HHS Issues Highly Anticipated Final Regulations for Stark, AKS and the Beneficiary Inducements Provision of the CMP Statute

By Reesa N. Benkoff, Esq., Benkoff Health Law, PLLC, Bloomfield Hills, MI

On November 20, 2020, the Department of Health and Human Services (HHS) revealed its highly anticipated final regulations to update and modernize the Physician Self-Referral Law (Stark), the federal Anti-Kickback Statute (AKS), and the Beneficiary Inducements provision of the Civil Money Penalty Statute (CMP Law) as part of its Regulatory Sprint to Coordinated Care.1  These final regulations were published in the Federal Register on December 2, 2020. The final regulations promote and remove barriers to care coordination and maintain safeguards to protect against fraud and abuse, in addition to easing compliance burdens associated with existing regulatory provisions.2 The final regulations for Stark, and for the AKS and the CMP Law were issued by the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector General (OIG), respectively, and both agencies emphasize the need for these regulations to evolve to keep pace with the transition from volume-based healthcare to a value-based system that reimburses based on the quality of patient care provided rather than the volume of services provided.3  These final regulations modify and clarify the proposed regulations that were published by CMS and OIG on October 17, 2019 (Proposed Regulations) based upon comments received by the agencies in response to the Proposed Regulations.4 HHS intends for the final regulations to facilitate a range of arrangements that would improve coordination and management of patient care.5

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