An Advisory Perspective for Clinical Research Leadership
A cancer patient who lives 238 miles from the nearest research site should not have to choose between a promising clinical trial and the cost of getting there. Yet under today’s federal fraud and abuse rules, a sponsor who offers to cover that travel cannot be certain the gesture is lawful. That uncertainty is the problem the American Cancer Society Cancer Action Network (ACS CAN) and more than 100 patient advocacy and professional organizations have now asked the government to fix.
Their vehicle is an August 24, 2026 comment letter[1] responding to a Request for Information (RFI) issued by the Department of Health and Human Services Office of Inspector General (HHS OIG) on June 24, 2026.[2] The RFI was issued as part of Operation TrialBlazer, HHS’s broader push to restore U.S. leadership in clinical research.[3] It asks a deceptively simple question: Should the Anti-Kickback Statute (AKS) and the Beneficiary Inducements Civil Monetary Penalty law be modified to protect the reasonable support, such as transportation, lodging, childcare, meals, and modest stipends, that helps patients take part in trials? Neither law contains a carve-out for that kind of assistance today, so common forms of participant support sit in a gray zone.
What ACS CAN Is Asking OIG to Do
ACS and its coalition partners suggestion is unequivocal: Create a single, dedicated AKS safe harbor for reasonable, trial-related participant support, subject to clear safeguards. ACS CAN argues that covering incremental costs measurably increases enrollment and retention, narrows rural and low-income disparities, and produces more representative, and therefore more reliable, evidence. It marshals pointed data to make the case. Roughly 30% of trials between 2011 and 2021 closed without meeting enrollment targets. Nearly 38% of adults over 35 must drive more than 50 miles to reach a National Cancer Institute funded site. Lower-income patients travel an average of 238 miles to participate in a clinical trial, compared with under 50 miles for higher-income patients. An appendix drives the point home with a state-by-state mismatch between cancer burden and trial access, showing, for example, that West Virginia ranks second in cancer incidence but 47th in nearby trial availability.[4]
Just as important is what the coalition volunteers on the compliance side. Rather than ask for a blank check, ACS CAN pairs its request with the guardrails OIG cares about: support tied to actual trial-related burden rather than nominal inducement, Institutional Review Board (IRB) review of the type and amount of any payment, a firm anti-steering line so support is never conditioned on using a particular product or provider, and contemporaneous documentation available for audit. The coalition also urges OIG to reach every trial regardless of phase or sponsor type, noting that a government-only rule would exclude the roughly 90% of oncology trials that are industry-sponsored, and to codify the protection in regulation rather than rely on sub-regulatory guidance, because a criminal statute demands the certainty that only a safe harbor provides.
How HHS Is Likely to Receive It
The request lands on receptive ground since OIG did not stumble into this subject. It opened the door itself through the RFI, and it did so under a department-wide initiative whose stated goal is to reduce regulatory friction and improve patient access to trials. OIG has also spent two decades issuing favorable advisory opinions permitting cost-sharing waivers, signaling comfort with the underlying concept even though it has never addressed travel, lodging, or childcare head-on. Commentators reading the timing have concluded the agency is laying groundwork for possible rulemaking, not merely collecting views.
Receptive, however, does not mean automatic. OIG’s own questions telegraph where its caution lives, namely the risk that participant support becomes a marketing lure, steers beneficiaries toward federally reimbursable care, or escapes documentation. ACS CAN’s letter is effective precisely because it anticipates those concerns and answers them, which makes it more likely that OIG treats the coalition’s framework as a workable template than as an unrealistic suggestion to be pared back. The realistic path forward is a proposed rule that embraces participant support in principle while tightening the safeguards, defining reasonable amounts, and clarifying the anti-steering and advertising limits. Whether OIG favors one broad safe harbor or a narrower construct paired with interpretive guidance remains the open question.
What This Means for Research Institutions
For now, the law has not changed and no safe harbor exists. But the direction of travel is clear enough that clinical research leaders can prepare without getting ahead of the rule. The institutions positioned to benefit first will be those that already treat participant support as a governed, IRB-reviewed, well-documented capability rather than an ad hoc exception, because if OIG proceeds, the difference between protected support and a compliance problem will come down to whether an organization can show its assistance was reasonable, trial-related, approved, and never used to steer care.
Bottom Line: ACS CAN and its coalition have handed OIG a fraud-and-abuse fix that aligns neatly with the government’s own clinical research agenda and arrives pre-loaded with the safeguards regulators expect. HHS is likely to welcome the input and, in time, to build on it. The open questions seem to be timing and scope, not direction.
References
[1] American Cancer Society Cancer Action Network, Community Response to RFI on the Creation of a Clinical Trial Support Safe Harbor (Aug. 24, 2026), https://www.fightcancer.org/policy-resources/community-response-rfi-creation-clinical-trial-support-safe-harbor.
[2] Department of Health and Human Services, Office of Inspector General, RIN 0936–AA16, 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. 37902 (June 24, 2026), https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12676.pdf.
[3] See additional insights and questions on Operation Trial Blazer
[4] American Cancer Society Cancer Action Network, Community Response to RFI on the Creation of a Clinical Trial Support Safe Harbor (Aug. 24, 2026), https://www.fightcancer.org/policy-resources/community-response-rfi-creation-clinical-trial-support-safe-harbor.
© Copyright 2026. The views expressed herein are those of the author(s) and not necessarily the views of Ankura Consulting Group, LLC, its management, its subsidiaries, its affiliates, or its other professionals. Ankura is not a law firm and cannot provide legal advice.
