[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]
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