Modernization of Compliance Program Guidance Documents, 25000-25001 [2023-08326]

Download as PDF 25000 Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices Federal Register, but websites are subject to change over time. FOR FURTHER INFORMATION CONTACT: * 1. Sullivan, H.W., K.J. Aikin, and L.B. Squiers, ‘‘Quantitative Information on Oncology Prescription Drug Websites,’’ Journal of Cancer Education vol. 33, Issue 2, pp. 371–374, 2018. (https:// www.ncbi.nlm.nih.gov/pmc/articles/ PMC5334459/). 2. Dillman, D.A., J.D. Smyth, and L.M. Christian, Internet, Phone, Mail, and Mixed-Mode Surveys: The Tailored Design Method, 4th ed., John Wiley & Sons, Inc.: Hoboken, NJ, 2014. * 3. Cheung, Y.T.D., X. Weng, M.P. Wang, et al., ‘‘Effect of Prepaid and Promised Financial Incentive on Follow-Up Survey Response in Cigarette Smokers: A Randomized Controlled Trial,’’ BMC Medical Research Methodology, vol. 19, Article 138, 2019. (https:// link.springer.com/article/10.1186/ s12874-019-0786-9) 4. Mercer, A., A. Caporaso, D. Cantor, et al., ‘‘How Much Gets You How Much? Monetary Incentives and Response Rates in Household Surveys,’’ Public Opinion Quarterly, vol. 79, pp. 105–129, 2015. 5. Sun, H., J. Newsome, J. McNulty, et al., ‘‘What Works, What Doesn’t? Three Studies Designed to Improve Survey Response,’’ Field Methods, vol. 32, Issue 3, pp. 235–252, 2020. (https://doi.org/ 10.1177/1525822X20915464). 6. Ellis, J., J. Charbonnier, C. Lowenstein, et al., ‘‘Assessing the Impacts of Different Incentives and Use of Postal Mail on Response Rates,’’ American Association for Public Opinion Research (AAPOR) Conference, Chicago, IL, 2022, May. * 7. Yu, S., H.E. Alper, A.M. Nguyen, et al., ‘‘The Effectiveness of a Monetary Incentive Offer on Survey Response Rates and Response Completeness in a Longitudinal Study,’’ BMC Medical Research Methodology, vol. 17, Article 77, 2017. (https://bmcmedresmethodol. biomedcentral.com/articles/10.1186/ s12874-017-0353-1). Dated: April 20, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–08686 Filed 4–24–23; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Modernization of Compliance Program Guidance Documents Office of Inspector General (OIG), Department of Health and Human Services (HHS). ACTION: Notice. lotter on DSK11XQN23PROD with NOTICES1 AGENCY: This Federal Register notice sets forth upcoming procedures for issuing compliance program guidance documents from HHS–OIG. SUMMARY: VerDate Sep<11>2014 16:47 Apr 24, 2023 Jkt 259001 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 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 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 ThirdParty 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). 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). PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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. 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 • OIG has developed a new format for CPGs: Æ 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. Æ Second, we will publish industryspecific 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. 13 All CPGs issued to date are currently available on the Compliance Guidance page of our website at https://oig.hhs.gov/compliance/complianceguidance/ (last visited Mar. 6, 2023). 14 To join OIG’s listserv, visit https:// cloud.connect.hhs.gov/OIG/. E:\FR\FM\25APN1.SGM 25APN1 Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices 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 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Institute of Neurological Disorders and Stroke Special Emphasis Panel, which was published in the Federal Register on March 22, 2023, FR Doc. 2023–05787, 88 FR 17240. This notice is being amended to change the dates of this two-day meeting from April 20–21, 2023, to May 11–12, 2023. The meeting is closed to the public. Dated: April 19, 2023. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–08632 Filed 4–24–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health lotter on DSK11XQN23PROD with NOTICES1 Center for Scientific Review; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose VerDate Sep<11>2014 16:47 Apr 24, 2023 Jkt 259001 confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Respiratory Tobacco Fund K Awards. Date: May 25, 2023. Time: 9:30 a.m. to 7:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sara Ahlgren, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Rm. 4136, Bethesda, MD 20892, 301–435–0904, sara.ahlgren@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: April 19, 2023. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–08679 Filed 4–24–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Advisory Council on Drug Abuse. The meeting will be open to the public, as indicated below, with attendance limited to space available. Individuals who plan to attend as well as those who need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Dr. Gillian Acca via email at gillian.acca@nih.gov five days in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https:// videocast.nih.gov/). A portion of the meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 25001 property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Council on Drug Abuse. Date: May 9, 2023. Closed: 10:30 a.m. to 11:45 a.m. Agenda: To review and evaluate grant applications. Open: 12:45 p.m. to 5:00 p.m. Agenda: Presentations and other business of the Council. Place: Rockledge II, Conference Room 270 A/B, National Institutes of Health, National Institute on Drug Abuse, 6701 Rockledge Drive, Bethesda, MD 20892. Contact Person: Susan R.B. Weiss, Ph.D., Director, Division of Extramural Research, Office of the Director, National Institute on Drug Abuse, NIH, Three White Flint North, RM 09D08, 11601 Landsdown Street, Bethesda, MD 20852, 301–443–6480, sweiss@ nida.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to Dr. Gillian Acca via email at gillian.acca@ nih.gov. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has procedures at https://www.nih.gov/ about-nih/visitor-information/campusaccess-security for entrance into oncampus and off-campus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Additional Health and Safety Guidance: Before attending a meeting at an NIH facility, it is important that visitors review the NIH COVID–19 Safety Plan at https://ors.od.nih.gov/sr/ dohs/safety/NIH-covid-19-safety-plan/ Pages/default.aspx for information about requirements and procedures for entering NIH facilities, especially when COVID–19 community levels are medium or high. In addition, the Safer Federal Workforce website has FAQs for visitors at https://www.saferfederal workforce.gov/faq/visitors/. Please note that if an individual has a COVID–19 diagnosis within 10 days of the meeting, that person must attend virtually. (For more information please read NIH’s Requirements for Persons after Exposure at https://ors.od.nih.gov/sr/dohs/safety/ E:\FR\FM\25APN1.SGM 25APN1

Agencies

[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.

-----------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

     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 
---------------------------------------------------------------------------
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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