Changes To Stark Law Definitions Impact Innovative Relationships And "Commercially Reasonable" Considerations

Introduction

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) published a final rule titled "Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations" (the Final Rule) which follows the proposed rules issued on October 9, 2019 ( Proposed Rule). The Final Rule modifies the regulations for the Physician Self-Referral Law (Stark Law) in the Social Security Act (the Act). The Stark Law is a strict liability statute, and strict adherence to the elements of the applicable exception is required to be in compliance. CMS included changes to the Final Rule that revise existing definitions as well as added definitions to enable providers to comply more easily with the applicable exception requirements.