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Value-Based Safe Harbors and Exceptions to the Anti-Kickback Statute and Stark Law | K&L Gates LLP

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On 2 December 2020, the U.S. Department of Health and Human Services’ (HHS) issued two Final Rules in conjunction with its “Regulatory Sprint to Coordinated Care,” which will markedly change the regulatory fraud and abuse landscape for “value-based” arrangements:
The HHS Office of the Inspector General (OIG) published a Final Rule that introduces new safe harbor protections under the federal Anti-Kickback Statute (AKS) for certain coordinated care and risk-sharing value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions (AKS Final Rule). ....

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Breaking Down the New Stark Law and Anti-Kickback Statute Final Rules | Murtha Cullina

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In late November, the Centers for Medicare and Medicaid Services and the Office of the Inspector General released their final rules revising the Physician Self-Referral Law (the “
Stark Law”) and the Anti-Kickback Statute. The changes are sweeping and while they are generally designed to facilitate coordinated care, some of the changes will impact providers more broadly. Most provisions of the final rules are effective on January 19, 2021. The following is a brief overview of the hundreds of pages of rules and commentary:
The Stark Law Final Rule
New Value-Based Exceptions: New exceptions were created to permit compensation arrangements in the context of value-based arrangements designed to coordinate and improve the quality of care for patients and to lower costs. ....

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