To embed, copy and paste the code into your website or blog:
The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) published a final rule revising regulations to the Stark Law. The Stark Final Rule adds, modifies and clarifies key definitions and exceptions. On the same day, the HHS Office of Inspector General (OIG) published a final rule revising regulations to the Anti-Kickback Statute (AKS). The AKS Final Rule adds seven additional safe harbors, modifies four existing safe harbors, and codifies a statutory exception to the Civil Monetary Penalty (CMP) Rules. This Alert provides a high-level summary of the most notable changes, remaining questions, as well as action steps to consider for relationships subject to the Stark Law and AKS.