Notice2023-08326
Modernization of Compliance Program Guidance Documents
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 25, 2023
Issuing agencies
Health and Human Services Department
Abstract
This Federal Register notice sets forth upcoming procedures for issuing compliance program guidance documents from HHS-OIG.
Full Text
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<title>Federal Register, Volume 88 Issue 79 (Tuesday, April 25, 2023)</title>
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[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 25000-25001]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08326]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
Modernization of Compliance Program Guidance Documents
AGENCY: Office of Inspector General (OIG), Department of Health and
Human Services (HHS).
ACTION: Notice.
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SUMMARY: This Federal Register notice sets forth upcoming procedures
for issuing compliance program guidance documents from HHS-OIG.
FOR FURTHER INFORMATION CONTACT: Amanda Copsey, (202) 619-0335.
HHS-OIG is modernizing the accessibility and usability of our
publicly available resources, including OIG's Compliance Program
Guidances (CPGs). OIG developed CPGs as voluntary, nonbinding guidance
documents to encourage the development and use of internal controls to
monitor adherence to applicable statutes, regulations, and program
requirements. More specifically, beginning in 1998, OIG embarked on a
major initiative to engage the private health care community in
preventing the submission of erroneous claims and in combating fraud
and abuse in Federal health care programs through voluntary compliance
efforts. As part of that initiative, OIG developed a series of CPGs
directed at the following segments of the health care industry: (1)
hospitals; \1\ (2) home health agencies; \2\ (3) clinical laboratories;
\3\ (4) third-party medical billing companies; \4\ (5) the durable
medical equipment, prosthetics, orthotics, and supply industry; \5\ (6)
hospices; \6\ (7) Medicare Advantage (formerly known as
Medicare+Choice) organizations; \7\ (8) nursing facilities; \8\ (9)
ambulance suppliers; \9\ (10) physicians; \10\ and (11) pharmaceutical
manufacturers.\11\
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\1\ OIG Compliance Program Guidance for Hospitals, 63 FR 8987
(Feb. 23, 1998); Supplemental Compliance Program Guidance for
Hospitals, 70 FR 4858 (Jan. 31, 2005).
\2\ OIG Compliance Program Guidance for Home Health Agencies, 63
FR 42410 (Aug. 7, 1998).
\3\ OIG Compliance Program Guidance for Clinical Laboratories,
63 FR 45076 (Aug. 24, 1998).
\4\ OIG Compliance Program Guidance for Third-Party Medical
Billing Companies, 63 FR 70138 (Dec. 18, 1998).
\5\ OIG Compliance Program Guidance for the Durable Medical
Equipment, Prosthetics, Orthotics, and Supply Industry, 64 FR 36368
(July 6, 1999).
\6\ OIG Compliance Program Guidance for Hospices, 64 FR 54031
(Oct. 5, 1999).
\7\ OIG Compliance Program Guidance for Medicare+Choice
Organizations, 64 FR 61893 (Nov. 15, 1999).
\8\ OIG Compliance Program Guidance for Nursing Facilities, 65
FR 14289 (Mar. 16, 2000); OIG Supplemental Compliance Program
Guidance for Nursing Facilities, 73 FR 56832 (Sept. 30, 2008).
\9\ OIG Compliance Program Guidance for Ambulance Suppliers, 68
FR 14245 (Mar. 24, 2003).
\10\ OIG Compliance Program Guidance for Individual and Small
Group Physician Practices, 65 FR 59434 (Oct. 5, 2000).
\11\ OIG Compliance Program Guidance for Pharmaceutical
Manufacturers, 68 FR 23731 (May 5, 2003).
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Based on feedback received as part of OIG's Modernization
Initiative and other input,\12\ we understand that CPGs have served as
an important and valuable OIG resource for the health care compliance
community and industry stakeholders over the last 25 years. OIG has
carefully considered ways to improve and update existing CPGs and to
deliver new CPGs specific to segments of the health care industry or
entities involved in the health care industry that have emerged in the
last two decades. In modernizing OIG's CPGs, our goal is to produce
useful, informative resources--as timely as possible--to help advance
the industry's voluntary compliance efforts in preventing fraud, waste,
and abuse in the health care system.
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\12\ See, e.g., Department of Health and Human Services, Office
of Inspector General, OIG Modernization Initiative To Improve Its
Publicly Available Resources--Request for Information, 86 FR 53072
(Sept. 24, 2021).
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Through this Notice, OIG is notifying the public of the following:
<bullet> OIG will no longer publish updated or new CPGs in the
Federal Register. All current, updated, and new CPGs will be available
on our website.\13\
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\13\ All CPGs issued to date are currently available on the
Compliance Guidance page of our website at <a href="https://oig.hhs.gov/compliance/compliance-guidance/">https://oig.hhs.gov/compliance/compliance-guidance/</a> (last visited Mar. 6, 2023).
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<bullet> OIG has developed a new format for CPGs:
[cir] We will publish a General CPG (GCPG) that applies to all
individuals and entities involved in the health care industry. The GCPG
will address topics such as: federal fraud and abuse laws, compliance
program basics, operating effective compliance programs, and OIG
processes and resources. We anticipate updating the GCPG as changes in
compliance practices or legal requirements warrant. OIG plans to
publish the GCPG by the end of calendar year 2023.
[cir] Second, we will publish industry-specific CPGs (ICPGs) for
different types of providers, suppliers, and other participants in
health care industry subsectors or ancillary industry sectors relating
to Federal health care programs. ICPGs will be tailored to fraud and
abuse risk areas for each industry subsector and will address
compliance measures that the industry subsector participants can take
to reduce these risks. ICPGs are intended to be updated periodically to
address newly identified risk areas and compliance measures and to
ensure timely and meaningful guidance from OIG. OIG expects to begin
publishing ICPGs in calendar year 2024. Currently, OIG anticipates that
the first two ICPGs will address Medicare Advantage and nursing
facilities.
<bullet> When the new GCPG and ICPGs, along with any updates to
these documents, are published on OIG's website, OIG will notify the
public using our public listserv \14\ and other communications
platforms.
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\14\ To join OIG's listserv, visit <a href="https://cloud.connect.hhs.gov/OIG/">https://cloud.connect.hhs.gov/OIG/</a>.
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[[Page 25001]]
Neither OIG's existing CPGs nor any forthcoming GCPG or ICPG
constitutes a model compliance program. Rather, the goal of these
documents has been, and will continue to be, to set forth a voluntary
set of guidelines and identified risk areas that OIG believes
individuals and entities engaged in the health care industry should
consider when developing and implementing a new compliance program or
evaluating an existing one. Our existing CPGs and supplemental CPGs
will remain available for use as an ongoing resource as we develop and
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publish the GCPG and ICPGs.
Christi A. Grimm,
Inspector General.
[FR Doc. 2023-08326 Filed 4-24-23; 8:45 am]
BILLING CODE 4152-01-P
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