Volume Seven Number Eight August 2005 Published Monthly Becky Sutherland Cornett, Ph.D., CHC 2 PHYSICIAN PRACTICE COMPLIANCE CONFERENCES September 8 & 9 October 6 & 7 For more information see page 2
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.
REGISTERTODAY!
For more information visit: www.hcca-info.org Or call: (888) 580-8373 Fax 952-988-0146
San Francisco September 8 & 9
Renaissance Parc 55 Hotel
New York October 6 & 7Marriott New York East Side
PHYSICIAN PRACTICE COMPLIANCE CONFERENCES
Name:
Title:
Company:
Address:
City:
State: Zip:
Phone:
Fax:
Email:
Mail to: HCCA5780 Lincoln Drive, Suite 120Minneapolis, MN 55436
Phone: (888) 580-8373 FAX: (952) 988-0146
Online: www.hcca-info.org Email: [email protected]
Please make checks payable to the Health Care Compliance AssociationCode: CT0605 Tax ID No. 23-2882664
New York . . . . . . . . . . . . . . . . . .Until 9/8 After 9/8
San Francisco . . . . . . . . . . . . . . .Until 8/11 After 8/11
*HCCA Members $495 $545
*Non-Members $595 $645
*HCCA Membership & Registration $695 $745
Pre-conference AM sessions Wednesday FREE $100
Pre-conference PM sessions Wednesday FREE $100
New York, NY October 6 & 7, 2005
San Francisco, CA September 8 & 9, 2005
Total Payment $ ______________
Invoice MePurchase Order # _____________Check/Money OrderVISA MasterCard American Express
Card Number
Exp. Date
Name of Card Holder
Signature of Card Holder
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
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Continued on page 11
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
■ 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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Continued on page 23
14August 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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:
HCCA individual membership costs $295.00; corporate member-
ship (includes 4 indiv. memberships, and more) costs $2,500.00.
CT subscription is complimentary with membership.
HCCA non-member subscription rate is $357.00/year.
❑ Payment enclosed
❑ Pay by charge: ❑ AmEx ❑ MasterCard ❑ Visa
Card #: Exp. Date:
Signature:
❑ Please bill my organization: PO#
Please make checks payable to HCCA. Please return subscription coupon to
5780 Lincoln Drive, Suite 120, Minneapolis, MN 55436.
To order Compliance Today (CT) complete this coupon
18August 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
By Gregg D. Reisman, Esq. and Lara Jean Ancona, Esq.
T
21August 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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-
Continued on page 22
22August 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
■ 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
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
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
Layout:Gary DeVaan, HCCA, 888/580-8373, [email protected]
Story Editor:Margaret R. Dragon, HCCA, 781/593-4924, [email protected]
Proofreader:Wilma Eisenman, HCCA, 888/580-8373, [email protected]
Advertising:Margaret R. Dragon, HCCA, 888/580-8373, [email protected]
Compliance Today (CT) (ISSN 1523-8466) is published by the Health Care Compliance
Association (HCCA), 5780 Lincoln Drive, Suite 120, Minneapolis, MN 55436. Subscription
rate is $357 a year for non-members. Periodicals postage-paid at Minneapolis, MN 55436.
Postmaster: Send address changes to Compliance Today, 5780 Lincoln Drive, Suite 120,
Minneapolis, MN 55436. Copyright 2004 the Health Care Compliance Association. All rights
reserved. Printed in the USA. Except where specifically encouraged, no part of this publica-
tion may be reproduced, in any form or by any means without prior written consent of the
HCCA. For subscription information and advertising rates, call HCCA at 888/580-8373. Send
press releases to M. Dragon, PO Box 197, Nahant, MA 01908. Opinions expressed are not
those of this publication or the HCCA. Mention of products and services does not consti-
tute endorsement. Neither the HCCA nor CT is engaged in rendering legal or other profes-
sional services. If such assistance is needed, readers should consult professional counsel or
other professional advisors for specific legal or ethical questions.
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
SAVE THE DATE!
American Health Lawyers Associationand
Health Care Compliance Associationpresents
FRAUD AND COMPLIANCE FORUMSeptember 25-27, 2005
Renaissance Harborplace Hotel • Baltimore, MD
PLAN NOW TO ATTENDREGISTER BY SEPTEMBER 7, 2005 AND SAVE
Visit: www.healthlawyers.org/programs/prog_05fraud.cfm
Don't miss the Fraud and Compliance Forum!The program will provide legal analysis and practical compliance guid-ance on issues including:
• Fraud and Abuse Issues for Physicians, Long Term Care Facilities, Managed CareOrganizations, Hospitals and Health Systems and Pharmaceutical Manufacturers
• Stark II Phase II Regulations and Fair Market Value• EMTALA• Legal Ethics• Research Compliance and
Billing• Auditing and Monitoring
Compliance Plans• Internal Investigations
To register visit us online at: www.hcca-info.org For questions call HCCA at: (888) 580-8373
Early Registration Discounts!Register before September 7th
$810 AHLA/HCCA Member$735 each additional AHLA/HCCA Member$985 Non-Member
CONTINUING EDUCATION CREDITS: AAPC • ACHE • AHIMA • HCCB • NASBA • MCLE
November 7 - 10, 2005Disney’s Contemporary Resort
Lake Buena Vista, FLand
February 6-9, 2006Park Hyatt Los Angeles
Los Angeles, CA
ACT NOW! - SPACE IS LIMITED!
YES! I'm interested in taking the Healthcare Compliance Certification (CHC) exam!
YES! Please sign me up for the Compliance Academy!
$ 2500 Members$ 3000 Non-Members$ 2795 HCCA Membership & RegistrationSave $205.00 by joining HCCA today!
PLEASE TYPE OR PRINT
First Name Last Name
Credentials
Title
Company
Address
City State Zip
Phone
Fax
Federal Tax ID: 23-2882664
Payment TermsPlease enclose payment with your registration and return it to the confer-ence office at the above address, or fax your credit card payment to (952)988-0146.
Invoice mePO number_________________ CODE: CAM0605Check enclosed (checks payable to HCCA)American Express Visa MasterCard
Account No.
Exp. Date
Name of Cardholder
Signature
WEBwww.hcca-info.org
MAILSend form with tuition fee to:Conference Office 5780 Lincoln Dr., Suite 120 Minneapolis., MN 55436
FAX(952) 988-0146
[email protected] 1-888-580-8373
CC
Health Care Compliance Association
A Division of Health Systems Concepts, Inc.
HSC’s Management Billing Analyst (MBA)
Compliance Audit Software Laboratory
Version 1.2
Fully automated, laboratory retrospective
compliance claims monitoring tool
Audits from Physician order to Medicare
payment
Meets US Sentencing Guidelines
Meets OIG Guidelines
Identifies lost revenues
Reduces FTE cost for internal audits
Provides quantitative audit results
Fully tested and ready to help the lab
compliance manager gain:
Full control of the billing process
Compliant billing validated and
documented
Reduced culpability
In Development
MBA Cardiology Audit Software
MBA Radiology Audit Software
Significant return on investment!
Call HSC today at (877) 447-2700 to
arrange a demonstration or email us at
C O R P O R A T E C O M P L I A N C E & E T H I C S :G U I D A N C E F O R E N G A G I N G Y O U R B O A R D
Name:
Title:
Company:
Address:
City:
State: Zip:
Phone:
Fax:
Email:
Mail to: SCCE5780 Lincoln Drive, Suite 120Minneapolis, MN 55436
Phone: (888) 277-4977
Total Payment $ ______________
Invoice MePurchase Order # _____________Check/Money OrderVISA MasterCard American Express
Number
Exp. Date
Name of Card Holder
Signature of Card Holder
Code: CT1104Please make check payable to:
Society of Corporate Compliance and Ethics (SCCE)
FAX: (952) 988-0146
Online: www.corporatecompliance.org
Email: [email protected]
Non-Members $395SCCE/HCCA Members $345
www.corporatecompliance.org
Bringing the vision ofleadership together
with a compliant andethical culture
"This video provides anoverview of the Board’s rolein compliance."
Odell GuytonSenior Corporate Attorney,Director of ComplianceMicrosoft Corporation
“It’s pretty clear that the bestcompliance program in theworld is meaningless even ifit’s funded with a good wellmeaning compliance officer ifthe leadership of the compa-ny is not behind it and isn’tsupportive…”
Honorable Michael E. Horowitz,Commissioner, United StatesSentencing Commission
ORDER TODAY!
Telly AwardFinalist!
3838
At MC Strategies, we can help you get there. Our consultants provide comprehen-sive assessments, such as Chargemaster reviews that help you identify billingissues and ensure HCPCS/CPT accuracy. And APC validations that include CPT and ICD-9 accuracy verification. But helping you get compliant is only part of what we do.
Our WebInservice® online training features the industry‘s most comprehensive set of compliance curricula. Our EduCode® Compliance curriculum is a practical yetextremely informative program that covers general compliance as well as the highly-technical and high-risk areas of billing and coding compliance. And because allWebInservice training is delivered online, you can rest assured that you‘re tapping into the most efficient and cost-effective training method available today.
Achieving compliance today is a complex task. And it takes more than knowing the basics, but rather, knowing it all from A to Z. To learn more, log ontowww.mcstrategies.com or call us at 800-999-6274.
HCPCS/CPT, APC, ICD-9. No wonder you have to be compliant to the letter.
MC Strategies – Consulting Facilitating performance and compliance.
WebInservice® – Training Improving efficiency through knowledge.
3939
COMPLIANCE & ETHICS INSTITUTECorporate Compliance and Ethics
Programs:Case Studies and Risk Areas
September 12-14, 2005Chicago Downtown Marriott, Chicago, IL
Society of Corporate Compliance and EthicsThe Corporate Compliance Professionals’ Association
www.corporatecompliance.org
Continuing Education Credits: MCLE/CLE • CPE/NASBA • ACHE • HCCB
Case Studies From:AffymetrixAltria Corporate ServicesDell Inc.Delta Air LinesDuPont GE Commercial FinanceKraft FoodsMcDonalds
Microsoft CorporationRadioShackTenet HealthcareUPSU.S. BancorpUS FoodserviceQwest Communications
Sessions Include:• Problems of Internal Investigations
• Just Because it’s Legal, Doesn't Mean it’s Ethical
• FCPA, Patriot Act and Money Laundering
• Measuring Ethics & Integrity
• Designing an Antitrust Compliance Presentation That Works
• Compliance 101
SAVE$100
When You Register Before
August 12
Join SCCE
& Save $100
Conference fees: before after 8/12/05 8/12//05
SCCE/HCCA Members $499 $599
Non-Members $599 $699
Join the SCCE& Registration $649 $749
Student $50 $50
Student Join the SCCE & Registration $100 $100(student verification may be required)
Join the Society of CorporateCompliance & Ethics & Save
$100 off your first year of membership dues. Annualdues are normally $250!
www.corporatecompliance.org(888) 277-4977