Could New Anti-Kickback Protections Support Clinical Trial Participation?

By Lisa Damhof

OIG Considers Additional Protections for Clinical Trial Participant Support

On June 24, 2026, the HHS Office of Inspector General (OIG) issued a request for information (RFI) seeking input on whether additional protections under the federal Anti-Kickback Statute (AKS) and the Beneficiary Inducements Civil Monetary Penalty (CMP) provisions may be appropriate for remuneration provided to clinical trial participants. The comment period closed on August 24, 2026.

The RFI reflects recognition that financial and logistical barriers for participants may impede clinical trial enrollment and retention.

Why Is OIG Considering This Issue?

While clinical trial participation may not necessarily impose much (if any) additional expense upon patient participants in terms of healthcare costs, it can involve financial burdens that may discourage enrollment and retention. These costs may include:

• Travel and transportation expenses.
• Lodging costs.
• Meals.
• Childcare expenses.
• Lost wages.
• Other participation-related costs.

These potential barriers may prevent otherwise eligible individuals from participating in a clinical trial, hindering recruitment and retention efforts. This may limit diversity in the participant population and the generalizability of clinical trial results.

OIG is evaluating whether existing laws designed to combat fraud and abuse may unnecessarily impede support that could facilitate clinical trial participation.

What Did OIG Seek in the RFI?

Over the last several years, OIG has received requests for a safe harbor protecting certain remuneration provided to clinical trial participants. This RFI sought public input on whether OIG should create or provide:

• A new or modified AKS safe harbor;
• A new or modified exception under the Beneficiary Inducements CMP; or
• Other guidance, such as a Special Advisory Bulletin or FAQ response, to clarify OIG’s position on participant support, while protecting against fraud and abuse.

Current Compliance Challenges

The AKS is a criminal statute that prohibits the knowing and willful offer, payment, solicitation, or receipt of remuneration to induce or reward patient referrals or the generation of business that is reimbursable under a federal health care program. The Beneficiary Inducements CMP imposes civil monetary penalties on a person who offers or transfers remuneration to a Medicare or state health care program beneficiary when the person knows or should know that the offer or transfer is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier for an item or service that is reimbursable, in whole or in part, by Medicare or a state health care program, including Medicaid.

In structuring their clinical trials, sponsors face practical questions about participant support, including:

• Reimbursement of participant expenses, such as meals and childcare.
• Stipends.
• Transportation and lodging assistance.

These considerations may be particularly relevant for trial participants who live far from a clinical trial site and must travel for investigational procedures and follow-up visits, as well as for trials with significant time commitments. Sponsors, investigational sites, and study teams want to ensure that eligible and willing participants can enroll and remain in a trial, but clinical trial participant reimbursement and support can present AKS and Beneficiary Inducements CMP concerns.

The issuance of this RFI suggests that OIG recognizes a tension between encouraging clinical trial enrollment and retention and the potentially broad reach of the AKS and Beneficiary Inducements CMP. Although support arrangements can be structured to comply with applicable law, sponsors and investigational sites should remain mindful of potential AKS and Beneficiary Inducements CMP concerns. There is no dedicated safe harbor for clinical trial participant support, and stakeholders frequently must rely on a fact-specific risk analysis. An arrangement that does not fit within a safe harbor does not automatically violate the AKS.

OIG has issued favorable advisory opinions addressing certain clinical trial cost-sharing arrangements. Those opinions bind OIG only with respect to the requesting parties and the specific arrangements reviewed.

“As clinical trials often rely on diverse and geographically dispersed patient populations, OIG is taking a closer look at whether existing fraud and abuse frameworks inadvertently discourage participation. Sponsors should continue to assess participant support under existing law while OIG considers whether additional protections are needed.”

Lisa Damhof, Associate Attorney

Key Takeaways

This RFI does not change current law or create new protections. But it does signal that OIG is actively considering whether existing fraud and abuse frameworks appropriately balance compliance concerns with the practical realities of clinical research and how those realities affect participants.

Sponsors, research institutions, investigators, and study teams should continue to evaluate participant support programs for AKS and Beneficiary Inducements CMP risk while monitoring future regulatory developments.

How Gardner Law Can Help

Gardner Law advises medical products companies and other FDA-regulated companies on clinical trial compliance, AKS issues, and clinical trial agreements, including participant support arrangements. We help organizations structure these arrangements to advance study objectives while managing regulatory and compliance risk.