CMS, OIG Finalize Changes to Stark Law and Anti-kickback Statute to Encourage Value-Based Care and Reduce Technical Trip Wires

Regulatory Advisory

December 8, 2020

At a Glance

The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) 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 rules are effective Jan. 19, 2021.

The principal focus of both regulations is the expansion of protections for value-based arrangements (VBAs). The new Stark regulations will provide substantially broader protections for VBAs than the AKS regulations.

In addition, CMS provides long sought guidance on key requirements for Stark law compliance.

The OIG adds several other new AKS safe harbors related to VBAs and expands other existing safe harbors.

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