INSIDE · 2012. 4. 18. · 2 HCCB CEUs) HIPAA Forum Digital Reference CD (with 20 HCCB CEUs)...
Transcript of INSIDE · 2012. 4. 18. · 2 HCCB CEUs) HIPAA Forum Digital Reference CD (with 20 HCCB CEUs)...
Volume SixNumber T h r e e
March 2004Published Monthly
INSIDELeadership letterSites & scenesOn the calendarA little Medicare reliefSpecial Report: Revis-iting an omnipresentf r a m e w o r kSpecial Report:Proposed Guidelinessignal future directionsSteve Ortquist on theCompliance InstituteCEO’s letterAuditing physicalrehabilitation servicesHIPAA securityOvercrowding crisisCT 2003 indexNew members
Steve Ortquistd i s c u s s e sH C C A’s u p c o m i n gC o m p l i a n c eI n s t i t u t e
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REGISTER TODAY!FOR THE HCCA COMPLIANCE INSTITUTE, CHICAGO, IL–APR 25-28,2 0 0 4 - For registration info go to the HCCA Website, www.hcca-info.org, or see page 39 of this issue.
INSIDE
HCCA exists to champion ethicalpractice and compliance standards in the health care community and
to provide the necessary resources for compliance professionals and others who share these principles.
DearColleagues:
“What have we done for you lately?” is a
good daily motivational question for those
of us in a leadership role of HCCA. Often
times the efforts of individual HCCA
Sheryl Vacca assumed the
office of President in 2002,
she found herself immersed
in the management of the
transition. She, along with
Greg spent countless hours
working with Roy Snell and
Dan Roach to set up an
AL JOSEPHSHCCA President
HCCA’SM I S S I O N
2March 2004
board members, staff, or members go without notice, because
they quietly go about the business of getting things done. As I
began this year, I found the responsibilities of the President
include the assignment of projects and responsibilities to vari-
ous board members. I quickly discovered that HCCA has a
“gold mine” of resources in our board, membership, and staff.
We all work together as an effective team, and it is always
difficult to single out any individual for his or her contribu-
tion without first recognizing the support of the team.
During my short tenure as President I have been asked
numerous times, “how can I become a member of the HCCA
Board?” or “How can I become a Board Officer?” My answer
has been and will always be, “Become involved, work hard,
and it will happen”.
At the risk of leaving someone out, I want to share with you
what I think is the “behind the scenes” story of the efforts of
several members of HCCA. As we all know, we each find our-
selves where we are today, in a large part, as the result of what
we did yesterday. If we reflect back on HCCA’s yesterdays to a
board meeting in 2001, the topic of self-management (hiring
a CEO and our own staff to run the association, as opposed
to an association management company) was raised by then
President Greg Warner. The plans were laid that day for a
project that would take a full three years to complete. As
office in Minnesota. There is not space in this newsletter to
recount the details of contract negotiations, equipment pur-
chases, records transfers, and on and on and on…….. Then
Alan Yuspeh’s leadership brought us through the first full year
of operations. In addition, if you were to review the many
other efforts these individuals made during those years, your
first question would have to be; “Where did they find the
time?” One other individual that has worked tirelessly since
the beginning of the Association and, in fact was the recipi-
ent of the HCCA Pinnacle Award, is Debbie Troklus. She did
not retire after receiving that award for her tremendous con-
tributions to HCCA. Since her year as President, Debbie
continues to be the “go to” person for education and training
and has been instrumental in the development of many of
the HCCA educational products and publications. And
simply stated, the HCCB would not exist today without
Debbie’s leadership.
This provides a highlight of only a few of the leaders of
HCCA. Trust me, there are many more. If you want to know
how to become involved and work hard, ask Greg, Sheryl,
Dan, Alan, Roy, Debbie, or any other member of the HCCA
Board. Odell Guyton shared a quote with me the other day
which is fitting here: “We are standing on the shoulders of
giants”. I’ll close by again answering the questions of “How
can I become a member of the HCCA Board?” and “How
can I become a Board Officer?” by simply saying “Become
involved, work hard and it will happen!” ■
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
HCCA • 5780 LINCOLN DRIVE, SUITE 120 • MINNEAPOLIS, MN 55436
3March 2004
R E S O U R C E S
T H E C A L E N D A RONON
HCCAHCCA
2004
CONFER-
ENCES:
(See page 5 for upcoming
audioconferences)
ANCHORAGE, AK■ JUL 22-23, Alaska Area
Meeting
LOS ANGELES, CA■ JUL 16, (Date Changed)
Southwest Area Meeting
WASHINGTON, DC■ MAY 21, Northeast Area
Meeting
ORLANDO, FL■ OCT 22, Southeast Area
Meeting
ATLANTA, GA■ MAR 26, Southeast Area
Meeting
CHICAGO, IL■ APR 25-28, HCCA
Compliance Institute ■ SEPT 17, North Central Area
Meeting
BOSTON, MA■ SEPT 10, New England Area
Meeting
BALTIMORE, MD■ MAR 1-4, Advanced
Compliance Academy
MINNEAPOLIS, MN■ MAY 24, Upper Midwest Area
Meeting
KANSAS CITY, MO■ AUG 6, Midwest Area
Meeting
LAS VEGAS, NV■ NOV 5, Southwest Area
Meeting
NEW YORK, NY■ NOV 15, Mid Atlantic Area
Meeting
PHILADELPHIA, PA■ OCT 15, Northeast Area
Meeting
SALT LAKE CITY, UT■ SEPT 13, Mountain Area
Meeting
SEATTLE, WA■ JUN 4, Pacific Area
Meeting ■
For more information about eventsor resources, check out the HCCAWebsite, h t t p : / / w w w. h c c a - i n f o . o r gor call 888/580-8373.■ Monitoring & Auditing Prac-
tices for Effective Compliance■ H C C A’s Compliance, Consci-
ence, and Conduct™, a video-based compliance training p r o g r a m
■ HCCA’s book, Compliance 101■ Individual & Small Group
Physician Practice Compliance:
What every physician shouldknow
■ Privacy Matters–HCCA’s video-based HIPAA Training Program
HCCA’s CD Videos - ■ Alice Gosfield-Unplugged (with
2 HCCB CEUs)■ HIPAA Forum Digital Reference
CD (with 20 HCCB CEUs)■ Physician Group Practices
Compliance Conference (with3.6 HCCB CEUs) ■
HCCA • 888-580-8373 • www.hcca-info.org
& S C E N E SSITESSITES from the january board meeting
N E W S F L A S H: Compliance among Top 10 hot executive jobsThe ranking, according to a December 3, 2003 press release fro m
Christian & Timbers, says the 10 Hot Exe c u t i ve Jobs in 2004 are :1. Board director at public company2. Human resource director: tech or health care3. Executive VP of sales4. Executive at medical devices company5. Campaign managers6. Chief nursing officer7. Chief ethics officer8. Chief compliance officer9. VP data mining10. EVP at national security/DOD consulting companyFor more information, go to:http://www.ctnet.com/pr/releaseDetails.asp?prid=256<http://eccn.c.tep1.com/maabUeyaa325ja8YhGVe/> andhttp://wwwctnet.com/pr/studies/hotjobs2004/pfversion.html<http://twcc.c.tep1.com/maabUtlaa34T2a78pgie/> ■
4March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
s e rvices? Since such providers are not
e m p l oyees, how is the medical group to
re c e i ve payment from Me d i c a re dire c t l y,
rather than have the funds paid to the
physician? Essentially, the answer is that
the group cannot have the benefits re a s-
signed and paid directly from Me d i c a re .
In practice, the medical group seeks to
collect the Me d i c a re re i m b u r s e m e n t s
f rom the independent contractor physi-
cian directly; not always an efficient and
e f f e c t i ve pro c e d u re .
A l t e r n a t i ve l y, the Me d i c a re Ca r r i e r’s
Ma n u a l p rovides, in Section 3060.11,
that payments can be made to the physi-
cian via a bank account, so long as only
the physician has control over the bank
account and the bank is not otherw i s e
p roviding financing to the physician.
Again, this is not an error free pro c e-
d u re. The physician still has control ove r
the funds in the bank account and can
abscond with the funds at any time
without turning them over to the med-
ical gro u p. As a pro t e c t i ve measure ,
medical groups can establish the bank
account as a “ze ro balance” account,
meaning that the contents of the bank
account will be transferred daily to the
medical gro u p’s account. The medical
g roup can further protect itself by hav-
ing a contract with the physician where-
by the physician agrees to assign all
accounts re c e i vable for his services, and
set up and transfer the contents of the
ze ro balance account. This is a complicat-
ed process, and is often misunderstood
by Me d i c a re re p re s e n t a t i ves, the medical
g roups, and the physician.
Howe ver the new Me d i c a re legislation
amends 42 U.S.C. §1395u(b)(6)(A) by
revising the entities entitled to re c e i ve
reassigned Me d i c a re benefits. The
reassignment exception to the facility is
amended to state that payment can be
made to the entity “when the service was
p rovided under a contractual arrange-
m e n t” between the physician and anoth-
er entity, if under the contractual
arrangement, the entity bills for the
p rov i d e r’s services. The addition of the
“contractual arrangement” language is
c rucial. It is what now allows an inde-
pendent contractor to directly re a s s i g n
Me d i c a re benefits to the medical gro u p.
T h e re f o re, if a physician contracts with a
medical group to provide services, the
Me d i c a re benefits for those services can
n ow be reassigned to the medical gro u p
as the entity entitled to bill for the
s e rvices. This is a huge relief for medical
g roups across the country trying to hire
p roviders in a market where only inde-
pendent contractors are available. Now,
the expense and inconvenience of finan-
cially collecting Me d i c a re accounts
re c e i vable paid to an independent
c o n t r a c t o r, or setting up ze ro balance
bank accounts, is obviated. All Me d i c a re
benefits can be reassigned directly to the
medical gro u p.
Also, this particular provision of H.R. 1
is effective upon enactment. However,
it is subject to the Secretary of Health
maintaining “program integrity and
other safeguards.” Naturally these latter
terms have yet to be defined by either
Congress or Medicare. ■
Ed i t o r’s note: Clare Stebbing is staff attor-
ney for Team Health Anesthesia Ma n a g e -
ment Se rvices, Inc. in San Diego, CA. Sh e
may be reached at 858/277-4767.
he recent Medicare reform
legislation, the Medicare
Prescription Drug and
Modernization Act of 2003 (H.R. 1),
signed on December 8, 2003, by
President Bush, does much more than
establish a prescription drug benefit
under the current Me d i c a re laws and
guidelines. The Act includes an amend-
ment that could dramatically affect how
physicians and medical groups are paid
by Me d i c a re for their services. Prior to
the enactment of H.R. 1, Me d i c a re
would only reassign Me d i c a re benefits
d i rectly to the physician’s employer (as a
condition of employment) or to the facil-
ity when a facility contracted dire c t l y
with the physician. Other exceptions to
the general prohibition on re a s s i g n m e n t
of Me d i c a re benefits included payments
to an organized health care delive ry sys-
tem and payments to a physician for pur-
chased diagnostic tests. Thus physicians
e m p l oyed by a medical group could re a s-
sign Me d i c a re benefits directly to their
e m p l oyer medical group if it was a condi-
tion of employment.
But what about physicians hired by the
medical group as independent contrac-
tors and paid on a per diem basis for their
By Clare Stebbing
T
5March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Get the latest “ how to” information–tools you can imple-ment–without even leaving your office! Register on theHCCA Website–www.hcca- info.org. Once payment isreceived you are registered and will receive an email a fewdays before the conference with any conference handoutsand contact phone number and instructions.
➤ ➤ Anatomy of a Fraud InvestigationSpeakers: Gabe Imperato and Dan SmallFebruary 25 and 26
➤ ➤ HIPAA Secur itySpeakers: Frank Bresz, Michael McDermand and Nancy ScottMarch 10 and 12
➤ ➤ Pr ivacy LitigationSpeakers: Edward Shay and Ronald LevineMarch 23 and 24
➤ ➤ HIPAA Research Repositor iesSpeakers: Linda Malek and Marti ArvinApr il 6
➤ ➤ JCAHO and Pr ivacySpeakers: John Knapp and Joette HannaApr il 8 and 9
Be on the lookout for :
➤ ➤ Stark Final RulesSpeakers: Lisa Murtha, Dan Roach, John Knapp, and Roy Jaffe
➤ ➤ Coding and Documentation: Anesthesiology and Cr itical Care
➤ ➤ Surgical Documenting and Coding
March 2004
6 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editor’s note: José A. Tabuena provides
Investigative and Integrity Services with
KPMG's Forensic Practice, including the
design and evaluation of compliance and
fraud prevention programs. He is based
in Dallas, TX, and can be contacted at
214/840-2666 or by e-mail at
rofessionals in the industry
are by now well acquainted
with the framework in which
health care compliance programs are
based. Adopted in 1991, the Federal
Sentencing Guidelines for organizations
(the Guidelines) revolutionized how the
government responds when an organi-
zation is convicted of wrongdoing.
Thereafter, the Office of Inspector
General (OIG) for the Department of
Health and Human Services began to
issue sector-specific voluntary compli-
ance program guidances for health care-
related organizations who do business
with the federal government. The OIG
guidances essentially follow the federal
sentencing framework, with the addi-
tion of more specific criteria for meet-
ing the steps or elements of an effective
program, based on the particular risks a
particular industry sector is said to face.
The Guidelines have had far reaching
impact in influencing the development
of corporate compliance programs. Yet
they have not been formally evaluated
or revised since they were adopted in
1991, although the statute contem-
plates ongoing amendment. The U.S.
Sentencing Commission finally con-
vened a panel of experts in 2002 to
revisit the Guidelines with particular
focus on the definition of an effective
program–which has emerged as the cor-
nerstone for designing and implement-
ing compliance programs since
its inception.
As a general matter, the Guidelines
mandate severe monetary fines when
misconduct occurs. On the other hand,
companies can have the greater part of
their penalties waived if they can
demonstrate good corporate citizenship
actions, including voluntary disclosure,
cooperation with authorities and, most
importantly, having in place an effec-
tive compliance program.
The Guidelines are important in the
context of compliance program evalua-
tions because they have created: (i) a
judicial framework that rewards respon-
sible, self-governing companies; (ii) a
sound model that companies can follow
for managing their business conduct;
and (iii) a standard that is influencing
regulatory enforcement policies, crimi-
nal prosecutions, and the liability of the
board of directors in civil litigation.
Extending the frameworkMuch has changed in the field of
organizational compliance since the
advent of the organizational sentencing
guidelines back in 1991, even beyond
what is espoused in the OIG guidances.
While legal standards that have
emerged are built upon the federal
sentencing guidelines model, more
detailed and sophisticated criteria
continue to be articulated.
This was demonstrated when an
influential Delaware court broke new
ground in 1996 with the decision,
In re Caremark Int’l Inc. Derivative Lit1.
The court opined that boards of direc-
tors that exercise reasonable oversight of
a compliance program might be eligible
for protection from personal liability in
shareholder civil suits resulting from
employee misconduct. The Caremark
case also makes it clear that a director’s
fiduciary duty goes beyond ensuring
that a compliance program is in place
in that “[t]he director’s obligation [also]
includes a duty to attempt in good faith
to assure that [the compliance program]
is adequate…”
➤➤ SPECIAL REPORT ➤➤ ➤➤ SPECIAL REPORT ➤➤
By José A. Tabuena By José A. Tabuena
P
7March 2004
that “[p]rosecutors should therefore
attempt to determine whether a corpo-
ration’s compliance program is merely a
‘paper program’ or whether it was
designed and implemented in an effec-
tive manner.”
The DOJ guidance, now titled Federal
Prosecution of Business Organizations,
was updated in January 2003. In the
commentary section, the DOJ added an
important dimension as to what makes
a compliance program worthy of posi-
tive consideration–namely the role of
the board of directors. Furthermore,
there is additional emphasis on the
importance of a company’s voluntary
disclosure and cooperation with the
government’s investigation. The DOJ
approach, as reflected in these memo-
randa, remains significant as the avoid-
ance of an indictment altogether is
generally of greater consequence than
reducing the harshness of a penalty
after a conviction.
The concepts found in the federal
sentencing guidelines continue to
appear in other frameworks. For
instance, on November 4, 2003, the
Securities and Exchange Commission
(SEC) approved new listing standard
requirements for the New York Stock
Exchange and NASDAQ. Those stan-
dards require, in part, that listed com-
panies adopt and disclose a code of
business conduct, including standards
and procedures that will facilitate the
effective operation of the code, such as
the reporting of compliance violations
and protection from retaliation. More
recently in response to the mutual fund
scandals, the SEC issued a new rule
requiring registered investment compa-
nies and advisors to designate a chief
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
compliance officer and have policies
and procedures designed to prevent vio-
lations of securities laws; subsequently
the SEC proposed that investment
firms that advise the funds adopt ethics
codes that spell out standards
of conduct.
Of course we cannot neglect Sarbanes-
Oxley. Although not explicitly men-
tioned, compliance programs are obvi-
ously impacted by the legislation and
resulting SEC rules. Requirements
pertaining to the adoption of a code of
conduct, and a whistleblower reporting
mechanism, clearly implicate a compli-
ance function. Further, the new annual
requirement for issuers to report on the
establishment, maintenance, and assess-
ment of a company’s internal control
structure bring to mind the sentencing
Guidelines, as the components of inter-
nal control overlap considerably with
the framework3–especially factors
pertaining to the control environment.
Features of the Guidelines can be found
in diverse frameworks such as the fraud
control models collectively offered by
the American Institute of Certified
Public Accountants, Association of
Certified Fraud Examiners, and other
professional associations, as well as the
business conduct management system
project to develop internationally recog-
nized standards, being pursued by the
Ethics Officers Association, and the
development of a system to accredit
compliance practitioners by the
Australian Compliance Institute–much
like the certification in health care com-
pliance (CHC) pioneered by t h e
HCCA. Also globally, similarities with
f r a m ew o rk can be seen abroad including
A similar theme emerged from the
1998 U.S. Supreme Court’s decision in
Faragher v. Boca Raton2, a case analyzing
an employer’s liability for sexual harass-
ment in the workplace. The Faragher
Court determined that an employer
may be able to avoid liability by
demonstrating that it exercised reason-
able care in preventing and correcting
the offending behavior. Interpreting the
Faragher decision, the United States
Equal Employment Opportunity
Commission issued an enforcement
guidance underscoring that this defense
rests not only upon whether the
employer had the “best policy and com-
plaint procedure but also on whether,
in light of specific facts of each claim,
the employer implemented the policy
and procedures effectively.”
In 1999, the U.S. Department of
Justice (DOJ) issued guidance to
federal prosecutors on bringing criminal
charges against corporations. The guid-
ance provides a number of factors that
prosecutors should consider in deciding
how to treat a corporate target poten-
tially involved in misconduct, including
the “existence and adequacy of the
corporation’s compliance program.”
Specifically, the guidance states that
“[w]hile the Department recognizes
that no compliance program can ever
prevent all criminal activity by a corpo-
ration’s employees, the critical factors in
evaluating any program are whether the
program is designed for maximum
effectiveness in preventing and detect-
ing wrongdoing by employees and
whether corporate management is
enforcing the program or is tacitly
encouraging or pressuring employees to
engage in misconduct to achieve busi-
ness objectives.” The guidance provides
➤➤ SPECIAL REPORT ➤➤ ➤➤ SPECIAL REPORT ➤➤
Continued on page 8
➤➤ SPECIAL REPORT ➤➤
March 2004
8 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
e f f o rts focused on corporate social
responsibility such as the corporate gov-
ernance initiatives of the Un i t e d
Kingdom, the AA 1000 assurance
s t a n d a rds, and the Global Re p o rt i n g
In i t i a t i ve .
Updating the GuidelinesThe advisory group appointed by the
U.S. Sentencing Commission consisted
of fifteen individuals with pro m i n e n t
b a c k g rounds in business, federal criminal
p rosecution and defense, legal scholar-
s h i p, and corporate compliance and
business ethics. The group issued a 137-
page re p o rt4 on October 7, 2003, re c o m-
mending that changes be made to give
organizations “g reater guidance on fac-
tors that are likely to result in effective
p rograms to pre vent and detect viola-
tions of law.” The re p o rt is definitely a
valuable read as it provides a compre h e n-
s i ve context with substantial discussion
on the evolution of the Guidelines since
1991, while capturing the leading ideas
and controversies in field of organiza-
tional compliance.
Two factors we re influential in the
g ro u p’s recommendation for changes.
First, recent re velations of widespre a d
misconduct went undetected, despite the
existence of compliance programs; and
second, the need was expressed to
update the organizational guidelines to
reflect the learning and pro g ress in the
compliance field since 1991. No t a b l y,
the recommendations elevate the stature
of the definition of an effective compli-
ance program. Cu r rently the d e f i n i t i o n
resides in “c o m m e n t a ry” to the Gu i d e -
lines and the proposal moves the defini-
tion from commentary to become its
own Guideline. The proposed new
Guidelines would have three parts. Pa rt
1 states that an effective pro g r a m
re q u i res two essential c o m p o n e n t s. An
organization must (i) exe rcise due dili-
gence to pre vent and detect violations of
l a w, and (ii) otherwise promote an orga-
nizational culture that encourages com-
mitment to compliance with the law.
The range of efforts to pre vent all viola-
tions of law would be re l e vant factors to
determining organization culpability.
Violations of law are defined as “v i o l a-
tions of any law or regulation to which
the organization is, or would be, liable.”
Pa rt 2 presents minimum s t e p s n e c e s s a ry
to achieve the two components re f e r-
enced above. These steps draw on the
c u r rent steps (or the seven elements
using OIG parlance) listed in the
Guidelines, with enhancements. Pa rt 3 is
an explicit re q u i rement for the need for
ongoing risk assessments in designing
and operating the program. In imple-
menting the steps provided in Pa rt 2, the
organization shall conduct ongoing risk
assessments and take steps to design,
implement, or modify each element to
reduce risk of violations of law identified
by the risk assessment.
The core recommendations can be sum-
m a r i zed as follow s :
■ A controversial new re q u i rement that
an effective compliance pro g r a m
should promote an “o r g a n i z a t i o n a l
c u l t u re” that encourages a commit-
ment to compliance with the law
(finding that culture, values, and
ethics we re becoming increasingly vis-
ible in government polices, with the
revised seven steps assisting in adding
clarity to the ambiguity inherent in
those terms)
■ A proposal for changing the pro g r a m
s t a n d a rds from focus on pre ve n t i n g
and detecting criminal conduct to
p re venting and detecting violations of
l a w
■ New explicit expectations for i)
b o a rds of directors; ii) organizational
leadership; and iii) specific individuals
for program implementation and
e va l u a t i o n
■ Mo re complete description on moni-
toring, auditing, and eva l u a t i o n
expectations, beyond auditing for ille-
gal acts, including requiring the
organization to “e valuate periodically
the effective n e s s” of its compliance
p rogram (nothing new for those uti-
lizing the OIG compliance guidances
in health care )
■ New re q u i rements to have a system
w h e re by the organization’s employe e s
and agents can “seek guidance”
re g a rding concerns or potential viola-
tions (in addition to a system to just
re p o rt violations after the fact)
■ New re q u i rement to provide “a p p ro-
priate incentive s” to perform in accor-
dance with the compliance pro g r a m
o b j e c t i ves (in addition to disciplinary
action for violations)
■ New explicit re q u i rement to perf o r m
ongoing risk assessment
■ A recommendation that the Se n t e n c -
ing Commission initiate dialogue
t ow a rd the resolution of the “litiga-
tion dilemma” with policymakers and
C o n g re s s
On November 5, 2003, the Commission
voted to publish for public comment the
a d v i s o ry gro u p’s proposed amendments.
Fo l l owing the public comment period,
the Commission has until May 1, 2004,
to decide whether to promulgate the
p roposed changes in whole or in part, or
Continued on page 32
Revisiting...continued from page 7
➤➤ SPECIAL REPORT ➤➤ ➤➤ SPECIAL REPORT ➤➤
9March 2004
of law;" a significant expansion in speci-
fied responsibilities of governance, senior
management, and the compliance exe c u-
t i ve, as well as the introduction of a
re q u i rement for an organization to con-
duct ongoing risk assessment and take
a p p ropriate steps to design, implement,
or modify each of the seven elements of
an effective compliance program to
reduce the risk of violations of law iden-
tified by the risk assessment process.
If implemented on November 1, 2004,
the amendments to the Guidelines will
bring changes both profound and subtle
to the stru c t u re and operation of com-
pliance programs in eve ry industry. It is
not too early to for health care compli-
ance officers to begin thinking about the
ramifications, and to start discussing and
planning for the implementation of the
Guidelines amendments.
B a c k g r o u n dIn conjunction with the 10t h a n n i ve r s a ry
of the Federal Sentencing Gu i d e l i n e s ,
the U.S. Sentencing Commission
appointed an Ad Hoc Ad v i s o ry Gro u p
to re v i ew the effectiveness of the
Guidelines. The Ad v i s o ry Gro u p, com-
missioned in September 2001, was
charged with re v i ewing the organization-
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editor's note: Mr. Koenig is Vice
President, Corporate Responsibility, for
Catholic Healthcare Partners, in
Cincinnati, OH. He may be reached at
513/639-2833.
n December 30, 2003, the
U.S. Sentencing Commission
proposed amendments to the
Sentencing Guidelines for United St a t e s
C o u rts (the Guidelines). Chief among
the proposed amendments are ten major
enhancements and refinements to
Chapter Eight of the Guidelines dealing
with organizational misconduct and
e f f e c t i ve compliance programs. Chapter
Eight's provisions apply to "organiza-
tions," rather than individuals and this
includes both for-profit corporations as
well as not-for-profit organizations, part-
nerships, associations, joint-stock com-
panies, unions, trusts, pension funds,
unincorporated associations, and gove r n-
ment and political subdivisions there o f.
Proposed changes to Chapter Ei g h t
include, among others, an expansion of
the definition of "established compliance
s t a n d a rds and pro c e d u res" to include
" s t a n d a rds of conduct and internal con-
t rol systems that are reasonably capable
of reducing the likelihood of violations
al sentencing guidelines, and urged to
place particular emphasis on examining
the criteria for an effective program to
e n s u re an organization's compliance
with the law. During its 18-month
t e n u re, the Ad v i s o ry Group's 15 mem-
bers surve yed the scholarly literature ,
i n t e rv i ewed federal prosecutors, re v i ewe d
re g u l a t o ry guidance of gove r n m e n t a l
agencies and departments, solicited
input from the public on the effective-
ness of the compliance criteria of the
Guidelines, and conducted a public
hearing.
Perhaps even more important than its
scheduled re v i ew activities we re the envi-
ronmental factors swirling about the
Ad v i s o ry Group at this time–En ro n ,
WorldCom, Tyco In t e r n a t i o n a l ,
Adelphia Communications, and
C o n g ress's response to these corporate
scandals: the Sarbanes-Oxley Act of
2002. Section 805(a)(2)(5) of the Ac t
d i rected the Commission to re v i ew and
amend the Guidelines to ensure that the
Guidelines are "sufficient to deter and
punish organizational criminal
misconduct."
A d v i s o ry Group report and SentencingCommission action
By Donald E. Koenig, Jr., JD
O
Continued on page 10
March 2004
10 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
offers demonstrable and concrete incen-
t i ves to organizations that will re d u c e
their culpability score if they face sen-
tencing in any federal court .
Format change to underscore theimportance of effective compliancep r o g r a m sAs a pre l i m i n a ry matter, the Commis-
sion proposes to raise the visibility of
the seven elements of an effective com-
pliance program by moving them out of
Application Note 3(k) to §8A1.2 and
establishing them as a new guideline at
§8B2.1. The intent is to provide gre a t e r
visibility to the importance of compli-
ance program development by eleva t i n g
the seven elements of an effective com-
pliance program to a specified guideline
in the main body of the Guidelines, ve r-
sus a commentary footnote.
Expansion of "Violation of Law"The Commission proposes to expand
the focus of compliance pro g r a m
b e yond the current definition that
includes only criminal law to include
"violations of any law, whether criminal
or non-criminal (including a re g u l a-
tion), for which the organization is, or
would be, liable." In its re p o rt, the
Ad v i s o ry Group indicated its belief that
the past responsibility of an organization
in addressing possible criminal conduct
does not completely measure an organi-
zation's culpability in connection with a
criminal offense. Rather, the full range
of efforts undertaken by an organization
to comply with the law, including, but
not limited to, criminal offenses, are re l-
e vant factors to determining organiza-
tional culpability.
Organizational culture of complianceas a purpose for compliance programs
ership for compliance effort s
(3) Explicitly requiring organizations to
focus their compliance efforts by con-
ducting careful risk assessments of
p robable types and sources of miscon-
duct in company operations and then
using the results of these assessments
to target compliance efforts and tailor
compliance program feature s
These emerging compliance standard s
a re reflected in the amendments pro-
posed in the Ad v i s o ry Group's re p o rt to
the Sentencing Commission.
The U.S. Sentencing Commission
p romulgated a formal proposal to amend
the Guidelines on December 30, 2003
in the Fe d e ral Re g i s t e r. The Commission
adopted the Ad v i s o ry Groups' re c o m-
mendations extensively re g a rd i n g
Chapter Eight and compliance pro-
grams. Public comments on the pro-
posed amendments are due to the
Sentencing Commission by Ma rch 1,
2004. The Commission will submit its
Guideline amendments to Congress by
May 1, 2004, with an effective date of
November 1, 2004, unless Congress acts
to change the effective date or modify or
d i s a p p rove the amendment. Or g a n i z a -
tions will have six months to pre p a re for
the effective date of final amendments to
the Guidelines, absent Congre s s i o n a l
action to delay or re v i s e .
Amendments proposedThe amendments proposed for Chapter
Eight are intended to provide gre a t e r
guidance to organizations and court s
re g a rding the criteria for an effective
compliance program to pre vent and
detect violations of the law. Compliance
p rograms play a fundamental part in the
Guidelines, as an effective pro g r a m
On October 7, 2003, the Ad Ho c
Ad v i s o ry Group released its re p o rt to the
U.S. Sentencing Commission on pro-
posed amendments for Chapter Eight of
the Guidelines. The Ad v i s o ry Gro u p
reached two major conclusions in its
re p o rt that shaped the proposed amend-
ments: First, re velations of widespre a d
misconduct in some of the nation's
largest publicly held companies–miscon-
duct perpetrated at the highest levels of
corporate leadership that went undetect-
ed despite the existence of compliance
p ro g r a m s – re q u i red evaluation of
whether the compliance efforts pre c i p i-
tated by the Guidelines could be made
m o re effective in pre venting and detect-
ing violations of law.
Second, the Ad v i s o ry Group re c o g n i ze d
that much has changed in the field of
organizational compliance since the
a d vent of the organizational Gu i d e l i n e s
in November 1991. Ef f o rts and experi-
ence by industry and organizations con-
tributed to an evolution of "best prac-
tices" during the 1990s that should be
reflected in updated Guidelines.
The Ad v i s o ry Group re p o rt re c o g n i ze d
the emergence of three new compliance
s t a n d a rds that re p resent a shift in the
compliance paradigm, as a result of
analyses of the corporate scandals of
2001 and 2002 and the legislative and
re g u l a t o ry responses to them:
(1) Extending conduct codes and re l a t e d
compliance efforts beyond mere law
compliance to the development of an
organizational culture that encourages
a more effective commitment to com-
pliance with the law, including ethics-
based standards and pro c e d u re s
(2) Recognizing the responsibilities and
accountability of organizational lead-
➤➤ SPECIAL REPORT ➤➤
Sentencing Guidelines...continued from page 9
11March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
The Commission proposes an amend-
ment to amplify the definition of
re q u i red "compliance standards and pro-
c e d u res that are reasonably capable of
reducing the prospect of criminal con-
duct" to include "standards of conduct
and internal control systems that are
reasonably capable of reducing the likeli-
hood of violations of the law." (Em p h a -
sis mine.) The Ad v i s o ry Group deter-
mined that it was necessary to amplify
the sorts of pro c e d u res that are re q u i re d
for effective compliance standards, and
concluded that standards of conduct and
internal controls are essential aspects of
e f f e c t i ve compliance programs and that
these measures should be deve l o p e d ,
implemented, and evaluated in terms of
their impact on reducing the likelihood
of violations of law. The Ad v i s o ry Gro u p
indicated that the results of risk assess-
ments are linked inextricably to the
n a t u re of internal controls that manage-
ment would implement to manage the
d i s c ove red risks, as well as the fre q u e n c y
of monitoring and testing of those
implemented internal controls to assure
compliance with expected actions.
Organizational leadership & gover-nance responsibility for complianceThis is one of the most significant are a s
of proposed changes. The Commission
p roposes to expand the second element
of an effective compliance program (that
dealing with the re q u i rement for speci-
fied high-level personnel within the
organization to have overall re s p o n s i b i l i-
ty for the implementation of an effective
compliance program), to define basic
g overnance and senior management
responsibilities vis á vis compliance pro-
gram oversight to underscore that the
ultimate responsibility for an effective
compliance program rests with gove r-
nance. Ad d i t i o n a l l y, the proposal estab-
lishes a re q u i rement for the "high-leve l
person with overall responsibility for
compliance" to have adequate authority
and re s o u rces to implement an effective
compliance program, as well as mandat-
ing direct re p o rting by the compliance
official to the governance authority
re g a rding the effectiveness of the compli-
ance program.
The Ad v i s o ry Group re p o rt stated that it
was struck by the pattern of senior man-
agement misconduct evident in the pub-
l i c i zed corporate scandals, as well as the
malfeasance or negligence of gove r n a n c e
at those companies. In view of that pat-
tern, the Ad v i s o ry Group concluded it
was unacceptable for the Guidelines to
be wholly silent re g a rding the role of
g overnance and senior management in
compliance. Fu rt h e r, the Ad v i s o ry
Group noted that in a 2000 survey of
the top 1,000 corporations, De l o i t t e
found that 77% specified the role of the
g overning authority or its audit commit-
tee in their compliance pro g r a m s .
Sp e c i f i c a l l y, the Ad v i s o ry Group pro-
posed three new provisions, namely:
■ The organizational leadership shall be
k n owledgeable about the content and
operation of the compliance pro g r a m
■ The organization's governing authori-
ty shall be knowledgeable about the
content and operation of the compli-
ance program and shall exe rcise re a-
sonable oversight with respect to the
implementation and effectiveness of
the compliance program
■ The high-level individual(s) who are
assigned direct, overall re s p o n s i b i l i t y
to ensure the implementation and
e f f e c t i veness of the compliance pro-
The Commission proposes to expand
the purpose of a compliance pro g r a m
b e yond the obligation to exe rcise due
diligence to pre vent and detect violations
of the law, by adding a re q u i rement that
an organization shall also "otherw i s e
p romote an organizational culture that
encourages a commitment to compliance
with the law." This proposed amend-
ment reflects the paradigm shift of
emerging compliance practices, noted by
the Ad v i s o ry Gro u p, that arose from the
corporate scandals: the expectation that
an organization cannot and should not
limit itself to a narrow focus on pre ve n t-
ing criminal misconduct, but must
accept a broader responsibility to ethical-
ly comply with all civil and criminal laws
as well as regulations governing an orga-
nization's activities and operations. T h e
Ad v i s o ry Group also noted the grow i n g
t rend in ethics-based compliance pro-
grams as a "best practice" of the 1990s,
as evidenced by the 2000 Ethics Of f i c e r s
Association survey that indicated that
86% of compliance programs we re a
combination of ethics-based and compli-
ance-based components, while just 6%
we re described as solely "compliance-
based" programs. The Ad v i s o ry Gro u p
concluded that abundant evidence exists
that the effectiveness of compliance pro-
grams can be enhanced if, in addition to
due diligence in maintaining compliance
p rograms, organizations also took steps
to build cultures that encouraged
e m p l oyee commitment to compliance.
Ac c o rding to the Ad v i s o ry Gro u p, pri-
m a ry responsibility for building a culture
of organizational integrity rests with the
organization's leadership and gove r-
n a n c e .
Internal controls as part of compliances t a n d a r d s
➤➤ SPECIAL REPORT ➤➤ ➤➤ SPECIAL REPORT ➤➤
Continued on page 12
March 2004
12 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Hi g h - l e vel person with ove r a l l
responsibility for compliance. T h e
specified accountabilities and re s p o n-
sibilities within the proposal may
re q u i re significant changes to how,
what, and when compliance officers
re p o rt to organizational leadership
members, as well as to the Board or
B o a rd committee members if a Board
Compliance Committee is assigned
p r i m a ry oversight re s p o n s i b i l i t y. T h e
p roposal also addresses the expecta-
tions for the "high-level person within
the organization with overall re s p o n s i-
bility for the implementation of an
e f f e c t i ve compliance program." T h e
p roposal specifies "high-level person-
nel of the organization" (HLP) to
e n s u re that this person has the formal
a u t h o r i t y, access to senior manage-
ment, and the respect needed to man-
age and oversee the implementation
of a compliance program. HLP are
persons with substantial control ove r
the organization or with a substantial
role in the organization policy-mak-
ing. Examples include a dire c t o r,
e xe c u t i ve officer, individual in charge
of a major business or functional unit
of the organization, or an individual
with a substantial ownership intere s t .
The proposal also specifies that the
activities of the HLP, and the opera-
tion of the program as a whole, must
be supported by the organization
with reasonable re s o u rces sufficient to
e n s u re due diligence on the part of
the organization to pre vent and detect
violations of law and to otherw i s e
p romote an organizational culture
that encourages a commitment to
compliance with the law. The alloca-
tion of these sorts of re s o u rces is
needed to ensure that a company's
compliance program is not just a
organization or a unit of the organiza-
tion and substantial authority person-
nel within the organization. T h e
terms collectively mean the key deci-
sion-makers within organization man-
agement–the group of leaders who set
d i rections for organizational actions
and who determine when organiza-
tional performance is successful in
attaining organizational goals. T h e
p roposal specifies that organizational
leaders must be knowledgeable about
the content and operation of the
compliance program. The expectation
of the Ad v i s o ry Group is that such
organizational leaders will gain infor-
mation about these programs on a
regular basis, as well as act on this
information to pursue constant
i m p rovement in the programs. Each
organizational leader is expected to be
a t t e n t i ve to matters relating to com-
pliance with the law and appro p r i a t e
responses within the bounds of his or
her area of re s p o n s i b i l i t y.
Organizational leaders are expected to
s c ru t i n i ze periodically the adequacy of
p rogram features in their areas of
l e a d e r s h i p, analyze gaps, if any, in
those features, and appropriately alter
compliance practices or other organi-
zational conduct to eliminate re a s o n-
ably foreseeable risks of future illegal
conduct. In short, the Ad v i s o ry
Group advocates that ongoing organi-
zational compliance within the law is
a task that must be pursued by orga-
nizational leaders, based on re g u l a r
attention to compliance program fea-
t u res and operations and the pursuit
of compliance excellence thro u g h
ongoing risk assessments and program
a d j u s t m e n t s .
gram shall be given adequate re -
s o u rces and authority to carry out
such responsibility and shall re p o rt on
the implementation and effective n e s s
of the compliance program directly to
the governing authority or an appro-
priate subgroup of the gove r n i n g
a u t h o r i t y.
Gove rning authority. The pro p o s a l
defines "governing authority" of an
organization as the Board of Di re c -
tors, or, if lacking a Board, the highest
l e vel governing body of the organiza-
tion. Ac c o rding to the Ad v i s o ry
Group re p o rt, the compliance pro-
gram knowledge that members of the
g overning authority should gain
includes: practical management infor-
mation about the major risks of
unlawful conduct facing the organiza-
tion; the primary compliance pro-
gram features aimed at counteracting
those risks; and the types of pro b l e m s
with compliance that the organization
and other similar parties have encoun-
t e red re c e n t l y. The oversight obliga-
tion related to the implementation
and effectiveness of a compliance pro-
gram is a critical duty of gove r n a n c e ,
just as compliance with the law is a
critical feature of organizational con-
duct. The Ad v i s o ry Group re p o rt sets
an expectation that effective ove r s i g h t
re q u i res governing authorities to be
p ro a c t i ve in seeking information
about compliance problems, eva l u a t-
ing that information when re c e i ve d ,
and monitoring the implementation
and effectiveness of responses when
compliance problems are detected.
Organizational leadership. The pro-
posal defines "organizational leader-
ship" as high-level personnel of the
➤➤ SPECIAL REPORT ➤➤
Sentencing Guidelines...continued from page 11
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org 13March 2004
training has two components: (1) edu-
cating all employees about compliance
re q u i rements, and (2) motivating all
e m p l oyees to comply. Ad d i t i o n a l l y, the
p roposal establishes a re q u i rement that
compliance training be provided to all
e m p l oyees, organizational leadership,
and the governing authority in order to
qualify as part of an effective compliance
p rogram. The burden is on the organiza-
tion to determine what training will be
p rovided and to explain why it believe d
it to be effective training, in order to
re c e i ve the credit in culpability scoring
p o rtion of sentencing.
Monitoring and auditing as a re q u i re-
ment. Similar to above, the Commission
p roposes to underscore that monitoring,
auditing, and periodic evaluations of the
e f f e c t i veness of compliance programs are
not just examples of how an organiza-
tion can demonstrate it undertook re a-
sonable steps to come into compliance
with its standards, but are essential
re q u i red components of an effective
compliance program. Ad d i t i o n a l l y, the
p roposal re q u i res that the monitoring
and auditing systems are to be designed
to detect violations of the law. T h e
Ad v i s o ry Group concluded that an
i n c reased emphasis on monitoring,
auditing, and evaluation practices is jus-
tified on three independently sufficient
g rounds: (1) the recognition of the
i m p o rtance of compliance monitoring,
auditing, and evaluation in recent legal
s t a n d a rds; (2) practical evidence of the
i m p o rtance of these practices in re ve a l-
ing recent incidents of major corporate
misconduct; and (3) privately deve l o p e d
s t a n d a rds and expert opinions identify-
ing monitoring, auditing, and eva l u a t i o n
e f f o rts as important components of
paper program, but rather a substan-
tial management effort with the
re s o u rces needed to succeed.
Fi n a l l y, the proposal specifies that the
HLP with overall responsibility for
compliance should periodically re p o rt
on the nature, pro g ress, and success of
the program to the governing authori-
ty of the organization or some appro-
priate subgroup (such as an audit
committee) within the gove r n i n g
a u t h o r i t y. Such re p o rting is designed
to bring two types of information
d i rectly from the head of the compli-
ance program to the gove r n i n g
authority without any potential filter-
ing or censuring influence of senior
organization managers: 1) Pe r i o d i c
re p o rts to update governance mem-
bers on the current features of the
company's compliance program and
the compliance problems that are
being addressed; and 2) in cases of
actual or apparent invo l vement in, or
s u p p o rt for, illegal conduct by top
l e vel organizational exe c u t i ves, the
head of the compliance pro g r a m
should ensure that re p o rts of this
behavior are made directly to the gov-
erning authority, an appropriate sub-
g roup of the governing authority, or
the organization's qualified legal com-
pliance committee. These re p o rts will
help the governing authority fulfill its
p roper role in ensuring accountability
on the part of senior organizational
managers and pre venting the initia-
tion or continuation of misconduct at
upper organizational levels. The above
listed types of re p o rts are intended to
e n s u re that the governing authority
will have key information necessary to
m e a n i n gfully exe rcise its ove r s i g h t
responsibilities. Howe ve r, additional
➤➤ SPECIAL REPORT ➤➤ ➤➤ SPECIAL REPORT ➤➤
operational information may be
re q u i re d .
Day-to-day compliance administra-
t o r. To further assist the gove r n i n g
authority in obtaining an understand-
ing of how a program operating
under its oversight is actually work-
ing, the Ad v i s o ry Group believes that
the governing authority should typi-
cally re c e i ve re p o rts from the person
with day-to-day administrative
responsibility for compliance, if that
person is different than the HLP with
overall responsibility for compliance.
These re p o rts would periodically sup-
plement, but not replace, re g u l a r
re p o rting by the HLP with ove r a l l
compliance re s p o n s i b i l i t y. T h e
Ad v i s o ry Group believes that periodic
re p o rts directly from the individual(s)
with day-to-day responsibility for the
p rogram will enable the gove r n i n g
authority to form an even more prac-
tical and compre h e n s i ve understand-
ing of how the program is function-
ing. Di rect contact with those who
h a ve day-to-day responsibility might,
for example, help the gove r n i n g
authority more effectively assess the
adequacy of re s o u rces being made
a vailable to the pro g r a m .
Compliance training as a requirementThe Commission proposes to underscore
that effective training is not an example
of one way that an organization can
communicate effectively its standard s
and pro c e d u res, but is a distinct re q u i re-
ment. The Ad v i s o ry Group's re p o rt stat-
ed that training should not merely be
c o n s i d e red as one of the many ways to
"communicate effectively [organization-
al] standards and pro c e d u res. T h e
Ad v i s o ry Group believes that effective Continued on page 14
14March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
e f f e c t i ve compliance programs. T h e
Ad v i s o ry Group re p o rt also pro p o s e d
that compliance monitoring, auditing,
and effectiveness evaluation practices
should be based on compliance risk
assessments. This change clarifies that
characteristics of monitoring, auditing,
and evaluation efforts, such as the target-
ing and frequency of compliance assess-
ments, should correspond to the likeli-
hood of compliance problems in part i c-
ular organizational activities, as identi-
fied in ongoing risk assessments.
Reporting systems to provide adviceand ensure anonymityThe Commission proposes to amend the
re q u i rement for having in place and
publicizing a re p o rting system where by
e m p l oyees could re p o rt criminal conduct
by others within the organization with-
out fear of retribution into more specific
re q u i rements for "a system where by the
organization's employees and agents may
re p o rt or seek guidance re g a rding poten-
tial or actual violations of law without
fear of retaliation, including mechanisms
to allow for anonymous re p o rting." T h e
Ad v i s o ry Group proposed these changes
for several reasons, 1) to re i n f o rce that
an organization committed to compli-
ance with the law should seek to prov i d e
guidance to employees facing difficult
ethical choices and not limit itself to
receiving re p o rts of criminal violations,
in order to encourage early re p o rt i n g
and consultations to pre vent violations;
2) to reiterate that internal re p o rt i n g
mechanisms should encourage self-
re p o rts of potential violations by
e m p l oyees, and not merely re p o rting on
the misconduct of others, and 3) to re i t-
erate the critical nature of a mechanism
to facilitate anonymous re p o rting to
encourage re p o rts of concerns.
Compliance standards enforcementi n c e n t i v e sThe Commission proposes to augment
the re q u i rement re g a rding appro p r i a t e
d i s c i p l i n a ry action for detected violations
of organization standards with a re q u i re-
ment for appropriate organizational
i n c e n t i ves to perform in accordance with
the compliance standards. The Ad v i s o ry
Group determined that compliance pro-
gram effectiveness can be enhanced by
including both the "carrot and the
s t i c k . "
Ongoing risk assessmentsThe final major amendment pro p o s e d
by the Commission to Chapter Eight of
the Guidelines introduces an additional
re q u i rement upon organizations as they
e n d e a vor to implement effective compli-
ance programs that include the seve n
elements: ongoing risk assessment.
Ad d i t i o n a l l y, the proposal will re q u i re
organizations to act upon the results of
the risk assessment to design, imple-
ment, or modify any of the program ele-
ments implemented to achieve compli-
ance with the seven effectiveness ele-
ments in order to reduce the risk of vio-
lations of the law identified by the risk
assessment. Fu rt h e r, the proposal would
re q u i re that risk assessments include
t h ree critical steps:
a. Assessing periodically the risk that
violations of law will occur, including
assessment of 1) the nature and seri-
ousness of such violations; and 2) the
likelihood that certain violations may
occur because of the nature of the
organization's business; and 3) the
prior history of the organization re l a t-
ed to violations of law
b. Prioritizing as most likely to occur
and most serious the actions taken
under each of the seven effective n e s s
elements in order to focus on pre ve n t-
ing and detecting compliance viola-
t i o n s
c. Modifying, as appropriate, the actions
taken under any of the elements of an
e f f e c t i ve compliance program to
reduce the risk of violations of law
identified in the risk assessment
The Ad v i s o ry Group concluded that the
need for risk assessment in designing and
operating an effective compliance pro-
gram is implicit in the definition of
e f f e c t i ve. The Ad v i s o ry Group deter-
mined that risk assessments need to be
made at all stages of the deve l o p m e n t ,
testing, and implementation of a com-
pliance program to ensure that compli-
ance efforts are properly focused and
e f f e c t i ve. An explicit provision is war-
ranted in the proposed Gu i d e l i n e
a d d ressing risk assessment and its re l a-
tionship to compliance program activi-
ties to emphasize both the importance of
risk assessment and its re l e vance in con-
nection with a wide variety of compli-
ance program activities. A detailed risk
assessment is re q u i red to appro p r i a t e l y
tailor a compliance program to a compa-
ny's business circumstances. T h e
Ad v i s o ry Group favorably cited the com-
pliance program evaluation standard s
d e veloped by the Health Care
Compliance Association (HCCA) that
re c o g n i ze the central role of risk assess-
ment in law compliance programs. T h e
drafters of the HCCA standards con-
cluded that "[c]reating an effective com-
pliance program . . . re q u i res a
systematic effort (scaled to the size ,
re s o u rces, and complexity of the organi-
zation) to understand its principle legal
obligations and risks and to make
e m p l oyees aware of how the re l e va n t
laws and risks impact the performance of
➤➤ SPECIAL REPORT ➤➤
Sentencing Guidelines...continued from page 13
the governance authority to point out
w h e re the organization stands in alre a d y
having adopted the 10 critical pro p o s a l s
or which provision(s) might re q u i re
additional organizational action, should
it or they appear in the final version of
amendments to Chapter Eight of
the Gu i d e l i n e s .
If adopted as proposed, the amendments
would further elevate compliance fro m
an operational program to a critical
information source through which the
g overnance authority assures itself of the
extent to which the organization is oper-
ating legally and ethically, in fulfillment
of the Board's fiduciary duties. Gove r n -
ance oversight of the effectiveness of the
p rogram and adequacy of re s o u rc e s
assigned has the potential to ensure a
committed organization can create an
e f f e c t i ve program, but it has the poten-
tial to also create additional tension for
compliance officers as they maneuver to
obtain re q u i red re s o u rces without alien-
ating senior leadership's support and
confidence by putting management in
the position of defending compliance
budget cuts to the Board .
Ad d i t i o n a l l y, the amendments would
establish a second focus area for
compliance efforts–to wit, the establish-
ment of an organizational culture that
encourages a commitment to compli-
ance with the law. This deve l o p m e n t
will offer compliance officers the oppor-
tunity to develop communications for
and from the governance authority and
organizational leadership to assist in
communicating that top-down commit-
ment and support for compliance.
Fi n a l l y, the advent of re q u i red internal
c o n t rols related to compliance and on-
15March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
their job functions."
Ad d i t i o n a l l y, the Ad v i s o ry Gro u p
intended to emphasize that the results of
risk assessments should influence the
design and implementation of a bro a d
range of features of an effective compli-
ance program. For example, risk assess-
ments identifying an organization's legal
obligations and the types of practices
that may cause an organization not to
meet those obligations can provide va l u-
able information for decisions on com-
pliance program standards, pro c e d u re s ,
and internal controls. These assessments
may be able to specify actions that
e m p l oyees and other organizational
agents should take to ensure compliance
with legal re q u i rements. Si m i l a r l y, risk
assessments that identify likely means of
violating legal standards in an organiza-
tion's operating context can help the
organization develop training pro g r a m s
for pre venting and detecting its most
p robable forms of unlawful conduct.
Ad d i t i o n a l l y, risk assessments identifying
a company's law violation risks will help
company auditors and compliance pro-
gram evaluators target the frequency and
content of program evaluations in ord e r
to make the most effective and efficient
use of these studies.
C o n c l u s i o nThe formalization of compliance stru c-
t u res and practices that have been largely
cited as best practices (e.g., anonymous
hotlines, direct re p o rting to the Board
on effectiveness of compliance pro g r a m s ,
a c t i ve monitoring, and auditing of com-
pliance) and adopted by many organiza-
tions over the past decade should enable
compliance officers to pre p a re a compar-
ison score c a rd for further discussions
with both organizational leadership and
going risk assessment will further opera-
t i o n a l i ze compliance as a function of
e ve ry operational manager and dire c t o r,
as they will be in the best position to
identify the controls that will be most
e f f e c t i ve in managing or contro l l i n g
identified risks. This is a favorable deve l-
opment, as it bucks a natural tendency
of some to view compliance as the com-
pliance officer's job instead of eve ryo n e ' s
re s p o n s i b i l i t y. Howe ve r, more disci-
plined risk assessments to prioritize com-
pliance risks will re q u i re additional col-
laboration between compliance officers
and operational managers and dire c t o r s
t h roughout health facilities and systems
to coordinate the many risk assessment
and management activities underw a y.
Collaboration and coordination will be
essential to maximize efficiency, mini-
m i ze duplication of efforts, and enable
compliance officers and organizational
leadership to assure the gove r n a n c e
authority that key compliance risks
t h roughout the organization are being
e valuated, monitored, controlled, tested,
and re p o rted in a rational pro c e s s .
November 1, 2004 looks like it is just
a round the corner when you consider all
that these amendments entail. Back to
w o rk ! ■
➤➤ SPECIAL REPORT ➤➤ ➤➤ SPECIAL REPORT ➤➤
HCCA Call for authors! HCCA is seeking authors for upcom-
ing issues of Compliance To d a y. All
members who wish to propose topics
and write articles are welcome. We seek
a rticles focused on new regulations and
related compliance issues, as well as
compliance program deve l o p m e n t ,
monitoring, and evaluation. Art i c l e s
a verage 1,250 to 2,500 words, and
often include “how to” tips. Pl e a s e
email the editor Ma r g a re t . d ra g o n @ h c c a -
i n f o. o r g with your article topic. ■
featureHCCA’s Compliance Institute
Steve Ortquist discusses HCCA's upcomingCompliance Institute, April 25-28, 2004
article
16March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
weekly for several months to conceive a
plan for the conference, and to refine
the plan until it reached final form.
These folks include Dan Roach from
Catholic Healthcare West in San
Francisco (Dan was last year's CI pro-
gram chair), Lisa Murtha from
Children's Hospital of Philadelphia,
and Wilma Acosta from Franciscan
Health System in Tacoma, Washington.
HCCA's staff has also been hard at
work–Erin O'Donnell and Tracy
Hlavacek have been especially busy
with the behind the scenes work that
makes the Compliance Institute so suc-
cessful each year.
M D : What are some of the highlights
from this year's program agenda?
S O : As I mentioned earlier, we've
Editor's note: The following Q & A
with Steve Ortquist, CI 2004 Planning
Committee Chair, offers a short preview
of the premier compliance conference for
the health care compliance professionals
in 2004. Margaret Dragon conducted
this interview with Steve Ortquist in
January 2004. Steve may be reached at602/495-4845.
M D : Steve, you are chair of this
year's Compliance Institute planning
committee. Tell us a bit about what
the committee has put together for
CI 2004.
S O : The planning committee
worked hard this year to put together
a phenomenal program. We've taken
steps to make certain that there will
be a significant amount of new mate-
rial for HCCA members. The most
important addition is inclusion of a
corporate responsibility tract in CI
2004.
Some of the general session
speakers, and speakers in at least one
break out session during each time
slot, are folks who work in ethics and
compliance roles outside of the health
care industry. We wanted to bring
these non-health care professionals to
the Compliance Institute this year so
that a larger number of our members
could benefit from what those of us
who have been able to attend the
HCCA Corporate Responsibility
Conference in Seattle have heard.
We have also considered develop-
ments in health care, and included
speakers who will incorporate informa-
tion on the Medicare Prescription Drug
Act, on the new Stark regulations, and
on other current topics on which our
members need to stay updated to
remain effective in their roles as
compliance professionals.
M D : Can you tell us a little bit about
the CI 2004 venue?
S O : The 2004 Compliance Institute
will be held April 25th through April
28th in downtown Chicago. As a former
resident of Chicago, I can tell you this
is one of the best times of year to be in
the Windy City. We will be at the
Downtown Chicago Marriott again this
year, right in the heart of the
Magnificent Mile and within a short
walk or cab ride from some of the best
museums, best dining, and best shop-
ping in the United States. Of course, no
one will be able to pull themselves away
from the fantastic CI program to take
advantage of all that Chicago has to
offer–but the weekend before the CI,
and evenings are fair game.
M D : Who was involved in planning
this year's Compliance Institute?
S O : There are literally dozens of peo-
ple who worked diligently to help
HCCA put this year's Compliance
Institute together. A core group met
included several corporate responsibility
sessions featuring speakers from outside
of health care. One session, for exam-
ple, will feature the Chief Compliance
Officer from Dupont who will discuss
the structure and operation of Dupont's
compliance program.
We also have as a luncheon speaker
this year, a business ethics professor
from Arizona State University. Professor
Marianne Jennings recently published
an allegory on business ethics titled A
Business Tale: A Story of Ethics, Choices,
Success, [and a Very Large Rabbit]1. I
learned about Professor Jennings from a
colleague in Phoenix who is the local
compliance officer for the Boeing
Corporation. Last year Boeing went
through a process very similar to what
we in health care would experience
when implementing a corporate integri-
ty agreement. As part of this process all
Boeing employees in Phoenix were
given five hours of ethics and compli-
ance training. Boeing hired Ms.
Jennings on short notice to record a
two hour video on ethical decision
making that was included in this train-
ing. Boeing's Phoenix training program
was administered in July in large circus
tents on the Boeing campus. While the
tents were cooled, this still creates an
amazing mental picture. Thousands of
employees in circus tents in 110 degree
heat for five hours of ethics and com-
pliance training! Boeing's employees
were so engaged by Ms. Jennings' video
presentation that their compliance offi-
cer described them as being on the edge
of their seats and raising their hands
whenever Ms. Jennings' video image
asked them a question. Several Boeing
employees approached the compliance
officer after this training to confess
their own ethical failures! Professor
Jennings' perspective on incorporating
ethics in a compliance program should
make an interesting addition to this
year's Compliance Institute.
The Compliance Institute will also
include regulatory updates from several
key health care regulatory bodies:
Acting Principal Deputy Inspector
General Dara Corrigan from the OIG,
Jim Sheehan from the United States
Attorney's Office, Leslie Norwalk and
Kim Brandt from CMS.
M D : The addition of a corporate
responsibility tract seems to be a focal
point in this year's Compliance
Institute. Why did the planning com-
mittee believe that this addition was
important?
S O : There are actually several reasons
for inclusion of corporate responsibility
in this year's conference. First, we
believe that understanding the require-
ments of Sarbanes-Oxley, and under-
standing what is being done within and
outside of health care to address those
requirements, is important for health
care compliance officers. Another sig-
nificant motivator for including corpo-
rate responsibility in the CI this year is
that HCCA members who have been
able to attend an HCCA Corporate
Responsibility Conference have consis-
tently said it is one of the better meet-
ings they have attended. We wanted to
bring the benefits of content developed
for the Corporate Responsibility
Conference to a larger group of HCCA
members.
Finally, we believe with the enact-
ment of Sarbanes-Oxley and the
increased focus on ethics and compli-
ance programs in the public sector, that
there will increasingly be opportunities
for professionals who have honed their
skills as health care compliance profes-
sionals, to apply those skills in indus-
tries outside of health care. We includ-
ed a corporate responsibility tract this
year in part to introduce HCCA mem-
bers to this new opportunity for profes-
sional growth.
M D : The industry immersion sessions
were a big hit last year. Has the plan-
ning committee included industry
immersion sessions in this year's
Compliance Institute?
S O : Yes, there will be industry
immersion sessions, and we've taken
steps based on what we learned last year
to make these sessions even more useful
for compliance professionals. We have
some great session chairs working on
putting together interactive immersion
sessions that compliance professionals
will not want to miss.
M D : Are there other new areas of
focus in this year's Compliance
Institute?
S O : One other thing I would men-
tion–HCCA's leadership has been
discussing recently the need to provide
opportunities for Board training to
HCCA's membership. We think it is
increasingly important for compliance
professionals to promote understanding
of what a well conceived compliance
program looks like, and of regulatory
requirements, within the ranks of their
own organization's Board and Board
Committees. This year we're offering
HCCA members an opportunity to
bring a Board member with them to
the Compliance Institute at a reduced
registration cost. Details of this offer
will be forthcoming in a flyer and in
emails from HCCA's office. ■
17March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org1 Marianne Jennings, AMACOM (2003)
People who debate
effectively remove
emotions from the
debate which are
often caused by the
desire for victory or
the frustration of
being questioned.
18March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
teaching or convincing someone to change their mind. De b a t e
helps us cut through complex government regulations. De b a t i n g
is difficult. If done poorly you may not only fail but irre vo c a b l y
e n t rench someone in their position. Compliance pro f e s s i o n a l s
use debate constantly. Debate is important to the field of compli-
ance. It doesn't always occur on a stage. Debate occurs during
e ve ry day conversation in offices, meeting rooms, and in the hall-
w a y. You debate more than you re a l i ze. It's best to be as good as
you can be. Many lawyers I know are ve ry skilled at debate.
Much of what I know about debate has come
f rom my legal colleagues. I have learned from
two of the best. So that I will not embarrass
them and to conceal their identity I will refer to
them as Orville Orbuch and Redenbacher Roach.
Much of what I share in this article has come as
a result of debating Orville and Re d e n b a c h e r.
The key to their success is their attitude tow a rds
debate. Orville and Redenbacher are more
successful in the field of compliance because of
their debating skills.
G e n e r a l i z a t i o n sThe generalization I just made about lawyers can be helpful for
getting a point across. Some generalizations can be constru c t i ve
and some can be destru c t i ve. You may agree or disagree with a
generalization but it does help you understand where the person
making the generalization is coming from. Ge n e r a l i z a t i o n s
b e t ween two contrasting groups of people can be even more
helpful to make a point. Generally speaking, generalizations are
r i s k y. T h e re f o re it is at some risk that I say lawyers generally
debate effective l y. It is at even greater risk that I say physicians
generally struggle with debate.
Why lawyers are effective at debateL a w yers are taught to question and be questioned. They are
ROY SNELLDebate is an important part of learning.
Debate is an important part of pro b l e m
resolution. It is an important part of
Debate:It’s important
c o m f o rtable with being questioned.
Physicians are not questioned on a
regular basis. They are less comfort-
able with being questioned which
makes debate difficult. Physicians are
trained to make serious decisions in a
s h o rt period of time. T h e re is little
time for debate. This type of training
can be good for your health but
c o u n t e r p ro d u c t i ve for debate. How you view debate affects yo u r
ability to debate.
L a w yers have an edge on the rest of us because they debated all
t h rough school and then spent years perfecting it. We can learn
f rom them. T h e re is a reason why they are so effective. I some-
times disagree with their point but I am often impressed with
their skill at making it. I have learned one ve ry valuable lesson
f rom my legal colleagues about the spirit of debate. Don't view
e ve ry debate as a life or death struggle.
People that don't like to be questioned re m i n d
me of the now famous scene from the Indiana
Jones movie, Raiders of the Lost Arc. In that
m ovie, a guy jumps out of a crowd to fight
Jones. The opponent is standing 15 feet away
and begins chanting and waving two long
s w o rds. It was like he had been training for
this encounter his whole life. He was ready for
a dual with Jones. He was proud to be up to
the challenge. Then Jones pulls a gun and
shoots him dead. People who debate effective -
ly enjoy the art of the duel and the challenge
of the encounter as much as they enjoy vanquishing their oppo-
nent. They want more than a win. They want an encounter that
they can learn from and an encounter they can teach with.
I don't think lawyers enjoy winning when they are wrong. T h e y
don't enjoy battling with an unskilled opponent. The joy of victo-
ry is tainted when a lawyer wins against an unskilled opponent.
L a w yers get in to the process as much as the outcome of a debate.
Debate is a way of life. The whole experience is appreciated and
respected. It's not so much about winning and losing, it's the duel
they enjoy.
Emotion and Anger
19March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
L a w yers are often surprised and disappointed when their va n-
quished opponent runs off in a huff. The good ones fight hard
but fight with a smile. They don't blink, or back down. Pe o p l e
who are effective at debate stay calm because they fight to learn
and teach. They want to keep a clear head. People who debate
e f f e c t i vely re m ove emotions from the debate. Emotions are often
caused by the desire for victory or the frustration of being ques-
tioned. Don't confuse passion with emotion. Individuals who
k n ow how to debate are passionate or pretend to be passionate
but they don't get emotional. Out of control passion can turn
into emotion. Out of control emotion can turn into anger. Anger
kills your ability to think and entrenches your opponent. So m e
deliberately try to anger their opponent. If they do, they often
win but really nobody wins. Don't let it happen to yo u .
If you see the end of a debate as winning and losing or life and
death you react differently before you finish the debate. If you see
value in the debate no matter what the outcome you will re a c t
d i f f e rently before you finish the debate. If you enjoy the experi-
ence as much or more than the outcome you will react differe n t l y.
Looking at a debate as a starting point rather than an end point
can change your actions during the debate. If you see the debate
as a winning experience no matter what the outcome and you will
h a ve a better chance of being victorious. Calm clear thinking helps.
You can lose a debate and still learn or teach. A successful debat-
er often sees debate as a beginning point, not an end point. Fo l l ow
t h rough helps you aim a ball even though it happens after you hit
the ball. Thinking about the desirable outcomes of a debate helps
you even though the outcome occurs after the debate.
The flip sideSometimes it helps to describe what not to do as opposed to what
to do. Take, for example, my 15 year old daughter Jessica whose
name I will not disguise because she will never read this. Sh e
should probably read this article but I don't want to give her any
edge. She is a wonderful student and athlete but effective debate
skills have eluded her. Iro n i c a l l y, I have told Jessica several times
that she should be a lawyer because she loves to debate with her
p a rents so much. Her debating style reminds me of the TV show
The Rat Pa t ro l .
The Rat PatrolMachine guns we re mounted on the back of jeeps with good guys
bouncing through the desert going after bad guys. The gunner in
the back of the jeep is hanging onto the machine gun for dear life
firing randomly in the direction of the bad guys. If it we re re a l ,
and not a TV show, they would have killed a dozen of their driv-
ers each month. That's how Jessica debates. Random arguments
shooting out in all directions hoping one hits her target. Debate a
15 year old and you will see the greatest example of someone who
sees debate as a life and death struggle. She must win at all cost.
Forget passion, it's full out emotion and anger. T h e re is no hope
of thinking straight. T h e re is no hope of seeing debate as a posi-
t i ve experience.
List of recommended booksI sent 10 people an email asking for the name of a good book on
the subject of debate. I wanted to share those books with you. I
sent the email to some of the best in the business. Un f o rt u n a t e l y,
no one had a clue as to what to read. Not only do they not have
one on their shelf but they didn't even remember the name of
one. I am disappointed that I have no books to recommend but I
think there is a far greater message in my discove ry that these peo-
ple have no books on debate. I don't think they have studied
debate that intently. I think they’re naturally effective.
How could they be good without studying tactics and strategy on
a regular basis? T h ree hundred page books on debate discuss step
by step strategy. Ex p e rts tell you hundreds of things to re m e m b e r.
Like most things it may not be as complicated as the expert s
make it out to be. Could it be that strategy and tactics are not
that important? Are effective debaters good because they naturally
come by the skills that I have observed; attitude, perspective ,
p rocess verses outcome, and avoiding emotion and anger? If so,
becoming effective at debate could be as simple as flipping a
switch. Just decide to take their approach and do it. Un f o rt u n a t e -
l y, changing is hard. Howe ve r, the first step in changing behavior
is acknowledging that change would be helpful.
Debate is important to compliance professionalsGood debating skills are particularly important for dealing with
physicians and administrators. Debate is a constant in our job.
Compliance professionals re s o l ve difficult issues. We are here to
change behavior. We are here to challenge behavior. We are here
to sort through complex regulations. We are here to be sure that
all sides are considered and eve ryone gets a voice. Ef f e c t i ve debate
can help us perform our function within the organization.
Ef f e c t i ve debate can reduce stress. In e f f e c t i ve debate will incre a s e
s t ress. Study debate and observe those who debate effective l y. Yo u
will sleep better. ■
Editor's note: Becky Sutherland Cornett,
PhD, CHC, is Director, Compliance
Coordination for The Ohio State
University Health System, Columbus,
Ohio. She holds a doctoral degree in com-
munication disorders, is a former speech-
language pathologist, and was director of
inpatient rehabilitation services at the
same organization. Dr. Cornett is a
Fellow of the American Speech-Language-
Hearing Association. She may be reached
at 614/293-5937 or via email at:
hysical rehabilitation services
have been in the news
frequently over the past few
years as CMS [Centers for Medicare
and Medicaid Services] introduced the
Inpatient Rehabilitation Facilities
Prospective Payment System (IRF-PPS),
and the on-again, off-again nature of
the financial limitation on outpatient
therapy services [Note, the moratorium
on the financial limitation, or "therapy
cap," is on again as of December 8,
2003 through December 31, 2005. See
CMS Pub. 100-4, Transmittal 42,
Change Request 3005 for more infor-
mation. The "cap" did not apply to
outpatient hospital services].
Further, the HHS' OIG targeted the
medical necessity of inpatient rehabili-
tation facilities stays in both its 2003
and 2004 Work Plans (see www.oig.hhs.
gov). CMS and its fiscal intermediaries
(FI) struggle to educate therapy
providers about the many service deliv-
ery and documentation requirements
associated with these services via Local
Medical Review Policies (LMRP - now
Local Coverage Determinations -LCD)
and through medical review
seminars, Q&A sessions, and other
teaching tools.
Compliance professionals should audit
and monitor the provision of inpatient
and outpatient rehabilitation services in
their organizations, but may find the
task daunting. There are many rules
and regulations published, but the
amount of information may be over-
whelming and difficult to organize (for
extensive educational information see
"Therapy Resources" at www.cms.hhs.
gov/medlearn/therapy and the applicable
FI's website (www.adminastar.com is an
excellent source of reference materials ).
An article in Report on Medicare
Compliance titled "Audit Highlights
Problems with Physical Therapy
Certification" (10/24/02) pointed out
the difficulties rehabilitation service
providers face in complying with
government payer requirements. For
example, in one FI audit, half of a
hospital's PT claims were denied
because the physician certification was
not obtained promptly or at all. In
addition, the FI denied services that
were found to be non-skilled (not
requiring the services of a PT) and
repetitive services.
Adminastar Federal, Inc., FI for the
quad-state region including Ohio,
Indiana, Illinois, and Kentucky pub-
lished a "Frequently Asked Questions"
document in January, 2003. Providers
were concerned about denials due to
insufficient documentation and the
nature of services rendered. Excerpts of
helpful answers that address frequent
problem areas found in audits are pro-
vided here:
■ Documents must demonstrate that
treatment is medically necessary and
provided on the dates billed, includ-
ing nurses and other clinicians' notes
demonstrating that the therapy serv-
ices are helping the beneficiary, and
causative factors that support the
start of therapy and the continuation
of therapy services, as well as expla-
nations for therapy absences.
■ We review the medical records to
determine whether therapy is effec-
tive and producing results or if
progress plateaus. In order to make a
determination on progress, we need
20March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
By Becky Sutherland Cornett, Ph.D., CHC
P
Text continued on page 27
21Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
EXHIBIT A: Audit Template for Inpatient Rehabilitation Services
Source Documents: CMS Publication 100-2, Medicare Benefit Policy and Draft LCD for Inpatient Rehabilitation (Draft PMR-1-003),Adminastar Federal, Inc.
Patient’s Name: MRN: Physician: Service: Reviewer’s Name: Date of Review:
Rehabilitation hospital care criteriaPatients needing inpatient rehabilitation services must require a hospital level of care. Rehabilitation care in a hospital is reasonable andnecessary for a patient who requires a more coordinated, intensive program of multiple services than is ordinarily available outside of ahospital. To qualify for a Medicare inpatient rehabilitation admission, the patient must meet two basic requirements: 1. The services must be reasonable and necessary (in terms of efficacy, duration, frequency, and amount) for the treatment of the patient’s
condition; and2. It must be reasonable and necessary to furnish the care on an inpatient hospital basis, rather than in a less intensive facility such as a
SNF, or on an outpatient basis.
Inpatient rehabilitation in a hospital setting will be considered medically reasonable and necessary if: ■ there is a reasonable expectation of measurable improvement that will be of practical value to the patient within a predictable and rea-
sonable period of time, and ■ the patient requires the active and ongoing therapeutic interventions of at least two disciplines (physical therapy [PT], rehabilitation
nursing, occupational therapy [OT], speech-language pathology services (also referred to as “speech therapy” in some Medicare docu-ments), psychology, social work, and prosthetics/orthotics, one of which must be a therapy, acting in a coordination fashion, and
■ the patient requires and can tolerate a least three hours per day of skilled therapy at least five days per week, or, in the instance of amedical condition that limits participation, an equivalent amount of combined therapy, medical, and nursing care, and
■ the therapy cannot be provided in a less intensive setting due to the need for 24-hour per day access to a registered nurse (RN) withspecialized training in rehabilitation or a need for frequent physician assessment or intervention due to a significant risk of rapid dete-rioration of physical or mental status, or the need for specialized equipment at such a frequency and duration so that it is impracticalfor the patient to use the equipment in an outpatient facility.
The patient meets criteria to qualify for a hospital-level-of-care. ❏ Yes ❏ No Comments:_____
Patients for whom admission was for evaluation Inpatient assessment of individual’s status and potential for rehabilitation (for cases in which hospitalization was focused on intensiveassessment):a) There is evidence in the record of extensive assessment by multiple professionals. ❏ Yes ❏ Nob) If the patient’s stay is longer than 10 days, the record contains evidence that very careful review was conducted to ensure that addition-
al time was necessary for evaluation. ❏ Yes ❏ Noc) If the patient received therapy prior to admission to this hospital for the same condition, it is documented that this evaluation admis-
sion was necessary because: ■ some intervening circumstance rendered such an assessment reasonable and necessary; or■ this hospital uses techniques or technology not previously available in the first hospital.
Close medical supervision, monitoring, and oversight by a physician with specialized training or experience in rehabilitation Patient’s condition must require the 24-hour availability of a physician with special training in rehabilitation. The documentation reflectsfrequent and direct, medically-necessary physician involvement in the patient’s care (at least every 2-3 days during the patient’s stay.) ❏ Yes ❏ No
In order to support the medical necessity of the services, the plan of care must contain the following elements:
March 2004Continued on page 22
EXHIBIT A: continued ■ diagnosis being treated and specific functional problem areas identified■ specific functional goals in measurable terms■ specific treatment modalities or procedures being used for each specific problem to attain the stated goals ■ amount, frequency, and duration of each therapeutic modality■ documentation at initiation of treatment that there is reasonable expectation the patient possesses the rehabilitation potential to meet
the treatment goals
The plan of care documents the required elements. ❏ Yes ❏ NoPhysician progress notes reflect the need for active and ongoing medical management. ❏ Yes ❏ No Comments:_____
The patient requires rehabilitation nursing care on a twenty-four hour basis The patient requires the 24-hour availability of a registered nurse with specialized training in rehabilitation.
Examples of nursing documentation reflecting specialized nursing care: ■ Progress in bowel and bladder continence or regulation following an injury that impacts such functions■ Skin integrity issues, including positioning techniques and weight shifting to prevent pressure areas in relatively immobile patients, and
care for any wounds or areas of already-compromised skin integrity■ Ongoing assessment of nutritional and hydration status in patients who are no longer able to eat and/or drink in the manner to which
they were accustomed■ Ongoing assessment of safety concerns, including not only physical limitations, but also such cognitive functions as memory, judg-
ment, pathfinding skills, and problem-solving abilities■ Educational interventions with the patient and/or family members/caregivers in how to maintain optimal health despite changes in the
way the patient’s body functions. Such interventions may include: training in medical techniques (e.g., tube feedings, tracheostomycare, catheterization), medication administration, bowel and bladder programs, prevention of complications, and planning for follow-up care
■ The patient’s proficiency on the nursing unit with techniques learned in therapy sessions ■ Discharge planning - assisting in the identification of the patient’s special medical needs for after-care
The documentation reflects the patient’s need for 24-hour RN care. ❏ Yes ❏ No Comments:_____
The patient requires a relatively intense level of rehabilitation therapy services The general threshold for establishing the need for inpatient hospital services is 3 hours a day of PT and/or OT, 5 days per week.However, other combinations of therapies, such as speech-language pathology services, or prosthetic/orthotic services, depending uponthe patient’s condition and individual needs, can qualify the patient for the inpatient stay. An inpatient stay can also be covered eventhough the patient has a secondary diagnosis or medical complication that prevents him/her from participating in a program consisting of3 hours of therapy per day. Inpatient hospital care may be the only reasonable means by which even a low intensity rehabilitation pro-gram can be carried out.
Note: the “three hour rule” should not be considered an inflexible “rule of thumb,” but a patient receiving a less intensive schedule oftherapy will require additional documentation to explain why he or she requires an inpatient rehabilitation facility level of care.
The medical record justifies an inpatient rehabilitation level of care, either by demonstrating at least 3 hours per day of therapies (PT, OT,or other combination), or by explaining why a low-level intensity is needed due to complicating factors. ❏ Yes ❏ NoComments:_____
The patient requires a coordinated, multidisciplinary team approach to rehabilitation Documentation should reflect not only the active involvement of multiple clinical disciplines, but also the interdisciplinary nature of theirtreatment. A multidisciplinary team usually includes a physician, rehabilitation nurse, social worker and/or psychologist, and those thera-pists involved in the patient’s care.
Auditing...continued from page 21
March 2004
22
EXHIBIT A: continued Example of interdisciplinary care: a long-term goal of independent bathing may require physical therapy to work on transfer techniques,occupational therapy to work on adaptive mechanisms for washing all body parts, and nursing to assess how well the patient remembersand follows through with these skills outside of therapy sessions.
Documentation demonstrates the team used an interdisciplinary approach to rehabilitation care. ❏ Yes ❏ No Comments:_____
Team conferences Team conferences are held at least every two weeks* to: assess the individual’s progress or problems impeding progress; consider possibleresolutions to problems; and reassess the validity of the rehabilitation goals initially established. Decisions made during such conferences,such as those concerning discharge planning and the need for any adjustment in goals or in the treatment program are recorded in theclinical record. ❏ Yes ❏ No
Note: Although CMS requires the frequency of team conferences to be “at least every two weeks,” more frequent (i.e. weekly)team conferences may be required to effectively demonstrate that the requisite interdisciplinary intensive rehabilitation is beingprovided and the patient is making measurable progress. Comments:_____
The patient demonstrates the potential for significant practical improvement“Practical improvement” is evaluated in the context of individual patient’s physical impairment. For example, practical improvement in apatient with paraplegia might include learning to manage a wheelchair, transfer back and forth from the wheelchair to bed, toilet, etc.,and dress, bathe, and toilet himself independently. For a patient with quadriplegia, however, practical improvement may include learninghow to direct others in his day-to-day care needs, achieve independent mobility with a customized electric wheelchair, and use adaptivedevices such as a mouth-stick or remote control unit to increase independence in controlling the environment.
There must be a reasonable expectation of improvement that will be of practical value to the patient, measured against his condition atthe start of the rehabilitation program. “Significant, practical improvement” in the patient’s condition is evident in the clinical record. ❏ Yes ❏ No Comments:_____
The patient has realistic goals requiring inpatient rehabilitation The most realistic rehabilitation goal for most Medicare beneficiaries is self-care or independence in the activities of daily living; i.e., self-sufficiency in bathing, ambulation, eating, dressing, homemaking, etc., or sufficient improvement to allow a patient to live at home withfamily assistance rather than in an institution. The aim of treatment is achieving the maximum level of function possible within a realistictimeframe.
Goals should be measurable and stated in terms of their functional impact. A goal of ambulating only 2-3 feet without assistance mayappear to be of little functional use to a patient unless it is also noted that he or she lives in a home with no accessible bathroom, thusrequiring the person to leave the wheelchair at the bathroom doorway and ambulate a few steps to the toilet or shower chair.
Both short-term and long-term goals should be documented. If the patient has not made the projected amount of progress between teamconferences, documentation should include the reasons and the plan for changes in the goals or treatment program.
Realistic goals are evident in the clinical record. ❏ Yes ❏ No Comments:_____
Length of rehabilitation program Coverage stops when further progress toward the established rehabilitation goal is unlikely or it can be achieved in a less intensive setting.There is evidence in the clinical record that the team considered all factors when planning discharge, and that the patient’s stay in theintensive rehabilitation setting was appropriate for the patient’s condition, progress made, and suitability of placement in a less-intensivedischarge setting. ❏ Yes ❏ No Comments:_____
Prepared by Becky Sutherland Cornett, Ph.D., CHC, The Ohio State University Medical Center, 1/04
23March 2004
Continued on page 24
March 2004
24 Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Auditing...continued from page 23
EXHIBIT B: Outpatient Rehabilitation Services Audit Template INDIVIDUAL RECORD WORKSHEET
Patient Name: MRN: Acct.:Referring Physician: DOS: Today’s Date:Rehabilitation services are designed to improve or restore physical and cognitive functioning following disease, injury, or loss of a bodypart. Impairments, functional limitations, and disabilities are assessed and addressed by the design and implementation of a therapeuticintervention tailored to the specific needs of the individual patient.
Therapy staff Qualified staff members provide PT, OT, and SLP services. ❏ Yes ❏ NoThe services provided are of such a level of complexity and sophistication that such services can be provided safely and effectively only byor under the supervision of a therapist. ❏ Yes ❏ No
Physician certification/approval/supervision All therapy services must be ordered, certified, and supervised by a physician. The physician order (prescription) alone does not consti-tute approval. The physician must certify approval of the plan of care/treatment by reviewing and signing the plan.
All records for Medicare beneficiaries contain the required physician certification. ❏ Yes ❏ NoIf applicable, the physician recertifies the plan of treatment every 30 days. ❏ Yes ❏ No
The written plan of treatment contains the following information: A plan of treatment for each therapy service is established by the physician, or the qualified therapist (PT, SLP, or OT). The physicianmust review and approve the plan and certify the need for treatment as soon as possible after the initial evaluation. ❏ Yes ❏ NoPrimary diagnosis resulting in the therapy disorder. ❏ Yes ❏ NoTreatment diagnosis for which services are rendered. ❏ Yes ❏ No
Initial assessment information - current relevant history; major functional limitations; prior hospitalization and therapy for the samecondition; pertinent baseline tests and measurements from which to judge future progress or lack of progress. Functional limitations aredocumented in terms that are objective and measurable. ❏ Yes ❏ No
Re-evaluations are completed only when a significant change in condition necessitates a revision of the current plan of treatment (re-evaluations are not routine, and are not indicated for all patients). ❏ Yes ❏ No
Long-term treatment goals focus on functional gain geared toward “significant, practical improvement within a reasonable and generallypredictable period of time;” short-term goals state objectives for the monthly billing period. Goals reflect the level of independence thepatient is expected to achieve in the discharge environment. Activities are designed to have a positive effect on the quality of the patient’severyday life. ❏ Yes ❏ No
Specific treatment modalities, activities, or interventions to be used to treat each specific problem are identified. ❏ Yes ❏ No
Type, amount, frequency, and duration of treatment are documented (e.g., PT, 3 times per week for 4 weeks). ❏ Yes ❏ No
Documentation of discharge planning is indicated early in the treatment plan. ❏ Yes ❏ No
The plan is sufficiently detailed to permit an independent evaluation of the patient’s specific need for the indicated services and of thelikelihood that he/she will derive meaningful benefit from the services. ❏ Yes ❏ No
Progress reports Progress notes may be written daily or weekly (however, each session must be documented) and reflect specific progress toward long-termdischarge goals.
25March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
EXHIBIT B: continued Documentation in the medical record is descriptive, clearly related to functionality, and reflects interaction among the professionalsinvolved. ❏ Yes ❏ No
Timelines are established for short-term goals (2-4 weeks), and reasons for not achieving short-term goals are documented in the record.❏ Yes ❏ No
Documentation includes information about the patient’s prior and current level of function, progress made (or lack thereof) for thisbilling/reporting period; techniques used to achieve goals; the patient’s continued potential to make “significant, practical improvement,”and changes in the plan of treatment. ❏ Yes ❏ No
All adaptive equipment and supplies used (billed) are documented. ❏ Yes ❏ No
Group therapy Group therapy consists of simultaneous treatment to two or more patients who may or may not be doing the same activities. If the ther-apist is dividing attention among the patients, providing only brief, intermittent personal contact, or giving the same instructions to twoor more patients at the same time, it is appropriate to bill each patient one unit of group therapy - 97150 (untimed code).
When direct one-to-one contact is provided, the therapist bills individual therapy and counts the minutes of therapy provided to eachpatient in order to determine how many units of therapy to bill each patient for timed codes. These direct one-on-one minutes may becontinuous (15 minutes straight) or in notable episodes ( 10 minutes now, 5 minutes later). Each direct one-on-one episode should be ofsufficient length of time to provide the appropriate treatment in accordance with each patient’s plan of care. The manner of practiceshould clearly distinguish from care provided simultaneously to two or more patients.
No more than four (4) patients may participate in a group therapy session conducted by one therapist; 6 patients may participate ifa therapist and one assistant (PT assistant) conducts the session (according to PT LMRP, Adminastar Federal).
Therapy sessions must be conducted by either a qualified therapist or therapist assistant, with appropriate supervision. Medicare will notpay for therapy conducted by therapy aides, regardless of the amount or type of supervision provided.
The -59 modifier is used to bill for both a group therapy session and an individual therapy session in the same day (CCI edit require-ment). The -59 modifier signifies that distinct, separately identifiable services were provided on the same day. CCI edit rules must befollowed (e.g., CPT codes may not be billed together if both codes require one-to-one patient contact or “constant attendance.” Grouptherapy codes may not be billed with individual codes that require constant attendance, etc.).
In a hospital setting, group therapy codes may be billed more than once per day, but sufficient documentation must be provided to deter-mine medical necessity and clinical appropriateness.
Billing issues Specific minutes of therapy provided are recorded in the record (no less than 8 minutes can be provided to bill for one unit - 8 to 22min.= 1 unit; 23-37 minutes = 2 units, etc.). ❏ Yes ❏ NoThe number of minutes recorded is correct and correlates with units of therapy billed. ❏ Yes ❏ NoTherapy codes billed are supported in the clinical record. ❏ Yes ❏ NoPhysician involvement in therapy intervention is evident in the clinical record. ❏ Yes ❏ NoDocumentation is legible, and is authenticated and dated promptly by the person (identified by name and profession), who is responsiblefor ordering, providing, or evaluating the service furnished. ❏ Yes ❏ No
Source documents•Medicare Coverage Guidelines for Medical Review of Hospital Therapy Services, AdminaStar Federal Part A Customer Service Center,9/15/00. •Outpatient Therapy Services Coverage Guidelines, AdminaStar Federal Medical Review Seminar, 6/02.
Continued on page 26
26March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
the initial evaluation. The initial
evaluation should document the rea-
son therapy has been ordered,
including the history of the injury or
illness. We also need to see that the
services rendered are physician-
approved and the service is reason-
able for the condition being treated.
We look for reduction in pain,
increases in joint movement, ADL
(activities of daily living) ability or
performance, and any other objective
and measurable data.
■ Medicare law requires that the physi-
cian be involved in the beneficiary's
care. An order for therapy does not
necessarily indicate that the physi-
cian is aware of the services you are
providing. The physician's signature
on the plan of treatment indicates
the physician is involved in the bene-
ficiary's treatment and endorses the
plan of treatment and services pro-
vided under that plan. A certification
form alone is insufficient for services
to be covered; there must also be an
associated plan of treatment.
Documentation of treatment goals is
another area of contention. Therapists
often seem to focus on short- and long-
term goals that address impairments,
but struggle to write goals that reflect
the patient's functional improvement
(ability to function in practical, every-
day situations and environments). For
example, an impairment-focused goal
is: "patient will maintain single-leg
stance greater than 5 seconds" or
"patient will be able to match pictures
with printed names with 80%
accuracy." Functional goals include
statements such as "patient will be able
to toilet independently;" "patient will
be able to reach left upper extremity to
shoulder height to comb his hair with-
out assistance" "patient will be able to
take all nutrition and hydration by
mouth."
The following statements have been
found in actual documentation, and
will likely result in denial of services:
"Patient making slow progress, weather
fluctuations affect her." "Saturday was a
good day." "Balance is improving"
(from what to what? No measures
included). "Speech somewhat slurred
today." The World Health
Organization's publication
International Classification of
Functioning, Disability, and Health
(2001) is an excellent source of infor-
mation about treatment goals and activ-
ities that focus on functionality, activi-
ties, and participation in society. Note
particularly the "ICF Checklist" (which
can be downloaded at www.who.int/
classification/icf/checklist/icf-checklist.pdf).
The checklist provides a complete
overview of impairments of body struc-
tures and functions, activity limitations
and participation restrictions, and envi-
ronmental factors that influence the
individual's participation in society.
Checklist items can be easily translated
into a hierarchy of therapy goals and
activities that would "pass" any CMS or
FI audit.
The two audit templates (see Exhibits A
and B) provided with this article are
intended to be both audit tools and
instructional guides because they incor-
porate a synopsis of CMS' rules for
delivery of inpatient (distinct rehabilita-
tion units and freestanding rehabilita-
tion hospitals) and outpatient rehabili-
tation services. Compliance profession-
als, most of whom are not experts in
rehabilitation, can use these tools to
assess rehabilitation departments' com-
pliance with the regulations, while also
providing rehabilitation managers with
easy-to-use guides to improve docu-
mentation and quality of services. ■
Auditing...continued from page 25
EXHIBIT B: continued •Guidelines for Medicare Coverage of Speech-Language Pathology Services, American Speech-Language-Hearing Association, 10/01. •11 FAQs - Post 9/13/02 Open Door on Group Therapy - Centers for Medicare & Medicaid Services (cms.gov website, 9/02). •LMRP - Outpatient Physical Therapy. AdminaStar Federal, Part A News, 6/02. •LMRP - Speech Pathology Services. AdminaStar Federal, 1/01. •Outpatient Physical Therapy - Speech Pathology Survey Report. (CMS Form 1893) 10/99•Plan of Treatment for Outpatient Rehabilitation. CMS Form-700-(11/91). •Outpatient Therapy Services, Frequently Asked Questions. AdminaStar Federal, 1/03. ■
Prepared by: Becky Sutherland.Cornett, Ph.D., CHC, The Ohio State University Medical Center, Rev. 1/04
27March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Editors note: Eric W. Klavetter, JD, works for the Office for Compliance at
the Mayo Foundation. He may be
reached at 507/266-0195.
ntroductionIn less than 16 months, the
1996 Health Insurance
Portability and Accountability Act
(HIPAA) Security Regulations will be
effective. As institutions recover from
Privacy or continue to work on
Transaction and Code Sets, they are
faced with another question: How do
we deal with HIPAA Security?
As we are all well aware, there are mul-
tiple stages to implementing a regula-
tion: Denial, Anger, Blame, Helpless-
ness, Hopelessness, and then Imple-
mentation. Seriously, there are multiple
approaches with one goal in mind:
Ensuring patient trust by having an
effective and efficient Privacy andSecurity Program.
With numerous implementation
approaches available, the opportunity to
better integrate Privacy and Security is
readily at hand and essential. Frequent-
ly, privacy will set the policy and securi-
ty will enforce it. For example, "mini-
mum necessary" is a privacy standard
and security enforces it through numer-
ous access and authorization schemes,
whereby the users are only able to
access the information they have been
authorized to review or manipulate.
Importance of semanticsAs institutions begin to tackle HIPAA
Security, it is essential to define terms as
quickly and succinctly as possible. For
this article, security is the protection of
people, property, and data. Data securi-
ty's primary components are:
1) Confidentiality through appropriate
access and authorization controls
2) Integrity which ensures data consis-
tency with the source
3) Availability that certifies proper net-
work monitoring, firewall, and a
virus strategy, to name a few
Privacy is ensuring patients can exert
their rights, such as:
1) Requesting an amendment to their
record
2) Requesting alternative communica-
tions
3) Requesting a copy of their protected
health information
4) Right to accounting of disclosures
5) Right to a copy of Notice of Privacy
Practices
6) Right to complain, to name a few
Additionally, privacy implements vari-
ous policies and process for proper use
and disclosure of information, which
ensures patient autonomy.
Institutional integrity is the ethics and
the code of conduct of the institution.
This has been in place since the mid-
90s when most institutions formalized
the standards of honesty, integrity, and
ethical and moral behavior for their
respective institutions. Institutional
Integrity is designed to educate staff
about the current health care environ-
ment, to raise staff awareness of the
Icomplexities of regulatory requirements,
and to provide resources to assist staff
in complying with those requirements.
As such, confidentiality is defined as,
"trust that personal information will be
secure, private, and managed ethically."
Depending on what expert is speaking,
each one of these artful terms can be a
leading component for any institutional
infrastructure. No matter, each institu-
tion's goal is to ensure patient trust;
therefore confidentiality is the leading
component. See Figure 1.
Confidentiality as a serviceConfidentiality is a service that patients
come to expect, which HIPAA has
re-emphasized through various stan-
dards. One unique attribute of this
service is that the patient sets the expec-
tation. We've all interacted with
patients and realize how unique each
one is. At the same time, we can forget
how vulnerable and/or desperate our
patients can be and that it can be or
"is" our fiduciary duty to protect them.
By labeling confidentiality as a service,
it can be incorporated into every aspect
of the institution.
Continued on page 28
By Eric W. Klavetter
28March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
The confidentiality programBy establishing definitions, defining a
virtual infrastructure as illustrated above
and labeling it as a "service", a confi-
dentiality program begins to take shape.
A confidentiality program can coordi-
nate the various issues, while ensuring
compliance with numerous regulations
and standards. The program can ensure
a consistent strategy that patients can
embrace, employees can promote, and
that leadership can utilize as a resource
when assessing new services, like
Telemedicine and Telecommuting. This
is where the value of the program can
be easily illustrated to leadership, as it
comes in the form of Risk Manage-
ment.
By implementing a clear strategy,
employees and work areas are able to
validate which practices and processes
need to be adjusted, eliminated, or sup-
ported. Often times, simple adjust-
ments can reduce the greatest amount
of risk. For example, assessing the need
for a department name on a return
label can subtly communicate to
employees that every detail is important
and often goes unnoticed by patients.
Necessity of a confidentiality programIn 1999, the California HealthCare
Foundation conducted a survey where-
by they found that computerization of
medical records is seen as the most seri-
ous threat to medical privacy. More
than half of all U.S. adults (54%)... say
the shift from paper record keeping sys-
tems to electronic or computer-based
systems makes it more difficult to keep
personal medical information private
and confidential. Most people consider
electronic piracy–not disclosure of per-
sonal information by medical person-
nel, health plan officials, or other
authorized users–as the bigger threat to
privacy. Nationally, 55% say they worry
more about computer hackers breaking
into a system, while only 30% worry
more about authorized users leaking
information.1
When institutions implement elements
of an electronic medical record (EMR)
or as the field of Genomics evolves, the
questions surrounding confidentiality
arise and can be effectively addressed
through a successful confidentiality pro-
gram. Once patients begin to under-
stand the societal benefits of Genomics
HIPAA Security...continued from page 27
Administrative Safeguards
StandardNumber Standard Implementation Specifications
(R)=Required ( A ) = Ad d re s s a b l eHospital A'sEnvironment
ComplianceGAP
1Security
ManagementProcess
Re: InformationSecurity Policies andStandards:
Other groups thatemploy risk analysis:• Internal Audit
Services• IT• Physical Security • Risk Office
(R)Risk Analysis
FIGURE 2
CONFIDENTIALITY
INTEGRITY/ETHICS PRIVACY SECURITY
Relationshipwith industry
Fraud & Abuse
Code of Conduct
Use of confidentialinformation
Disclosure of confi-dential information
Patient rights
Protection ofpersons
Protection ofdata
Availability
Integrity
Confidentiality
Authorizationcontrols
Access controls
Network
Database
Application
Data consistency
FIGURE 1
29March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
or the improvements of care through
EMRs, patients will participate with lit-
tle reservation.
Security dashboardOne way to begin is by constructing a
HIPAA Security Dashboard that can be
cross matched with other initiatives that
support confidentiality. Here is an illus-
tration of a HIPAA Security Dashboard
that outlines one HIPAA Security stan-
dard and the other institutional
resources that have some responsibility.
See Figure 2. By combing through the
regulation there are around 18 to 20
standards that can be entered into this
dashboard and rolled up into the confi-
dentiality program.
ConclusionAfter a policy inventory and work area
interview is complete and documented
in a Security Dashboard, the contents
can be rolled up with Privacy and In-
stitutional Integrity for an overall Con-
fidentiality Dashboard. See Figure 3.
With this strategic dashboard in place,
the institution is better positioned to
set a confidentiality strategy that
empowers employees and facilitates
patient trust. ■
1 Accessed on 1/12/03 http://www.chcf.org/
documents/ihealth/survey.pdf
Service Area
Integrity &
Ethics
Privacy
Security
ResponsibleParty
Compliance
Compliance
Compliance
Privacy
Privacy
Privacy
Privacy
Privacy
Privacy
Privacy
Privacy
Privacy
Privacy
Security
Security
Security
Sponsor
Compliance
Leadership
Finance
Compliance
HIM
IT
IT
Component
Relationship
with Industry
Code of Conduct
Fraud & Abuse
Patient Rights
Use
Disclosure
Confidentiality
Integrity
Availability
Initiative
Pharmaceutical Sponsor
OIG Workplan
Amendment
Alternative Com.
Notice of Privacy Practice
Complain
Disclosure Accounting
Copies of Medical Info
Restriction
Revoke Authorizations
Minimum Necessary
Implant Vendor
Donor Documentation
Research
Access Controls
Authorization Controls
Firewall Management
Anti-virus response plan
Back up Planning
Type
P
I
E
E
E
E
E
E
E
E
P
I
I
M
E
Priority
1
2
3
3
3
3
3
3
3
3
1
2
1
3
3
ConfidentialityStrategy, Risk, Initiative Dashboard
Type:
P - PlanningI - InvestigativeE - ExecuteM- Monitor
Priority
1 - Urgent2 - High3 - Routine
FIGURE 3
30March 2004
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
By Susan Steed
Editor's note: Susan Steed is a consultant
with Cap Gemini Ernst & Young LLC.
She may be reached at 972/556-7531 or
by email at [email protected]
emand for health care
services throughout the
country is on the rise.
Today’s hospitals face many challenges
in terms of providing services to meet
the heightened demand. Hospital
Emergency Departments (EDs) are
directly impacted and frequently reach
dangerously high saturation levels,
which pose risks to the ability to pro-
vide quality care, reach strategic objec-
tives, and achieve financial viability.
The term Emergency Department
“crowding” refers to the saturation crisis
that many hospitals face on a daily basis
when timely evaluation and treatment
by fully committed ED resources can-
not be provided. Extended patient
lengths of stay, delays in treatment,
inability to obtain inpatient beds, and
diversion of ambulances to other facili-
ties all serve as evidence of the crowd-
ing crisis. It is important to note that
ED crowding is not a stand-alone prob-
lem, but rather a symptom of a capacity
constrained hospital. This article out-
lines the causes of ED crowding, poten-
tial solutions, and the impact on com-
pliance.
Causes of ED crowdingThe causes of ED crowding are many
and interrelated. Key contributing fac-
tors include the following:
D
■ Over recent years, many of the
nation’s general acute care hospitals
have closed, resulting in fewer beds
available to accommodate admissions
from the ED
■ The national nursing shortage has
forced many hospitals to reduce their
number of staffed beds, further
reducing inpatient capacity
■ The aging population has brought
with it more complex diseases and a
requirement for specialized medical
services. As a result, patients present-
ing in the ED are “sicker” and
require a higher level of care
■ The numbers of middle class
Americans who now find themselves
without health care insurance cover-
age are seeking primary health care
in the ED. The rise of non-urgent
patients visiting EDs adds stress to
an already capacity constrained
system
■ Facility downsizing and decreased
capital investment in hospitals over
the past several years has led to out-
dated, inadequate, and misaligned
space to efficiently handle current
and future needs
■ The ability of hospitals to manage
current capacity is often impacted by
a lack of information and communi-
cation technologies, which often
times are inconsistently deployed,
cumbersome, and may not provide
real time information on bed avail-
ability status
Implications of ED crowdingAn even more severe downstream effect
of ED crowding is ambulance diver-
sion. According to a March 2003,
report by the U.S. General Accounting
Office (GAO), two-thirds of EDs
diverted ambulances to other hospitals
during 2001. ED diversions have the
potential for significant impacts on
quality of patient care, patient safety,
and patient, physician, and staff satis-
faction and retention. Care must be
taken to work collaboratively with city
and county EMS services to create
diversion policies and protocols that
decrease risk of EMTALA violations
and promote the health of the popula-
tion.
Potential solutionsHospitals can meet the ED crowding
challenge by employing a series of
strategies to optimize hospital capacity
while driving top down growth and
positioning themselves competitively in
their market. Benefit can be achieved
from turning around current opera-
tional problems by knowing where beds
are, ensuring appropriate utilization of
beds, matching staff resources to
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
Continued on page 32
31Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
March 2004
Each time you add a compliance docu-ment to the HCCA Website you will have
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Revisiting...continued from page 8Overcrowding...continued from page 30
demand, investigating bottlenecks, and
aggressively working toward improving
patient flow processes.
As ED crowding becomes more preva-
lent, hospitals will continue to look for
new and creative ways to respond to
demands. A few hospitals have utilized
areas such as ED parking lots, auditori-
ums, and other locations for treating
patients when EDs are saturated and
ambulance diversions have a high prob-
ability of occurrence.
Automated patient tracking systems
offer dynamic workflow solutions
aimed toward improving patient flow
and maximizing capacity. The newer
and more innovative systems on the
market take capacity management to
the next level by allowing “real time”
monitoring of patients throughout the
entire spectrum of care.
Although crowding is most prominent
in large metropolitan areas, it is a wide-
spread problem affecting EDs in all
areas of the country. It is important to
note that ED crowding is not a prob-
lem in and of itself, but rather a symp-
tom of multiple, system-wide factors
that act together to create bottlenecks
that impede access to timely and high
quality emergency care. Although long-
term solutions will likely require timely
and significant policy changes, hospitals
can benefit from implementing one or
more short-term capacity management
solutions to help ease the problem of
crowding in the nation’s EDs. ■March 2004
not at all. The Commission can also
choose to defer action until a later time.
It is worth noting that the pro p o s e d
changes add significantly greater strin-
gency to the present day criteria and
raise the bar in defining what is re q u i re d
for an ‘e f f e c t i ve’ program. T h e re f o re ,
organizations should continue to moni-
tor the U.S. Sentencing Commission
revision process, and be ready to make
p reparations to adjust its compliance
p rogram as warranted.
C o l l e c t i ve l y, the legal environment is
saying that having a compliance pro-
gram matters–in fixing liability, setting
fines, and even determining whether an
entity may continue to do business at all.
But more than just having a compliance
p rogram, management must have a basis
for knowing–and must be able to
demonstrate–that its compliance pro-
gram is effective. In sum, the ove r a l l
t rends suggest that dynamic demands
will continue to be placed on the deve l-
opment of organizational compliance
p ro g r a m s . ■
1 698 A.2d 959 (Ct. Chanc. Del. 1996). Anoverview of the duty of care owed by Boards ofDirectors, including discussion on the implica-tions of Caremark can be found in CorporateResponsibility and Corporate Compliance: AResource for Health Care Board of Directors, aguide developed jointly by the AmericanHealth Lawyers Association and the OIG.
2 118 S.Ct. 2275 (1998).3 Most companies in meeting this requirement,
will likely adopt the internal control modeldeveloped by the Committee of SponsoringOrganizations (COSO, also known as theTreadway Commission), which consists of fivecomponents: control environment, risk assess-ment, control activities, information and com-munication, and monitoring.
4 An executive summary and the full report canbe obtained from the U.S. SentencingCommission website located athttp://www.ussc.gov
33Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
March 2004
June, p. 12
■ Outpatient outlier payments are also
coming under government scrutiny,
J. Witten, R. Howard, Nov., p. 8
■ Provider alert: Watchdogs are
increasing scope and expertise, C.
Sreckovich, P. Calvin, Sept., p. 6
■ Top ten Part B errors, T. Gilbert,
Mar., p. 12
Compliance Focus Group (CFG)CFG: Academic
■ Data to information: Getting the
best value for your investment,
N. Tarnuzzer, July, p. 7
CFG: Academic
■ Private and public health care:
Regulation application, S. DeGroot,
Sept., p. 25
CFG: Home Care
■ CMS certification on homebound
criteria for home care industry
remains unclear, L. Silveria, July, p. 9
■ New hospice regulations include
many changes, D. Randall, Esq.,
C. Raffa, Esq., Feb., p. 11
■ Do bad surveys make bad claims,
D. Randall, Esq., Mar., p. 9
■ Maintaining profitability for DME-
POS in an environment of
compliance, K. Scamperle, Sept.,
p.22
■ OIG targets overpayments made to
home health agencies for OASIS
answer M0175, L. Silveria, Oct., p.
24
■ Surveys, compliance, and home
health OASIS reports, C. Hughes,
May, p. 25
CFG: Large Health System
Back to basics
■ Hotlines: More than a basic element
of a compliance program, A. Quinn,
Aug., p. 18
■ Measuring the effectiveness of your
compliance program, S. Ortquist,
May, p. 15
■ Strategies for Effective Compliance
Training, R. Frank, S. Ortquist,
Feb., p. 21
CEO's Letter
■ R. Snell, Jan., p. 15; Feb., p. 20;
Mar., p. 16; Apr., p. 18; May, p. 22;
June, p. 20; July, p. 23; Aug., p. 23;
Sept., p. 26; Oct., p. 23; Nov., p. 27;
Dec., p. 25
Compliance
■ Are you ready to deal with what
squirms up when you turn over the
rock?, D. Sheets, Feb., p. 6
■ Blending corporate compliance into
the collegial environment, M.
Walker, Aug., p. 11
■ Cataract surgery comanagement, B.
Peters, Dec., p. 10
■ Clinical quality as a compliance
issue: An update, A. Helder, B.
Cornett, Nov., p. 22
■ Compliance and quality combined,
K. Jenkins, June, p. 18
■ Compliance professionals and
administration: Living in perfect
harmony, B. Crewse, May, p. 23
■ Continuous regulatory compliance
improvement, C. Sreckovich, P.
Calvin, Oct., p.10
■ Corporate responsibility and the
compliance officer, F. L. Murtha,
Apr., p. 18
■ Corporate responsibility and corpo-
rate compliance, M. Hemsley, June,
p. 4
■ Corporate responsibility reflected in
hospital criminal conviction, G.
Imperato, July, p. 4
■ Compliance monitoring of the
research enterprise, F. L. Murtha,
Jan., p. 9
■ Developing a research audit plan,
F. L. Murtha, Oct., p. 6
■ Economic value of compliance,
T. Gregory, Mar., p. 6
■ Ever changing observation billing,
D. Sheets, May, p. 8
■ Fifteen new opportunities for com-
pliance professionals, F. Sheeder, July,
p. 17
■ Health care compliance professionals
faced with a unique opportunity, S.
Ortquist, Oct., p. 4
■ How CCOs enhance quality patient
care, K. Catalano, Oct., p. 25
■ Identifying elements and process for
conducting internal auditing and
monitoring, G. Gustin, Sept., p. 4
■ Inter-rater validity and the physician
audit, P. Moore, Nov., p. 6
■ Legal audit compliance check list,
J. Johnson, Dec., p. 18
■ Liability issues related to illegible
physician documentation, J. Russo,
July, p. 21
■ New risks of physician recruitment,
J. Krave, Sept., p. 12
■ No show: To bill or not to bill,
P. Moore, July, p. 20
■ Outpatient reimbursement: Based on
the setting, not the service, S. Steed, Continued on page 34
3434
2003 Index...continued from page 31
■ Update, M. Hemsley, Jan., p. 20
CFG: Payor/MC
■ Conflicts of interest in payor and
managed care organizations, R.
Freeman, V. McCormick, July, p. 11
■ HIPAA privacy rule preemption
analysis of the NAIC Insurance
Information and Privacy Protection
Act, J. Moen, Nov., p. 10
■ OIG Compliance Guide for
Pharmaceutical Manufacturers: A
defensive switch for health plans,
J. Michaels, Jan., p. 6
■ Refining your HIPAA privacy
implementation, R. Jones, Sept., p. 9
■ Refining your HIPAA privacy
implementation, R. Jones, Oct., p.17
■ Regulatory compliance: One
Medicare contractor's perspective,
E. Bair, Feb., p. 8
■ Government and Keystone develop
new credentialing policy, E. Moran,
Apr., p. 10
■ Monitoring and auditing the Claims
Prompt Payment process, C. Dubois,
May, p. 11
Focus on ethics
■ The Antonio Test, J. Oak, PhD,
Mar., p. 11
■ The interdependence of ethics,
J. Oak, PhD, Aug., p. 5
Feature
■ Meet L. Stephan Vincze, Jan., p. 11
■ Meet William N. Whatley, Feb.,
p. 18
■ Meet Odell Guyton, Mar., p. 14
■ Meet Janet Rehnquist, Apr., p. 14
■ Meet Rory Jaffe, May, p. 17
■ Meet Jeffrey Oak, PhD, June, p. 14
■ Meet Britt Crewse, July, p. 14
■ Meet Mac Thornton, Aug., p. 14
■ Meet Drema Pierson, Sept., p. 15
■ Meet Linda Wolverton, Oct., p. 15
■ Meet Sharon Hoyle, Nov., p. 15
■ Meet Al Josephs, Dec., p. 16
Government/enforcement/regulation■ CMS issues revised outlier payment
policy, J. Valenta, Aug., p. 6
■ Dara Corrigan named acting princi-
pal deputy inspector general, Aug.,
p. 9
■ Sarbanes-Oxley Act, F. Sheeder,
Jan., p. 4
■ Sarbanes Oxley Act of 2002:
Practical tips for providers,
F. Sheeder, Feb., p. 13
■ FYI, M. Dragon, Jan., p.21; Feb.,
p. 17; May, p. 28; Sept., p. 28; Nov.,
p.28; Dec., p. 22
■ PostSOX: Spotlight on private non-
profit boards brighter than ever,
J. Krave, Apr., p. 4
■ OIG Pharma Guidance released, M.
Dragon, June, p. 23
■ OIG 2004 Work Plan, eight actions
for hospitals, G. Herschman, Dec.,
p. 8
■ The New EMTALA: Part I What
you need to know, M. S. Lipton,
Nov., p. 18
■ The New EMTALA: Part II,
M. S. Lipton, Dec., p. 12
■ The next focus area for Medicare
payment reviews: Outliers, J.
Valenta, Apr., p. 7
■ In the Federal Register, Dec., p. 29
HCCA
■ Alan Yuspeh HCCA's 2003
President, M. Dragon, Jan., p. 17
■ Announcing the 2004 HCCA Board
of Directors, M. Dragon, Nov., p. 24
■ HCCA Appoints Greg Warner to
serve as HCCA's CO, M. Dragon,
Aug., p. 4
■ HCCA new members, Jan., p. 18;
Mar., p. 20; May, p. 26; Aug., p. 24;
Nov., p. 30; Dec., p. 28
■ HCCA Compliance Focus Groups,
Apr., p. 20
■ Introducing your HCCA staff,
Mar., p. 17; June, p. 24; July, p. 24;
Aug., 22; Nov., p. 29; Dec., p. 27
■ Preview of HCCA's Compliance
Institute 2003, M. Dragon, D.
Roach, Feb., p. 15
■ Compliance Performance
Measurement Initiative Task Force
Letter, Mar., p. 5
■ Regional contacts, June, p. 22
HIPAA
■ Common HIPAA privacy implemen-
tation misconceptions, J. Sanders,
M. Ortenberg, May, p. 4
■ HIPAA privacy compliance phase
two: Constant vigilance, G. Hughes,
June, p. 7
■ HIPAA transaction and code set
compliance, E. Klavetter, Dec., p. 6
■ Next stage of privacy compliance,
E. Klavetter, Aug., p. 20
■ Survey on HIPAA preparedness
released, M. Dragon, Feb., p. 5
Leadership letter
■ A. Yuspeh, Jan., Feb., March, April,
May, June, July, Aug., Sept., Oct.,
Dec., p. 2
■ Al Josephs, Nov., p. 2
Website Resources
■ Website Resources, Aug., p. 17,
Nov., p. 31 ■
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
March 2004
353535Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
The Health Care Compliance
Association welcomes the following
new members and organizations (U.S.
states Maryland to Oklahoma) who
joined HCCA. All 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 Kraft
([email protected]) with changes
or correction to your membership
information.
Maryland■ Kathy Bradley-Wells, JD, Kaiser
Permanente ■ Debbie Eccles, Specialized Care Services
Maine■ Steven K. Sanborn, BA, JD,
MaineHealth
Michigan■ Barbara J. Cliff, RN, BSN, MSA, MPA,
Cheboygan Memorial Hospital ■ Shawn P. Eyestone, Cox, Hodgman &
Giarmarco PC ■ Jim King, Gogebic Community Mental
Health ■ Mary K. Kralapp, RN, JD■ Priscilla K. Maher, United Mem.
Health System ■ Mary A. Storm, BS, RHIA, CHP,
McLaren Regional Medical Center
Minnesota■ Jennifer M. Anderson, Ernst & Young ■ Lyndy Benson, Specialized Care Services ■ Jodi L. Grimm, Mayo Clinic -
Rochester ■ Michelle L. Jezierski, Medica ■ Anna Korinko, Ovations ■ Thomas M. McSteen, JD, Compliance
Strategies, LLC■ Nancy Y. O’brien, LICSW, VA Medical
Center ■ Kim J. Tast, EMT, North Memorial
Medical Transport
■ Diana J. Vance-Bryan, BSN, JD, Briggsand Morgan
■ David A. Westlin, Arizant, Inc
Missouri■ Michael Cardenas, MHA, JD, St.
Anthony’s Medical Center ■ James W. Elder, Mallinckrodt Inc ■ Yvonnda L. Ford, JD, MHA, Lincoln
County Medical Ctr.■ Mark A. McKinney, Force 3, Inc. ■ Darlene Ornburn, Univ. of Missouri
Healthcare
Mississippi■ Debra A. Lawson, BBA, RHIA, Mid
South Rehab Services, Inc
Montana■ Mary B. Lazarus, RHIT, VA Montana
Healthcare System ■ Kristen K. Strizich, MT (ASCP),
Beartooth Hospital and Health Center
North Carolina■ Pam Benet, RHIA, Carolinas Health
Care System ■ Julie Ciarrocchi, UnitedHealthcare■ Pandora Holloway, CIA, WakeMed ■ M. Russell Payne, Alamance Regional
Medical Center
New Hampshire■ Deborah Shipman, MBA, Monadnock
Community Hospital
New Jersey■ Anna M. Burian, MHA, Monmouth
Medical Center ■ Mikole Burke-Anderson, JD, South
Jersey Health ■ Celia Connaire, Ortho Biotech
Products, LP ■ Darlene Den Hollander, Daiichi
Pharmaceutical Corp ■ Kellyann Dziedzic, Hunterdon
Healthcare System ■ Jean L. Furdella, MS, Catholic Charities ■ Deirdre Henry-Taylor, UMDNJ-
University Hospital ■ Kathleen Johnson, CPHRM, Kimball
Medical Center ■ Crystal London, MONOC ■ Paul Siock, Ortho Biotech Products, LP ■ S. Gilmore Stone, MA, CPA, FHFMA,
Peloquin & Associates ■ Melissa Straub, Ernst & Young, LLP ■ Donna Winters, Paralegal Certificat,
Physician Practice Services
New Mexico■ Don L. Daniel, JD, Presbyterian
Medical Services
New York■ Steven J. Chananie, JD, Garfunkel,
Wild & Travis, PC ■ Robert L. De Carlo, Slocum-Dickson
Medical Group, PC ■ Candace I. Finkelstein, MPA, Lutheran
Medical Center ■ Shari L. Grenier, RN, MPH, Esq.,
Staten Island Univ. Hosp.■ Brigid M. Maloney, JD, State Univ. of
New York at Buffalo ■ Lourdes M. Martinez, JD, Garfunkel,
Wild & Travis, PC ■ Darlene A. Noyes, RN, BS, Sunny
Upstate Medical University ■ Jane Smeland, Westchester Medical
Center ■ Marc B. Wilenzick, Pfizer ■ Leila Wilson, Versatile Innovative
Progressive Inc
Ohio■ Kevin T. Anderson, Esq., Kevin T.
Anderson, Esquire■ Beth Cesta, Premier Health Care Svcs.■ Istvan Hargitai, Legacy Health Services ■ Polly Maroun, RN, Associated
Physicians of MCO, Inc. ■ Angelia Z. Raney, M.Ed., CCDCI,
LSW, Scioto Paint Valley Mental HlthCntr.
■ Susan D. Ward, Barnesville HospitalAssociation
Oklahoma■ Deborah Rodgers, Duncan Regional
Hospital ■ Shawn Stone, Oklahoma Univ. Medical
Center ■
Editor:Margaret R. Dragon, Director of Communications, HCCA, 781/593-4924,[email protected]
Publisher:Health Care Compliance Association, 888/580-8373
Consulting Editors: Al Josephs, President, HCCA, 254/202-8620Roy Snell, CEO, HCCA, [email protected]
Design & Layout:Robin Taliesin, Raven Creative, 781/631-4639, [email protected]
Advertising:Erin O’Donnell, HCCA, 888/580-8373, [email protected]
HCCA Officers and Board of Directors:
Compliance Today (CT) (ISSN 1523-8466) is published by the Health Care ComplianceAssociation (HCCA), 5780 Lincoln Drive, Suite 120, Minneapolis, MN 55436. Subscription rateis $357 a year for non-members. Periodicals postage-paid at Minneapolis, MN 55436. Postmaster:Send address changes to Compliance Today, 5780 Lincoln Drive, Suite 120, Minneapolis,MN 55436. Copyright 2004 the Health Care Compliance Association. All rights reserved. Printedin the USA. Except where specifically encouraged, no part of this publication may be reproduced,in any form or by any means without prior written consent of the HCCA. For subscription infor-mation and advertising rates, call HCCA at 888/580-8373. Send press releases to M. Dragon, POBox 197, Nahant, MA 01908. Opinions expressed are not those of this publication or the HCCA.Mention of products and services does not constitute endorsement. Neither the HCCA nor CT isengaged in rendering legal or other professional services. If such assistance is needed, readers shouldconsult professional counsel or other professional advisors for specific legal or ethical questions.
Al W. Josephs, CHCHCCA PresidentDi rector of Corporate ComplianceHi l l c rest Health Sy s t e m
Odell GuytonHCCA 1st Vice PresidentSenior Corporate Attorney,Director of Compliance,US Legal-Finance & OperationsMicrosoft Corporation
Daniel Roach, Esq.HCCA 2nd Vice PresidentVP & Corporate Compliance OfficerCatholic He a l t h c a re We s t
Allison Maney, CPA, CHCHCCA TreasurerDirector of Claims Research andResolutionPacificare
Steven OrtquistHCCA SecretaryVP of Ethics & Compliance, Chief Compliance OfficerBanner Health Sy s t e m
Alan Yuspeh, JD, MBAHCCA Imme. Past PresidentSenior Vice PresidentEthics, Compliance & CorporateResponsibilityHCA, Inc.
Julene Brown, RN, BSN, CHC, CPCBilling Compliance ManagerMe r i t C a re Health Sy s t e m
CEO/Executive Director: Roy Snell, CHCHealth Care Compliance Association
Britt Crewse, MBA, MHSAssociate VP and Chief Compliance OfficerDuke Un i versity Health Sy s t e m
Shawn Y. DeGroot, CHCVice President of Corporate ComplianceRapid City Regional Hospital
Suzie Draper, BSN, RNCorporate Compliance Officer and PrivacyOfficerIntermountain Health Care
Rory Jaffe, MD, MBAChief Compliance OfficerU.C. Davis Health System
F. Lisa Murtha, Esq., CHCPrincipalParente Randolph
John Steiner, Jr., JDChief Compliance OfficerThe Cleveland Clinic Health Sy s t e m
Debbie Troklus, CHCAssistant Vice President for HealthAffairs/Compliance University of Louisville, School ofMedicine
Sheryl Vacca, CHCDirector, National Health Care RegulatoryPractice, Deloitte & Touche
Greg Warner, CHCDirector for ComplianceMayo Foundation
Counsel: Keith Halleland, Esq.Halleland Lewis Nilan Sipkins & Jo h n s o n
Place HCCA Cool Clothes
ad here: half page(exact reprint from
Jan. issue, p.33)
3636March 2004