Feds Ask if Paying Trial Participants Counts as Kickback
Published Date: 6/24/2026
Proposed Rule
Summary
The government wants your thoughts on whether rules about paying people to join clinical trials need updating. This affects anyone involved in Medicare and state health programs, especially those running or joining clinical trials. Comments are open until August 24, 2026, so speak up if you think changes could help or hurt trial participation or fairness.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
Possible Safe Harbor Changes for Trial Payments
The HHS Office of Inspector General is asking whether it should modify or add safe harbors at 42 CFR 1001.952 or exceptions at 42 CFR 1003.110 to protect payments (like waiving cost-sharing or other remuneration) given to people who join clinical trials. The request for information runs through August 24, 2026, and could lead OIG to propose regulatory changes affecting Medicare and State health care program beneficiaries and clinical trial sponsors or sites.
Existing Advisory Opinions Cover Cost-Sharing
OIG has published 10 favorable advisory opinions over the last two decades that permit waiver or subsidization of certain Federal health care program cost-sharing obligations for clinical trial participants by entities like manufacturers, trial sites, and non-profits. OIG has not issued advisory opinions or guidance about other payments to participants such as transportation, childcare, or stipends.
Guidance (Not Just Regulation) Is Under Consideration
OIG explicitly asks whether it should publish or amend guidance (for example, a Special Advisory Bulletin or FAQ) instead of or in addition to changing regulations to clarify protections for remuneration to clinical trial participants. Respondents are invited to comment and provide data by August 24, 2026.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-14709, Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program; Correction
This correction fixes some typos and technical mistakes in the 2027 health insurance rules under the Affordable Care Act. It mainly affects people and organizations involved in health coverage plans by clarifying when the rules take effect and restoring some important regulation details. These fixes take effect on July 20, 2026, ensuring smoother and clearer health plan operations next year.
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-12069, Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflicts of Interest, and Related Provisions
This new rule makes sure the groups that check Medicare providers play fair and follow clear rules to avoid conflicts of interest. It updates how psychiatric hospitals are reviewed and tightens rules for providers who lost their Medicare status but want back in. These changes affect Medicare providers and accrediting groups, start June 16, 2027, and aim to keep care safe and trustworthy.
2026-11530, Employment and Training Services for Noncustodial Parents in the Child Support Program; Rescission
The government plans to cancel a recent rule that let child support agencies offer job training to noncustodial parents using federal funds. This change affects agencies and parents involved in the child support program and could shift how support services are funded and delivered. Comments on this proposal are open until August 10, 2026, so folks have time to weigh in before it’s final.
2026-11140, Federal Independent Dispute Resolution Operations
Starting soon, health plans and insurers must share clearer info when they pay or deny surprise medical bills. They’ll use special codes to explain these decisions, especially when dealing with folks they don’t have contracts with. This helps patients and providers understand bills better and speeds up fixing disputes, with no extra costs for most people.
Previous / Next Documents
Previous: 2026-12644, Longshore and Harbor Workers' Compensation Act: Quality Standards for Hearing Loss Testing
The Department of Labor wants to update how hearing loss is tested for Longshore and Harbor workers who file claims. They’re asking for public input on new, high-tech hearing tests that might be better than the old audiograms. If you have ideas, send them in by October 22, 2026—this could change how hearing loss claims are handled and improve fairness and accuracy.
Next: 2026-12689, Safety Zone; Ohio River, Cincinnati, OH
The Coast Guard wants to create a temporary safety zone on the Ohio River in Cincinnati for a fireworks show on September 28, 2026, from 7:15 to 9:15 p.m. This means boats and people can’t enter the area unless they get special permission. The goal is to keep everyone safe from fireworks hazards, and the public can share their thoughts by July 24, 2026.