[Federal Register Volume 63, Number 183 (Tuesday, September 22, 1998)]
[Notices]
[Pages 50577-50578]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25224]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General


Solicitation of Information and Recommendations for Developing 
OIG Compliance Program Guidance for Certain Medicare+Choice 
Organizations

AGENCY: Office of Inspector General (OIG), HHS.

ACTION: Notice.

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SUMMARY: This Federal Register notice seeks the input and 
recommendations of interested parties into the OIG's development of a 
compliance program guidance for Medicare+Choice organizations that 
offer coordinated care plans (M+CO/CCPs). The OIG has previously 
developed compliance program guidances for hospitals, clinical 
laboratories and home health agencies in order to provide clear and 
meaningful guidance to those segments of the health care industry. In 
an effort to provide similar guidance to certain M+C organizations, we 
are soliciting comments, recommendations and other suggestions from 
concerned parties and organizations on how best to develop compliance 
program guidance and reduce fraud and abuse within M+CO/CCPs.

DATES: To assure consideration, comments must be delivered to the 
address provided below by no later than 5 p.m. on November 23, 1989.

ADDRESSES: Please mail or deliver your written comments, 
recommendations and suggestions to the following address: Office of 
Inspector General, Department of Health and Human Services, Attention: 
OIG-4-CPG, Room 5246, Cohen Building, 330 Independence Avenue, S.W., 
Washington, D.C. 20201.
    We do not accept comments by facsimile (FAX) transmission. In 
commenting, please refer to file code OIG-4-CPG. Comments received 
timely will be available for public inspection as they are received, 
generally beginning approximately 3 weeks after publication of a 
document, in Room 5527 of the Office of Inspector General at 330 
Independence Avenue, S.W., Washington, D.C., on Monday through Friday 
of each week from 8:00 a.m. to 4:30 p.m.

FOR FURTHER INFORMATION CONTACT: Susan Lemanski, Office of Counsel to 
the Inspector General, (202) 619-2078, or Joel Schaer, Office of 
Counsel to the Inspector General, (202) 619-0089.

SUPPLEMENTARY INFORMATION:

Background

    The creation of compliance program guidance has become a major 
initiative of the OIG in its effort to engage the private health care 
community in addressing and fighting fraud and abuse. Recently, the OIG 
has developed and issued compliance program guidance directed at 
various segments of the health care industry.1 The guidance 
is designed to provide clear direction and assistance to specific 
sections of the health care industry that are interested in reducing 
and eliminating fraud and abuse within their organizations.
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    \1\  63 FR 8987 (February 23, 1998) for hospitals; 63 FR 42410 
(August 7, 1998) for home health agencies; and 63 FR 45076 (August 
24, 1998) for clinical laboratories. The guidances can also be found 
on the OIG web site at http://www.dhhs.gov/progorg/oig.
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Compliance Program Guidance for Medicare+Choice Organizations

    Representatives of the managed care industry have expressed an 
interest in better protecting their operations from fraud and abuse. It 
is likely that the establishment of the new Medicare+Choice program 
will

[[Page 50578]]

significantly expand the health care options available to Medicare 
beneficiaries and result in a greater number of beneficiaries enrolling 
in so-called ``managed care'' plans than ever before. Therefore, we 
believe that it is crucial that the organizations offering these plans 
have effective compliance programs in place. In fact, one of the 
conditions necessary to contract with the Health Care Financing 
Administration (HCFA) as an M+C organization is that the organization 
must ``have administrative and management arrangements satisfactory to 
HCFA,'' including a compliance program that consists of specified 
elements (42 CFR 422.501(b)(3)(vi)). These elements are similar to the 
elements the OIG has identified in its previous compliance program 
guidances.
    The OIG has determined that it would be appropriate to issue 
compliance program guidance for a subset of M+C organizations, i.e., 
those that offer coordinated care plans. As defined by the HCFA in 42 
CFR 422.4(a)(1), a CCP is ``a plan that includes a network of providers 
that are under contract or arrangement with the organization to deliver 
the benefit package approved by HCFA,'' and includes ``health 
maintenance organizations (HMOs), provider-sponsored organizations 
(PSOs), preferred provider organizations (PPOs), religious and 
fraternal benefit and other network plans (except network MSA plans).'' 
Id.

Voluntary in Nature

    Compliance program guidance represents the OIG's suggestions on how 
entities can best establish internal controls and monitoring to correct 
and prevent fraudulent activities. The contents of the guidance should 
not be viewed as mandatory or as an exclusive discussion of the 
advisable elements of a compliance program. While the elements that the 
OIG considers necessary for a comprehensive compliance program are 
similar to the elements HCFA has included in its conditions to contract 
as an M+C organization, the planned guidance is intended to present 
voluntary guidance to the industry, and not represent binding standards 
for M+CO/CCPs.

Areas for Comment and Input in Developing This Guidance

    We are seeking, through this Federal Register notice, formal input 
from all interested parties as the OIG begins developing compliance 
program guidance directed at M+CO/CCPs. The OIG will give consideration 
to all comments, recommendations and suggestions submitted and received 
by the time frame indicated above.
    We anticipate that the M+CO/CCP guidance will contain the seven 
elements that we consider necessary for a comprehensive compliance 
program. These seven elements have been discussed in our previous 
guidances and include:
     The development of written policies and procedures;
     The designation of a compliance officer and other 
appropriate bodies;
     The development and implementation of effective training 
and education;
     The development and maintenance of effective lines of 
communication;
     The enforcement of standards through well-publicized 
disciplinary guidelines;
     The use of audits and other evaluation techniques to 
monitor compliance; and
     The development of procedures to respond to detected 
offenses and to initiate corrective action (including reporting to 
appropriate governmental authorities)
    We would appreciate specific comments, recommendations and 
suggestions on (1) risk areas for the M+CO/CCPs, and (2) aspects of the 
seven elements contained in previous guidances that may need to be 
modified to reflect the unique characteristics of M+CO/CCPs. Detailed 
justifications and empirical data supporting suggestions would be 
appreciated. We are also hopeful that any comments, recommendations and 
input be submitted in a format that addresses the above topics in a 
concise manner, rather than in the form of comprehensive draft guidance 
that mirrors previous guidance.

    Dated: September 11, 1998.
June Gibbs Brown,
Inspector General.
[FR Doc. 98-25224 Filed 9-21-98; 8:45 am]
BILLING CODE 4150-04-P