Alerts3.24.26
OIG Issues Favorable Advisory Opinion on Clinical Trial Cost-Sharing Subsidies
Highlights
- The arrangement involved a Centers for Medicare & Medicaid Service (CMS)-approved Category B Investigational Device Exemption (IDE) clinical trial of an implantable medical device for heart failure patients, in which the manufacturer would cover cost-sharing obligations so that Medicare enrollees would incur no out-of-pocket expenses relating to their participation.
- The Office of the Inspector General (OIG) concluded that although the proposed cost-sharing subsidies would generate prohibited remuneration under both the federal anti-kickback statute and the Beneficiary Inducements CMP (civil monetary penalties), the OIG would not impose administrative sanctions on the requestor in connection with the arrangement.
- The favorable opinion rested on several key factors, including that the subsidies were a reasonable means to promote enrollment and retention in the study, posed a low risk of overutilization, and were unlikely to result in improper increased costs to federal health care programs.
On March 11, 2026, the OIG of the U.S. Department of Health and Human Services (HHS) issued Advisory Opinion No. 26-05, concluding favorably on a medical device company's proposal to subsidize federal healthcare program cost-sharing obligations for participants in a clinical trial. The opinion addresses the intersection of the federal anti-kickback statute and the Beneficiary Inducements CMP with clinical trial enrollment incentives, providing important guidance for device manufacturers, clinical trial sponsors, and health care providers conducting FDA-approved studies.
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