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New Opportunities for Value-Based Care with HHS Finalization of Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties Law Reforms | Proskauer Rose LLP

To embed, copy and paste the code into your website or blog: The Department of Health and Human Services (“HHS”), in collaboration with the Centers for Medicare & Medicaid Services (“CMS”) and the Office of the Inspector General (“OIG”), has issued two final rules clarifying certain regulatory terms and adding and amending exceptions and safe harbors to accommodate “value” transactions under the Anti-Kickback Statute (“AKS”), the federal Physician Self-Referral Law (the “Stark Law”), and the Civil Monetary Penalties Law (the “CMP Law”). These changes, as we noted in our discussion of the proposed regulations, are arguably the most significant changes in the Stark Law, AKS, and the CMP Law in recent history.

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Key Takeaways from the Revised and Clarified Stark Law Regulations – Part 1 | Foley & Lardner LLP

To embed, copy and paste the code into your website or blog: CMS made impactful changes to the Federal physician self-referral law’s (i.e., Stark Law’s) regulations in its Final Rule that were effective January 19, 2021 (with the exception of the changes to 42 C.F.R. § 411.352(i) that are effective January 1, 2022). Although lengthy (190 pages/3-column format), the Final Rule is worth the read with multiple clarifications and revisions to the dense regulations. In this first part of our two-part blog, each reader will find gems in the Final Rule that are impactful, but we note particularly the following key changes, clarification, and discussion:

Clarification of Key Terms in Stark Law

Wednesday, January 6, 2021 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.

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