In the October 3 Federal Register (79 FR 59717), the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) published a proposed rule that would amend the safe harbor regulations to the Anti-Kickback Statute, as well as the civil monetary penalty (“CMP”) rules under the OIG’s authority (the “Proposed Rule”). Specifically, in addition to some minor technical tweaks to existing regulations, the OIG proposes to add new safe harbors manifesting from statutory changes in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, “ACA”). The Proposed Rule also proposes to amend the definition of “remuneration” added by the Balanced Budget Act (BBA) of 1997 and ACA, and to add a gainsharing CMP provision to the existing OIG regulations.

Proposed New Safe Harbors -

The OIG is proposing to amend the Anti-Kickback Statute’s implementing regulations to add safe harbors that provide new protections or codify certain existing statutory protections. Specifically, these changes include the creation of the following new safe harbors...