View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/OIG RIN: 0936-AA12 Publication ID: Fall 2023 
Title: Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities 

The proposed rule modifies several sections in 42 CFR 1001 relating to the exclusions authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or Department).  First, the proposed rule would implement in OIG’s exclusion regulations a statutory change to HHS’s authority found in the Medicaid Services Investment and Accountability Act of 2019 that authorizes exclusion of manufacturers that misclassify outpatient drugs, fail to correct such misclassifications, or provide false information or data related to drug pricing or product information.  Second, the proposed rule would update several sections of the exclusion regulations consistent with the corresponding statutory authority, including revising the section governing exclusion based on an individual’s default on a health education loan or scholarship obligation.  Third, the proposed rule would modify or eliminate various aggravating and mitigating factors used to set the length of an exclusion.  Fourth, the proposed rule would modify the exclusion regulations that govern OIG’s notice to the public and other agencies regarding exclusions, approval of reinstatement requests, and denial of reinstatement requests.  Finally, the proposed rule would include clarifying changes and updates to the exclusion regulations based on OIG’s recent experience related to exclusion actions.

Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 1001   
Legal Authority: 42 U.S.C. 1302    42 U.S.C. 1320a–7    42 U.S.C. 1320a–7b    42 U.S.C. 1395u(j)    42 U.S.C. 1395u(k)    42 U.S.C. 1395y(e)    42 U.S.C. 1395hh   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/00/2024 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
David Fuchs
Deputy Branch Chief
Department of Health and Human Services
Office of the Inspector General
233 N. Michigan Avenue, Suite 1330,
Chicago, IL 60601
Phone:202 763-4750