On June 24, 2026, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) published a Request for Information (“RFI”) seeking public input on whether OIG should add or modify its regulatory safe harbors for the Federal anti-kickback statute (“AKS”) or statutory exceptions to the Beneficiary Inducements Civil Monetary Penalties Law (“Beneficiary Inducements CMP”) for remuneration provided to individuals in connection with clinical trial participation.

The RFI sits within HHS’s broader clinical trial reform initiative. Dubbed “Operation Trailblazer”, HHS’s initiative seeks to strengthen U.S. leadership in early clinical research and development. To accomplish that goal, HHS created a Roadmap, which identifies the ways to modernize regulatory processes, encourage more efficient trial practices, better leverage existing data and technologies, and improve patient access and engagement in clinical trials. To increase clinical trial participation, HHS proposes expanding decentralized and hybrid trial models, embedding research in community-based settings, using telehealth, remote monitoring, AI-enabled tools, and real-world data. The roadmap also identifies patient financial burdens—including co-payment obligations for standard-of-care services delivered during a trial, tax issues, possible Medicaid eligibility impacts, and geography—as structural barriers to clinical trial access and retention.