New Proposed Rules for Stark and the Anti-Kickback Statute

On October 9, 2019, the Department of Health and Human Services (“HHS”) revealed its highly-anticipated proposals 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 proposed 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.The proposed rules are intended to remove barriers to and promote value-based arrangements and care coordination, and ease compliance burdens associated with existing regulations. These proposed rules are prospective and both agencies have stated that, unless finalized, the proposed changes to existing concepts are not applicable.

These proposed changes will affect how industry stakeholders approach Stark, the AKS and CMP law going forward. Interested parties should consider the impacts of these proposed rules and comment on issues relevant to their businesses by December 31, 2019.

General details regarding the changes proposed by HHS are available at: https://www.hhs.gov/about/news/2019/10/09/hhs-proposes-stark-law-anti-kickback-statute-reforms.html.

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

Details regarding the specific changes proposed by OIG relating to the AKS are available at: https://oig.hhs.gov/authorities/docs/2019/CoordinatedCare_FactSheet_October2019.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 proposed rules, please contact Benkoff Health Law at (248) 482-2780 or via email at [email protected].