouri■ Danette Anderson, BSN,RN,

Washington Univ School of Medicine

■ Betty S. Breshears, CoxHealth

■ Charla Craig, RN, St Lukes Hospital

■ Marsha Gant, RN, BSN, CCP, VA

Heartland Network

■ Susan Koenig, Univ of Missouri

■ Barbara Maloney, FirstGuard Health

Plan

■ Becky L. Miller, Cox Health

■ Katherine Moody, MA, LPN, St Louis

Connect Care Health Ctrs

■ Chad Moore, Centene

■ Carol A. Poindexter, JD, Shook,

Hardy & Bacon, LLP

■ Steven B. Smith, BS, Peterson

Management Svcs

Montana■ Patti Reisinger, Bozeman Deaconess

Hospital

26August 2005


Publisher:Health Care Compliance Association, 888/580-8373

Executive Editor: Roy Snell, CEO, HCCA, [email protected]

Contributing Editor: Odell Guyton, President, HCCA, 888/580-8373

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Compliance Today (CT) (ISSN 1523-8466) is published by the Health Care Compliance

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rate is $357 a year for non-members. Periodicals postage-paid at Minneapolis, MN 55436.

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HCCA Officers:

Odell GuytonHCCA PresidentSenior Corporate Attorney,Director of Compliance,US Legal-Finance & OperationsMicrosoft Corporation

Daniel Roach, Esq.HCCA 1st Vice PresidentVP & Corporate Compliance OfficerCatholic Healthcare West

Steven Ortquist, CHCHCCA 2nd Vice PresidentSenior Vice President, Ethics andCompliance/Chief Compliance OfficerTenet Healthcare Corporation

Rory Jaffe, MD, MBA, CHCHCCA TreasurerChief Compliance OfficerUC Davis Health System

Julene Brown, RN, BSN, CHC, CPCHCCA SecretaryMeritCare Health System

Al W. Josephs, CHCHCCA Immediate Past PresidentDirector of Corporate ComplianceHillcrest Health System

Cynthia Boyd, MD, FACP, MBAChief Compliance OfficerRush University Medical Center

CEO/Executive Director: Roy Snell, CHCHealth Care Compliance Association

Board of Directors:

Anne DoyleDirector, Corporate Learning andOrganizational DevelopmentTufts Health Plan

F. Lisa Murtha, Esq., CHCManaging DirectorHuron Consulting Group

Frank SheederPartnerBrown McCarroll, LLP

John Steiner, Jr., JDChief Compliance OfficerThe Cleveland Clinic Health System

Debbie Troklus, CHCAssistant Vice President for HealthAffairs/Compliance University of Louisville, School ofMedicine

Sheryl Vacca, CHCDirector, National Health CareRegulatory Practice, Deloitte &Touche

Cheryl WagonhurstChief Compliance OfficerTenet Healthcare Corporation

Greg Warner, CHCDirector for ComplianceMayo Foundation

Counsel: Keith Halleland, Esq.Halleland Lewis Nilan Sipkins &Johnson

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American Health Lawyers Associationand

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FRAUD AND COMPLIANCE FORUMSeptember 25-27, 2005

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