Meet Joseph Murphy

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.

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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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2427

29

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

[email protected]

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


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


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


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


allegations that it failed to provide

medical screening examinations

September 2005

By: Katherine Barnhart, Stephen J. Gillis and Kelly J. Sauders

TK

ELL

Y J

.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.


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



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10September 2005


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


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


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


5 SOM, pg 12 and pg 28



8 SOM, pages 29 and 36

9 OIG Semiannual Report October 2003-March 2004

10 SOM, pages 29-30


12 SOM, pg 6

13 SOM, pg. 24 - 25

14 SOM, pages 35 - 37

15 SOM, pg. 19 - 24

12September 2005


Editor's note: Ms. Murtha is managing

director with Huron Consulting Group.

She may be reached by email at

[email protected]

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

A

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


14September 2005


■ 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


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


September 2005

16September 2005


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


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-

[email protected].

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


20September 2005


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


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.


By Julie E. Chicoine

T

22September 2005


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


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:


25September 2005

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26September 2005


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

Full Name:

Title:

Organization:

Address:

City/State/Zip:

Telephone:

Fax:

E-mail:

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27September 2005


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


C

ED

WIN

D.R

AU

ZI

By Edwin D. Rauzi

29September 2005


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.


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.

Nebraska■ Gretchen Jopp, RHIA, CPC, Univ

Medical Associates■ DeeAnna Maine, Douglas County

Hlth Ctr■ Ann Sherman, Health Care

Professionals■ Thom Sinnette, Dept of Veteran Affairs■ Mark Vincent, Mary Lanning

Memorial Hosp

New Hampshire■ Louise L. Caputo, VA Medical Ctr■ Paul Cooper, MBA■ Ms. Kieran A Kays, New London

Hospital■ Brenda-Jean Paradis, RN, Anthem

BCBS (Northeast)

New Jersey■ Christopher Cannon, Novo Nordisk,

Inc.■ Joanne Carrocino, Burdette Tomlin

Memorial Hosp■ Linda Conticchio, Johnson &

Johnson■ Henry Ferraioli, Solaris Hlth System■ Mary Gerdes, BD■ Giovanni Goodrich, Robert Wood

Johnson Univ■ Patrick Guilfoyle, Medical Legal

Consulting Services LLC.■ Tony Harold, Kimball Medical Ctr■ Diane Herczeg, Johnson & Johnson■ Gary W. Herschman, Sills Cummis

Epstein & Gross PC■ Thomas C. Hiriak, Ortho Biotech

Products, LP■ David Kurlander

■ Deborah Montone, BS, RN, CCS-P, ■ Pamela Paul-McNeill, Ortho Biotech■ Brent Saunders, Schering-Plough■ James Schneider■ Elizabeth Serrano, RHIA■ Debra Tortora, RN, Esq., Clara Maass

Medical Ctr■ Brian VanVelzor, MPA, Bon Secours

Health System, Inc

New Mexico■ Gregory Grannan, Delta Dental Plan

of NM■ Paul F. Herzog, Memorial Medical

Ctr■ Sheila Hewitt, New Mexico Heart

Inst■ Gail Meidinger, RN, St Vincent

Hospital■ Mary Morse, RN, BS, MBA,

Presbyterian Healthcare Scvs■ Becky Strom, Presbyerian Healthcare

Services■ Jill Swagerty, Union County General

Hosp■ Elaine Wade, New Mexico Heart

Institute■ JoAnn Woolrich■ Jeff Zide, Off Hours Support

New York■ Steve Fraker, Banner Churchill

Community Hosp■ Jennifer Arnold,

PricewaterhouseCoopers■ Donna Bernardi, FTI Consulting■ Alexandra Bliss, Stony Brook Univ

Hosp■ Alfonso P. Conti, Holtz Rubenstein

Reminick■ Ms. Diane M. Conyers■ Barbara Cormier, BioScrip■ Mary Dalecki■ Michael Duke, Winthrop Univ Hosp■ Raymond Eck, Hillside Family of

Agencies■ Judith L. Fairweather, Morris

Heights Health Center, Inc■ Mario Felidi, MBA, NYS DOH■ Michael Gaughan, Pfizer■ Mark Goodman, Montefiore Medical

Ctr

■ Shari L. Grenier, RN, MPH, ESQ.,Staten Island Univ Hosp

■ Regina Gurvich, MetroPlus■ Marcia Halliday, Mount St. Mary's

Hospital■ James Horwitz, Esq, Glens Falls

Hospital■ Robert Jette, Columbia Memorial

Hospital■ Linda A. Karacoloff, Harborside

Healthcare■ Patricia Klein, Health Care

Compliance Strategies■ Holly Kramen, Visionarist

Consulting, LLC■ Joyce A. Leahy, Maimonides Medical

Ctr■ Marshall Lieberman, BA, Mt Sinai

Medical Ctr■ Leslie Lindenbaum, Montefiore

Medical Center■ Georgie MacMullen, North Shore LIJ

Health System■ Magdalena Mandzielewska,

Columbia University■ Douglas M. Marino, BSN, JD, RN,

Bassett Healthcare■ Maria Matzoros, Montefiore Medical

Center■ Barbara Morrow, MS, CPC,

Samaritan Medical Ctr■ Dana Penny, MBA, The Jewish

Home & Hospital■ Patricia Porter, South Oaks Hospital■ Lynette Powell-Wick, RN, MPH,

Community Choice Health Plans■ Luz M. Puentes, Columbia Univ■ Amy M. Rhone, St Joseph's Hosp

Hlth Ctr■ Tzipora Schindel, CCS-P, Columbia

Univ Medical Ctr■ Karen Silliter■ Lynn Stansel, Esq, Montefiore

Medical Center■ Anthony J. Taranto, Calvary Hospital■ Alice Ting, PricewaterhouseCoopers■ Sonia Valerio, Mount Sinai Medical

Cntr■ Stuart Weiner, Mount Sinai Medical

Ctr■ Ewa Winiarska, RN, BSN, Schervier

Nursing Care Ctr

31September 2005


North Carolina■ Raymond Baker■ Sue Brown, Mission Hosp■ Leah Brown, JD, CTG Healthcare

Solutions■ Mark Cantrell, Duke Univ Health

System■ Sandy Dixon, CPC, Northeast Med

Cte■ John C. Eaton, Jr., CPA, Wake Forest

Univ■ Stephen Farrar■ Lori Feezor, The Feezor Group, PC■ Angela Jeffries, Duke University

School of Medicine■ Beth A. Miller, Caldwell Memorial

Hosp■ Regina Murphy, Winston-Salem

Pediatrics■ Andrea T. Neumeyer, RHIA, Margaret

R Pardee Memorial Hosp■ Donna Peter, Duke University

Hospital■ Kim Wallace, CPA, GSK■ Patricia Weaver, Wilmington Medical

Supply

North DakotaMarilyn A. Cullen, VA Medical Ctr

Ohio■ Kenyokee C. Crowell, MBA, CPC,

Cleveland Health Network MSO■ Amy Dahm, PHR, Hospice of Dayton■ Jeanine Fisher, JD, Ault Care

Corporation■ Nita Frazier, Ohio Health■ Sharon Harwood, RN, JD, Fisher-

Titus Medical Center■ Sheryl Head, Community Mercy

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

System

■ Cassandra Pullen, Fresenius MedicalCare

■ Jeri L. Rose, RN, Health Alliance■ Deborah Sheets, RN, Navigant

Consulting, Inc■ Lora Steiner, MidOhio Cardiology

and Vascular Consultants, Inc■ Vicki Stubbers, Mercy Health Partners■ Carol Urbanija, CPC, Ohio Health■ Kelly Wibbenmeyer, The Children's

Medical Center■ Tammy C. Wood, BS, Brown County

General Hosp■ Robyn Yates, Comphensive Medical

Data Mgmt

Oklahoma■ Marge Burton, Cherokee Nation

Health Service■ Sharon Hall, Memorial Hospital of

Texas County■ Linda Knecht, Perry Memorial Hosp■ Chris Ossenbeck, McAlester Regional

Health Ctr■ Robert Thomas, MBA,

Comprehensive Medical BillingSolutions

■ Terry Walker, Cross Timbers Hospice

Oregon■ James Anderson, BBS, Northwest

Spine & Pain Center■ Janis E. Anderson, Oregon Medical

Group■ Susan S. Coombes, Legacy Health

System■ Colleen Croghan, Pioneer Memorial

Hospital■ Dolores J. Empey, Kaiser Foundation

Health Plan of NW■ Colleen Fair, Samaritan Health

Services■ Mark A. Harris, FamilyCare,Inc■ Elizabeth Hulbert, Kaiser

Permanente■ Julie Koch, Leagacy Health System■ Paul Shorb, Grande Ronde Hospital■ Jane Y. Van Ness, Kaiser Permanente■ Robert Whinery, Grande Ronde

Hosp■ Melinda Whittemore, RHIT, MBA

Pennsylvania■ Kristie Bailey, Hanover Hospital■ Janice M. Bates, SPHR, CATCH, Inc.■ Kurt M. Baumgartel, Celtic

Healthcare■ Cathy L. Codrea, B. Braun Medical

Inc■ Jennifer Daniels, Blank Rome, LLP■ David J. Felicio, Geisinger Health

System■ Sharon Graham, CMS■ Pamela Harsch, ENA Quality

Consulting Services■ Veronica Hegge, Northwestern

Human Svcs■ Marcia Hoover, Butler Memorial

Hosp■ William A. Hunt, MedCom

Solutions, Inc■ Jeffrey Kahn, Children's Hospital of

Philadelphia■ Jodi Kreger, Conemaugh Health

SystemCara Lucas■ Jason B. Martin, JD, Law Offices of

Jason B Martin PC■ Kearline McKellar-Jones, Health

Partners, Inc■ Theresa Miles, Precision

Therapeutics, Inc■ Kim D. Miller, CPC, Per-Se

Technologies■ James Palovick, Veritus Medicare

Svcs■ Ann Powers■ Sandra Puka, Crozer Keystone

Health System■ Shelley Serene, Apex Rehab Solutions■ Sandra L. Sessoms, MPM, RN, West

Penn Allegheny Hlth System■ Heather Smith, Children's Paraclete,

Inc.■ Garcia Wilkins, Inglis Foundation■ Mary Ann Wilson, Sunbury

Community Hosp■ Teresa Yeager, Consultants in

Cardiovascular Disease, Inc■ Ami Zumkhawala-Cook, MHSA,

MBA, Holy Spirit Health System

32September 2005


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

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

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

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other professional advisors for specific legal or ethical questions.

HCCA Officers:

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

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

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

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

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

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

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

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

Board of Directors:

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

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

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

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Attend the Pre and Post Conference for FREE – a Savings of $375Receive the Early Bird discounted conference rate of $799 members/ $949 non-members – a Savings of $50

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!

REGISTERBEFORE

JANUARY 1, 2006 &

SAVE

$425!

November 7 - 10, 2005Disney’s Contemporary Resort

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$ 2500 Members$ 3000 Non-Members$ 2795 HCCA Membership & RegistrationSave $205.00 by joining HCCA today!

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Federal Tax ID: 23-2882664

Payment TermsPlease enclose payment with your registration and return it to the confer-ence office at the above address, or fax your credit card payment to (952)988-0146.

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MAILSend form with tuition fee to:Conference Office 5780 Lincoln Dr., Suite 120 Minneapolis., MN 55436

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Health Care Compliance Association

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Code: CT1104Please make check payable to:

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At MC Strategies, we can help you get there. Our consultants provide comprehen-sive assessments, such as Chargemaster reviews that help you identify billingissues and ensure HCPCS/CPT accuracy. And APC validations that include CPT and ICD-9 accuracy verification. But helping you get compliant is only part of what we do.

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© 2005 PricewaterhouseCoopers LLP. All rights reserved. "PricewaterhouseCoopers" refers to PricewaterhouseCoopers LLP (a Delaware limited liability partnership) or, asthe context requires, other member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity. *connectedthinkingand SMART2.o are trademarks of PricewaterhouseCoopers LLP (US).

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