Nearly a decade after the Affordable Care Act signaled a transition of the U.S. health care system to value-based care, the Department of Health and Human Services (HHS) published on October 9 two long-awaited proposed rules intended to “modernize and clarify” the physician self-referral law (Stark Law) and federal anti-kickback statute (AKS) to reduce regulatory burdens and accelerate the transition. These proposals – an AKS Proposed Rule issued by the HHS Office of Inspector General (OIG) and a Stark Proposed Rule issued by the Centers for Medicare & Medicaid Services (CMS) – follow and incorporate feedback from corresponding Requests for Information issued in summer 2018 as part of HHS’s “Regulatory Sprint to Coordinated Care.”
Part 1 of this client alert focuses on HHS’s proposals to allow and encourage the shift toward value-based payment under both the AKS and Stark Law, as well as other key AKS proposals, including important changes to the warranty and personal services safe harbors. Part 2 will follow and will focus on important proposals to further update and amend the Stark Law regulations.
