OIG Issues RFI on Anti-Kickback Statute Safe Harbors for Clinical Trial Participant Remuneration – Comments Due August 24, 2026

The U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) has issued a meaningful Request for Information (“RFI”) seeking stakeholder input on potential new or modified Anti-Kickback Statute (“AKS”) regulatory safe harbors and Beneficiary Inducements Civil Monetary Penalty (“CMP”) exceptions for remuneration to clinical trial participants. The RFI was published as part of HHS’s Operation TrialBlazer, a coordinated department-wide initiative aimed at promoting clinical research leadership and engagement in the United States, including a push to expand subject participation in clinical trials.

Comments are due August 24, 2026, creating a short window that warrants prompt internal coordination and strategy development.

Timeline

• June 24, 2026: RFI published in the Federal Register (see Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, 91 Fed. Reg. 37,902 (June 24, 2026)).
• August 24, 2026 (5:00 PM ET): Deadline to submit comments via the Federal Register or Regulations.gov.

OIG Areas of Focus for Comment

In connection with this recent RFI, OIG is considering whether clinical trial participant remuneration should be more clearly protected under AKS safe harbors and/or CMP exceptions, and what safeguards are needed to reduce fraud and abuse risks attendant to such remuneration.

Core themes of a comment to the RFI could include:

1. Does remuneration improve participation? OIG seeks input on whether offering remuneration to federal health care program enrollees helps facilitate clinical trial participation, and what factors make remuneration effective or ineffective. Consider commenting on whether reimbursement of out-of-pocket costs and compensation for time reduces barriers for enrollment and improves participation, retention and diversity. Consider application to unique and vulnerable populations (e.g., older adults, rural patients, patients with limited income).
2. Do AKS and CMP restrictions create barriers? OIG asks whether stakeholders view AKS or the Beneficiary Inducements CMP as barriers to offering appropriate remuneration to trial participants and how those barriers interact with other operational or legal constraints. Commenters may cite:
   1. Uncertainty regarding when participant payments may be viewed as inducing the use of federally reimbursable items or services.
   2. The absence of a clear safe harbor for many common clinical trial support arrangements.
   3. Differences between cost-sharing support, which has been addressed in certain favorable advisory opinions, and other forms of remuneration such as stipends, meals, travel, lodging, childcare or compensation for time.
   4. The practical compliance burden of evaluating each arrangement under a facts-and-circumstances analysis.
   5. The overall compliance burden and inconsistent treatment across arrangements.
3. Types and Levels of Remuneration. OIG requests input on the categories and amounts of remuneration that are useful to facilitate participation, including reimbursement for actual expenses, stipends, compensation for time and incentives to encourage enrollment or completion of trial activities.

In addressing this point, commenters may elect to define the categories of remuneration by risk profile under current AKS safe harbors and the Beneficiary Inducements CMP. For example:

• • Lower Risk: Documented expense reimbursement (travel, lodging, childcare).
  • Moderate Risk: Participant burden compensation (e.g., reasonable stipends or time compensation).
  • Higher Risk: Large incentives or completion bonuses tied to participation.

4. Value Caps, Documentation and Other Limits. OIG asks whether clinical trials currently impose value caps, financial-need requirements and/or documentation requirements for participant remuneration, and whether those limits adequately facilitate participation while guarding against fraud and abuse. Commentors may consider addressing industry common safeguards such as fair market value caps, financial need documentation and tracking, expense reimbursement-only models and consistent policies and procedures. Notably, the OIG seeks information on whether current caps are too restrictive to meaningfully support participation.
5. Who can provide remuneration? OIG seeks input on whether industry stakeholders currently limit who can provide remuneration. For example, sponsors, investigators, trial sites, providers, suppliers, third-party vendors, etc. The OIG also seeks input on what limitations would reduce harms resulting from fraud and abuse. As an industry, we know remuneration is typically provided by sponsors, sites and limited additional parties. We also know that the risk of harm varies depending on alignment with referral sources, downstream services and steering concerns.
6. Role of the Institutional Review Boards (“IRBs”). OIG specifically asks about the role of IRBs in reviewing participant remuneration, including the type, amount, frequency and advertising of remuneration. This question creates a meaningful opportunity for respondents to explain whether IRB review should serve as a compliance safeguard specific to remuneration. Potential issues to address include the pros and cons of an IRB evaluating:

• • Whether financial incentive(s) align with participant burden rather than, e.g., the value of federally reimbursable items or services;
  • Whether proposed payments are reasonable/not coercive;
  • Whether remuneration is consistent with the informed consent process;
  • Whether recruitment materials adequately and accurately describe remuneration without inappropriate emphasis on financial incentives; and
  • Whether payment schedules are appropriately phased/prorated.

7. Anti-Steering Protections. OIG asks what safeguards should be implemented to prevent participants who receive remuneration from being inappropriately steered to items or services offered by the person or entity providing remuneration outside the clinical trial.
8. Differences by Trial Phase/Type. OIG asks whether (a) remuneration is provided during all stages of product development (e.g., Phase 1 through Phase 4 trials) and (b) different types or amounts of remuneration are appropriate for the different phases. OIG also asks whether certain categories of trials should be ineligible for protection based on relative fraud and abuse risk.
9. Advertising Limitations. OIG is considering whether recruiting materials advertising participant payments should be limited to prevent undue influence. Toward this end, OIG requests input on whether advertising limitations are needed for remuneration offered to clinical trial participants to protect trial integrity and reduce fraud and abuse risk.
10. Potential Safe Harbor Design. Stakeholders may propose protections for remuneration that are:

• • Reasonable and not tied to referrals;
  • Limited to trial participation needs;
  • Subject to IRB/written policy oversight;
  • Transparently disclosed; and/or
  • Consistently applied.

OIG also asks commenters to address how such a protection would relate to the statutory criteria for establishing safe harbors, including potential effects on access, quality, patient choice, competition, underserved populations, federal health care program costs, overutilization and fraud and abuse prevention.

When commenting on this issue, consider addressing the fact that existing safe harbors were not designed for the unique clinical trial context. As a result, they do not account for participant burden (e.g., with respect to travel, lodging, meals, childcare and parking; time and inconvenience; long-term participation).

11. Guidance vs. Rulemaking. OIG asks for stakeholder input on whether some issues could be addressed through guidance rather than formal regulation, such as a Special Advisory Bulletin, FAQ or other interpretive guidance. This creates an opportunity for commenters to take a position and distinguish between (a) issues requiring regulatory safe harbor protection and (b) issues suitable for guidance, such as examples of documentation and transparency expectations or advertising principles.
12. Broader Policy Implications. OIG also seeks input on the broader implications of protecting clinical trial participant remuneration, including whether increased participation by federal health care program enrollees could improve access, equity and quality of care.

We encourage respondents to keep in mind HHS’s stated mission in Operation TrialBlazer’s HHS Roadmap to Maintaining U.S. Leadership in Early Clinical Research and Development (2024), at 2–3, which includes:

• • Modernizing regulatory requirements and processes.
  • Improving transparency for regulated entities.
  • Encouraging the adoption of more efficient practices.
  • Ensuring federal dollars are allocated to adequately powered and designed trials.
  • Better utilizing existing data sources and technologies for regulatory and data-generation purposes.
  • Improving patient and participant access and engagement in clinical trials and removing disincentives preventing health care workers from being involved in the conduct of research.

Strategic Considerations for Comment Planning

Given the fixed timeline, organizations may want to prioritize:

1. Rapid Issue Spotting (Next 1–2 Weeks)

• • Inventory existing:
    • Participant reimbursement practices (e.g., travel, stipends).
    • Internal compliance constraints under AKS/Beneficiary Inducements CMP.
  • Identify areas of regulatory uncertainty or operational friction.

2. Policy Position Development (Weeks 2–5)

• • Evaluate:
    • Whether existing safe harbors are insufficient.
    • Whether specific remuneration categories (e.g., childcare, stipends) need protection beyond existing safe harbors and safeguards.
  • Align across:
    • Legal/compliance.
    • Clinical operations.
    • Government affairs.

3. Drafting and Submission (Weeks 5–8)

• • Determine which areas of the RFI your organization will address.
  • Prepare data-supported responses tied to OIG’s enumerated questions.
  • Develop concrete proposals for:
    • New safe harbors and/or other guidance; and
    • Safeguards to mitigate fraud and abuse risk.
  • Submit comments through regulations.gov before the submission deadline.

4. Prioritizing, Selecting and Framing Comments

• • OIG allows targeted responses; in other words, not all questions must be addressed by a commenter.
  • To maximize the impact of your submission, consider:
    • Using clear, realistic use cases.
    • Data showing participation impact.
    • Reference to specific safe harbor conditions.
    • Clear identification of existing or potential safeguards.

Why the Timeline Matters

The August 24, 2026, deadline presents a unique, but time-sensitive opportunity to influence how OIG addresses participant remuneration in clinical trials under the AKS and Beneficiary Inducements CMP frameworks. Early engagement is important for stakeholders seeking greater flexibility or clarity in supporting trial participation. While the RFI itself does not change current law, it is an early-stage policy development opportunity in the context of a newsworthy, “unprecedented” HHS initiative designed, in part, to enhance clinical trial participation. OIG is explicitly evaluating whether (a) to create new safe harbors under the AKS and (b) to expand exceptions under the Beneficiary Inducements CMP Law.

Input received during this window may:

• Shape future proposed rulemaking.
• Influence OIG guidance priorities.
• Establish the policy record for industry positions on clinical trial remuneration.

Comments on the RFI are due August 24, 2026.

Practical Takeaways

• Stakeholders effectively have approximately 60 days to:
  • Assess how current AKS and Beneficiary Inducements CMP constraints affect clinical trial participation;
  • Identify priority areas for regulatory relief or clarification; and
  • Develop and submit formal comments through regulations.gov.
• Comments must be submitted by the stated deadline to ensure consideration.
• Submissions will be publicly posted in the rulemaking docket.

If you have any questions or require additional information on this topic, or if you would like assistance with developing and submitting comments, please contact:

• Rebecca Merrill at rmerrill@hallrender.com or (984) 244-5383;
• Summer Martin at smartin@hallrender.com or (984) 244-5382; or
• Your primary Hall Render contact.

Special thanks to Summer Associate Nick Baker for his assistance with the preparation of this article.

Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.