Special Bulletin: Highlights of HHS Final Regulations to Modernize Stark and Anti-kickback

November 23, 2020

The Department of Health and Human Services (HHS) on Nov. 20 released two final rules that will modernize and make important changes to physician self-referral (Stark law) and federal Anti-kickback statute (AKS) regulations.

The final regulations will substantially expand protections for value-based arrangements (VBA) under the Stark law and establish more limited-but-important additional protections for such arrangements under the AKS. In addition, the Centers for Medicare & Medicaid Services (CMS) addresses key issues in the current regulations that have been important in compliance efforts and several False Claims Act cases, including what is fair market value, when does compensation take into account the volume or value of referrals, and when arrangements are commercially reasonable.

The HHS Office of Inspector General (OIG) adds several other new AKS safe harbors related to VBAs, including in-kind support for beneficiaries to maintain or improve their health, and expands other existing safe harbors, most notably the personal services safe harbor.

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