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“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:

Quality assurance programOr no risk shareLaboratory companies physicianOr no risk share arrangementsCenters for medicareMedicare programMedicare shared savings program acosHuman serviceMedicare shared savings programHealth technology companies not otherwiseCenters for medicare medicaid servicesKl gatesUs department of healthOffice of the inspectorHealth outcomesHealth care programs