meet joseph murphy
TRANSCRIPT
Volume SevenNumber Nine
September 2005Published Monthly
MeetJosephMurphy
PHYSICIAN PRACTICE
COMPLIANCE CONFERENCE
October 5 - 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 CONFERENCE
2nd2nd
The Health Care Compliance Association (HCCA) will hold its 2005 Physician Practice ComplianceConference in New York, October 5 & 7. The conference will provide physicians, practice managers,compliance officers and others involved with physician practices with the most current information andcompliance strategies for physician practices.
REGISTERTODAY!
For more information visit: www.hcca-info.org Or call: (888) 580-8373 Fax 952-988-0146
New York October 5 - 7Marriott New York East Side
PHYSICIAN PRACTICE COMPLIANCE CONFERENCE
Name:
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September 2005
CMS■ National Provider Identifier (NPI) links Instructional Web
Tool http://www.cms.hhs.gov/medlearn/npi/npiviewlet.asp
■ CMS Facilitates Access to Innovative Technology
http://www.cms.hhs.gov/spotlight-technology.asp
■ The CMS Quarterly Provider Update
http://www.cms.hhs.gov/providerupdate/
■ Medicare Part D Electronic-Prescribing Proposed Rule
http://www.cms.hhs.gov/media/press/
release.asp?Counter=1117
DOJ■ Improper Use of Patient Restraints: First in the Nation
Settlement Announced
http://www.usdoj.gov/usao/pae/News/Pr/2005/jul/CMMC.html
Federal Register■ CMS Proposed Rule: Inpatient Rehabilitation Facility
Prospective Payment System for FY 2006 http://a257.g.aka-
maitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov
/2005/05-10264.htm
■ Medicare Program; Electronic
Submission of Cost Reports:
Revision to Effective Date of
Cost Reporting Period
http://a257.g.akamaitech.net
/7/257/2422/01jan20051800/
edocket.access.gpo.gov
/2005/05-10570.htm
■ CMS Proposed Rule:
Medicare and Medicaid
Programs: Hospice
Conditions of Participation;
http://a257.g.akamaitech.net
/7/257/2422/01jan20051800/
edocket.access.gpo.gov
/2005/05-9935.htm
3September 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 7-9
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
Las Vegas, NV■ Advanced AcademyOctober 24-28■ Desert Southwest MeetingNovember 4
New York, NY■ Physicians Practice
Compliance ConferenceOctober 5-7
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
Las Vegas, NV■ Compliance InstituteCaesars PalaceApril 23-17
■ National CorporateCompliance and Ethics Week
May 21-27
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 CalendarWeblinksOvercoming barriers tocomplianceCompliance with EMTALAMisconduct in clinicalresearchMeet Joseph MurphyCompliance educationMedicare contractingreformRecipe for effective complianceCEO’s letterRevenue integrity and coding compliance Keeping Stark II Records
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INSIDE
4September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editor's Note: Andrea McElroy is the
Senior Director of Compliance
System Integrity at Beverly
Enterprises, Inc. Ms. Elroy reports
directly to Pat Kolling, Chief
Compliance Officer. She may be
reached by phone at 414-529-3747
or by email at
nsuring that 35,000 employees
are aware of an organization's
compliance policies and mak-
ing sure that they receive and complete
annual compliance training is challenge
enough. But when those employees are
scattered across the country at more
than 1,000 locations, the challenge
increases exponentially.
Beverly Enterprises, Inc. (BEI) - a large
multi-state healthcare organization -
faced this challenge. BEI operates 344
skilled nursing facilities, 60 hospice and
home health agencies and a large reha-
bilitation business that provides rehabili-
tation services in more than 700 loca-
tions exclusive of our own skilled nurs-
ing facilities. To ensure that our associ-
ates working in these diverse locations
received our compliance message - and
to fulfill the requirements of the
Corporate Integrity Agreement with the
OIG under which we operate - we uti-
lized a variety of creative approaches.
Creating "buy-In"When polled, participants at the HCCA
Compliance 101 educational session ref-
erenced in the HCCA Compliance 101
publication, 2001, listed "creating buy-in
and enthusiasm" as well as "education
and training" as two of the top ten
obstacles to effective compliance imple-
mentation. The OIG, in its "Seven
Essential Elements of a Compliance
Program," lists education as a key com-
ponent of any compliance program. In
fact, the OIG Compliance Program
Guidance for Skilled Nursing Facilities
states: "The development and imple-
mentation of a regular effective educa-
tion and training program for all affect-
ed employees" is an essential element
of a compliance program.
Recognizing the need and referencing
the regulatory support is the starting
point, and is also the easiest part.
Creating the process and following
through in the organization is where the
true challenge lies - particularly in a
company where the workforce is
diverse in both position and education,
and dispersed geographically.
In the early stages of our compliance
program commitment at BEI, we knew
that associate education would be a cru-
cial element. A requirement of our
Corporate Integrity Agreement was to
deliver in-depth general and specific
training to all of our associates. In the
interest of timely implementation, video
versions of "classroom lecture" type
training were created, using senior lead-
ership, as well as professional talent, to
present the required information. While
the finished product was informative
and professional, motivation to view,
learn, retain and transfer the content
decreased over time. New energy and
focus and an updated approach were
required to continue to effectively edu-
cate associates about compliance.
Realizing that there was a need to
revise the training and to launch a
"compliance awareness campaign," we
looked to experts within the company
to understand adult learning styles for
effective training as well as to create a
brand for the compliance "product."
All compliance strategic initiatives
require the support of company leader-
ship to succeed. The preparation to roll
out our compliance awareness cam-
paign and revised training included a
presentation and solicitation of feedback
from senior company leadership where
we gained commitment to support the
compliance initiatives and overall strate-
gic plan. As recommended by the
By Andrea McElroy
E
Continued on page 6
AN
DR
EA
MC
ELR
OY
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 youcan use daily without even leaving your office! Registeron the HCCA Website–www.hcca-info.org. You willreceive an email a few days before the conference withany conference handouts, and dial-in information andinstructions.
➤ ➤ Auditing Your AuditSpeaker: Theresa BivensSeptember 21, 2005
➤ ➤ Two-Part Recovery Audit ContractorsSpeakers: Michael Smith, Chris Myers, Melanie Combs and Connie Leonard September 28 and 29, 2005
➤ ➤ Compliance with Conditions of Participation Speaker: David HoffmanOctober 18, 2005
➤ ➤ Two Part Privacy IssuesSpeakers: Marti Arvin and Deann BakerOctober 19 and 20, 2005
*Audio CDs are available for all past audio conferences.
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org 5
6September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Compliance 101 "Organizational Steps to
Gain Support and Commitment," senior
management attends regularly sched-
uled meetings designed to reinforce the
message of compliance-and this demon-
strated support was essential to a suc-
cessful implementation.
Using the principles of adult learningWhen approaching education and train-
ing, it is important to recognize the
unique learning styles of the audience.
Malcolm Knowles, the pioneer of adult
learning, identified key characteristics of
how adults learn. His research and other
literature have shown that adults have
some common traits that facilitate and
improve learning. Regardless of how
goal-directed or autonomous an individ-
ual is, all adult learners are oriented to
what is relevant to them and their accu-
mulated personal life experiences. In
other words, they want to know why
they need to know, and how the infor-
mation fits into their world! Also, gener-
ally speaking, adults are practical and
are problem solvers - they want to inter-
act with, and reason through, situations
presented during a learning session. An
adult who is made to listen to fact dis-
semination via a lecture format, quickly
becomes bored and inattentive. Finally,
adult learners want respect for what
they already know and the experiences
they bring to the learning event.
Considering these key traits of adult
learners, we approached the re-design
of our general compliance training with
the following goals in mind:
■ Guide the participant to their own
knowledge
■ Relate the information to the partici-
pant's own experiences
■ Help the participant realize how the
information will lead them to achieve
their goals
■ Create a value for learning the infor-
mation
■ Ensure that the participant realizes
the relevance of the training to their
job function
■ Provide the opportunity for the par-
ticipant to bring their opinions and
experiences into the learning activity
Beyond learning styles, we also gave
consideration to motivation and barriers.
The typical motivations of the adult
learner include requirements for certifi-
cation/licensure, anticipation of a pro-
motion, job enrichment or adaptation to
job changes, or compliance with com-
pany directives. Because compliance
training is a company expectation, moti-
vation and overcoming barriers for time-
ly completion and active learning
became a significant focus. The goal of
creating cognitive interest was a corner-
stone to what we believed would lead
to a successful learning experience.
Piquing their interestTo accomplish our goals, we elected to
develop an interactive computer-based
program in conjunction with a company
that specializes in multi-media presenta-
tions. The company we contracted to
produce the training assisted us with
making the content "conversational" in
its presentation style. A combination of
narration, slide presentation and filmed
scenes entices the learner to interact
with the content of the training. For
example, learners view video of poten-
tial real-life occurrences that would
present an employee with a dilemma.
Scenarios include a resident offering an
employee money as a loan to assist
with school tuition, and an employee
observing a co-worker/friend take the
pain medication of a resident due to a
genuine pain condition that is interfer-
ing with work.
The video-stream creates a "human link"
to the scenario and evokes emotion that
causes the participant to give greater
consideration to the situation, how it
should be handled, and why. As the
learner progresses through the training,
he/she is presented with questions that
can be answered with a "drag and
drop" or direct selection response on
the computer screen. Each time an
answer is selected, the participant is
given immediate feedback. Following
the participant's response, the narrator
describes the proper way to handle the
situation as well as the rationale for the
correct answer. The information also is
enacted on the screen in the way that
the situation should be handled. In
addition to the frequently injected ques-
tions, the program pauses periodically
allowing the user to go back and
review a segment, or continue to the
next segment.
By using this approach, we learned that
the secret to piquing the interest of
employees lies in recognizing learning
styles, modifying the format to allow inter-
action with the material, and ensuring that
content is practical and has relevancy.
Delivering the messageBarriers to learning extended beyond
just motivation, scheduling challenges
and the potential for procrastination.
Because we had to reach thousands of
associates nationwide-some in facilities
and other office locations, some home
based, and some at the corporate office-
the method of delivery presented a
Overcoming barriers to compliance ...continued from page 4
7September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
potential barrier as well. We decided on
an electronic learning format and devel-
oped a customized training program
that met the needs of our associates at
all levels-incorporating the adult learn-
ing techniques described above.
The use of information technology
strategies to release the trainings proved
to be the most economical method for
delivery. However, key aspects to
resolve in advance included:
■ User computer technology knowledge
■ User access to computer workstations
■ Program function on various comput-
er operating systems
■ Connection and computer band-
width speed to support the demands
of video-stream presentation
These barriers were overcome through
the use of clear instructions including
screen shots to aid the user, strong
communication with, and support from,
the information technology department
and flexibility to use the training pro-
gram via CD or direct server access. We
initially handled the "procrastination fac-
tor" by setting a company deadline for
training completion. However, as our
associates began to view the training,
positive "water cooler" discussions
about the new format resulted in the
achievement of the ultimate motivation
goal of piqued interest.
In addition, it was our goal that associ-
ates take responsibility for completing
their own training. This latitude of
autonomy demonstrates our respect for
their integrity and commitment.
Everyone is aware that at BEI we rely
on the integrity of our associates to
complete the training and to seek
answers to questions they may have.
Ethics and integrity messages are inter-
woven into all chapters of the training.
Finally, the training is divided into mod-
ules or chapters that allow the busy par-
ticipant to complete the training as
his/her time permits. Each chapter is
labeled regarding completion time, and
at the end of the chapter the participant
can choose to continue to the next
chapter or to return and complete at a
later time. By allowing this flexibility,
we were able to overcome the schedul-
ing barrier.
Building awarenessThe goal of building compliance aware-
ness and "Achieving Results with
Integrity"-the motto for our program
and a Guiding Principle for BEI-began
with allowing our associates to be
responsible for their own compliance
learning. The implementation of the
new training was introduced as part of
our overall compliance awareness cam-
paign. As we continued to focus on
compliance awareness, it was apparent
that compliance at BEI needed some
"product recognition" or branding.
To build our "brand" of compliance
among our associates and as an indus-
try leader, we utilized key marketing
principles. Our focus was and will con-
tinue to be based on the following
strategic functions stated as critical ele-
ments by Steven Van Yoder in his article
"The Brand Called You":
■ Position your focused message in the
hearts and minds of your target audi-
ence
■ Persist and be consistent in your
communication
■ Project credibility
■ Strike an emotional chord
■ Create strong loyalty
■ Make and keep a promise of value
We initiated a "call to arms" to solicit
the creative energies of our associates.
We requested ideas for logos and
themes from across the company. The
goal was to create a standard "brand"
that would tell our associates: "This is
important information from your com-
pliance department - listen up". We
selected a new logo from among the
entries and we recognized the creative
associate in a company-wide publica-
tion. The contest resulted in a perfect
brand that was light-hearted but could
get the compliance point across. This
logo-contest had the added benefit of
placing the topic of the compliance pro-
gram on the agenda of daily conversa-
tion. A graphic designer further devel-
oped and expanded the logo and
theme, for use with payroll stuffers and
"trading cards" with a compliance mes-
sage, posters to be placed in all loca-
tions, and other general compliance
communications.
Our journey for increasing awareness of
compliance principles will never be
complete. However, as we continue to
enhance our compliance awareness
campaign, we will rely on proven theo-
ries in "branding."
We continue to work to involve all staff
in the reporting of activities that may
place the company at risk. We have
encouraged associates at all levels to
take advantage of opportunities to share
their ideas on systems that will improve
quality and compliance. An email
address has been established that
employees can use to submit ideas and
serve as a sounding board for ques-
Continued on page 18
8 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editor's note: Kelly, Katherine and
Stephen are part of
PricewaterhouseCoopers Healthcare
Advisory Practice. They specialize in
delivering compliance-related servic-
es to hospitals, health systems, physi-
cian groups and other providers.
Kelly J. Sauders is a Director in the
Healthcare Advisory Practice based in
Albany, New York. She may be reached
by telephone at 518/427-4431.
Stephen J. Gillis is a Manager in
PricewaterhouseCooper's Healthcare
Advisory Practice based in Boston.
Stephen may be reached by tele-
phone at 617/530-4115.
Katherine Barnhart is a Senior
Associate in the Healthcare Advisory
Practice based in Albany, New York.
Katherine can be reached by tele-
phone at 518/427-4529.
he Emergency Medical
Treatment and Labor Act
(EMTALA) was passed in 1986,
primarily in response to concerns that
hospitals were refusing to treat indigent
and uninsured patients or were inappro-
priately transferring them to other hospi-
tals solely for economic reasons. EMTA-
LA requires hospitals that participate in
Medicare to provide a medical screening
exam to any person who comes to the
emergency department and requests it,
regardless of the individual's ability or
intention to pay for the services ren-
dered. Additionally, if a hospital deter-
mines that the person has an emergency
medical condition, it must provide treat-
ment to stabilize the condition or pro-
vide for an appropriate transfer to
another facility. EMTALA also prohibits
hospitals from delaying a medical
screening exam, and/or stabilizing treat-
ment, in order to inquire about the per-
son's method of payment or insurance
status. Hospitals that do not comply
with EMTALA risk possible Medicare
decertification actions and civil monetary
penalties up to $50,000 per violation.
The Centers for Medicare and Medicaid
Services (CMS) published a final rule in
the Federal Register1 on September 9,
2003, which was intended to clarify
policies relating to the responsibilities of
Medicare-participating hospitals in treat-
ing individuals with emergency medical
conditions, who present to a hospital
under the provisions of the EMTALA.
Following the release of this document,
CMS issued Revised EMTALA
Interpretive Guidelines (the Guidelines)
in the State Operations Manual (SOM)
to regional offices and State Survey
Agencies on May 13, 2004.2 The pur-
pose of the Guidelines was to update
the guidance given to State or Federal
surveyors, who conduct investigations
of reports of EMTALA violations, so that
enforcement is consistent with recent
changes to the federal regulations prom-
ulgated under EMTALA.
The enforcement of EMTALA is a com-
plaint driven process. The investigation
of a hospital's policies/procedures and
processes, and any subsequent sanc-
tions, is initiated by a complaint. If the
results of a complaint indicate that a
hospital violated one or more of the
anti-dumping provisions of section 1866
or 1867 of the Social Security Act, a
hospital may be subject to termination
of its provider agreement and/or the
imposition of civil monetary penalties.
Enforcement is handled by the Office of
the Inspector General (OIG). Under the
Civil Monetary Penalties Law (CMPL) the
OIG is authorized to impose administra-
tive penalties and assessments for viola-
tions of the EMTALA statute. Between
April 1, 2003 and March 31, 2005, OIG
collected civil monetary penalties of
more than $1.1 million from 43 hospitals
and physicians. Examples of these settle-
ments and a discussion of the applicable
regulations are presented below:
■ A hospital paid $15,000 to resolve
allegations that it failed to provide an
appropriate medical screening exami-
nation or stabilization treatment to a
pregnant woman. The woman was
transferred to another hospital
approximately one hour away in a
private vehicle. The patient delivered
her baby in the vehicle prior to
reaching the second hospital.3
■ A hospital paid $100,000 to resolve
allegations that it failed to provide
medical screening examinations
September 2005
By: Katherine Barnhart, Stephen J. Gillis and Kelly J. Sauders
TK
ELL
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.SA
UD
ER
S
and/or stabilization treatment to four
individuals who presented in the
emergency department. One individ-
ual presented with a blood alcohol
level of .43, another with lacerations
on both wrists, another with high
blood pressure and dizziness, and
the last complained of depression,
stating she had been raped.4
In both of the above examples, a key
issue was provision of an appropriate
medical screening exam. Under EMTA-
LA, the term "appropriate" does not
mean "correct," in the sense that the
treating emergency physician is required
to correctly diagnose the individual's
medical condition. When used in the
context of EMTALA, "appropriate"
means that the depth of the screening
examination was suitable for the symp-
toms presented and conducted in a
non-disparate fashion. A medical
screening exam is the process required
to reach, with reasonable clinical confi-
dence, the point at which it can be
determined whether a medical emer-
gency does or does not exist. If a hospi-
tal applies, in a nondiscriminatory man-
ner (i.e., a different level of care must
not exist based on payment status, race,
national origin) a screening process that
is reasonably calculated to determine
whether an emergency medical condi-
tion exists, it has met its obligations
under EMTALA.5
■ A hospital paid $40,000 to resolve alle-
gations that it did not provide an
appropriate medical screening examina-
tion to an individual who presented to
its emergency department for evalua-
tion. He was allegedly refused such
treatment based on his inability to pay.6
The key allegation in this example is
the ability to pay. A hospital is obligat-
ed to provide the services specified in
the EMTALA status, regardless of
whether a hospital will be paid.
■ A hospital paid $25,000 to resolve
allegations that it failed to provide an
appropriate medical screening exami-
nation, stabilization treatment, or an
appropriate transfer to a woman who
presented to its emergency depart-
ment by order of her physician.
Instead, for insurance-related reasons,
she was directed to seek treatment at
another hospital.7
Also involving payment, this example
involves a hospital's contractual arrange-
ments with insurers. It is not impermissi-
ble under EMTALA for a hospital to fol-
low normal registration procedures for
individuals who come to the emergency
department. For example, a hospital
may ask the individual for an insurance
card as long as doing so does not delay
the medical screening exam. A hospital
that is not in a managed care plan's net-
work of designated providers cannot
refuse to screen (or appropriately trans-
fer, if the medical benefits of the transfer
outweigh the risks or if the individual
requests the transfer) individuals who
are enrolled in the plan who come to
the hospital if that hospital participates
in the Medicare program. The
Guidelines clearly state that EMTALA is a
requirement imposed on hospitals, and
the fact that an individual who comes to
the hospital is enrolled in a managed
care plan, that does not contract with
that hospital, has no bearing on the obli-
gation of the hospital to conduct a med-
ical screening exam and to at least initi-
ate stabilization treatment. A managed
health care plan may only state the serv-
ices for which it will pay or decline pay-
ment, but that does not excuse the hos-
pital from compliance with EMTALA.8
■ A hospital paid $15,000 to resolve an
allegation that it failed to provide
appropriate examination and treat-
ment to a man who presented by
ambulance with the chief complaint
of rectal bleeding. He was turned
away because the hospital was on
diversion status. He proceeded to
another hospital where he was found
to have a life-threatening upper gas-
trointestinal bleed.9
In this example, the alleged failure to
9September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Continued on page 10
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10September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
compliance with EMTALA ...continued from page 9
treat illustrates confusion around the
definition of "comes to" the ED. EMTA-
LA provides that the patient must come
to the hospital before the hospital's
obligations related to screening, stabi-
lization and transfer are implicated. The
Guidelines state that hospital property
includes ambulances owned and operat-
ed by the hospital, even if the ambu-
lance is not on the hospital campus. An
individual in a non-hospital owned
ambulance, which is on hospital proper-
ty, is considered to have come to the
hospital's emergency department. If an
individual is in an ambulance, regard-
less of whether the ambulance is owned
by the hospital, a hospital may divert
individuals when it is in "diversionary"
status because it does not have the staff
or facilities to accept any additional
emergency patients at that time.
However, if the ambulance is owned by
the hospital, the diversion of the ambu-
lance is only appropriate if the hospital
is being diverted pursuant to communi-
ty-wide EMS protocols. Moreover, if any
ambulance (regardless of whether or
not owned by the hospital) disregards
the hospital's instructions and brings the
individual on to the hospital campus,
the individual has come to the hospital
and the hospital has incurred an obliga-
tion to conduct a medical screening
examination for the individual.10
■ A hospital paid $50,000 to resolve
allegations that it failed to accept the
appropriate transfer of a burn patient
who needed its specialized capabili-
ties to treat burn victims.11
Specialized capabilities are the key issue
in this example. In discussing special-
ized capabilities, the Guidelines indicate
that if the receiving hospital has the
capacity and capabilities, the hospital
would have a duty to accept an appro-
priate transfer of an individual requiring
the hospital's capabilities, providing the
transferring hospital lacked the special-
ized services or capacity to treat the
individual.
As a compliance officer, these settle-
ments may provide some insight into
the possible consequences of an EMTA-
LA violation. However there are many
additional risk areas under EMTALA that
may not be as obvious until you've
thoroughly reviewed the Interpretive
Guidelines. A good starting point for
conducting an EMTALA review is to
focus on the methodology outlined in
the Guidelines that a CMS surveyor
would follow when investigating a
reported violation. Among the items the
CMS surveyor would likely request are
the following:12
■ Hospital EMTALA (Dedicated ED and
other areas) logs for the past 6-12
months;
■ The dedicated ED policy/procedures
manual (review triage and assess-
ment of patients presenting to the ED
with emergency medical conditions,
assessment of labor, transfers of indi-
viduals with emergency medical con-
ditions, etc);
■ Consent forms for transfers of unsta-
ble individuals;
■ Bylaws/rules and regulations of the
medical staff;
■ Current medical staff roster; and
■ Physician on-call lists for the past six
months.
We've provided a few excerpts from the
Guidelines here along with examples of
typical "EMTALA compliance" audit find-
ings.
■ Maintenance of Central Log
■ Central log with patient treatment
status
■ Log is maintained of all individuals
presenting to the hospital
Emergency Services Treatment Log: A
hospital that is subject to EMTALA is
required to keep a central log on each
individual who comes to the emergency
department seeking assistance, and their
disposition (patient refused treatment,
left without being seen, evaluated and
discharged, admitted and treated, or sta-
bilized and transferred). Separate logs
may be maintained in areas where indi-
viduals may seek emergency treatment;
as long as they are incorporated, either
directly or by reference, into one central
log.13 Finding example: Patients who
enter the hospital through the emer-
gency department, and who believe
they are in labor, may be sent to the
Labor and Delivery Department for an
evaluation, and treatment may not be
recorded on the ED treatment log. They
also may not be recorded by the Labor
and Delivery Department within their
Emergency Services Treatment log
because the Labor and Delivery
Department was not aware that such a
log was required or thought the
Emergency Department logged the
patient information.
■ Medical Screening Exam (MSE) per-
formed by qualified medical person-
nel (QMP)
Under EMTALA, Hospitals are obligated
to perform an MSE on all individuals
who request emergency treatment. An
MSE must be performed by a Qualified
Medical Person (QMP). Hospitals are
allowed to use their own discretion to
11September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
identify who, at their hospital, can be
designated as a qualified medical per-
son capable of performing the MSE.
Generally, this includes all physicians
credentialed by the Hospital and part of
the Medical Staff. Hospitals may also
choose to utilize non-physician practi-
tioners to perform Medical Screening
Exams. However, if a Hospital wishes to
do so, it needs to develop a process of
authorizing specific individuals to per-
form MSE. A screening exam performed
by a person who is not authorized may
place the hospital at risk of not having
performed a medical screening exam.
For example, a hospital may determine
that a nurse practitioner can request
approval to perform medical screening
exams. However, until that individual is
approved, based on a hospital approval
process, the exams they perform will
not be considered valid medical screen-
ing exams for the purposes of meeting
EMTALA obligations.
■ Stabilization and Transfers
■ Provide stabilization treatment
■ Provide appropriate transfer
Transfers: Hospitals are responsible for
treating and stabilizing, within their
capacity and capability, any individual
who presents him/herself to a hospital
with an emergency medical condition.
The hospital must provide care until the
condition ceases to be an emergency or
until the individual is properly trans-
ferred to another facility. If community
wide plans exist for specific hospitals to
treat certain emergency medical condi-
tions (e.g., psychiatric, trauma, physical
or sexual abuse), the hospital must
meet its EMTALA obligations (screen,
stabilize, and or appropriately transfer)
prior to transferring the individual to the
community plan hospital. A hospital
may appropriately transfer an individual
before the sending hospital has used
and exhausted all if its resources avail-
able if the individual requests the trans-
fer to another hospital for his or her
treatment and refuses treatment at the
sending hospital.14
■ Maintaining On-call physician lists
■ Maintain a list of physicians on call
■ Back-up on-call
■ Policies and procedures
Maintaining Lists of On-Call Physicians:
The Guidelines reaffirmed some previ-
ously established expectations and cre-
ated clarification for topics that were
once vague, related to on-call activities.
Hospitals have the ultimate responsibili-
ty for ensuring adequate on call cover-
age. Applicable components of the
Guidelines include:
■ Physician group names are not
acceptable for identifying the on-call
physician, individual physician names
are to be identified on the list;
■ On-call physicians may direct a non-
physician practitioner to respond to a
call as a representative of the on-call
physician, even though the physician
is ultimately responsible for respond-
ing to the call. However, if this is to
occur, the conditions must be out-
lined in the Hospital's written policies
and procedures;
■ Hospitals may adopt policies and
procedures to permit on-call physi-
cians to schedule elective surgery
while on-call, or to be on-call at
more than one hospital simultaneous-
ly, as long as the hospital has estab-
lished a backup on-call plan, in the
event that a physician is unavailable
due to elective surgery or simultane-
ous call responsibilities and,
■ Hospitals may not use the term "rea-
sonable" when articulating the expec-
tation of an on-call physician
response to a call. A specific time
parameter should be identified. 15
Finding example: The on-call list does
not identify an individual physician who
is on call. Rather, the phone number of
a group practice or an answering serv-
ice is listed.
Based on the outcome of the EMTALA
compliance audit, your organization
may need to consider changing docu-
mentation processes, re-educating ED
staff and physicians, updating policies
and procedures, and putting ongoing
monitoring processes in place, as a con-
trol in this area. Given the OIG's
enforcement capabilities and frequent
inclusion of EMTALA in its Annual Work
Plan, this is clearly an area for compli-
ance review. ■
1 Federal Register, Vol 68, No. 174, pg 53222
2 CMS State Operations Manual (SOM), Revised
Appendix V, Interpretive Guidelines - Responsibilities
of Medicare Participating Hospitals in Emergency Cases
3 OIG Semiannual Report April-September 2003
4 OIG Semiannual Report April-September 2004
5 SOM, pg 12 and pg 28
6 OIG Semiannual Report April-September 2004
7 OIG Semiannual Report April-September 2004
8 SOM, pages 29 and 36
9 OIG Semiannual Report October 2003-March 2004
10 SOM, pages 29-30
11 OIG Semiannual Report April-September 2004
12 SOM, pg 6
13 SOM, pg. 24 - 25
14 SOM, pages 35 - 37
15 SOM, pg. 19 - 24
12September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editor's note: Ms. Murtha is managing
director with Huron Consulting Group.
She may be reached by email at
ver the course of the last fif-
teen years, we have wit-
nessed a number of promi-
nent enforcement initiatives pursued by
the DHHS Office of Inspector General
(OIG) and the Department of Justice
(DOJ). These initiatives have ranged
from the Physicians at Teaching
Hospitals (PATH) projects, the clinical
laboratory bundling/unbundling scan-
dals, the pharmaceutical company com-
pliance cases, and much, much more.
Research compliance cases have recent-
ly received a great deal of attention as
well. These cases include the "double
billing" cases (e.g. billing Medicare and
charging costs against a research grant
or clinical trial), conflict of interest
cases, and of course, scientific miscon-
duct cases. While the concerns over
misconduct in science are not necessari-
ly new, a fresh crop of cases has
received a great deal of attention from
the press and from the National
Institutes of Health (NIH) Office of
Research Integrity (ORI).
One recent case is particularly interest-
ing. The case is entitled, United States
of America v. Paul H. Kornak, Criminal
Action No. 03-CR-436 (FJS). A Plea and
Cooperation Agreement was signed in
January 2005. The Defendant was a
research assistant at the Stratton VA
Medical Center in Albany, New York.
The Defendant helped manage studies
in which payments were made by spon-
sors based upon enrollment. In the
course of his work, the Defendant sent
a Case Report Form to a sponsor which
indicated that a participant met the
inclusion criteria for the study and the
participant was, in fact, enrolled in the
study. The participant passed away. It is
alleged that the participant in fact, did
not meet the inclusion criteria for the
study. The Defendant is being prosecut-
ed under criminal and civil proceedings
and the Defendant will have jail time.
There have been many other reported
instances of misconduct in science.
Cases of plagiarism, fabrication and fal-
sification are well reported on ORI's
website. The motivations for these
actions are varied and always fascinat-
ing. In some cases, the motivation
amounts simply to the fact that the
respondents are overworked and lack
resources to pursue the research proj-
ects appropriately. Providing insufficient
resources can be a serious institutional
compliance risk-in other words, if
research organizations do not devote
sufficient resources to conduct research
appropriately, then any problems or
issues will amount to significant expo-
sure for the research organization. As
such, research organizations are well
advised to ensure that the organization
has effective scientific misconduct poli-
cies and procedures in place to deal
with allegations of fraud in science.
Given the increased focus on miscon-
duct in science, ORI has updated its
regulations, which became effective on
June 16, 2005. For any allegations of
scientific misconduct occurring after
May 16, 2005, the new regulations must
be followed. The new regulations can
be found at 42 CFR Parts 50 and 93.
Research misconduct is defined in the
new regulation (42 CFR 93.103) as: "fab-
rication, falsification, or plagiarism (or
FFP) in proposing, performing, or
reviewing research or in reporting
research results. Research misconduct
does not include honest error or differ-
ences of opinion." In addition, the regu-
lation states that "Fabrication is making
up data or results and recording or
reporting them. Falsification is manipu-
lating research materials, equipment, or
processes, or changing or omitting data
or results such that the research is not
accurately represented in the research
record. Plagiarism is the appropriation
of another person's ideas, processes,
results, or words without giving appro-
priate credit." (42 CFR 93.103) In con-
trast to the previous rule, the Final Rule
would require that FFP be a "significant
By F. Lisa Murtha, J.D., CHC
O
F.LI
SA
MU
RTH
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Health Care Compliance Association • 888-580-8373 • www.hcca-info.orgSeptember 2005
13
departure" from accepted practices as
opposed to the "serious deviation" stan-
dard in the previous regulation. (This
new rule is located on the Web at:
http://ori.dhhs.gov/documents/FR_Do
c_05-9643.shtml )
The Final Rule expands the type of PHS
support beyond grants and cooperative
agreements to include support provided
through contracts and through direct
funding of PHS intramural research pro-
grams. The Final Rule also extends the
rules related to plagiarism to include
plagiarism during the journal peer
review process as well. The statute of
limitations for raising an allegation of
scientific misconduct is six years from
the date that the alleged misconduct
actually occurred.
The ORI regulations state that it is the
responsibility of each PHS awardee to
have policies and procedures in place
for investigating and reporting instances
of scientific misconduct. Moreover, each
institution that applies for and receives
PHS funds for research must file an
assurance with ORI that affirms that the
applicant has established a process for
reviewing, investigating, and reporting
allegations of misconduct in research.
Therefore, when conducting a compli-
ance assessment into organizational
compliance with the ORI regulations,
one must start with ensuring that an
appropriate assurance is in place and
that the organization, in fact, has the
required policies and procedures in
place for dealing with allegations of
misconduct in science.
An institutional or HHS finding of
research misconduct must be proved by
a preponderance of the evidence and
the institution or HHS has the burden of
proof for making a finding of research
misconduct. The destruction, absence
of, or respondent's failure to provide
research records documenting the ques-
tioned research is evidence of research
misconduct where the institution or
HHS establishes, by a preponderance of
the evidence, that the respondent inten-
tionally, knowingly, or recklessly had
research records and destroyed them,
had the opportunity to maintain the
records and did not do so, or main-
tained the records and failed to produce
them in a timely manner. The respon-
dent's conduct in this case constitutes a
significant departure from accepted
practices of the relevant research com-
munity. The Respondent, in turn, has
the burden of proving any affirmative
defenses or mitigating factors by a pre-
ponderance of the evidence standard.
The ORI Regulations outline the specific
process to be followed for investigating
an allegation of scientific misconduct.
The process can be broken down into
four general Phases:
■ Inquiry
■ Investigation
■ Reporting
■ Appeals
InquiryAn Inquiry is a means of gathering and
initial fact finding to determine whether
an allegation or apparent instance of
misconduct warrants an investigation.
(42 CFR Part 212 and 93.307) At the time
of or before the beginning of an Inquiry,
an institution must make a good faith
effort to notify, in writing, the presumed
respondent. The institution must also, on
or before the date on which the respon-
dent is notified, take all reasonable and
practical steps to obtain custody of all
research records and evidence needed
to conduct the Inquiry, inventory the
records in evidence, and sequester them
in a secure manner. An Inquiry does not
require a full review of all evidence col-
lected, but rather, to review sufficient
evidence to determine whether an inves-
tigation is warranted. The institution
must complete its Inquiry within 60 cal-
endar days of its initiation unless cir-
cumstances clearly warrant a longer
period. Any time extensions must be
documented in writing. The institution
must provide the respondent an oppor-
tunity to review and comment on the
Inquiry Report and attach any comments
received to the report.
In the event that the results of the
Inquiry indicate that the allegation of
scientific misconduct has merit, the
institution will (within 30 days) provide
ORI with the written finding by the
responsible institutional official. The
written Inquiry Report must include:
■ The name and position of the
respondent
■ A description of the allegations of
research misconduct
■ The PHS support, including, for
example, grant numbers, applica-
tions, contracts, and publications list-
ing PHS support
■ The basis for recommending that the
alleged actions warrant an investigation
■ Any comments on the report by the
respondent and complainant
ORI may further request that the institu-
tion provide information related to:
■ The institutional policies and proce-
dures under which the Inquiry was
conducted
Continued on page 14
14September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
■ The research records and evidence
reviewed, transcripts, or recordings
of any interviews, and copies of all
relevant documents
■ The charges for the investigation to
consider
In the event that the institution deems
that insufficient evidence exists to sup-
port an allegation of scientific miscon-
duct, it must keep complete documenta-
tion to support this conclusion in its
files. ORI may request a review of these
documents at any time.
InvestigationIf the results of the Inquiry reflect a like-
lihood of scientific misconduct, the insti-
tution will begin an Investigation within
30 days of the completion of the Inquiry.
The Institutional Official must contact the
ORI Director of the decision to begin an
Investigation on or before the date that
the Investigation begins. (42 CFR Part
93.310 (b)) The respondent must also be
notified in writing of the allegations
within a reasonable period of time after
determining that the investigation is
going to begin, but before the investiga-
tion actually begins. The investigation
must be fair and complete. Interviews
will be conducted at this stage and all
leads must be pursued. The institution
must complete the Investigation within
120 days of beginning it. This period
includes all time required to prepare the
Investigation report. (42 CFR Part 93.311)
Extensions may be granted by ORI if a
request is made in writing and if circum-
stances warrant it. The respondent has
the right to review and comment on the
report within 30 days after receiving the
Investigation report. The institution may
also provide the complainant with a
copy of the report.
The Investigation Report must include
the following information:
■ The allegations of research misconduct
■ PHS support information including
grant numbers, etc.
■ The specific allegations of research
misconduct subject to the investigation
■ If not already provided, copies of the
institutional policies and procedures
■ The research records and evidence
reviewed, and identify any evidence
taken into custody and not reviewed
■ Statement of findings
■ Whether the misconduct was falsifica-
tion, fabrication, or plagiarism and if
it was intentional, knowing, or in
reckless disregard
■ The facts which support the conclusion
■ Whether any publications need correction
■ The person responsible for the mis-
conduct
■ Any current support or known appli-
cations or proposals for support that
the respondent has pending with
non-PHS Federal agencies
■ Any comments made by the respon-
dent and complainant
■ All relevant research records and
records of the investigation (includ-
ing interview notes, etc.) (42 CFR
Part 93.313)
The institution must give ORI the fol-
lowing information:
■ The Investigation Report
■ Final institutional action
■ A statement as to whether the institu-
tion accepts the Investigation's findings
■ A description of any institutional admin-
istrative actions (42 CFR Part 93.315)
ReportingOnce ORI has completed its review, it
may either close the case without a
finding of scientific misconduct, or it
may make a finding of research miscon-
duct and obtain HHS approval of
administrative actions based on the
record. ORI may also recommend that
HHS seek to settle the case. (42 CFR
Part 93.405) Some of the possible out-
comes of a finding of scientific miscon-
duct include debarment, suspension, let-
ters of reprimand, restriction on
research activities, special review of all
requests for PHS funding, imposition of
supervision requirements, termination of
grants, certification or attribution of all
requests for support and reports to the
PHS, and more. (42 CFR Part 93.407)
Moreover, HHS may seek to recover
PHS funds spent in support of activities
that involved research misconduct. HHS
will take into account whether the
actions were knowing or reckless,
whether the actions were part of a pat-
tern or practice of wrongdoing, the
impact of the misconduct, the respon-
dent's acceptance of responsibility, and
other mitigating circumstances.
AppealsClearly the ramifications of engaging in
scientific misconduct are grave for those
individuals involved. Respondents have
appeal rights (even appeals to District
Court); however, the process can be
extremely costly and time intensive.
Perhaps even more problematic is the
damage to reputation and career that
can result from an allegation of scientif-
ic misconduct. In addition, institutions
that do not develop and implement the
required process for dealing with allega-
tions of scientific misconduct have great
exposure. ORI can pursue various
enforcement actions against research
institutions, including letters of repri-
misconduct in clinical research ...continued from page 13
Continued on page 18
15Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editor's note: This feature interview
was conducted in July by John E.
Steiner, Chief Compliance Officer for
Cleveland Clinic Health System, with
Joseph E. Murphy, a partner in
Compliance Systems Legal Group,
and Managing Director of Integrity
Interactive Corporation, who has
worked in the organizational com-
pliance area for over twenty years.
Joseph E. Murphy may be reached by
telephone at 856/429-5355 and by
email at [email protected].
JS: Please describe briefly your back-
ground in corporate compliance.
JM: I have been in the corporate
compliance and ethics field for 30 years,
20 of them in-house at Bell Atlantic
doing compliance work there. For the
past 10 years I have been a partner in
the law firm of Compliance Systems
Legal Group, and a co-editor of ethikos,
a bi-monthly compliance and ethics
journal. I am also vice chairman and co-
founder of Integrity Interactive
Corporation, one of the largest online
compliance training companies. And I
guess I should mention that in 1988, my
former college professor and I pub-
lished the first book on corporate com-
pliance as a topic.
JS: Could you elaborate more on
your current activities?
JM: In Compliance Systems Legal
Group, we limit our practice to compli-
ance and ethics work only. We help com-
panies develop and enhance their compli-
ance programs in industries across the
board and in companies around the
world. We have even been retained by
federal prosecutors to help them assess
company programs. As an editor of
ethikos, I help bring attention to new
ideas in compliance programs and publish
stories about new tools and ideas so that
others can benefit from the experience.
In Integrity Interactive, Kirk Jordan
and I started a company that applied
our experience in doing compliance
training and took a practical approach
to the use of computers. The company
is now the leader in online compliance
training, with over 200 corporate cus-
tomers and with offices in the United
States and Europe.
JS: Could you comment on key
changes in the Federal Sentencing
Guidelines that you think every compli-
ance professional should know?
JM: Everyone in the compliance field
should focus on the implications of
these changes that went into effect in
November 2004. The Sentencing
Commission, in making these changes,
really delved deeply into the compliance
field and focused the spotlight on some
important elements that need to be in
compliance programs. I think special
attention should be paid to the new
focus on boards, the need to train every-
one who can get the company in trou-
ble, evaluation of the program, and the
role of incentives to drive the program.
On the incentives point, I still hear
people say they cannot figure out how
to offer incentives related to compli-
ance. However, some companies have
been doing it for quite some time. My
colleague, Christopher Vigale and I
wrote an article, recently published in
ethikos, that gives specific examples.
People should also be sensitive to,
but not get too distracted by, the new
reference to culture and ethics in the
revised Guidelines. The key issue here
is that the government wants something
featureMeet Joseph E. Murphy
Partner in Compliance Systems Legal Group, andManaging Director of Integrity Interactive Corp.
article
Continued on page 16
September 2005
16September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
that actually works, and gets your
employees believing that your company
really does want to do the right thing. If
the government interviews your people
in an investigation and your employees
(including the top people) consistently
say, "yes, I was trained on our code and
compliance program and the company
made it clear they would not tolerate
wrongdoing," then you will get at least
a passing grade on culture and ethics.
JS: How would you recommend a
compliance professional explain these
changes to management and the board?
JM: With developments like the sen-
tencing of senior corporate executives
to decades of prison time, and individ-
ual directors being forced to pay for
violations out of their own personal
pockets, you may already have the
attention of senior managers. I think
that explaining the Guidelines standards
requires an understanding of what com-
pliance is about. Surprisingly, even after
years of development of this field, you
will still find managers and board mem-
bers who think compliance is nothing
more than paper and preaching. Just
issue a code, issue some policies, give a
few speeches about doing the right
thing, and you are done. But that is just
wishful thinking. Management and the
board need to understand that effective
compliance programs really need to use
all the management techniques available
to prevent and detect misconduct.
They also need to understand that
the government will not accept an "I
didn't know" defense from the top peo-
ple. More and more, the board and
management are expected to be actively
on the side of doing the right thing. If
the company wants to be treated by the
government as a good corporate citizen,
then it needs to show that it was doing
its best to prevent bad things from hap-
pening, and detecting them early if they
happened. If the board and manage-
ment want to be sure they are doing
the right thing (or at least to avoid 20 to
30 years in prison), then they should
understand that you and the compliance
program are the best insurance policy
they could get.
JS: What trends do you see in the
compliance field that compliance pro-
fessionals need to be alert to?
JM: There are several new trends.
One trend is the globalization of compli-
ance, although this has less impact on
the health care field. I think we are also
all aware of the increased enforcement
efforts and penalties being handed out.
But one less visible trend is a
movement on the part of governments
to require compliance programs. This
change stems from a fairly simple exer-
cise of government logic:
1. Voluntary compliance programs are
good because they can help prevent
and detect violations of law. They are
valuable because companies are apply-
ing their own resources and expertise
to this socially beneficial task.
2. Not all companies have these pro-
grams, and more could be done even
in the ones that exist.
3. Therefore, if voluntary programs are
good, but there are not enough of
them, then let's make the voluntary
programs mandatory. Then everyone
will have voluntary programs that
meet every risk the legislature or reg-
ulatory agencies want addressed.
The result is a rising trend to
require these programs. In health care,
for example, there are now hundreds of
CIA's that require programs. Under
HIPAA there must be privacy compli-
ance program elements. Our Canadian
neighbors require privacy compliance
programs in all companies. In the phar-
maceutical industry the state of
California now requires all companies
doing business in that state to have
compliance programs that follow the
OIG Guidance.
Also, at the state level, three states
- Maine, Connecticut and California -
mandate harassment training. And on
the federal level, Sarbanes Oxley
requires certain compliance programs
elements for public companies; the
NYSE, as well, requires even more than
Sarbanes Oxley.
In fact, I have invented a word to
describe this trend, since it is rather
cumbersome to keep saying "mandatory
voluntary" programs; I call it "mandavo-
lent compliance."
One other comment about this
trend I'd like to make is that generally,
when legislatures impose these pro-
grams they seek out little or no input
from those in our field, and the result is
something typically written by people
who do not have the necessary back-
ground to do this. Because our field has
been rather passive in the political envi-
ronment, we may be living with mis-
guided requirements from the govern-
ment. We in compliance need to get
better organized and vocal, or we will
be struggling with government-dictated
standards that may not work.
JS: The revised Sentencing Guidelines
call for evaluations of compliance pro-
grams, and there has been an increasing
call for metrics in this area. What do
you recommend for compliance pro-
gram evaluation?
JM: This is certainly one of the most
Joseph Murphy
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org 17September 2005
challenging questions in the compliance
field today. I would like to start with a
couple of cautions. The first caution is
that there can be a tendency to count
what is easiest to count, and ignore
what is more difficult. The result of this
is that the things that get measured get
done, and the others are overlooked.
Yet some of the greatest compliance
risks do not readily lend themselves to
measurement.
The second caution is in reference
to what the Sentencing Guidelines say.
When the Guidelines talk about auditing,
they refer to approaches that will "detect
criminal conduct." This should remind us
that whatever we measure, we need to
look at its relationship to serious miscon-
duct. Measurement cannot just be about
bean counting; it must be connected to
the purpose of programs under the
Guidelines-to prevent crime.
A final caution is to consider what
compliance is about. This is not like
measuring production. It is about hav-
ing systems to prevent and detect mis-
conduct. Unlike other things you may
have to measure as a manager, in this
area you have active adversaries-people
who are deliberately trying to do the
wrong thing. I am not saying that most
or even many people are like this, but it
only takes a very small group to wreak
havoc on a company. And whatever it
is you plan to measure, they will be
constantly testing your defenses, look-
ing for weaknesses to exploit. Whatever
you fail to measure they will pursue just
that line of least resistance.
So what does this tell us about
evaluations and metrics? It says to be as
diligent as possible. By all means, meas-
ure how many people use your helpline
and how many people are trained. But
you cannot stop with that-it does not
meet the Guidelines standards and does
not tell you all you need to know.
By all means, use surveys-they pro-
vide useful background data and may
clue you in to failures in your commu-
nications methods. But remember that
business crime is not committed by
majority vote. You can have a work-
place where 90% of the employees hate
the company and hate their boss; this is
a red flag, but it could also mean they
just have a bad boss, and otherwise do
everything by the book. You could also
have a workplace where people express
all the right things-they love the compa-
ny, trust management, and say they
never see any wrongdoing-and yet have
a location where three executives are
actively perpetrating a massive fraud.
Surveys only tell you what people are
willing to volunteer to you.
A big risk here, however, is that
these surrogate measures-numbers of
helpline calls, survey results, billing
accuracy studies-may attract all the
attention because they are quantifiable.
Everyone can read the numbers. But
numbers in the compliance area can
easily provide false comfort.
In short, do not let yourself get
trapped by using simple measures. In
addition to measuring billing accuracy,
also look for the things that may be a
little hidden-fraud, anti-competitive
activity, privacy violations. These
require more careful measurement
steps-unannounced audits, deep dives,
other tests. And ultimately, you need to
be sure management knows that num-
bers will never tell it that the job is
done. The nature of human misconduct
is constantly changing; programs must
always be adapting and changing, no
matter what the metrics say.
JS: What do you see as the future for
compliance professionals?
JM: I see the future to be much more
promising than most people would
imagine. In fact, a colleague and I are
working on a book about compliance
and ethics as a career. The book should
be out in 2006; the Society of Corporate
Compliance and Ethics is publishing it.
As we see it, this field is large and
growing. It includes all those whose
jobs relate to preventing and detecting
misconduct in organizations. They are
not the whistleblowers, but they are the
internal people the whistleblowers
depend on. They are not the people
who defend companies in court, but
they are the ones who help keep the
company out of court in the first place.
They are not the prosecutors and
inspectors general who pounce on com-
panies after something bad happens;
they are the ones who stand up against
wrongdoing in companies before any-
one gets hurt.
Right now this field is fractional-
ized. People in health care do not know
how many opportunities they might find
in related areas. People in privacy have
no real idea how similar their work is to
their counterparts in environmental,
health and safety.
What we see from working with
compliance and ethics professionals in
dozens of industries and different risk
areas is that the people with this func-
tion have a core set of beliefs and com-
petencies; they share a mission that sets
them apart from others who work
around them. A compliance person at a
manufacturer or financial services com-
pany may have more in common with a
hospital compliance officer than they do
with the fellow employee down the hallContinued on page 26
tions. This is in addition to our
compliance Hotline for reporting
potential compliance issues. Our
associate-generated "brand" is making
frequent appearances and keeps compli-
ance top-of-mind for our associates and
management. ■
References:
- Blackmore, Jessica (1996) Pedagogy: Learning Styles
Retrieved Feb 10, 2005 from Telecommunications for Remote
Work and Learning.
- Kear, Jeff (2003). Branding Through Effective Logo Design.
Retrieved May 1, 2005 from www.marketingsource.com.
- Lieb, Stephen (1991). Principles of Adult Learning. Retrieved
February 4, 2005 from http://honolulu.hawaii.edu. Faculty
Development Guidebook.
- OIG DHHS, Compliance Program Guidance for Third Party
Medical Billing Companies, US Department of Health and
Human Services, 1999, (pp 10)
- Troklus, Debbie & Warner, Greg, (2001). What's in A Name.
In Compliance 101 (pp. 9). Pennsylvania: Health Care
Compliance Association.
- Troklus, Debbie & Warner, Greg, (2001). The Seven Essential
Elements - Education. In Compliance 101 (pp. 17-19).
Pennsylvania: Health Care Compliance Association.
- Troklus, Debbie & Warner, Greg, (2001). Organizational
Steps - Gain Support and Commitment. In Compliance 101
(pp. 31-34). Pennsylvania: Health Care Compliance
Association
- Van Yoder, Steven (2003). The brand Called You. Retrieved
May 10, 2005 from www.marketingsource.com.
18September 2005
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 profes-
sionals
■ Facilitates compliance work for com-
pliance 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 Fager
Coleen Fair
Paul Flanagan
Debbie Adams
Sunday Aigbohoh
Heather Caldwell
Scott Desmond
Carol Edelberg
Cheryl Harrison
Karleen Hulbert
Stephen Kelly
Mary Laboy
Juan Roadas
Health Care Compliance Association • www.hcca-info.org
misconduct in clinical research...continued from page 14
mand, refer the matter to HHS, place the
institution on special review status, debar-
ment or suspension of the institution and
much more. (42 CFR Part 93.413)
Given what is at stake today, research insti-
tutions should strongly consider developing
and implementing a research compliance
program. This effort should include (at a
minimum) comprehensive training and edu-
cation for all administrative staff, investiga-
tors and coordinators, and detailed auditing
and monitoring. Being proactive, and hav-
ing an effective offense, is always the best
defense. ■
Overcoming barriers to compliance
...continued from page 7
19September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editor's Note: Danna R. Teicheira is
the Manager of Compliance
Education and Audit for the Tulane
University Medical Group. You may
contact her at 504-988-9816 or dte-
n July 1, 2004, a new compliance
policy for the Tulane University
Medical Group (TUMG) mandat-
ed that physicians earn three compli-
ance credits each fiscal year. For each
unearned credit, a fine of $1,000 will be
levied on the department(s) with non-
complying physicians.
The Compliance Staff responded to the
new policy by offering education
options designed to:
■ provide more and different educa-
tional options for physicians
■ provide educational options that were
directly applicable to physicians and
their practices, as opposed to general
education sessions
■ make compliance education more
accessible for physicians.
Providing easily accessible and relevant
billing compliance education to a facul-
ty practice of more than 300 physicians
has challenged the creativity and
resources of the Tulane University
Medical Group (TUMG) Billing
Compliance staff. At the end of March
2005, we took some time to assess how
far we had (or had not) come in reach-
ing our goals.
In order to gauge our progress, we
looked at the following items:
■ number of educational options avail-
able prior to the implementation of
the new policy
■ types of education that were most
frequently accessed
■ percentage of physicians who had
earned their three compliance credits
as of March 31, 2005
Education options increased in FY2005Prior to FY2005, the following billing
compliance education options were
available:
■ Quarterly education presentations -
every hour on the hour education
presented by the Compliance Staff (4
topics presented each year)
■ Videotaped presentations (e.g. ABN's,
Consults, Teaching Physician Rule)
which could be checked out from
the Compliance Office for viewing.
Physicians could earn credit by earn-
ing 70% or better on a quiz.
■ Medicare web-based training. Proof of a
passing score on the post-test required.
■ One-on-one education as requested;
this included New Physician
Compliance Orientation.
■ Department/section-specific educa-
tion as requested
■ Other non-Tulane education/training
sessions, as approved for content and
relevancy
In response to the new policy, the edu-
cational options were increased. Besides
offering new training options, the exist-
ing training was revised with the goal of
fostering physician participation and dis-
cussion. At present, the following edu-
cation options are available:
■ Quarterly education presentations -
These presentations have been
revamped to offer physicians a variety
of compliance topics, and the presen-
tation formats range from PowerPoint
sessions to interactive workshops.
■ DVD/VHS presentations - In order to
make this education option more
accessible, three new presentations
were produced and copies of each
presentation format given to each
clinical department, eliminating the
need to check tapes in and out of
the Compliance Office.
■ Three-part interactive Evaluation and
Management Coding (E/M) workshop.
■ Department/Section-specific educa-
tion - This option has been much
more in demand this fiscal year. The
heightened interest can be attributed
to the Compliance Staff's active solici-
tation of clinical departments
■ Tulane website presentations
■ Medicare web-based training
■ One-on-one education
■ Other non-Tulane education/training
sessions, as approved for content and
relevancy
An interactive approach to educationOne of the main complaints that physi-
cians frequently voiced about education
was that it was repetitive and "nothing
new" was presented. A primary focus of
our compliance education is the under-
standing and appropriate application of
Evaluation and Management (E/M)
guidelines. The Compliance Staff agreed
with the physicians that E/M coding edu-
cation seemed to be "same old - same
old." To shake things up and invigorate
the education, we mapped out an E/M
coding education series designed to pro-
mote physician participation and foster
By Danna R. Teicheira, CHC
I
Continued on page 20
20September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
discussion. This is what we did:
■ We divide the E/M education into
four distinct sections: 1) Intro to E/M
Coding, 2) E/M Key Components
(History, Exam, and Medical Decision
Making) - a three-part series, 3)
Documenting E/M Services in a
Teaching Setting, 4) Consults and
Time-Based Codes. Each topic was
developed as a 45-60 minute interac-
tive presentation
■ We provide the physicians with a 60-
page E/M Key Component manual we
developed that begins with an intro-
duction to the process by which E/M
levels are determined - the "Meet or
Exceed" principle. This 15-20 minute
introduction to E/M coding allows
physicians to determine the level of
service using computation charts for
new and established patients.
■ Following this brief exercise, we pres-
ent the Medical Decision Making
(MDM) Key Component and physi-
cians used an auditing template to
determine the level of medical decision
making for sample documentation.
■ The History and Exam Key Components
is then presented. In deciding to pres-
ent the MDM section first, we hoped
that physicians would see how History
and Exam Key Components serve to
support the MDM, and ultimately, the
level of service.
■ The E/M series concludes with physi-
cians using audit templates to deter-
mine a level of service for several
sample progress notes.
The first E/M workshop was scheduled
for September 17, 2004, but the untimely
arrival of Hurricane Ivan delayed the
rollout until October 22, 2004. We
engaged an outside coding instructor to
teach the first class. The physicians
attending were a lively group and, as
hoped, the interactive approach prompt-
ed discussion. Evaluations of the session
were positive, with several physicians
noting that department/section-specific
sessions would be well received.
There were some negatives to the ses-
sion, for example, prolonged discus-
sions led to a race against time to finish
the presentation and, we noted that
some of the materials needed revision
because what looked good on paper,
but in some instances, didn't translate
well to an interactive class.
When the session went 15 minutes
overtime, with not one physician run-
ning for the door, we deemed the
workshop a success. We worked quick-
ly to iron out the kinks, and then incor-
porated the E/M Key Component series
into our Quarterly Education series. We
offered each key component separately,
so that physicians could opt to take the
complete series, or pick and choose the
E/M training of their choice.
Tracking EducationAfter tracking compliance education for
nine months, it was easy to identify the
compliance education options most uti-
lized and best received.
The Quarterly Education series, with
improved content and format, has not
drawn high attendance - even with all
of our efforts to offer this type of edu-
cation on different days, and different
times, in order to reach more physi-
cians. Physician evaluations are general-
ly positive, but it is the least utilized of
our education options.
Department/Section-specific education
has risen dramatically. We have been
invited by several departments/sections
to present the E/M series. Some depart-
ments request a marathon session,
while others prefer one topic at a time.
For departments where E/M coding
education is not needed, we have
actively solicited invitations to physician
meetings. It is the second most popular
education option.
The most accessible and most frequent-
ly utilized option is the Tulane website,
where there are currently nine educa-
tion sessions available. Each PowerPoint
presentation may be viewed, and an
accompanying quiz printed. Physicians
may complete the quiz and fax it to the
Compliance Office - a score of 70% or
higher earns a compliance credit. We
definitely plan to add three more pre-
sentations to the web for the next fiscal
year. We are currently discussing how
to add the E/M coding series to the web
and keep the interactive format.
Final comments: Measuring successThe TUMG Compliance Staff continues
to work with physicians to establish
billing compliance as an integral part of
day-to-day physician practice. The
mandatory education policy has height-
ened compliance awareness. Options
for earning compliance credits have cer-
tainly increased, and at the same time,
compliance education has become more
accessible, interactive, and relevant. If
we go by numbers, our new and
improved approach to compliance edu-
cation is working well. With three
months left in the fiscal year, 42% of
TUMG physicians have already complet-
ed their three compliance credits, and
96% have earned at least one compli-
ance credit. ■
Compliance education ...continued from page 19
21September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editor's note: Julie E. Chicoine, JD,
RN, CPC, is Compliance Director at
The Ohio State University Medical
Center, Columbus Ohio. She may be
reached at 614/293-2007 or by
email: [email protected]
he Medicare program pro-
vides health care coverage to
approximately 42 million
Americans.1 The Medicare Fee For
Service component of the Medicare pro-
gram continues to represent the majority
of overall Medicare enrollment. In fact,
government data indicates that 86% of
today's beneficiaries continue to partici-
pate in the traditional Fee-For Service
program. However, the Medicare pro-
gram, as currently structured, is not
capable of addressing the pending
impact of retiring baby-boomers, who
will become beneficiaries in the very
near future.
The Medicare Prescription Drug
Improvement and Modernization Act of
2003, (MMA) brings significant and far-
reaching changes to the way Medicare
program contractors will provide servic-
es to health care providers and benefici-
aries. The most significant change will
be the elimination of all current con-
tracts with existing fiscal intermediaries
and carriers. CMS will replace these enti-
ties with a new contract entity known as
Medicare Administrative Contractors
(MAC). MMA requires that the transition
from fiscal intermediaries and carriers to
MACs be completed by October, 2011.
The goals of consolidating intermedi-
aries and carriers, and replacing them
with MACs, are to: create a uniform and
seamless approach to management and
payment of Part A and Part B claims;
improve Medicare's administrative servic-
es through the consolidation of contrac-
tors; and create performance incentives
for improved services to both beneficiar-
ies and providers.
On February 7, 2005, the Secretary of the
U.S. Department of Health and Human
Services (DHHS) submitted a report to
Congress outlining the plan for imple-
mentation of contracting reform. The
reforms contemplated under the MMA
will have a dramatic effect on how CMS
contracts will be entered into, adminis-
tered, and ultimately; how services are
offered to health care providers, profes-
sionals, suppliers, and beneficiaries.
Multiple contractorsUnder the current intermediary/carrier
contracting model, CMS contracts with
51 private insurance companies around
the country to process Medicare claims
and perform other administrative servic-
es. These contractors include 25 Fiscal
Intermediaries and 18 Carriers who
operate in multiple, and sometimes
overlapping jurisdictions. Current con-
tractor jurisdictions vary widely. Some
contractors cover several states, while
others are limited to a single county.
Because no uniform process was initially
established for the contracting network,
current intermediary and carrier con-
tracts differ widely in terms of the num-
ber of beneficiaries served, and in the
number of claims processed. This
uneven process has led to an uneven
distribution of workload among all of
the contractors.
Furthermore, as both health care
provider and Medicare program benefi-
ciaries are well aware, the current sys-
tem allows for no single Medicare point
of contact for claim-related inquiries.
The Medicare program processes
approximately one billion claims each
year from over one million health care
providers. However, both Part A and
Part B claims are processed and paid
through separate contractors who do not
communicate with one another. This sit-
uation can be confusing and frustrating
for both beneficiaries and providers who
seek clarification and guidance regarding
coverage and coordination of care.
Open competition for contractorsUnder contracting reform, CMS will
expand competition for Medicare's
claims-payment business beyond tradi-
tional health insurance companies
through an extensive operational over-
haul. CMS will accomplish this strategic
goal by offering contracts to a broader
range of private sector organizations.
Historically, a provider was allowed to
nominate the intermediary of its choice.
Continued on page 22
By Julie E. Chicoine
T
22September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Under the new law, CMS will award con-
tracts to "any eligible entity" through a
competitive bidding process, which
includes "demonstrated capability" to
carry out the required contractor func-
tions. Minimum MAC requirements
include: compliance with Federal
Acquisition Regulations and conflict of
interest standards; sufficient financial
assets to support performance functions;
and any additional requirements imposed
by the Secretary of DHHS. CMS will re-
compete all contracts every five years.
Consolidation and reconfigurationBeginning September 2005 (a start-up
cycle followed by two transition cycles)
CMS will openly compete contracts to
establish 23 MACs operating in distinct,
non-overlapping jurisdictions. The
Primary A and B MACs will operate in
15 distinct geographical jurisdictions.
These 23 MACs will replace the services
currently provided by all 51 existing
intermediaries and carriers around the
country. CMS will also establish four
specialty durable medical equipment
(DME) and four specialty Home Health
MACs. CMS determined the new MAC
jurisdictions based upon the following
criteria:
■ Promote competition
■ Balance work load
■ Account for integration of claims pro-
cessing activities
Single Point of Contact Currently, multiple contractors create
administrative burdens for health care
providers and beneficiaries in terms of
time spent contacting both intermedi-
aries and carriers for coverage and other
issues. In addition, all current CMS con-
tractors provide services under cost-
based reimbursement contracts, with
limited or no competition. This arrange-
ment has fostered little incentive to
improve the quality of services. For
example, a July 2004 Government
Accountability Office (GAO), (formerly
General Accounting Office), report2
found that only four percent (4%) of
contractor staff member responses to
GAO's four-question "secret shopper"
test calls to 34 contractor call centers3
were correct and complete. The GAO
stated that the level of correct and com-
plete responses posed to billing ques-
tions ranged from "one to five percent."
Most of the remaining responses were
incorrect, partially correct or incomplete.
The MACs will establish a single point of
contact for the information needs of
Medicare beneficiaries and health care
providers. The beneficiary point of con-
tact will be 1-800-MEDICARE, a cus-
tomer service center that will provide
information about the Medicare pro-
gram, prescription drug coverage, and
how to find and compare nursing
homes.4 Beneficiaries will receive one
Explanation of Benefits (EOB) for all
health care services.
Medicare Administrative Contractors will
be the single point of contact for con-
ducting all claims-related business for
providers, including verifying claims sta-
tus, beneficiary eligibility, and the claims
payment process. CMS intends to
accomplish this goal through modern-
ized IT systems that will enable provider
access through a secure web-portal.
Historically, intermediary and carrier
contracts were limited to a cost reim-
bursement or no-profit model. To
improve customer services for both ben-
eficiaries and providers, CMS will estab-
lish pay for performance incentives,
allowing contractors to earn profits
when they are efficient, innovative, and
cost-effective. CMS will also develop
performance requirements and standards
for MACs to ensure higher quality serv-
ice, including timely and accurate claims
payment, provider education and out-
reach activities, and more timely corre-
spondence requests. These incentives
will be incorporated into all MAC con-
tracts, and will be evaluated through
provider and beneficiary surveys and
consultations.
Changes to IT infrastructureThe current claims system operates on
Medicare contracting reform ...continued from page 21
Reform Timeline: ■ February 2005 - CMS issued initial Primary A/B MAC Statement of Work (SOW) for
public comment■ March 2005 - CMS released formal Request for Proposal (RFP) for DME MAC's.■ September 2005 - CMS will release a formal primary A/B MAC RFP for Jurisdiction
3 - Arizona, Montana, North Dakota, South Dakota, Utah and Wyoming.■ December 2005 - CMS will award the DME MAC contracts and will immediately
begin necessary transitions.■ June 2006 - CMS will award the first Primary A/B MAC for Jurisdiction 3 and
immediately begin necessary transitions. ■ September 2006 - CMS will issue RFP's for Jurisdictions, 1, 2, 4, 5, 7, 12 and 13■ September 2007 - RFP issuance for Primary A/B MAC Jurisdictions 6, 8, 9, 10, 11, 14,
and 15 ( Kentucky and Ohio). Award date for Jurisdictions 1, 2, 4, 5, 7, 12 and 13■ September 2008 - Award date for Jurisdictions 6, 8, 9, 10, 11, 14, and 15.Projected cost savings estimated to be $900 million by FY 2010. Beyond, FY 2011,CMS estimates annual savings of $100 million, through administrative reductions
an increasingly outdated information
technology infrastructure. The FFS
claims processing system is composed of
separate shared systems that process
claims by provider type. The Common
Working File (CWF) is a prepayment val-
idation and claims authorization system
designed to check beneficiary eligibility
and utilization. These systems make up
a loose "patchwork" that cannot meet
the impending challenges to the
Medicare program. CMS will replace its
existing accounting systems with a new
entity known as the Healthcare
Integrated General Ledger Accounting
System (HIGLAS), which will operate as
a single, integrated financial accounting
system. Once a Medicare claim has been
processed, HIGLAS will perform the
payment calculation, formatting, and
accounting; as well as recording and
tracking accounts receivables. Improved
integration will establish a unified and
more efficient claims system, and will
also enable CMS to more aggressively
identify patterns of fraud and abuse
through data mining activities.
Contractor Exposure for Overpayments One of the more interesting changes
under contracting reform will be con-
tractor liability. Under current law, inter-
mediaries and carriers are not liable to
CMS for inadvertent overpayments made
to providers. However, under the MMA,
MACs will be immune from liability for
overpayments unless the MAC acted
with "reckless disregard" of its obliga-
tions under its Medicare administrative
contract, or with intent to defraud the
government. The reckless disregard stan-
dard does not require specific intent and
is the same standard applied to
providers under the False Claims Act.
ConclusionMedicare contracting reform is long
overdue. The changes discussed here
will lead to improved services for both
health care providers and beneficiaries;
in terms of payment determinations,
consultative services, and outreach and
assistance. However, reform also pres-
ents compliance challenges.
Consolidation and improved IT infra-
structure creates the opportunity for
powerful automated data mining of both
Part A and Part B claims. Accordingly,
compliance professionals will need to
remain alert to the potential for
increased scrutiny of payment for
Medicare claims. A reform timeline is
presented in the Figure. Readers may
access detailed information about
Medicare Contracting Reform, including
the Secretary's Report to Congress at the
following website:
http://www.cms.hhs.gov/medicarere-
form/contractingreform/ ■Report to Congress at page I-1GAO Report to Ranking Minority Member, Subcommittee
on Health, Committee on Ways and Means, House ofRepresentatives: "Medicare - Call Centers Need toImprove Responses to Policy-Oriented Questions FromProviders" (GAO-04-669)
Questions included 1) billing for beneficiaries transferredfrom one hospital to another, 2) billing for servicesdelivered by therapy students, 3) billing of multiple sur-geries for same patient on same day, 4) billing anoffice visit and procedure for same patient on sameday.
Interesting point in that Medicare coverage does notinclude convalescent nursing home care.
23September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.orgHealth Care Compliance Association • 888-580-8373 • www.hcca-info.org
Ingredients:■ Patient and family
■ Quality healthcare services
■ Caring
■ Compliance standards and policies
■ Compliance officer
■ Leadership with high ethical standards
■ Values: Respect, Integrity, compassion,
collaboration, stewardship and quality
■ Confidentiality
Directions:Put Patient and family in center of every-
thing. Stir in several cups of quality
health care services from all hospital
departments . Mix with equal cups of car-
ing (from Medicine, Nursing, and all hos-
pital departments). Simmer until patient
and family feel warm. Next, surround
with several compliance standards and
policies, and stir, using a knowledgeable
and personable Compliance officer.
Monitor and audit to make sure patient
and family feel warm. Next, season with
a heaping tablespoon of respect, integri-
ty, compassion, collaboration, steward-
ship and quality. Monitor to make sure
patient and family are still in the center!
On top of this well-seasoned mixture,
sift leadership with high ethical stan-
dards. Continue stirring until all ingredi-
ents are well blended.
Serve on a warm platter, making sure
patient and family are still in the center!
There you have it—an effective compli-
ance department—and remember, each
time this mixture occurs, it is different
because every patient is a unique indi-
vidual. ■
By Gynelle Baccus, RN, PhD
24September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
As I wrote this article, my spell
check caught me spelling
effectiveness as effectivemess,
and the Freudian slip sounded like a great title. It pretty much
sums up my view on the whole effort to measure the effec-
tiveness of compliance programs. I have seen millions of dol-
lars spent by the industry's most knowledgeable compliance
professionals on attempts to develop a way to measure the
effectiveness of a compliance program. This has been the sin-
gle most interesting thing I have observed in the compliance
profession. Almost everyone thinks it is necessary and almost
everyone thinks it can be done. It seems obvious, easy,
doable, and so very important. However, I have yet to see
two people agree on how it should be done. David Orbuch
and I agreed on something once but I forgot what it was.
I think we should at least be able to agree that there is a dif-
ference between measuring effectiveness and measuring the
existence of the seven elements. We lump them together as
though they are the same, but they couldn't be more differ-
ent. Separating these discussions during our debate may help
make this easier.
For six years, I have sat in rooms full of industry experts try-
ing to develop a compliance program measurement tool.
There has been significant frustration. I have been through
three major attempts to set a standard to measure effective-
ness, and all three times the group has gone through similar
stages. The stages are:
(1) They are full of glee because they are finally going to
achieve this great accomplishment (probably thinking
about the ease of measuring the existence of the elements).
(2) They pound the living daylights out of each other for
hours (arguing about measuring effectiveness).
(3) Then they compromise and walk away feeling less than
satisfied.
Some evaluation methodologies seem
simple and straight forward, and
would probably conclude that if sev-
eral problems are revealed, your com-
pliance program is not working. That
is an easy method of evaluating a
compliance program, but is it accu-
rate? Let's take Boeing for example.
They have one of the country's most exhaustive ethics pro-
grams. They have given money to Seattle University to set up
the Boeing Chair of Ethics. The Chair is occupied by John
Dienhart, a great Ethicist. Boeing has had three huge compli-
ance issues in the recent past. In one case, the top manage-
ment (including the CEO) left, after allegedly hiring a procure-
ment officer from the government in an effort to get a big con-
tract. The incoming CEO was selected to send a message to
the employees that Boeing was committed to ethics. He was
asked to leave for allegedly having an affair with an employee.
One could say that Boeing's ethics/compliance program does-
n't work. However, one could argue that it works effectively
because they found and fixed the problems. Isn't that what
compliance programs do? Their program appears to have "big
teeth." The discipline seems more than adequate. It is not a
question of whether you have problems, but rather, how you
deal with them. Did they deal with them? I am sure you could
criticize something that Boeing did, but their actions appear
pretty serious to me. I really could argue it either way, but the
point is that the existence of problems is not necessarily an
effective indicator of compliance program effectiveness.
There are a myriad of issues that complicate this effort to meas-
ure compliance program effectiveness-issues which are not
apparent to many people. Because the pitfalls are not apparent,
and the cause so important, it creates a perfect storm for argu-
ment. We want effectiveness measurement very badly and
because we can't see why it won't work, we really get frustrat-
ed. People are so absolutely sure how it ought to be done;
however, they all see it differently. There is so little agreement
that there are no competing philosophies. There are no "groups
of people" who are pushing for one way to do it. Why,
because to form a group, two people would have to agree.
The following are specific examples of the debate that occurs
Roy Snell
Effectivemess:
Continued on page 27
25September 2005
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Share Compliance Documents With Other HCCA Members...
And win one of 12 Portable DVD PlayersCourtesy of:
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from them.
I see the numbers of people doing
compliance work expanding among all
different industries and on a global basis.
It is inevitable. Companies and other
organizations have been getting larger
and larger in modern society. With that
comes much more capacity to both do
good and to cause harm. Look at the
impact from Enron's failure, for example.
At the same time, government cannot
really control this. Government only
comes into play well after the disaster
happens and the harm is caused. They
can then punish everyone (which usually
means more harm to those employees in
the offending company - e.g., look at
Anderson), but only after the fact.
The only realistic alternative is to pres-
sure companies to police themselves, and
for that to happen there must be strong,
effective in-house compliance people.
This is a trend that is universal; we see
rapid growth in compliance efforts
around the world, wherever there are
large companies. We see growth within
companies. The company that starts with
one compliance officer soon realizes
there must be a staff, risk area subject
matter experts, and equivalent compli-
ance operations at the field locations.
We have seen no statistics on the
total numbers of compliance people -
part time and full time - around the
world, but we estimate it may be in the
150,000 to 200,000 range.
We see a time when being a com-
pliance professional will be a recog-
nized career, opening doors into corpo-
rations and other organizations around
the world. We also see more mobility
among the different industries and risk
areas, at least as much as you see now
for lawyers and auditors.
One other point about the future
for our profession that I'd like to make;
I believe that we must become stronger.
Here, I mean that compliance profes-
sionals need to be in a stronger position
within their companies-they need to
have the support and clout to stand up
to even the most forceful and powerful
executive in the company. I also mean
that we must become stronger as a pro-
fession. We need a strong ethics code
for all compliance people. And we need
to be organized and have a strong voice
in the political arena.
More than most fields and profes-
sions, ours is directly affected by what
happens in government. Consider that
the whole foundation of our field rests
with a few government initiatives like
the Sentencing Guidelines and other
standards like the HHS OIG Guidances.
We need to be in there making sure
that government knows what it is doing
when it ventures into this area.
Otherwise we will end up with things
like Sarbanes Oxley, which completely
overlooked the existence of compliance
people, and imposed things like codes
of ethics, even though the poster child
for corporate corruption-Enron-had a
code of ethics and a values statement
that failed miserably.
We need to be there so that good
faith compliance programs get the sup-
port and recognition they need and
deserve, and that government does not
waste everyone's time by imposing
things that take attention and resources
from the things that do work. ■
Joseph Murphy
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Effectiveness ...continued from page 24
during effectiveness meetings. Two of
the brightest people I know argued that
audit results should not be a measura-
ble outcome. I still don't get that one,
nor can I even explain their logic, but I
will tell you that they are two of our
best, brightest, and most respected com-
pliance professionals in the industry.
The second example is the value of the
anonymous reporting mechanism. What
if you don't have one? Most people
would say that if you don't have one,
your compliance program is not effec-
tive. Are there companies that don't
have one, have no history of compli-
ance issues, all employees feel comfort-
able going to their supervisor, and com-
plaints are followed up on? I know
there may not be many companies that
can do this, but an evaluation tool may
reject an organization's compliance pro-
gram erroneously.
Even though measuring outcomes or
effectiveness is better than measuring
the existence of the elements, it can still
be imperfect. Take education for exam-
ple. Measuring the existence of educa-
tion is relatively easy. Measuring the
effectiveness of education is better. Most
people would say measure retention.
They debate endlessly how to do it;
pre-test, post-test and/or retention tests
are often discussed. They argue about
testing 30, 60, 90, days after education
for retention. However, if you measure
the retention of education, does that
mean that the education is effective? If
employees retain education, do they put
it into action? Some may know what to
do and could pass a compliance educa-
tion retention test six years later, but
they may choose not to do the right
thing. You have to audit their actions,
not just their retention.
I was talking to Jim Sheehan from the
Department of Justice about this and my
most recent observation (it's always
changing) is that the best you can do is
to sample an organization's actions/out-
comes, not just the existence of ele-
ments. As cited in the education exam-
ple, you also have to be careful not just
to measure "1st tier" outcomes. You
have to look at how specific investiga-
tions were conducted. You would have
to do some auditing. You have to
review follow up on complaints. Along
the way you will talk to many people.
Probably one of the best indicators is
the general attitude and effort. It sounds
a bit simplistic but I really don't think
there is an easy formula. We all want a
formula. We are all sure it is highly
measurable. But is it?
There is no formula for hiring the right
people. We don't think that there is a
way to measure the beauty of a paint-
ing. These are subjective things.
Compliance effectiveness measurement
may just end up being a subjective call.
For some things, the best you can say
is, "I know it when I see it." It's a lousy
solution, but it just may be all we have.
I know of a consulting firm that will
certify your compliance program, but I
really don't know how they do it. I
would think that the best they could do
it is to measure the existence of the
seven elements. Would you call that
certification? Would you value that certi-
fication? My view is that it has some
value, but it is not the Holy Grail.
Let's try to agree on something. To ease
some of the painful debate, it might be
helpful to stop lumping, into the same
conversation, measuring effectiveness
and measuring existence. Let's make
sure that we clarify which we are talk-
ing about before we start debating
again. Maybe we could agree that audit-
ing for the existence of elements is easi-
er and has some limited value. We
could agree that measuring the effec-
tiveness is hard but it has greater value.
The key to all this, as it is with many
things, is that effort counts. I have found
that whatever you work very hard on
usually ends up being successful. I
know it sounds like the "blinding state-
ment of the obvious" but we can
become discouraged if we can't see spe-
cific results along the way or if there is
no clear roadmap. Sometimes I charge
in a general direction with no clear
instructions about what I should do. It
usually works out. Don't get discour-
aged. Don't quit just because the path is
not clear and there is little professional
agreement about what to do. Do some-
thing. We may never agree on effective-
ness, but trying to measure effectiveness
will tell you something. Even though
measuring effectiveness is imprecise,
and measuring the existence of the
seven elements is of dubious value, they
are both better than doing nothing. ■
Editor's note: Edwin D. Rauzi is a
partner in Davis Wright Tremaine
LLP's Seattle office. He focuses his
practice on Health Care matters,
designing and implementing corpo-
rate compliance plans; advising cor-
porate compliance officers. He may be
reached by telephone at 206/622-3150
ompliance departments that
are well-organized and prop-
erly funded are likely to have
developed an inventory of financial
relationships with physicians, which
were then analyzed and-if necessary-
modified. That effort is one basis for a
Compliance Officer to report legitimate-
ly to his or her Board that the organiza-
tion is "in compliance." Once such
inventories are developed, however,
they must be maintained.
In addition to voluntary efforts under-
taken by organizations pursuing best
practices, the Stark II regulations author-
ize CMS to demand that a facility pro-
vide certain defined records that
demonstrate compliance with the
statute's substantive requirements.
Although the agency has the discretion
to extend the time that an entity has to
respond, the regulations only require 30
days' advance notice. The penalty for
failing to comply is up to ten thousand
dollars for each day past the deadline
that CMS imposes.
Although the data required to be pro-
vided under the regulations is not volu-
minous, compiling it in 30 (or 60 or
even 90) days would be a daunting task
for an organization that seeks to capture
the information for the first time. Think
about it-could your organization gather,
analyze and present data on each finan-
cial relationship that it had with a physi-
cian and why it came within the scope
of a Stark exception in a month? If the
answer is "no," then you might want to
consider beginning to capture the infor-
mation in a data base.1
BackgroundFor over ten years now, the Stark II
statute has authorized the Secretary of
HHS to require an organization to pro-
vide information on its financial rela-
tionships with physicians.2 For much of
that time, the agency signaled its inten-
tion to make the reporting mandatory.
Not only would the reporting be
mandatory, but it would be done on an
annual basis with a duty to give the
agency notice of changes.
As an initial step to defining a reporting
form and drafting instructions on how
to complete it, the agency conducted a
pilot program in ten states. It comes as
no surprise to any in the compliance
community that the task of gathering
the information proved formidable for
the agency and providers alike. Without
final rules, the physicians and organiza-
tions had questions about how to com-
plete the forms. Without final rules, the
agency had difficulty in answering the
questions posed. The pilot project was
completed in the mid-1990's, and is
largely forgotten today.
The final "final" phase of the Stark II
RegulationsOn March 26, 2004, CMS published the
final regulations implementing its
authority to require information. To the
relief of the health care community, the
idea of mandatory annual reporting was
abandoned. Instead, CMS identified the
following elements of information that
should be available if requested:
■ The name and unique physician
identification number (UPIN)3 of each
physician who has a financial rela-
tionship4 with the entity.
■ The name and UPIN of each physi-
cian who has an immediate family
member who has a financial relation-
ship with the entity.
■ The covered services furnished by
the entity.
■ The nature of the financial relation-
ship, including the extent and/or
value of the financial relationship
The regulations also identified the mini-
mum time that the agency must give the
entity to respond (30 days) and the
maximum daily penalty that it might
impose ($10,000 per day).
The Information is "MaintainedAlready"As initially envisioned, the reporting
28September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
C
ED
WIN
D.R
AU
ZI
By Edwin D. Rauzi
29September 2005
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
requirement was to be widespread,
comprehensive, made on an annual
basis and on a standard form; with an
ongoing duty to notify the regulators of
changes.5 By tracing the evolution and
development of the reporting regula-
tion, it is clear that industry representa-
tives argued that the proposed reporting
duties would be onerous, burdensome
and expensive. Those arguments even-
tually carried the day, and most of the
requirements were abandoned in favor
of a duty to report, if and when
requested to do so.
It is worth noting, however, the Agency's
comments with respect to whether
responding to a request for information
would be onerous or burdensome. The
exchange reads as follows:
The burden associated with these
requirements is that of maintaining doc-
umentation and, if necessary, making it
available to the Secretary. We believe
that the information we are requiring
the entities to maintain is information
that they would have and maintain
already. The proposed rule proposed
that entities that are subject to require-
ments of this section must report to the
agency on a prescribed form, and there-
after report once a year, all changes to
the submitted information that occurred
in the previous 12 months. In this rule,
the requirement has been modified to
require entities to make information
available only upon request and to
maintain the information only for the
length of time specified by the applica-
ble regulatory requirements for the
information (that is, IRS, SEC, Medicare,
Medicaid, or other programs). This sub-
stantially reduces the burden on entities,
since this is information that is required
to be maintained by other regulatory
agencies in the usual course of busi-
ness. We believe that this burden is a
result of usual and customary business
practice and, as such, is exempt from
the PRA under 5 CFR 1320.3(b)(5).6 69
Fed. Reg. 16121 (Mar. 26, 2004)(empha-
sis added).7
Should your organization compile theStark II compliance records?No organization has unlimited resources
to devote to compliance; hence, any
compliance initiative needs to demon-
strate that it has value and is a cost-
effective approach to take. Here are the
"pros and cons":
■ Arguments in favor--
■ It gives the Compliance Officer a
legitimate foundation to answer
questions that his Board or CEO
poses about whether the organiza-
tion is complying with Stark
■ Some organizations are so large
and complex that it is not realistic
to expect them to be able to gath-
er the data "from scratch" in a
short period of time
■ By gathering the information over
time, the data base can grow by
accretion
■ By including the expiration date of
written agreements in the data base,
it helps the organization avoid hav-
ing them expire unnoticed
■ Arguments against-
■ CMS will never ask for the infor-
mation-and if they do, they will
not ask my organization
■ The organization has other compli-
ance projects with higher priority
One way to keep the recordsOnce you decide to keep the records,
you need to (a) define what data you
want to capture and (b) how to record
it. One approach is illustrated by the
data base form that is available on the
HCCA web site. The data to be cap-
tured is limited to that required by the
regulations, plus fields for the expiration
date of written agreements and com-
ments. Your organization may choose
to develop a different form, use a differ-
ent data base program, or capture addi-
tional data. ■
* This article is not intended, nor should it be used, as a
substitute for specific legal advice as legal counsel may
be given only in response to inquiries regarding partic-
ular situations.
** Copyright © 2005, Davis Wright Tremaine LLP. Please
do not reprint, or post on your website, without
explicit permission. Thank you.
1 One way to begin is by using a computer tool or form
that HCCA and the law firm Davis Wright Tremaine
have developed jointly. The form may be down-
loaded without cost at www.hcca-info.starkII.htm, but
it requires Microsoft Access to operate. Alternatively,
you may wish to develop your own form internally.
2 The authorization is in section 1877(g) of the Social
Security Act, 42 U.S.C. 1395(g).
3 Note that this regulation needs a technical amendment
to cover the new “National Provider Identifier” number
that each physician is required to obtain.
4 Financial relationships that result from ownership of
publicly traded stocks or mutual funds are not included.
5 See, discussion in 63 Fed. Reg. 1659, 1703 (Jan. 9, 1998).
6 This article is not intended, nor should it be used, as a
substitute for specific legal advice as legal counsel may
only be given in response to inquiries regarding partic-
ular situations.
7 Although the Agency noted that making the informa-
tion would “rarely be necessary,” that statement was
made in the context of explaining the Agency’s posi-
tion on why the action was exempt from the
Paperwork Reduction Act. For those activities that
were not exempt, the Agency estimated that the first
year would require the health care industry to spend
over $800,000 to comply. The Agency also noted that
the information would likely be sought in the context
of investigations. Query whether CMS will decline to
use its authority to demand records forever.
30 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
The Health Care ComplianceAssociation welcomes the followingnew members and organizations (StatesNebraska - Pennsylvania). Member con-tact information is available on theHCCA website in the Members Onlysection - http://www.hcca-info.org.Please update any contact informationusing the HCCA Website or email AprilKiel ([email protected]) withchanges or corrections to your member-ship information.
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of NM■ Paul F. Herzog, Memorial Medical
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Inst■ Gail Meidinger, RN, St Vincent
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Heights Health Center, Inc■ Mario Felidi, MBA, NYS DOH■ Michael Gaughan, Pfizer■ Mark Goodman, Montefiore Medical
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Hospital■ Robert Jette, Columbia Memorial
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Healthcare■ Patricia Klein, Health Care
Compliance Strategies■ Holly Kramen, Visionarist
Consulting, LLC■ Joyce A. Leahy, Maimonides Medical
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Medical Ctr■ Leslie Lindenbaum, Montefiore
Medical Center■ Georgie MacMullen, North Shore LIJ
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Corporation■ Nita Frazier, Ohio Health■ Sharon Harwood, RN, JD, Fisher-
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Health Partners■ Tony Helton, Cincinnati Children's
Hosp Med Ctr■ Christoher Kenyhercz, MHA, DPM, RN, ■ Linda Lesher, James A. Rhodes State
College■ Janice Meister, UHHS Richmond
Heights Hospital■ Diane O'Boyle, KPMG LLP■ Barbara Pore, Third St Family Health■ Diane M. Powell, Summa Health
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Consulting, Inc■ Lora Steiner, MidOhio Cardiology
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Postmaster: Send address changes to Compliance Today, 5780 Lincoln Drive, Suite 120,
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HCCA Officers:
Odell GuytonHCCA PresidentSenior Corporate Attorney,Director of Compliance,US Legal-Finance & OperationsMicrosoft Corporation
Daniel Roach, Esq.HCCA 1st Vice PresidentVP & Corporate Compliance OfficerCatholic Healthcare West
Steven Ortquist, CHCHCCA 2nd Vice PresidentSenior Vice President, Ethics andCompliance/Chief Compliance OfficerTenet Healthcare Corporation
Rory Jaffe, MD, MBA, CHCHCCA TreasurerChief Compliance OfficerUC Davis Health System
Julene Brown, RN, BSN, CHC, CPCHCCA SecretaryMeritCare Health System
Al W. Josephs, CHCHCCA Immediate Past PresidentDirector of Corporate ComplianceHillcrest Health System
Cynthia Boyd, MD, FACP, MBAChief Compliance OfficerRush University Medical Center
CEO/Executive Director: Roy Snell, CHCHealth Care Compliance Association
Board of Directors:
Anne DoyleDirector, Corporate Learning andOrganizational DevelopmentTufts Health Plan
F. Lisa Murtha, Esq., CHCManaging DirectorHuron Consulting Group
Frank SheederPartnerBrown McCarroll, LLP
John Steiner, Jr., JDChief Compliance OfficerThe Cleveland Clinic Health System
Debbie Troklus, CHCAssistant Vice President for HealthAffairs/Compliance University of Louisville, School ofMedicine
Sheryl Vacca, CHCDirector, National Health CareRegulatory Practice, Deloitte &Touche
Cheryl WagonhurstChief Compliance OfficerEmeritus
Greg Warner, CHCDirector for ComplianceMayo Foundation
Counsel: Keith Halleland, Esq.Halleland Lewis Nilan Sipkins &Johnson
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COMPLIANCE INSTITUTE 2006
HCCA’S 10TH ANNIVERSARYCOMPLIANCE INSTITUTE
LAS VEGAS, APRIL 23 - 26, 2006Register by January 1, 2006 and SAVE $425!
Sessions at the HCCA 2006 Compliance Institute will offer the latest com-pliance information on the hottest topics and current events in compliance.The program will feature multiple HIPAA and compliance sessions and acorporate responsibility track. Industry immersion sessions for a varietyof health care segments are also being planned, including:
• Large Health Systems • Payor/Managed Care• Long Term Care• Pharmaceutical Compliance• Durable Medical Equipment• Physician Group Practices • Research/IRB Issues • Academic Medicine• Behavioral Health• Government Providers
Join your colleagues in Las Vegas for HCCA’s 2006 Compliance Institute – the single most comprehensive compliance conference designed specifically to meet the needs of today’s health care compliance professionals
and their staff. The 2006 Compliance Institute will be held at Caesars Palace from April 23 - 26, 2006.
BROAD SPECTRUM OF SPEAKERSRepresenting Policymakers, Enforcement Officials, Practicing Lawyers, Active Compliance and Privacy Officers
This year’s full program will be available in January 2006Find the program at www.hcca-info.org
See the Registration Insert in this Issue of Compliance Todayor Visit www.hcca-info.org to Register Now!
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November 7 - 10, 2005Disney’s Contemporary Resort
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