OIG Proposes Significant Changes to Anti-kickback Statute Safe Harbors to Support Value-Based Arrangements

By Sheva Sanders and Jessica Wheeler

Last week, the Office of Inspector General (OIG) released a proposed rule that would add a suite of additional safe harbors to the Federal Anti-kickback Statute as well as modify existing safe harbors. These changes are intended to maintain protections against the traditional fraud, waste and abuse concerns underpinning the Anti-Kickback Statute while facilitating greater flexibility for value-based arrangements. As proposed, these rules provide a new framework for executing compliant arrangements designed to incentivize providers, payors and patients towards better economic and clinical outcomes, but fall short of the broad revisions for which some stakeholders had been hoping. In particular, pharmaceutical manufacturers are excluded from the protection of many of the new safe harbors and OIG is soliciting comments on whether medical device manufacturers should share in the same treatment.

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