Last week, the HHS OIG released a proposed rule published in the October 3 Federal Register that would add new safe harbors to the Anti-Kickback Statute and expand the list of conduct exempt from civil monetary penalties (CMP). Comments are due by December 2, 2014. The proposed new safe harbors cover (1) pharmacies offering Part D cost-sharing waivers, (2) state or municipal-owned organizations offering cost-sharing waivers for emergency ambulance services, (3) remuneration between Medicare Advantage organizations and federally qualified health centers, (4) manufacturer discounts for drugs provided through the Medicare Coverage Gap Discount Program, and (5) certain free or discounted local transportation services that meet specified criteria. The OIG also proposed a technical correction to the safe harbor for referral services located at 42 C.F.R. § 1001.952(f).

In expanding the list of conduct exempt from CMP, the OIG proposed to amend the definition of remuneration to create certain statutory exceptions. The proposed exceptions cover (1) copayment reductions for certain hospital outpatient services, (2) remuneration that poses a low risk of harm while promoting access to care, (3) coupons, rebates and other retailer rewards programs that meet specific requirements, (4) remuneration offered to financially needy individuals, and (5) copay waivers for the first fill of generic drugs. The OIG also proposed to codify the gainsharing CMP provision in 42 U.S.C. § 1320a-7a(b).

The proposals would codify changes originally included in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003, as well as the Affordable Care Act. Comments should be submitted no later than December 2, 2014, at 5:00 p.m. Eastern Standard Time.

Reporter, Paige Fillingame, Houston, +1 713 615 7632, pfillingame@kslaw.com.