OIG Approves Medicare Cost-Sharing Subsidies for Heart Failure Device Clinical Trial

The U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion on March 11, 2026, allowing a medical device manufacturer to subsidize Medicare cost-sharing obligations for participants in an FDA-approved clinical trial. Advisory Opinion No. 26-05 addresses the intersection of federal anti-kickback statute and beneficiary inducements regulations with clinical trial enrollment incentives, providing important guidance for device manufacturers and clinical trial sponsors.

Clinical Trial Details

The requestor manufactures an implantable device that delivers electrical pulses to baroreceptors in the wall of the carotid artery, currently FDA-approved for 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. The trial 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 Cost-Sharing 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, resulting in Medicare enrollees incurring 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. Importantly, 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.

OIG's Favorable Determination

Although the OIG found the arrangement would technically generate prohibited remuneration under both the Federal Anti-Kickback Statute and the Civil Monetary Penalty Rules regarding Beneficiary Inducements, it determined that the risk of fraud and abuse was sufficiently low to warrant a favorable opinion.

The OIG identified four key factors supporting its conclusion:

Reasonable means of promoting enrollment: The OIG accepted the requestor's assertion that out-of-pocket cost-sharing expenses would be cost-prohibitive for many Medicare enrollees, and that the subsidies may be essential to enrolling enough participants and reducing attrition over the study's 24-month follow-up period.

Low risk of overutilization and inappropriate steering: Participants must satisfy enrollment criteria and execute informed consent, and investigators and sites must comply with the study protocol and are subject to IRB oversight. Non-advertisement of the subsidies further mitigates the risk that cost-sharing waivers would function as an inducement to select a particular provider.

Low risk of increased costs to Federal health care programs: The device is intended as a one-time treatment, and the requestor does not anticipate that its use would prompt future utilization of other products it manufactures. The OIG found this distinguishable from problematic "seeding" arrangements designed to lock in future utilization of reimbursable items or services.

CMS Category B IDE approval: The Centers for Medicare & Medicaid Services approved the study as a Category B IDE study, confirming that it includes appropriate patient protections, a methodologically sound design, and an adequate anticipated number of enrolled subjects.

Important Safeguards

The opinion underscores several critical guardrails that supported the favorable determination. Participants must satisfy enrollment criteria set forth in the study protocol and execute an informed consent document. Investigators and sites must comply with the study protocol and are subject to IRB oversight. Cost-sharing subsidies are not advertised, with participants learning of them only during consent discussions after expressing interest and being confirmed as eligible for the study.

Implications for Industry

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 emphasizes 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.

Companies considering similar arrangements should note that the OIG carefully evaluated whether the arrangement was distinguishable from problematic seeding arrangements. The device's intended use as a one-time treatment with no anticipated downstream product utilization was a significant factor in the favorable opinion. Additionally, CMS's prior approval of the study as a Category B IDE study provided additional support for the OIG's conclusion.