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.

Background of Advisory Opinion 26-05

The requestor is a medical device company that manufactures an implantable device delivering electrical pulses to baroreceptors in the wall of the carotid artery, currently FDA-approved for use in heart failure patients with a left ventricular ejection fraction of 35 percent or less. The company is sponsoring a clinical trial to evaluate the safety and efficacy of the device in a new population — heart failure patients with a left ventricular ejection fraction higher than 35 percent and up to 50 percent. The FDA approved the device through the Category B  IDE, and CMS approved Category B IDE coverage for the study. The study plans to enroll up to 3,600 potential participants for screening, with up to 2,500 participants expected to be randomized into control and device groups. Eligible participants must satisfy the enrollment criteria set forth in the study protocol and execute an informed consent document. The study will be conducted at up to 200 investigational sites in the United States and Europe, with the majority of participants in the United States.

Proposed Arrangement

Under the proposed arrangement, the requestor would pay cost-sharing obligations that Medicare enrollees participating in the study otherwise would owe for study-related Medicare-reimbursable items and services. The requestor would pay the cost-sharing amounts directly to the investigational site, and as a result, Medicare enrollees would incur no cost-sharing expenses relating to their participation in the study. For Medicare enrollees who have supplemental insurance offering full or partial coverage of cost-sharing obligations, the requestor would subsidize only the remaining cost-sharing obligations for which a participant is personally responsible.

The requestor would not advertise or promote the cost-sharing subsidies to prospective participants. Rather, potential participants would first learn of the subsidy during their initial study consent discussion. 

 Key Elements of the Advisory Opinion 

Practical Takeaways

The OIG's analysis highlights several factors that clinical trial sponsors and medical device companies should consider when structuring cost-sharing subsidies for study participants. The opinion underscores the importance of ensuring that subsidies are genuinely tied to facilitating clinical trial enrollment and retention rather than serving as a mechanism to drive utilization of reimbursable products or services outside the study context. Sponsors should ensure that cost-sharing subsidies are limited to items and services furnished as part of the study, and that the arrangement includes guardrails such as restrictions on advertising the subsidies, informed consent disclosures, and IRB oversight.

Companies considering similar arrangements should also note that the OIG carefully evaluated whether the arrangement was distinguishable from problematic seeding arrangements — those in which manufacturers offer initial subsidies to lock in future utilization of a reimbursable item or service. In this case, the device was intended as a one-time treatment with no anticipated downstream product utilization, which was a significant factor in the favorable opinion. Finally, CMS's prior approval of the study as a Category B IDE study provided additional support for the OIG's conclusion, as it confirmed the study met requirements for appropriate patient protections, methodological soundness, and adequate enrollment.

Providers and sponsors considering similar arrangements should carefully evaluate whether their particular facts and circumstances align with the factors identified in Advisory Opinion No. 26-05 and should seek legal guidance before implementing any cost-sharing subsidy arrangement in connection with a clinical trial.

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