Medical Technology Company Arrangements and Opportunities for Participation in Value Based Care under AKS Final Rule

The Health and Human Services (HHS) Office of Inspector General’s (OIG) final rule amending the safe harbors to the federal Anti-Kickback Statute (AKS) recently took effect on January 19, 2021. The AKS final rule significantly changes the regulatory landscape, especially for value-based care arrangements, and provides new (although more limited than some had hoped) opportunities for medical technology company engagement and participation in value-based and other arrangements. The OIG issued the final rule on November 20, 2020, as part of HHS’s Regulatory Sprint to Coordinated Care, which aims to advance the transition to value-based care and improve care coordination across settings, and in conjunction with the Centers for Medicare and Medicaid Services’ final rule amending the Stark Law regulations.

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