0936-AA06 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0936 Office of the Inspector General OIG 0900 Department of Health and Human Services HHS 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.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage No No 42 CFR 1001 42 CFR 1003 Not Yet Determined No NPRM 10/03/2014 79 FR 59717 NPRM Comment Period End 12/02/2014 Final Action 11/00/2016 No No None No No No No Heather Westphal L. Senior Counsel 0936 Office of the Inspector General OIG 202 619-0335 heather.westphal@oig.hhs.gov 330 Independence Avenue SW, Washington DC 20201 Patrice Drew S. Regulations Analyst 0936 Office of the Inspector General OIG 202 619-1368 patrice.drew@oig.hhs.gov 330 Independence Avenue SW., Washington DC 20201