On June 24, 2026, the Office of Inspector General for the US Department of Health and Human Services published a Request for Information seeking public input on clinical trial participant remuneration.
The OIG is asking whether it should add or modify regulatory safe harbors under the Federal anti-kickback statute or the Beneficiary Inducements Civil Monetary Penalties Law.
The request sits within HHS’s broader clinical trial reform initiative, dubbed “Operation Trailblazer,” which seeks to strengthen US leadership in early clinical research and development.
HHS created a Roadmap under Operation Trailblazer that identifies ways to modernise regulatory processes, encourage efficient trial practices, and improve patient access and engagement.
To increase participation, HHS proposes expanding decentralised and hybrid trial models, using telehealth, remote monitoring, AI-enabled tools, real-world data, and community-based research settings.
The Roadmap also identifies patient financial burdens, including co-payment obligations, tax issues, Medicaid eligibility impacts, and geography, as structural barriers to clinical trial access and retention.
The OIG’s RFI asks stakeholders whether remuneration facilitates clinical trial participation and whether existing laws operate as barriers to encouraging such participation.
The consultation also asks what types of remuneration are appropriate, including cost-sharing support, travel, lodging, parking, childcare, meals, stipends, and completion incentives.
The OIG further requests feedback on what safeguards should apply, including Institutional Review Board review, value caps, advertising limits, and anti-steering protections.
Stakeholders are also asked whether formal regulatory protection is necessary or whether sub-regulatory guidance, such as a Special Advisory Bulletin or FAQ, would be sufficient.
The AKS prohibits the knowing and willful offering, paying, soliciting, or receiving of remuneration to induce or reward referrals reimbursable by a Federal health care programme.
The Beneficiary Inducements CMP separately prohibits offering or transferring remuneration to Medicare or State health care programme beneficiaries likely to influence their selection of a provider or supplier.
Although clinical trials are not often reimbursed by Medicare, Medicaid requires coverage of routine patient costs in qualifying clinical trials, meaning Federal health care programme risk remains relevant.
OIG cites two decades of favourable advisory opinions permitting waiver or subsidisation of certain Federal health care programme cost-sharing obligations for clinical trial participants as existing precedent.
OIG has acknowledged it has not yet opined on other forms of remuneration via advisory opinion, including transportation costs, childcare costs, or stipends paid to participants.
Two recently issued unfavourable opinions, AO 24-05 and AO 24-06, addressing financial assistance for commercial gene therapy treatment, may serve as cautionary reference points for stakeholders submitting comments.
Those opinions turned specifically on potential influence over treatment centres and physicians, rather than protocol-bound remuneration paid directly to clinical trial participants.
A critical structural limitation is that OIG advisory opinions may only be legally relied upon by the opinion requestor, unlike the broader protection offered by regulatory safe harbours.
The Medicare Secondary Payer rules also present a financial limitation, as any AKS safe harbour or CMP exception would likely remain subject to those payment priority rules.
Comments in response to the OIG’s Request for Information are due by 5:00 p.m. on August 24, 2026.