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


“Full Financial Risk”
A. Overview of Key Safe Harbors and Exceptions
An important initial consideration is that there are multiple differing requirements between corresponding Stark Law exceptions and AKS safe harbors. Stakeholders must navigate the requirements under both regulatory regimes for arrangements that potentially implicate each law. Although a number of commenters sought a unified set of requirements between Stark Law and AKS requirements, CMS and OIG rejected this approach, noting the different purposes of each law. In general, CMS provides more flexibility for Stark Law exceptions, given its strict liability standard. In contrast, OIG felt it was appropriate for the AKS which is an intent-based law to serve as “backstop” protection for arrangements that implicate both laws. The six safe harbors and exceptions set forth by OIG and CMS are as follows: ....

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Anti-Kickback Statute, Stark Law Value-Based Safe Harbors


Tuesday, February 2, 2021
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:
(i) 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).   
(ii) The HHS Centers for Medicare & Medicaid Services (CMS) published a Final Rule that finalizes similar exceptions to the Physician Self-Referral Law (Stark Law) for certain value-based compensation arrangements between or among physicians, providers, and suppliers (Stark Final Rule, and together with t ....

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Takeaways From AHLA Webinar, "CMS, OIG Insights into Stark and AKS Final Rules Part I: Supporting Value-Based Care" | Seyfarth Shaw LLP


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On Thursday, December 17, 2020, senior representatives of the US Department of Health and Human Services’ Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) delivered a virtual presentation to American Health Law Association members and other health industry stakeholders to explain and elaborate on significant new regulations that become final on January 19, 2021. OIG Senior Counselor for Policy, Vicki Robinson, OIG Industry Guidance Branch Chief, Susan Edwards, and OIG Senior Counsel, Samantha Flanzer, discussed OIG’s recently issued final rules amending current and adding new safe harbors to the Anti-Kickback Statute (“AKS”). CMS Senior Technical Advisors, Lisa Wilson and Catherine Martin, discussed CMS’s recently issued final rules amending current and adding new exceptions to the Physician Self-Referral Law (“Stark Law”). ....

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