New Final Regulations for Stark and the Anti-Kickback Statute

On November 20, 2020, the Department of Health and Human Services (“HHS”) revealed its highly-anticipated final regulations to update the Physician Self-Referral Law (“Stark”), the Federal Anti-Kickback Statute (“AKS”), and the Beneficiary Inducements Civil Money Penalty (“CMP”) law as part of its Regulatory Sprint to Coordinated Care. The final regulations for Stark and the AKS (and the CMP law) were issued by Centers for Medicare and Medicaid Services (“CMS”) and Office of Inspector General (“OIG”), respectively. These final regulations modify and clarify the proposed regulations that were published by CMS and OIG on October 17, 2019.

These finalized changes will affect how industry stakeholders approach Stark, the AKS and CMP law going forward. the final regulations become effective on January 19, 2021, except for one provision within Stark that becomes effective on January 1, 2022.

General details regarding the final regulations are by HHS are available at: https://www.hhs.gov/about/news/2020/11/20/hhs-makes-stark-law-and-anti-kickback-statute-reforms-support-coordinated-value-based-care.html.

Details regarding the specific changes finalized by CMS relating to Stark are available at: https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-final-rule-cms-1720-f.

Details regarding the specific changes finalized by OIG relating to the AKS and CMP are available at: https://oig.hhs.gov/reports-and-publications/federal-register-notices/factsheet-rule-beneficiary-inducements.pdf.

Benkoff Health Law advises health care providers and suppliers with respect to Stark, the AKS and CMP law. If you have any questions regarding Stark, the AKS, the CMP law, or the final regulations, please contact Benkoff Health Law at (248) 482-2780 or via email at [email protected].