# 2026-12676: Feds Ask if Paying Trial Participants Counts as Kickback

2026-12676, Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP, is a Federal Register proposed rule from Health and Human Services Department published 2026-06-24, effective To ensure consideration, comments must be received no later than 5 p.m. on August 24, 2026.; PRIA reads it as touching household money (as of 2026-07-01).

- Canonical: https://policyrisk.com/federal-register/2026-12676
- As of: 2026-07-01
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12676
- Title: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP
- Type: Proposed Rule
- Agencies: Health and Human Services Department
- Citation: 91 FR 37902
- Published: 2026-06-24
- Effective: To ensure consideration, comments must be received no later than 5 p.m. on August 24, 2026.
- Comments close: 2026-08-24
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: 0936-AA16
- Last updated: 2026-07-01

## In one line

Feds Ask if Paying Trial Participants Counts as Kickback

## 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.

## Abstract

This request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monetary penalty provision prohibiting inducements to beneficiaries (the "Beneficiary Inducements CMP") for remuneration provided to individuals in connection with their participation in clinical trials.

## Effects PRIA read

- Possible Safe Harbor Changes for Trial Payments: mixed, medium. 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 Aug…
- Existing Advisory Opinions Cover Cost-Sharing: benefit, low. 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 op…
- Guidance (Not Just Regulation) Is Under Consideration: benefit, low. 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 2…

## Related documents

- [2026-20447](https://policyrisk.com/federal-register/2026-20447): Transparency in Coverage, 2026-10-06
- [2026-20281](https://policyrisk.com/federal-register/2026-20281): Global Benchmark for Efficient Drug Pricing (GLOBE) Model, 2026-10-02
- [2026-20131](https://policyrisk.com/federal-register/2026-20131): Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality…, 2026-10-01
- [2026-19959](https://policyrisk.com/federal-register/2026-19959): Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Prog…, 2026-09-30
- [2026-20067](https://policyrisk.com/federal-register/2026-20067): Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction, 2026-09-30
- [2026-19946](https://policyrisk.com/federal-register/2026-19946): Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospectiv…, 2026-09-29

## Sources
- [2026-12676 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/24/2026-12676/medicare-and-state-health-care-programs-fraud-and-abuse-request-for-information-regarding-the)
- [2026-12676 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12676.pdf)

## Related
- [Previous: 2026-12644, Longshore and Harbor Workers' Compensation Act: Quality Standards for Hearing L…](https://policyrisk.com/federal-register/2026-12644)
- [Next: 2026-12689, Safety Zone; Ohio River, Cincinnati, OH](https://policyrisk.com/federal-register/2026-12689)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12676 (as of 2026-07-01).