PHYSICIAN PRACTICE - Health Care Compliance Association

Volume Seven 

Number Nine 

September 2005 

Published Monthly 

Meet 

Joseph 

Murphy 

PHYSICIAN 

PRACTICE 

COMPLIANCE 

CONFERENCE 

October 5 - 7 

For more information see page 2

Health Care 

Compliance 

Association 

2 presents 

nd 

REGISTER TODAY! 

New York 

October 5 - 7 

Marriott New York 

East Side 

PHYSICIAN PRACTICE 

COMPLIANCE CONFERENCE 

The Health Care Compliance Association (HCCA) will hold its 2005 Physician Practice Compliance 

Conference 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 and 

compliance strategies for physician practices. 

New York . . . . . . . . . . . . . . . . . .Until 9/8 After 9/8 

Name: 

*HCCA Members $495 $545 

*Non-Members $595 $645 

Title: 

*HCCA Membership & Registration $695 $745 

Company: 

Pre-conference AM sessions Wednesday FREE $100 

Pre-conference PM sessions Wednesday FREE $100 

Address: 

City: 

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Phone: 

Fax: 

Zip: 

New York, NY October 5 - 7, 2005 

Total Payment $ ______________ 

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Email: 

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5780 Lincoln Drive, Suite 120 

Minneapolis, MN 55436 

Phone: (888) 580-8373 FAX: (952) 988-0146 

Online: www.hcca-info.org Email: info@hcca-info.org 

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Please make checks payable to the 

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Code: CT0605 Tax ID No. 23-2882664 

For more information visit: www.hcca-info.org Or call: (888) 580-8373 Fax 952-988-0146 


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

WEBLINKS 

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.aspCounter=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.akamaitech.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 

INSIDE 

On the Calendar 

3 

3 

4 

8 

12 

15 

19 

21 

23 

24 

27 

29 

Weblinks 

Overcoming barriers to 

compliance 

Compliance with EMTALA 

Misconduct in clinical 

research 

Meet Joseph Murphy 

Compliance education 

Medicare contracting 

reform 

Recipe for effective 

compliance 

CEO’s letter 

Revenue integrity and 

coding compliance 

Keeping Stark II Records 

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

2005 CONFERENCES: 

(See page 5 for upcoming audio 

conferences) 

Los Angeles, CA 

■ SCCE Workshop 

November 10 

San Francisco, CA 

■ Physician Practice 

Compliance Conference 

September 7-9 

Buena Vista, FL 

■ Compliance Academy 

November 7-10 

Atlanta, GA 


December 1 

Chicago, IL 

■ SCCE's Compliance & Ethics 

Institute 

September 12-14 

■ North Central Meeting 

October 7 

Baltimore, MD 

■ Fraud & Compliance Forum 

September 25-27 

Boston, MA 

■ New England Area Meeting 

September 9 

HCCA 

For more information about 

resources, go to the HCCA 

Website, http://www.hccainfo.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 

ON 

THE 

ONCALENDAR 

Minneapolis, MN 

■ Upper Midwest Area Meeting 

September 16 

Las Vegas, NV 

■ Advanced Academy 

October 24-28 

■ Desert Southwest Meeting 

November 4 

New York, NY 

■ Physicians Practice 

Compliance Conference 

October 5-7 

Philadelphia, PA 

■ Northeast Meeting 

September 30 

Houston, TX 


December 2 

Seattle, WA 


November 11 

2006 Conferences: 


■ Compliance Academy 

February 6-10 

Las Vegas, NV 

■ Compliance Institute 

Caesars Palace 

April 23-17 

■ National Corporate 

Compliance and Ethics Week 

May 21-27 

RESOURCES 

■ 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 ■ 


3

By Andrea McElroy 

Editor's Note: Andrea McElroy is the Creating "buy-In" 

Senior Director of Compliance When polled, participants at the HCCA 

System Integrity at Beverly 

Compliance 101 educational session referenced 

in the HCCA Compliance 101 

Enterprises, Inc. Ms. Elroy reports 

directly to Pat Kolling, Chief 

publication, 2001, listed "creating buy-in 

Compliance Officer. She may be and enthusiasm" as well as "education 

reached by phone at 414-529-3747 and training" as two of the top ten 

or by email at 

obstacles to effective compliance implementation. 

The OIG, in its "Seven 

Andrea_McElroy@beverlycorp.com 

Essential Elements of a Compliance 

Ensuring that 35,000 employees Program," lists education as a key component 

of any compliance program. In 

are aware of an organization's 

compliance policies and making 

sure that they receive and complete Guidance for Skilled Nursing Facilities 

fact, the OIG Compliance Program 

annual compliance training is challenge states: "The development and implementation 

of a regular effective educa- 

enough. But when those employees are 

scattered across the country at more tion and training program for all affected 

employees" is an essential element 

than 1,000 locations, the challenge 

increases exponentially. 

of a compliance program. 

Beverly Enterprises, Inc. (BEI) - a large Recognizing the need and referencing 

multi-state healthcare organization - the regulatory support is the starting 

faced this challenge. BEI operates 344 point, and is also the easiest part. 

skilled nursing facilities, 60 hospice and Creating the process and following 

home health agencies and a large rehabilitation 

business that provides rehabili- 

true challenge lies - particularly in a 

through in the organization is where the 

tation services in more than 700 locations 

exclusive of our own skilled nurs- 

diverse in both position and education, 

company where the workforce is 

ing facilities. To ensure that our associates 

working in these diverse locations 

and dispersed geographically. 

received our compliance message - and In the early stages of our compliance 

to fulfill the requirements of the 

program commitment at BEI, we knew 

Corporate Integrity Agreement with the that associate education would be a crucial 

element. A requirement of our 

OIG under which we operate - we utilized 

a variety of creative approaches. Corporate Integrity Agreement was to 

deliver in-depth general and specific 

ANDREA MCELROY 

training to all of our associates. In the 

interest of timely implementation, video 

versions of "classroom lecture" type 

training were created, using senior leadership, 

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 educate 

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 leadership 

to succeed. The preparation to roll 

out our compliance awareness campaign 

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 strategic 

plan. As recommended by the 

Continued on page 6 


4 

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

Join us for the following 

HCCA Audio 

Conferences 

Get the latest “how-to” information–tools and advice you 

can use daily without even leaving your office! Register 

on the HCCA Website–www.hcca-info.org. You will 

receive an email a few days before the conference with 

any conference handouts, and dial-in information and 

instructions. 

➤ 

➤ Auditing Your Audit 

Speaker: Theresa Bivens 

September 21, 2005 

➤ 

➤ Two-Part Recovery Audit Contractors 

Speakers: Michael Smith, Chris Myers, 

Melanie Combs and Connie Leonard 

September 28 and 29, 2005 

➤ 

➤ Compliance with Conditions of Participation 

Speaker: David Hoffman 

October 18, 2005 

➤ 

➤ Two Part Privacy Issues 

Speakers: Marti Arvin and Deann Baker 

October 19 and 20, 2005 

*Audio CDs are available for all past audio conferences. 

HCCA Audio Conferences are a fast 

and easy way to aquire HCCB CEUs! 

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

Overcoming barriers to compliance ...continued from page 4 

Compliance 101 "Organizational Steps to 

Gain Support and Commitment," senior 

management attends regularly scheduled 

meetings designed to reinforce the 

message of compliance-and this demonstrated 

support was essential to a successful 

implementation. 

Using the principles of adult learning 

When approaching education and training, 

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 individual 

is, all adult learners are oriented to 

what is relevant to them and their accumulated 

personal life experiences. In 

other words, they want to know why 

they need to know, and how the information 

fits into their world! Also, generally 

speaking, adults are practical and 

are problem solvers - they want to interact 

with, and reason through, situations 

presented during a learning session. An 

adult who is made to listen to fact dissemination 

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 participant's 

own experiences 

■ Help the participant realize how the 

information will lead them to achieve 

their goals 

■ Create a value for learning the information 

■ Ensure that the participant realizes 

the relevance of the training to their 

job function 

■ Provide the opportunity for the participant 

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 certification/licensure, 

anticipation of a promotion, 

job enrichment or adaptation to 

job changes, or compliance with company 

directives. Because compliance 

training is a company expectation, motivation 

and overcoming barriers for timely 

completion and active learning 

became a significant focus. The goal of 

creating cognitive interest was a cornerstone 

to what we believed would lead 

to a successful learning experience. 

Piquing their interest 

To accomplish our goals, we elected to 

develop an interactive computer-based 

program in conjunction with a company 

that specializes in multi-media presentations. 

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 potential 

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 interfering 

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 questions, 

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 interaction 

with the material, and ensuring that 

content is practical and has relevancy. 

Delivering the message 

Barriers 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 officethe 

method of delivery presented a 


6 


potential barrier as well. We decided on 

an electronic learning format and developed 

a customized training program 

that met the needs of our associates at 

all levels-incorporating the adult learning 

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 computer 

operating systems 

■ Connection and computer bandwidth 

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 program 

via CD or direct server access. We 

initially handled the "procrastination factor" 

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 associates 

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 interwoven 

into all chapters of the training. 

Finally, the training is divided into modules 

or chapters that allow the busy participant 

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 scheduling 

barrier. 

Building awareness 

The goal of building compliance awareness 

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 campaign. 

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 industry 

leader, we utilized key marketing 

principles. Our focus was and will continue 

to be based on the following 

strategic functions stated as critical elements 

by Steven Van Yoder in his article 

"The Brand Called You": 

■ Position your focused message in the 

hearts and minds of your target audience 

■ 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 compliance 

department - listen up". We 

selected a new logo from among the 

entries and we recognized the creative 

associate in a company-wide publication. 

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 program 

on the agenda of daily conversation. 

A graphic designer further developed 

and expanded the logo and 

theme, for use with payroll stuffers and 

"trading cards" with a compliance message, 

posters to be placed in all locations, 

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 theories 

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- 


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


7

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

Editor's note: Kelly, Katherine and vide for an appropriate transfer to 

Stephen are part of 

another facility. EMTALA also prohibits 

PricewaterhouseCoopers Healthcare hospitals from delaying a medical 

Advisory Practice. They specialize in screening exam, and/or stabilizing treatment, 

in order to inquire about the per- 

delivering compliance-related services 

to hospitals, health systems, physician 

groups and other providers. status. Hospitals that do not comply 

son's method of payment or insurance 

with EMTALA risk possible Medicare 

Kelly J. Sauders is a Director in the decertification actions and civil monetary 

Healthcare Advisory Practice based in penalties up to $50,000 per violation. 

Albany, New York. She may be reached 

by telephone at 518/427-4431. 

The Centers for Medicare and Medicaid 

Stephen J. Gillis is a Manager in Services (CMS) published a final rule in 

PricewaterhouseCooper's Healthcare the Federal Register 1 on September 9, 

Advisory Practice based in Boston. 2003, which was intended to clarify 

Stephen may be reached by telephone 

at 617/530-4115. 

Medicare-participating hospitals in treat- 

policies relating to the responsibilities of 

Katherine Barnhart is a Senior ing individuals with emergency medical 

Associate in the Healthcare Advisory conditions, who present to a hospital 

Practice based in Albany, New York. under the provisions of the EMTALA. 

Katherine can be reached by telephone 

at 518/427-4529. 

CMS issued Revised EMTALA 

Following the release of this document, 

Interpretive Guidelines (the Guidelines) 

The Emergency Medical in the State Operations Manual (SOM) 

Treatment and Labor Act to regional offices and State Survey 

(EMTALA) was passed in 1986, Agencies on May 13, 2004. 2 The purpose 

of the Guidelines was to update 

primarily in response to concerns that 

hospitals were refusing to treat indigent the guidance given to State or Federal 

and uninsured patients or were inappropriately 

transferring them to other hospi- 

of reports of EMTALA violations, so that 

surveyors, who conduct investigations 

tals solely for economic reasons. EMTA- enforcement is consistent with recent 

LA requires hospitals that participate in changes to the federal regulations promulgated 

under EMTALA. 

Medicare to provide a medical screening 

exam to any person who comes to the 

emergency department and requests it, The enforcement of EMTALA is a complaint 

driven process. The investigation 

regardless of the individual's ability or 

intention to pay for the services rendered. 

Additionally, if a hospital deter- 

processes, and any subsequent sanc- 

of a hospital's policies/procedures and 

mines that the person has an emergency tions, is initiated by a complaint. If the 

medical condition, it must provide treatment 

to stabilize the condition or pro- 

hospital violated one or more of 

results of a complaint indicate that a 

the 

KELLY J. SAUDERS 

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 administrative 

penalties and assessments for violations 

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 settlements 

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 examination 

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 



is reasonably calculated to determine 

whether an emergency medical condition 

exists, it has met its obligations 

under EMTALA .5 

STEPHEN J. GILLIS 

■ A hospital paid $40,000 to resolve allegations 

that it did not provide an 

appropriate medical screening examination 

to an individual who presented to 

its emergency department for evaluation. 

He was allegedly refused such 

treatment based on his inability to pay. 6 

KATHERINE BARNHART 

and/or stabilization treatment to four 

individuals who presented in the 

emergency department. One individual 

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 symptoms 

presented and conducted in a 

non-disparate fashion. A medical 

screening exam is the process required 

to reach, with reasonable clinical confidence, 

the point at which it can be 

determined whether a medical emergency 

does or does not exist. If a hospital 

applies, in a nondiscriminatory manner 

(i.e., a different level of care must 

not exist based on payment status, race, 

national origin) a screening process that 

The key allegation in this example is 

the ability to pay. A hospital is obligated 

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 examination, 

stabilization treatment, or an 

appropriate transfer to a woman who 

presented to its emergency department 

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 arrangements 

with insurers. It is not impermissible 

under EMTALA for a hospital to follow 

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 network 

of designated providers cannot 

refuse to screen (or appropriately transfer, 

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 obligation 

of the hospital to conduct a medical 

screening exam and to at least initiate 

stabilization treatment. A managed 

health care plan may only state the services 

for which it will pay or decline payment, 

but that does not excuse the hospital 

from compliance with EMTALA. 8 

■ A hospital paid $15,000 to resolve an 

allegation that it failed to provide 

appropriate examination and treatment 

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 gastrointestinal 

bleed. 9 

In this example, the alleged failure to 




9

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, stabilization 

and transfer are implicated. The 

Guidelines state that hospital property 

includes ambulances owned and operated 

by the hospital, even if the ambulance 

is not on the hospital campus. An 

individual in a non-hospital owned 

ambulance, which is on hospital property, 

is considered to have come to the 

hospital's emergency department. If an 

individual is in an ambulance, regardless 

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 ambulance 

is only appropriate if the hospital 

is being diverted pursuant to community-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 obligation 

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 capabilities 

to treat burn victims. 11 

Specialized capabilities are the key issue 

in this example. In discussing specialized 

capabilities, the Guidelines indicate 

that if the receiving hospital has the 

capacity and capabilities, the hospital 

would have a duty to accept an appropriate 

transfer of an individual requiring 

the hospital's capabilities, providing the 

transferring hospital lacked the specialized 

services or capacity to treat the 

individual. 

As a compliance officer, these settlements 

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 assessment 

of patients presenting to the ED 

with emergency medical conditions, 

assessment of labor, transfers of individuals 

with emergency medical conditions, 

etc); 

■ Consent forms for transfers of unstable 

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 findings. 

■ 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 stabilized 

and transferred). Separate logs 

may be maintained in areas where individuals 

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 emergency 

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) performed 

by qualified medical personnel 

(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 


10 


identify who, at their hospital, can be 

designated as a qualified medical person 

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 practitioners 

to perform Medical Screening 

Exams. However, if a Hospital wishes to 

do so, it needs to develop a process of 

authorizing specific individuals to perform 

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 screening 

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 transferred 

to another facility. If community 

wide plans exist for specific hospitals to 

treat certain emergency medical conditions 

(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 available 

if the individual requests the transfer 

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 previously 

established expectations and created 

clarification for topics that were 

once vague, related to on-call activities. 

Hospitals have the ultimate responsibility 

for ensuring adequate on call coverage. 

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 nonphysician 

practitioner to respond to a 

call as a representative of the on-call 

physician, even though the physician 

is ultimately responsible for responding 

to the call. However, if this is to 

occur, the conditions must be outlined 

in the Hospital's written policies 

and procedures; 

■ Hospitals may adopt policies and 

procedures to permit on-call physicians 

to schedule elective surgery 

while on-call, or to be on-call at 

more than one hospital simultaneously, 

as long as the hospital has established 

a backup on-call plan, in the 

event that a physician is unavailable 

due to elective surgery or simultaneous 

call responsibilities and, 

■ Hospitals may not use the term "reasonable" 

when articulating the expectation 

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 service 

is listed. 

Based on the outcome of the EMTALA 

compliance audit, your organization 

may need to consider changing documentation 

processes, re-educating ED 

staff and physicians, updating policies 

and procedures, and putting ongoing 

monitoring processes in place, as a control 

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 compliance 

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 



11


12 

Editor's note: Ms. Murtha is managing 

director with Huron Consulting Group. 

She may be reached by email at 

lmurtha@huronconsultinggroup.com 

Over the course of the last fifteen 

years, we have witnessed 

a number of prominent 

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 scandals, 

the pharmaceutical company compliance 

cases, and much, much more. 

Research compliance cases have recently 

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 misconduct 

cases. While the concerns over 

misconduct in science are not necessarily 

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 interesting. 

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 

By F. Lisa Murtha, J.D., CHC 

research assistant at the Stratton VA 

Medical Center in Albany, New York. 

The Defendant helped manage studies 

in which payments were made by sponsors 

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 prosecuted 

under criminal and civil proceedings 

and the Defendant will have jail time. 


F. LISA MURTHA 

There have been many other reported 

instances of misconduct in science. 

Cases of plagiarism, fabrication and falsification 

are well reported on ORI's 

website. The motivations for these 

actions are varied and always fascinating. 

In some cases, the motivation 

amounts simply to the fact that the 

respondents are overworked and lack 

resources to pursue the research projects 

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 exposure 

for the research organization. As 

such, research organizations are well 

advised to ensure that the organization 

has effective scientific misconduct policies 

and procedures in place to deal 

with allegations of fraud in science. 

Given the increased focus on misconduct 

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: "fabrication, 

falsification, or plagiarism (or 

FFP) in proposing, performing, or 

reviewing research or in reporting 

research results. Research misconduct 

does not include honest error or differences 

of opinion." In addition, the regulation 

states that "Fabrication is making 

up data or results and recording or 

reporting them. Falsification is manipulating 

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 appropriate 

credit." (42 CFR 93.103) In contrast 

to the previous rule, the Final Rule 

would require that FFP be a "significant

departure" from accepted practices as 

opposed to the "serious deviation" standard 

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 programs. 

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 compliance 

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 questioned 

research is evidence of research 

misconduct where the institution or 

HHS establishes, by a preponderance of 

the evidence, that the respondent intentionally, 

knowingly, or recklessly had 

research records and destroyed them, 

had the opportunity to maintain the 

records and did not do so, or maintained 

the records and failed to produce 

them in a timely manner. The respondent's 

conduct in this case constitutes a 

significant departure from accepted 

practices of the relevant research community. 

The Respondent, in turn, has 

the burden of proving any affirmative 

defenses or mitigating factors by a preponderance 

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 

Inquiry 

An 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 respondent 

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 collected, 

but rather, to review sufficient 

evidence to determine whether an investigation 

is warranted. The institution 

must complete its Inquiry within 60 calendar 

days of its initiation unless circumstances 

clearly warrant a longer 

period. Any time extensions must be 

documented in writing. The institution 

must provide the respondent an opportunity 

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, applications, 

contracts, and publications listing 

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 institution 

provide information related to: 

■ The institutional policies and procedures 

under which the Inquiry was 

conducted 




13

may make a finding of research misconduct 

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 outcomes 

of a finding of scientific misconduct 

include debarment, suspension, letters 

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 pattern 

or practice of wrongdoing, the 

impact of the misconduct, the respondent's 

acceptance of responsibility, and 

other mitigating circumstances. 

Appeals 

Clearly 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 scientific 

misconduct. In addition, institutions 

that do not develop and implement the 

required process for dealing with allegations 

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 

■ 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 support 

an allegation of scientific misconduct, 

it must keep complete documentation 

to support this conclusion in its 

files. ORI may request a review of these 

documents at any time. 

Investigation 

If the results of the Inquiry reflect a likelihood 

of scientific misconduct, the institution 

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 investigation 

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 circumstances 

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 falsification, 

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 misconduct 

■ Any current support or known applications 

or proposals for support that 

the respondent has pending with 

non-PHS Federal agencies 

■ Any comments made by the respondent 

and complainant 

■ All relevant research records and 

records of the investigation (including 

interview notes, etc.) (42 CFR 

Part 93.313) 

The institution must give ORI the following 

information: 

■ The Investigation Report 

■ Final institutional action 

■ A statement as to whether the institution 

accepts the Investigation's findings 

■ A description of any institutional administrative 

actions (42 CFR Part 93.315) 

Reporting 

Once ORI has completed its review, it 

may either close the case without a 

finding of scientific misconduct, or it 


14 


feature 

article 

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 compliance 

area for over twenty years. 

Joseph E. Murphy may be reached by 

telephone at 856/429-5355 and by 

email at JEMurphy@cslg.com. 

JS: Please describe briefly your background 

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 cofounder 

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 published 

the first book on corporate compliance 

as a topic. 

Meet Joseph E. Murphy 

Partner in Compliance Systems Legal Group, and 

Managing Director of Integrity Interactive Corp. 

JS: Could you elaborate more on 

your current activities 

JM: In Compliance Systems Legal 

Group, we limit our practice to compliance 

and ethics work only. We help companies 

develop and enhance their compliance 

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 customers 

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 compliance 

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 everyone 

who can get the company in trouble, 

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 compliance. 

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 




15

Joseph Murphy 

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 sentencing 

of senior corporate executives 

to decades of prison time, and individual 

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 compliance 

is about. Surprisingly, even after 

years of development of this field, you 

will still find managers and board members 

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 people. 

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 happening, 

and detecting them early if they 

happened. If the board and management 

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 professionals 

need to be alert to 

JM: There are several new trends. 

One trend is the globalization of compliance, 

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 exercise 

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 applying 

their own resources and expertise 

to this socially beneficial task. 

2. Not all companies have these programs, 

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 regulatory 

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 compliance 

program elements. Our Canadian 

neighbors require privacy compliance 

programs in all companies. In the pharmaceutical 

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 "mandavolent 

compliance." 

One other comment about this 

trend I'd like to make is that generally, 

when legislatures impose these programs 

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 background 

to do this. Because our field has 

been rather passive in the political environment, 

we may be living with misguided 

requirements from the government. 

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 programs, 

and there has been an increasing 

call for metrics in this area. What do 

you recommend for compliance program 

evaluation 

JM: This is certainly one of the most 


16 


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 misconduct. 

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 having 

systems to prevent and detect misconduct. 

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, looking 

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, measure 

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 provide 

useful background data and may 

clue you in to failures in your communications 

methods. But remember that 

business crime is not committed by 

majority vote. You can have a workplace 

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 company, 

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 numbers 

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 companies 

after something bad happens; 

they are the ones who stand up against 

wrongdoing in companies before anyone 

gets hurt. 

Right now this field is fractionalized. 

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 function 

have a core set of beliefs and competencies; 

they share a mission that sets 

them apart from others who work 

around them. A compliance person at a 

manufacturer or financial services company 

may have more in common with a 

hospital compliance officer than they do 

with the fellow employee down the hall 



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

Overcoming barriers to compliance 

...continued from page 7 


18 

tions. This is in addition to our 

compliance Hotline for reporting 

potential compliance issues. Our 

associate-generated "brand" is making 

frequent appearances and keeps compliance 

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. 

misconduct in clinical research 

...continued from page 14 

mand, refer the matter to HHS, place the 

institution on special review status, debarment 

or suspension of the institution and 

much more. (42 CFR Part 93.413) 

Given what is at stake today, research institutions 

should strongly consider developing 

and implementing a research compliance 

program. This effort should include (at a 

minimum) comprehensive training and education 

for all administrative staff, investigators 

and coordinators, and detailed auditing 

and monitoring. Being proactive, and having 

an effective offense, is always the best 

defense. ■ 

CHC 

CERTIFIED IN 

HEALTHCARE 

COMPLIANCE 

The Compliance 

Professional’s Certification 

Congratulations on achieving 

CHC status! The Health care 

The Healthcare Compliance Certification 

Compliance Certification Board 

Board (HCCB) compliance certification 

announces that the following 

examination is available in all 50 States. 

individuals have recently 

Join your peers and become Certified in 

successfully completed the 

Healthcare Compliance (CHC). 

Certified in Healthcare 

Compliance (CHC) examination, 

CHC certification benefits: 

earning CHC designation: 

■ Enhances the credibility of the compliance 

practitioner 

Donna Fager 

■ Enhances the credibility of the compliance 

programs staffed by these 

Paul Flanagan 

Coleen Fair 

certified professionals 

Debbie Adams 

■ Assures that each certified compliance 

practitioner has the broad 

Sunday Aigbohoh 

Heather Caldwell 

knowledge base necessary to perform 

the compliance function 

Scott Desmond 

■ Establishes professional standards 

Carol Edelberg 

and status for compliance professionals 

Karleen Hulbert 

Cheryl Harrison 

■ Facilitates compliance work for compliance 

practitioners in dealing with 

Mary Laboy 

Stephen Kelly 

other professionals in the industry, 

Juan Roadas 

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 available 

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 compliance, 

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 hccb@hcca-info.org, or visit the HCCA 

Website: http://www.hccainfo.org/Template.cfmsection=HCCB_Certification 

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

By Danna R. Teicheira, CHC 

Editor's Note: Danna R. Teicheira is ■ number of educational options available 

prior to the implementation of 

the Manager of Compliance 

Education and Audit for the Tulane the new policy 

University Medical Group. You may ■ types of education that were most 

contact her at 504-988-9816 or dteichei@tulane.edu. 

■ percentage of physicians who had 

frequently accessed 

earned their three compliance credits 

In July 1, 2004, a new compliance as of March 31, 2005 

policy for the Tulane University 

Medical Group (TUMG) mandated 

that physicians earn three compli- 

Prior to FY2005, the following billing 

Education options increased in FY2005 

ance credits each fiscal year. For each compliance education options were 

unearned credit, a fine of $1,000 will be available: 

levied on the department(s) with noncomplying 

physicians. 

every hour on the hour education 

■ Quarterly education presentations - 

presented by the Compliance Staff (4 

The Compliance Staff responded to the topics presented each year) 

new policy by offering education ■ Videotaped presentations (e.g. ABN's, 

options designed to: 

Consults, Teaching Physician Rule) 

■ provide more and different educational 

options for physicians 

the Compliance Office for viewing. 

which could be checked out from 

■ provide educational options that were Physicians could earn credit by earning 

70% or better on a quiz. 

directly applicable to physicians and 

their practices, as opposed to general ■ Medicare web-based training. Proof of a 

education sessions 

passing score on the post-test required. 

■ make compliance education more ■ One-on-one education as requested; 

accessible for physicians. 

this included New Physician 

Compliance Orientation. 

Providing easily accessible and relevant ■ Department/section-specific education 

as requested 

billing compliance education to a faculty 

practice of more than 300 physicians ■ Other non-Tulane education/training 

has challenged the creativity and 

sessions, as approved for content and 

resources of the Tulane University 

relevancy 

Medical Group (TUMG) Billing 

Compliance staff. At the end of March In response to the new policy, the educational 

options were increased. Besides 

2005, we took some time to assess how 

far we had (or had not) come in reaching 

our goals. 

ing training was revised with the goal of 

offering new training options, the exist- 

fostering physician participation and discussion. 

At present, the following edu- 

In order to gauge our progress, we 

looked at the following items: 

cation options are available: 

■ Quarterly education presentations - 

These presentations have been 

revamped to offer physicians a variety 

of compliance topics, and the presentation 

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 education 

- This option has been much 

more in demand this fiscal year. The 

heightened interest can be attributed 

to the Compliance Staff's active solicitation 

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 education 

One of the main complaints that physicians 

frequently voiced about education 

was that it was repetitive and "nothing 

new" was presented. A primary focus of 

our compliance education is the understanding 

and appropriate application of 

Evaluation and Management (E/M) 

guidelines. The Compliance Staff agreed 

with the physicians that E/M coding education 

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 promote 

physician participation and foster 




19

Compliance education ...continued from page 19 

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 interactive 

presentation 

■ We provide the physicians with a 60- 

page E/M Key Component manual we 

developed that begins with an introduction 

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 present 

the Medical Decision Making 

(MDM) Key Component and physicians 

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 present 

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 physicians 

using audit templates to determine 

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 prompted 

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 session, 

for example, prolonged discussions 

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 running 

for the door, we deemed the 

workshop a success. We worked quickly 

to iron out the kinks, and then incorporated 

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 Education 

After tracking compliance education for 

nine months, it was easy to identify the 

compliance education options most utilized 

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 education 

on different days, and different 

times, in order to reach more physicians. 

Physician evaluations are generally 

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 departments 

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 frequently 

utilized option is the Tulane website, 

where there are currently nine education 

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 presentations 

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 success 

The 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 heightened 

compliance awareness. Options 

for earning compliance credits have certainly 

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 education 

is working well. With three 

months left in the fiscal year, 42% of 

TUMG physicians have already completed 

their three compliance credits, and 

96% have earned at least one compliance 

credit. ■ 


20 


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: Chicoine-1@medctr.osu.edu 

The Medicare program provides 

health care coverage to 

approximately 42 million 

Americans. 1 The Medicare Fee For 

Service component of the Medicare program 

continues to represent the majority 

of overall Medicare enrollment. In fact, 

government data indicates that 86% of 

today's beneficiaries continue to participate 

in the traditional Fee-For Service 

program. However, the Medicare program, 

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 farreaching 

changes to the way Medicare 

program contractors will provide services 

to health care providers and beneficiaries. 

The most significant change will 

be the elimination of all current contracts 

with existing fiscal intermediaries 

and carriers. CMS will replace these entities 

with a new contract entity known as 

By Julie E. Chicoine 

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 intermediaries 

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 services 

through the consolidation of contractors; 

and create performance incentives 

for improved services to both beneficiaries 

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 implementation 

of contracting reform. The 

reforms contemplated under the MMA 

will have a dramatic effect on how CMS 

contracts will be entered into, administered, 

and ultimately; how services are 

offered to health care providers, professionals, 

suppliers, and beneficiaries. 

Multiple contractors 

Under the current intermediary/carrier 

contracting model, CMS contracts with 

51 private insurance companies around 

the country to process Medicare claims 

and perform other administrative services. 

These contractors include 25 Fiscal 

Intermediaries and 18 Carriers who 


operate in multiple, and sometimes 

overlapping jurisdictions. Current contractor 

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 contracts 

differ widely in terms of the number 

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 beneficiaries 

are well aware, the current system 

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 situation 

can be confusing and frustrating 

for both beneficiaries and providers who 

seek clarification and guidance regarding 

coverage and coordination of care. 

Open competition for contractors 

Under contracting reform, CMS will 

expand competition for Medicare's 

claims-payment business beyond traditional 

health insurance companies 

through an extensive operational overhaul. 

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. 



21

Medicare contracting reform ...continued from page 21 

Under the new law, CMS will award contracts 

to "any eligible entity" through a 

competitive bidding process, which 

includes "demonstrated capability" to 

carry out the required contractor functions. 

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 recompete 

all contracts every five years. 

Consolidation and reconfiguration 

Beginning 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 processing 

activities 

Single Point of Contact 

Currently, multiple contractors create 

administrative burdens for health care 

providers and beneficiaries in terms of 

time spent contacting both intermediaries 

and carriers for coverage and other 

issues. In addition, all current CMS contractors 

provide services under costbased 

reimbursement contracts, with 

limited or no competition. This arrangement 

has fostered little incentive to 

improve the quality of services. For 

example, a July 2004 Government 

Accountability Office (GAO), (formerly 

General Accounting Office), report 2 

found that only four percent (4%) of 

contractor staff member responses to 

GAO's four-question "secret shopper" 

test calls to 34 contractor call centers 3 

were correct and complete. The GAO 

stated that the level of correct and complete 

responses posed to billing questions 

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 contact 

will be 1-800-MEDICARE, a customer 

service center that will provide 

information about the Medicare program, 

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 conducting 

all claims-related business for 

providers, including verifying claims status, 

beneficiary eligibility, and the claims 

payment process. CMS intends to 

accomplish this goal through modernized 

IT systems that will enable provider 

access through a secure web-portal. 

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 

Historically, intermediary and carrier 

contracts were limited to a cost reimbursement 

or no-profit model. To 

improve customer services for both beneficiaries 

and providers, CMS will establish 

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 service, 

including timely and accurate claims 

payment, provider education and outreach 

activities, and more timely correspondence 

requests. These incentives 

will be incorporated into all MAC contracts, 

and will be evaluated through 

provider and beneficiary surveys and 

consultations. 

Changes to IT infrastructure 

The current claims system operates on 


22 


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 validation 

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 contractor 

liability. Under current law, intermediaries 

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 obligations 

under its Medicare administrative 

contract, or with intent to defraud the 

government. The reckless disregard standard 

does not require specific intent and 

is the same standard applied to 

providers under the False Claims Act. 

Conclusion 

Medicare 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 presents 

compliance challenges. 

Consolidation and improved IT infrastructure 

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/medicarereform/contractingreform/ 

■ 

Report to Congress at page I-1 

GAO Report to Ranking Minority Member, Subcommittee 

on Health, Committee on Ways and Means, House of 

Representatives: "Medicare - Call Centers Need to 

Improve Responses to Policy-Oriented Questions From 

Providers" (GAO-04-669) 

Questions included 1) billing for beneficiaries transferred 

from one hospital to another, 2) billing for services 

delivered by therapy students, 3) billing of multiple surgeries 

for same patient on same day, 4) billing an 

office visit and procedure for same patient on same 

day. 

Interesting point in that Medicare coverage does not 

include convalescent nursing home care. 

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 

By Gynelle Baccus, RN, PhD 

Directions: 

Put Patient and family in center of everything. 

Stir in several cups of quality 

health care services from all hospital 

departments . Mix with equal cups of caring 

(from Medicine, Nursing, and all hospital 

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, integrity, 

compassion, collaboration, stewardship 

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 standards. 

Continue stirring until all ingredients 

are well blended. 

Serve on a warm platter, making sure 

patient and family are still in the center! 

There you have it—an effective compliance 

department—and remember, each 

time this mixture occurs, it is different 

because every patient is a unique individual. 

■ 


23

Effectivemess: 

Roy Snell 

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 effectiveness 

of compliance programs. I have seen millions of dollars 

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 single 

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 difference 

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 different. 

Separating these discussions during our debate may help 

make this easier. 

Some evaluation methodologies seem 

simple and straight forward, and 

would probably conclude that if several 

problems are revealed, your compliance 

program is not working. That 

is an easy method of evaluating a 

compliance program, but is it accurate 

Let's take Boeing for example. 

They have one of the country's most exhaustive ethics programs. 

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 compliance 

issues in the recent past. In one case, the top management 

(including the CEO) left, after allegedly hiring a procurement 

officer from the government in an effort to get a big contract. 

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 doesn'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. 

For six years, I have sat in rooms full of industry experts trying 

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 effectiveness, 

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. 

There are a myriad of issues that complicate this effort to measure 

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 argument. 

We want effectiveness measurement very badly and 

because we can't see why it won't work, we really get frustrated. 

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 



24 


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25

Joseph Murphy 

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 pressure 

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 compliance 

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 compliance 

professional will be a recognized 

career, opening doors into corporations 

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 professionals 

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 profession. 

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 professions, 

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 support 

and recognition they need and 

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26 


Effectiveness ...continued from page 24 

during effectiveness meetings. Two of 

the brightest people I know argued that 

audit results should not be a measurable 

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 compliance 

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 effective. 

Are there companies that don't 

have one, have no history of compliance 

issues, all employees feel comfortable 

going to their supervisor, and complaints 

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 program 

erroneously. 

Even though measuring outcomes or 

effectiveness is better than measuring 

the existence of the elements, it can still 

be imperfect. Take education for example. 

Measuring the existence of education 

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 education 

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/outcomes, 

not just the existence of elements. 

As cited in the education example, 

you also have to be careful not just 

to measure "1st tier" outcomes. You 

have to look at how specific investigations 

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 painting. 

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 certification 

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 talking 

about before we start debating 

again. Maybe we could agree that auditing 

for the existence of elements is easier 

and has some limited value. We 

could agree that measuring the effectiveness 

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 statement 

of the obvious" but we can 

become discouraged if we can't see specific 

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 discouraged. 

Don't quit just because the path is 

not clear and there is little professional 

agreement about what to do. Do something. 

We may never agree on effectiveness, 

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. ■ 



27

By Edwin D. Rauzi 

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 corporate 

compliance plans; advising corporate 

compliance officers. He may be 

reached by telephone at 206/622-3150 

Compliance departments that 

are well-organized and properly 

funded are likely to have 

developed an inventory of financial 

relationships with physicians, which 

were then analyzed and-if necessarymodified. 

That effort is one basis for a 

Compliance Officer to report legitimately 

to his or her Board that the organization 

is "in compliance." Once such 

inventories are developed, however, 

they must be maintained. 

In addition to voluntary efforts undertaken 

by organizations pursuing best 

practices, the Stark II regulations authorize 

CMS to demand that a facility provide 

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 provided 

under the regulations is not voluminous, 

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 financial 

relationship that it had with a physician 

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 information 

in a data base. 1 

Background 

For over ten years now, the Stark II 

statute has authorized the Secretary of 

HHS to require an organization to provide 

information on its financial relationships 

with physicians. 2 For much of 

that time, the agency signaled its intention 

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 organizations 

had questions about how to complete 

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 

EDWIN D. RAUZI 

Regulations 

On 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 relationship 

4 with the entity. 

■ The name and UPIN of each physician 

who has an immediate family 

member who has a financial relationship 

with the entity. 

■ The covered services furnished by 

the entity. 

■ The nature of the financial relationship, 

including the extent and/or 

value of the financial relationship 

The regulations also identified the minimum 

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 "Maintained 

Already" 

As initially envisioned, the reporting 


28 


equirement 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 regulation, 

it is clear that industry representatives 

argued that the proposed reporting 

duties would be onerous, burdensome 

and expensive. Those arguments eventually 

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 documentation 

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 requirements 

of this section must report to the 

agency on a prescribed form, and thereafter 

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 applicable 

regulatory requirements for the 

information (that is, IRS, SEC, Medicare, 

Medicaid, or other programs). This substantially 

reduces the burden on entities, 

since this is information that is required 

to be maintained by other regulatory 

agencies in the usual course of business. 

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)(emphasis 

added). 7 

Should your organization compile the 

Stark II compliance records 

No organization has unlimited resources 

to devote to compliance; hence, any 

compliance initiative needs to demonstrate 

that it has value and is a costeffective 

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 organization 

is complying with Stark 

■ Some organizations are so large 

and complex that it is not realistic 

to expect them to be able to gather 

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 having 

them expire unnoticed 

■ Arguments against- 

■ CMS will never ask for the information-and 

if they do, they will 

not ask my organization 

■ The organization has other compliance 

projects with higher priority 

One way to keep the records 

Once 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 captured 

is limited to that required by the 

regulations, plus fields for the expiration 

date of written agreements and comments. 

Your organization may choose 

to develop a different form, use a different 

data base program, or capture additional 

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 particular 

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 downloaded 

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 particular 

situations. 

7 Although the Agency noted that making the information 

would “rarely be necessary,” that statement was 

made in the context of explaining the Agency’s position 

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. 



29

The Health Care Compliance 

Association welcomes the following 

new members and organizations (States 

Nebraska - Pennsylvania). Member contact 

information is available on the 

HCCA website in the Members Only 

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

Please update any contact information 

using the HCCA Website or email April 

Kiel (april.kiel@hcca-info.org) with 

changes or corrections to your membership 

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 


■ 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 


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 Dakota 

Marilyn 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 Medical 

Care 

■ 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 


■ 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 Billing 

Solutions 

■ 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 

System 

Cara 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 


31

Publisher: 

Health Care Compliance Association, 888/580-8373 

Executive Editor: 

Roy Snell, CEO, HCCA, roy.snell@hcca-info.org 

Contributing Editor: 

Odell Guyton, President, HCCA, 888/580-8373 

Layout: 

Gary DeVaan, HCCA, 888/580-8373, gary.devaan@hcca-info.org 

Story Editor: 

Margaret R. Dragon, HCCA, 781/593-4924, margaret.dragon@hcca-info.org 

Proofreader: 

Wilma Eisenman, HCCA, 888/580-8373, wilma.eisenman@hcca-info.org 

Advertising: 

Margaret R. Dragon, HCCA, 888/580-8373, info@hcca-info.org 

HCCA Officers: 

Odell Guyton 

HCCA President 

Senior Corporate Attorney, 

Director of Compliance, 

US Legal-Finance & Operations 

Microsoft Corporation 

Daniel Roach, Esq. 

HCCA 1st Vice President 

VP & Corporate Compliance Officer 

Catholic Healthcare West 

Steven Ortquist, CHC 

HCCA 2nd Vice President 

Senior Vice President, Ethics and 

Compliance/Chief Compliance Officer 

Tenet Healthcare Corporation 

Rory Jaffe, MD, MBA, CHC 

HCCA Treasurer 

Chief Compliance Officer 

UC Davis Health System 

Julene Brown, RN, BSN, CHC, CPC 

HCCA Secretary 

MeritCare Health System 

Al W. Josephs, CHC 

HCCA Immediate Past President 

Director of Corporate Compliance 

Hillcrest Health System 

Cynthia Boyd, MD, FACP, MBA 


Rush University Medical Center 

CEO/Executive Director: 

Roy Snell, CHC 


Board of Directors: 

Anne Doyle 

Director, Corporate Learning and 

Organizational Development 

Tufts Health Plan 

F. Lisa Murtha, Esq., CHC 

Managing Director 

Huron Consulting Group 

Frank Sheeder 

Partner 

Brown McCarroll, LLP 

John Steiner, Jr., JD 


The Cleveland Clinic Health System 

Debbie Troklus, CHC 

Assistant Vice President for Health 

Affairs/Compliance 

University of Louisville, School of 

Medicine 

Sheryl Vacca, CHC 

Director, National Health Care 

Regulatory Practice, Deloitte & 

Touche 

Cheryl Wagonhurst 


Emeritus 

Greg Warner, CHC 

Director for Compliance 

Mayo Foundation 

Counsel: 

Keith Halleland, Esq. 

Halleland Lewis Nilan Sipkins & 

Johnson 


32 

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

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

Postmaster: Send address changes to Compliance Today, 5780 Lincoln Drive, Suite 120, 

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Exp. Date 

Name of Cardholder 

Signature

A Division of Health Systems Concepts, Inc. 

HSC’s Management Billing Analyst (MBA) 

Compliance Audit Software Laboratory 

Version 1.2 

Fully automated, laboratory retrospective 

compliance claims monitoring tool 

 

 

 

 

 

 

Audits from Physician order to Medicare 

payment 

Meets US Sentencing Guidelines 

Meets OIG Guidelines 

Identifies lost revenues 

Reduces FTE cost for internal audits 

Provides quantitative audit results 

Fully tested and ready to help the lab 

compliance manager gain: 

 

 

 

Full control of the billing process 

Compliant billing validated and 

documented 

Reduced culpability 

In Development 

MBA Cardiology Audit Software 

MBA Radiology Audit Software 

Significant return on investment! 

Call HSC today at (877) 447-2700 to 

arrange a demonstration or email us at 

info@hsc-clc.com

C ORPORATE C OMPLIANCE & ETHICS: 

G UIDANCE FOR E NGAGING Y OUR B OARD 

"This video provides an 

overview of the Board’s role 

in compliance." 

Odell Guyton 

Senior Corporate Attorney, 

Director of Compliance 

Microsoft Corporation 

www.corporatecompliance.org 

“It’s pretty clear that the best 

compliance program in the 

world is meaningless even if 

it’s funded with a good well 

meaning compliance officer if 

the leadership of the company 

is not behind it and isn’t 

supportive…” 

Honorable 

Michael E. Horowitz, 

Commissioner, United States 

Sentencing Commission 

Bringing the vision of 

leadership together 

with a compliant and 

ethical culture 

Telly Award 

Finalist! 

Name: 

Title: 

Company: 

Address: 

City: 

ORDER TODAY! 

Total Payment $ ______________ 

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VISA MasterCard American Express 

Number 

Exp. Date 

Non-Members $395 

SCCE/HCCA Members $345 

State: 

Phone: 

Fax: 

Email: 

Mail to: 

SCCE 

5780 Lincoln Drive, Suite 120 

Minneapolis, MN 55436 

Phone: (888) 277-4977 

Zip: 

Name of Card Holder 

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Code: CT1104 

Please make check payable to: 

Society of Corporate Compliance and Ethics (SCCE) 

FAX: (952) 988-0146 

Online: www.corporatecompliance.org 

Email: info@corporatecompliance.org

MC Strategies – Consulting 

Facilitating performance 

and compliance. 

WebInservice ® – Training 

Improving efficiency 

through knowledge. 

HCPCS/CPT, APC, ICD-9. No wonder 

you have to be compliant to the letter. 

At MC Strategies, we can help you get there. Our consultants provide comprehensive 

assessments, such as Chargemaster reviews that help you identify billing 

issues 

and ensure HCPCS/CPT accuracy. And APC validations that include CPT and ICD- 

9 accuracy verification. But helping you get compliant is only part of what we do. 

Our WebInservice ® online training features the industry‘s most comprehensive set 

of compliance curricula. Our EduCode ® Compliance curriculum is a practical yet 

extremely informative program that covers general compliance as well as the highlytechnical 

and high-risk areas of billing and coding compliance. And because all 

WebInservice training is delivered online, you can rest assured that you‘re tapping 

into the most efficient and cost-effective training method available today. 

Achieving compliance today is a complex task. And it takes more than knowing 

the basics, but rather, knowing it all from A to Z. To learn more, log onto 

www.mcstrategies.com or call us at 800-999-6274.

® 

SMART2.o : 

bringing HIM people 

and HIM technology 

together.* 

On one side, it’s a technology solution. On the other, a service 

solution. SMART2.o is more than a software tool, it’s a technology 

solution designed to help you continuously assess coding 

accuracy and data quality as an important part of your hospital’s 

compliance program. 

SMART2.o 

For more than 15 years, we’ve worked with HIM professionals 

providing affordable tools and services that help them with coding 

accuracy, regulatory compliance, data management and reports 

to monitor PPS requirements. 

So, whether you look at your hospital’s compliance program from 

a technology perspective or a service perspective, SMART2.o is 

a very smart, very budget-friendly way to work. 

To start an in-depth conversation about your particular needs, 

contact Doug Barry at 866-792-4920 or visit pwc.com/healthcare. 

*connectedthinking 

© 2005 PricewaterhouseCoopers LLP. All rights reserved. "PricewaterhouseCoopers" refers to PricewaterhouseCoopers LLP (a Delaware limited liability partnership) or, as 

the context requires, other member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity. *connectedthinking 

and SMART2.o are trademarks of PricewaterhouseCoopers LLP (US).

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