On October 3, 2014, the Office of the Inspector General (the “OIG”) of the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule1 that would amend regulations implementing the federal anti-kickback statute2 and the federal civil monetary penalties law.3
- The proposed rule would expand the “safe harbors” that protect certain activities from the broad scope of federal anti-kickback prohibition. The expansion would add new safe harbors responsive to requests from the health care industry that the OIG believes would present minimal risk to federal health care programs if appropriately structured. These would include:
- Part D cost-sharing waivers by pharmacies;
- Cost-sharing waivers for government owned and operated emergency ambulance services;
- Payments between Medicare Advantage plans and federally qualified health centers;
- Drug discounts under the Medicare Coverage Gap Program; and
- Free and discounted local transportation for established patients of certain providers.