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HHS/OIG RIN: 0936-AA10 Publication ID: Fall 2020 
Title: Revisions to the Safe Harbors Under the Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Rules Regarding Beneficiary Inducement  

This rule is being issued by the Office of Inspector General (OIG) in conjunction with the Department of Health and Human Services’ Regulatory Sprint to Coordinated Care.  It will add safe harbor protections under the Federal anti-kickback statute for certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions.  It also would add protections under the anti-kickback statute and civil monetary penalty (CMP) law that prohibits inducements offered to beneficiaries for certain patient engagement and support arrangements to improve quality of care, health outcomes, and efficiency of care delivery that squarely meet all safe harbor conditions. The rule also modifies some existing safe harbors and adds new safe harbors, including a statutory safe harbor and a CMP exception.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 42 CFR 1001.952    42 CFR 1003.110   
Legal Authority: Bipartisan Budget Act of 2018 (BBA, Pub. L. No. 115-123), secs. 50341 and 50412    sec. 1128D(b) of the Social Security Act and section 102 of the Social Security Act   
Legal Deadline:  None
Action Date FR Cite
Request for Information  08/27/2018  83 FR 43607   
Request for Information Comment Period End  10/26/2018 
NPRM  10/17/2019  84 FR 55694   
NPRM Comment Period End  12/31/2019 
Final Action  02/00/2021 
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:
Meredith Williams
Senior Counsel
Department of Health and Human Services
Office of the Inspector General
330 Independence Avenue SW,
Washington, DC 20201
Phone:202 619-2580