The Department of Health and Human Services Office of Inspector General (HHS-OIG) has published a Request for Information (RFI) asking whether the federal Anti-Kickback Statute (AKS, 42 U.S.C. § 1320a-7b(b)) and the Beneficiary Inducements Civil Monetary Penalty (CMP) law need a new or modified safe harbor or exception specifically covering remuneration paid to individuals for participating in clinical trials. The RFI, titled Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, was published in the Federal Register on June 24, 2026. Comments are due August 24, 2026.
What OIG is actually asking
Neither the AKS nor the Beneficiary Inducements CMP currently has a safe harbor or exception written specifically for clinical trial participant payments. In practice, sponsors and sites have relied on general principles — remuneration that is fair market value for genuine trial-related burden (time, travel, inconvenience) and not tied to referral volume or program enrollment has generally been treated as lower-risk — but that is informal industry practice, not a codified protection. OIG’s RFI asks stakeholders to weigh in on:
- Whether, and how, offering remuneration meaningfully increases participation by individuals enrolled in federal health care programs (Medicare, Medicaid, and similar);
- Whether sponsors, sites, IRBs, or other organizations see the AKS as a real barrier to offering appropriate remuneration, and if so, specifically why;
- The types and amounts of remuneration stakeholders would want to offer participants to facilitate enrollment and retention;
- The fraud-and-abuse risks that remuneration to participants could create;
- What kinds of payment arrangements would actually be needed; and
- What safeguards a new safe harbor or exception should require to prevent abuse.
This is an information-gathering RFI, not a proposed rule — OIG has not published draft regulatory text and has not committed to issuing one. It is the mechanism OIG typically uses before deciding whether rulemaking is warranted at all.
Where this fits: Operation TrialBlazer
The RFI is one strand of Operation TrialBlazer, the HHS department-wide initiative announced June 22, 2026 aimed at accelerating and modernizing U.S. clinical development and drawing early-phase trial activity back to the United States. Operation TrialBlazer spans multiple agencies and mechanisms under one umbrella, and this RFI should not be confused with the other piece of it CASRAI has already covered: the FDA’s proposed Expedited IND Pilot Program, which would let “Qualified Research Institutions” review sponsors’ nonclinical, clinical, and CMC packages on a rolling basis ahead of a formal IND submission, to speed the path to first-in-human trials.
The two items share a comment deadline (both now due August 24, 2026, after extension) and a common origin in Operation TrialBlazer, but they are otherwise separate proposals from separate HHS components addressing separate problems:
| Expedited IND Pilot Program | AKS Safe Harbor RFI (this article) | |
|---|---|---|
| Issuing office | FDA | HHS-OIG |
| Docket | FDA-2026-N-4699 | HHSIG-2026-0001 |
| What it addresses | Speed of IND review/first-in-human trial startup, via a new Qualified Research Institution network | Whether fraud-and-abuse law (AKS/Beneficiary Inducements CMP) discourages appropriate payment of clinical trial participants |
| Who it primarily affects | Sponsors, CROs, academic medical centers seeking QRI status | Sponsors, sites, and institutions structuring participant payment/reimbursement programs, especially where Federal health care program enrollees are involved |
Research administration offices tracking Operation TrialBlazer overall should treat these as two separate dockets requiring two separate comment submissions if an institution wants to weigh in on both.
Why participant remuneration is an AKS question at all
The AKS is a criminal, intent-based statute (42 U.S.C. § 1320a-7b(b)) that prohibits knowingly and willfully offering, paying, soliciting, or receiving remuneration to induce referrals or generate business reimbursable under a federal health care program. It applies to “any person,” not only providers, and its safe harbors at 42 CFR § 1001.952 are voluntary — failing to fit within one does not automatically mean a violation occurred, but it does remove the certainty a safe harbor provides. The Beneficiary Inducements CMP (Section 1128A(a)(5) of the Social Security Act) separately restricts offering remuneration likely to influence a Medicare or Medicaid beneficiary’s choice of provider. Because clinical trial participants are frequently also federal program beneficiaries, and because trial payments (stipends for time/travel, or compensation tied to procedures performed as part of the trial) can look, on paper, like inducements, sponsors and institutions have long had to structure participant payment programs conservatively in the absence of a purpose-built safe harbor — which is precisely the gap this RFI is testing whether to close.
What research administrators and compliance offices should do now
- Read the RFI’s specific questions before commenting. OIG has framed six distinct question areas (participation impact, barrier perception, remuneration types/amounts, fraud risk, arrangement structures, safeguards) — a useful institution response addresses the ones relevant to its own trial portfolio rather than a general statement of support or opposition.
- Coordinate with clinical trial billing compliance, not just research administration. Because this intersects directly with how participant payments are structured, documented, and screened for Federal-program-beneficiary status, institutions that already have a Medicare Coverage Analysis / billing compliance function should route the comment through that group as well as the IRB/OSP.
- Don’t wait on a final rule to review current practice. This is a request for input, with no guaranteed rulemaking outcome or timeline. Institutions with existing participant payment/reimbursement policies should still confirm those policies rest on the established fair-market-value, non-referral-linked framework in the interim — that baseline doesn’t change just because OIG is examining whether to formalize it.
- Track the docket, not just the deadline. Comments and any resulting proposed rule will be posted to the public docket (HHSIG-2026-0001) on Regulations.gov; as of this writing OIG has not indicated a timeline for next steps after the comment period closes.
Frequently asked questions
Is there currently an AKS safe harbor for paying clinical trial participants?
No. Neither the Anti-Kickback Statute’s safe harbors at 42 CFR § 1001.952 nor the Beneficiary Inducements CMP exceptions currently include one written specifically for clinical trial participant remuneration. That absence is the subject of this RFI.
When are comments due?
August 24, 2026. The RFI was published in the Federal Register on June 24, 2026.
Does this RFI propose a specific rule?
No. It is a request for information seeking stakeholder input on whether a new or modified safe harbor/exception is warranted and what it might need to contain. OIG has not published draft regulatory text.
Is this the same as the FDA Expedited IND Pilot Program?
No. They are separate proposals from separate HHS components, connected only by both falling under the broader Operation TrialBlazer initiative and by sharing an August 24, 2026 comment deadline. See CASRAI’s coverage of the Expedited IND Pilot Program for that separate docket.
Who should be involved in drafting an institutional comment?
Given the subject matter, a coordinated response typically draws on research compliance/billing compliance, the IRB or human subjects protection office, and sponsored programs/research administration — not any one office in isolation.
