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HHS/OIG RIN: 0936-AA06 Publication ID: Spring 2016 
Title: Medicare and State Health Care Programs: Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements and Gainsharing 

This final rule amends the safe harbors to the anti-kickback statute and the civil monetary penalty rules under the authority of the OIG. The final rule adds new safe harbors, some of which codify statutory changes set forth in the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) and the Affordable Care Act (ACA) designed to protect certain payment practices and business arrangements from criminal prosecution and civil sanctions under the anti-kickback provisions of the statute. OIG also codifies ACA's revised definition of "remuneration" and add a gainsharing civil monetary penalty provision in 42 CFR part 1003.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 1001    42 CFR 1003   
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Action Date FR Cite
NPRM  10/03/2014  79 FR 59717   
NPRM Comment Period End  12/02/2014 
Final Action  09/00/2016 
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:
Patrice S. Drew
Regulations Analyst
Department of Health and Human Services
Office of the Inspector General
330 Independence Avenue SW.,
Washington, DC 20201
Phone:202 619-1368