OIG Expands Protections Under the Anti-Kickback Safe Harbors and the CMP Exceptions

On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) published a final rule (Final Rule) that amends the safe harbors to the federal Anti-Kickback Statute (AKS) by modifying an existing safe harbor, adding new safe harbors and codifying existing statutory provisions that provide further protections from sanctions under the AKS with respect to certain payment practices and business arrangements.

The Final Rule also amends the exceptions to the civil monetary penalty rule (CMP) regarding beneficiary inducements by codifying revisions to the definition of “remuneration” added by the Balanced Budget Act of 1997 and the Patient Protection and Affordable Care Act, as amended (ACA).

The Final Rule expands AKS and related CMP protections by: (1) extending the existing AKS cost-sharing safe harbor to pharmacies and emergency ambulance services; and (2) adding new safe harbors for: (a) arrangements between Medicare Advantage (MA) organizations and federally qualified health centers (FQHCs), (b) certain manufacturer drug discounts and (c) qualifying free or discounted local transportation.