On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule also revises the definition of “remuneration” in the civil monetary penalty (CMP) rule. The Final Rule becomes effective on January 6, 2017.

This client alert summarizes changes that are likely to have the greatest potential impact on the health care and life science industries generally. However, the Final Rule will likely be of most significance to providers, including hospitals, pharmacies, and public ambulance services, and of lesser importance to manufacturers (which are explicitly excluded from utilizing many of the new and revised protections).