Lexology December 15, 2023
Earlier this month, the U.S. Department of Health and Human Services Office of the Inspector General (HHS-OIG) declined to establish new safe harbors that would protect arrangements under which clinical trial sponsors provide financial support to participants. Catherine Starks, Deeona Gaskin, Meenakshi Datta, and Taylor Andelman report.
To address some of the challenges in clinical trial enrollment, industry stakeholders have been advocating for the development of additional safe harbors under the federal Anti-Kickback Statute (AKS) to protect arrangements under which sponsors might provide compensation to study participants, such as through subsidies for patient cost-sharing obligations.
But, in its Semiannual Report to Congress released on December 1, 2023, HHS-OIG refused to adopt such safe harbors. In rejecting the request for additional...
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