OIG Seeks Public Comment on Clinical Trial Participant Remuneration and Fraud and Abuse Laws
On June 24, 2026, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a Request for Information (“RFI”) seeking public input on whether new or modified safe harbors to the federal anti-kickback statute (“AKS”) or exceptions to the Civil Monetary Penalty (“CMP”) law prohibitions on beneficiary inducements are needed for remuneration provided to individuals in connection with clinical trial participation. The RFI does not propose or implement any regulatory changes at this time; it is only intended to gather information to inform potential rulemaking or guidance. Nonetheless, the RFI signals OIG’s interest in this issue and gives stakeholders a meaningful opportunity to help shape future policy around clinical trial recruitment.
This article provides an overview of the RFI, including the regulatory background, areas where OIG is seeking input, and key considerations for stakeholders.
Financial Barriers to Clinical Trial Participation
As OIG explains in the RFI, the reliability and validity of clinical trial results depend on enrolling a sufficient and representative pool of eligible participants, as well as sustained participant engagement with the trial and follow-up data collection efforts. For many individuals, the financial or logistical burdens associated with clinical trial participation create barriers to enrollment and disincentivize continued participation. These burdens may include travel and lodging expenses, parking and transportation costs, childcare needed during study visits, lost wages from time away from work, and cost-sharing amounts, such as copays or coinsurance for trial-related items and services. To address these challenges, prospective and current clinical trial participants often receive support from study sponsors, clinical trial sites, or other organizations to facilitate participation, such as cash stipends, expense reimbursement for the above costs, or subsidized cost-sharing amounts.
Anti-Kickback Statute and Beneficiary Inducements Civil Monetary Penalties Law
As background, the AKS makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive remuneration to induce referrals of items or services reimbursable by a federal health care program. “Remuneration” is broadly defined to include anything of value, whether provided directly or indirectly, covertly or overtly, in cash or in kind. Because the AKS’s reach is broad enough to encompass potentially legitimate, non-abusive arrangements, the Social Security Act (the “Act”) authorizes HHS to create “safe harbor” regulations that identify specific payment and business practices that are not subject to AKS liability, provided the arrangement satisfies all conditions of the applicable safe harbor.
The beneficiary inducements prohibition of the CMP law authorizes penalties against anyone who offers remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s choice of a particular provider, practitioner, or supplier. “Remuneration” is defined to include waivers of coinsurance and deductible amounts (or any part thereof) and transfers of items or services for free or for other than fair market value. Similar to the AKS safe harbors, the CMP law contains exceptions to the definition of remuneration that protect certain transactions from liability.
Given the broad scope of the AKS and beneficiary inducement prohibitions, the forms of support provided to clinical trial participants described above can implicate these laws by inducing federal health care program beneficiaries to participate in clinical trials and receive items and services reimbursable by a federal health care program and/or influence beneficiaries to receive reimbursable items and services from a particular provider, practitioner, or supplier.
OIG’s Prior Guidance
As discussed in the RFI, OIG has issued 10 favorable advisory opinions over the last two decades permitting waiver or subsidization of federal health care program cost-sharing obligations for clinical trial participants. These opinions involve various entities providing such remuneration, including manufacturers, clinical trial sites, and other nonprofit organizations. OIG notes in the RFI that it has not issued any advisory opinions or guidance addressing other common forms of participant support, such as transportation assistance, childcare reimbursement, or stipends. As a result, stakeholders have expressed uncertainty about how such other compensation arrangements fit within the existing regulatory framework. In addition, advisory opinions are fact-specific and binding only on the requesting party. Because stakeholders stand to benefit from more authoritative guidance in this area, OIG has received requests over the years to establish a safe harbor that would formally protect certain forms of remuneration in connection with clinical trial participation.
Areas Where OIG is Seeking Input
The RFI seeks input on how OIG might (i) modify or add new safe harbors to the AKS or exceptions to the CMP law’s definition of remuneration, or (ii) publish or amend guidance to help facilitate clinical trial participation while continuing to safeguard against fraud and abuse. Through the RFI, OIG seeks to understand how the AKS and CMP law currently limit the ability of clinical trial stakeholders to provide support that could facilitate participation in clinical research. Specifically, OIG is seeking input on the following areas:
Effectiveness and Benefits of Remuneration to Promote Clinical Trial Involvement: The RFI asks whether and how offering appropriate remuneration to federal health care program enrollees meaningfully facilitates clinical trial participation. OIG specifically wants to understand the factors that make remuneration effective or ineffective at facilitating participation and whether different amounts or types of remuneration are necessary to promote participation in different phases of clinical studies (e.g., early-stage versus late-stage development). OIG also requests input on the broader implications of providing remuneration to clinical trial participants or creating additional or modified safe harbors. Notably, Section 1128D(a)(2) of the Act sets forth criteria HHS must consider when modifying or establishing new AKS safe harbors. Accordingly, OIG asks commenters to identify impacts that directly relate to such criteria (e.g., increased access to health care services, increased ability to provide services to medically underserved populations, decrease in costs to federal health care programs, etc.).
Impact of Federal Prohibitions: OIG seeks input on whether and why clinical trial stakeholders view the AKS and/or the beneficiary inducements CMP as barriers to offering and providing appropriate remuneration to clinical trial participants. OIG requests specific explanations as to why existing safe harbors and exceptions do not adequately extend to such remuneration to understand whether and how such safe harbors or exceptions could be modified or expanded to encompass appropriate forms of remuneration.
Appropriate Types and Amounts of Remuneration: OIG also invites comment on the categories and amounts of remuneration stakeholders consider useful to facilitate participation in clinical trials and, conversely, categories that are less useful or may present heightened risk of fraud and abuse. For example, OIG asks whether expense reimbursement, stipends, or compensation for participant time have different levels of utility and the extent to which various forms of remuneration are currently being offered.
Role of IRBs: OIG is also requesting information regarding the role Institutional Review Boards (“IRBs”) can and should play in overseeing the type, amount, and frequency of remuneration provided to clinical trial participants and the advertising of such remuneration. The RFI specifically asks about the standards and rationale IRBs should use when evaluating proposed remuneration and considering safeguards against potential harms.
Need for New or Modified Safe Harbors/Exceptions: The RFI asks commenters to identify additional or modified safe harbors to the AKS or exceptions to the definition of remuneration under the beneficiary inducements CMP that should be considered to address remuneration to clinical trial participants. OIG is requesting input on key provisions and conditions that would be appropriate to include in such safe harbors or exceptions to safeguard against fraud and abuse (e.g., disclosures). Additionally, commenters are asked to identify other opportunities for OIG to clarify its position through interpretive guidance rather than formal rulemaking (e.g., Special Advisory Bulletin, FAQs, etc.).
Safeguards Against Fraud and Abuse: OIG is also seeking input on safeguards needed to prevent fraud and abuse when clinical trial participants receive remuneration. Specifically, OIG asks whether protections are needed to ensure that participants are not inappropriately steered toward items or services outside the clinical trial offered by the individual or entity providing the remuneration, and whether current trials limit or prohibit which entities may provide remuneration (e.g., sponsors, investigators, etc.). OIG further requests input on what limitations or prohibitions, including potential advertising restrictions, would guard against fraud and abuse risk, as well as whether trials currently impose value caps or other limits (such as demonstrated financial need) and whether such limits permit sufficient remuneration to facilitate participation. Finally, OIG asks whether certain categories or phases of clinical trials present heightened fraud and abuse risk such that remuneration should be limited or excluded altogether.
Why Stakeholders Should Consider Submitting Comments
The RFI offers an important opportunity for clinical trial stakeholders to affect regulatory decision-making in a way that could have significant implications for clinical trial recruitment, enrollment, and retention. Although OIG is not proposing any regulatory changes at this time, the RFI gives stakeholders a chance to help inform OIG’s understanding of how financial barriers affect clinical trial participation and the role regulators can play in reducing those barriers while safeguarding against the fraud and abuse risks such remuneration may present.
Clinical trial sponsors, sites, investigators, IRBs, and other stakeholders with experience navigating these issues are well positioned to provide OIG with practical, data-driven input. Comments submitted through the RFI will help shape whether and how OIG proceeds with a new or modified safe harbor or CMP exception, including the specific conditions and safeguards such protections might include. Organizations involved in clinical research should consider submitting comments to influence participant recruitment and clinical trial compliance moving forward.
Comments are due no later than 5:00 p.m. ET on August 24, 2026, and may be submitted electronically here.
If you have questions about the RFI or how potential regulatory changes could affect your organization, London Legal Consulting, LLC can assist. Please contact us today.