OIG Greenlights Cost-Sharing Subsidies for Medicare Enrollees in Medical Device Clinical Trial

On March 11, 2026, the Office of Inspector General (OIG) issued Advisory Opinion No. 26-05, concluding that it would not impose sanctions on a medical device company (Requestor) that proposes to subsidize Medicare cost-sharing obligations for participants in an FDA-approved clinical trial of an implantable cardiac device. 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 Proposed Arrangement

The Requestor manufactures an implantable device that delivers electrical pulses to baroreceptors in the carotid artery for heart failure patients. The Requestor is the sponsor of a clinical trial to evaluate the device's safety and efficacy in a new patient population—heart failure patients with a left ventricular ejection fraction higher than 35 percent and up to 50 percent. The study expects to enroll up to 3,600 potential participants for screening and randomize up to 2,500 eligible participants across up to 200 investigational sites in the United States and Europe. 

Under the proposed arrangement, the Requestor would pay cost-sharing obligations that Medicare enrollees would otherwise owe for study-related Medicare-reimbursable items and services furnished during the trial. The Requestor would pay the cost-sharing amounts directly to the site and would not advertise or promote the subsidies to prospective participants. Potential participants would first learn about the subsidies during the initial consent discussion regarding the study, after they had already expressed interest in, and been confirmed as eligible for, the study. 

Why the OIG Issued a Favorable Opinion

The OIG identified four key factors supporting its conclusion that the fraud and abuse risk was sufficiently low:

1. 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.
2. 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 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.
3. 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.
4. 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. 

Takeaway

Advisory Opinion 26-05 provides a useful framework for medical device and pharmaceutical companies considering cost-sharing subsidies in the clinical trial context. Companies structuring similar arrangements should take note of the safeguards the OIG highlighted as important to its analysis: a legitimate scientific purpose for the subsidies, protocol-driven enrollment criteria, IRB oversight, non-advertisement of the financial benefit, and an absence of downstream utilization risk that could signal a seeding arrangement.