[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 25000-25001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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 https://oig.hhs.gov/compliance/compliance-guidance/ (last visited Mar. 6, 2023).
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     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.
     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 https://cloud.connect.hhs.gov/OIG/.

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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