“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:
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 the AKS Final