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 exce...