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 safe harbors, HHS-OIG cited its “longstanding concerns regarding the routine waiver and subsidy of cost-sharing incentives to Federal health care program enrollees.”
HHS-OIG’s Semiannual Report acknowledges the goal of improving diversity among clinical trial participants, but also demonstrates the agency is not adopting relaxed standards under the federal Anti-Kickback Statute when evaluating financial support to clinical trial participants. This is the case despite the call from other HHS agencies to encourage more diversity within clinical trial populations.
In light of HHS-OIG’s latest position, sponsors will need to continue to carefully balance the potential fraud and abuse risks associated with providing financial and other support to clinical trial participants against this new requirement that certain sponsors develop and submit diversity action plans to FDA. This requirement stems from the Food and Drug Omnibus Reform Act of 2022 (known as FDORA), which was enacted on December 29, 2022.
Further, despite the position adopted by HHS-OIG in the Semiannual Report, stakeholders should not stop advocating for clearer guidance from HHS-OIG on appropriate pathways to facilitate increased diversity in clinical trial participants, including through additional AKS safe harbors, appropriate advisory opinions, and other guidance from HHS-OIG.
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