Stark Law: Clarification of Key Terms

The National Law Review

Timothy Cahill, Joseph D. Wheeler

On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Physician-Self Referral Law (Stark Law) and the Anti-Kickback Statute (AKS) regulations (respectively the OIG Final Rule and the CMS Rule, collectively the Final Rules) will become effective.[1] This alert is a part of the Dinsmore Health Care practice group’s ongoing summary of the Final Rules.

The CMS Final Rule implements changes to the Stark Law and offers several clarifying provisions related to key Stark Law terms and concepts. Included in the changes are definitions and special rules related to: (1) commercial reasonableness, (2) the volume or value standard and other business generated standard, and (3) fair market value and general market value.

Commercial Reasonableness
The CMS Final Rule implements...

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