AdvaMed Comment Letter to OIG’s RFI on Clinical Trial Remuneration and Fraud & Abuse Laws

AdvaMed Comment Letter to OIG’s RFI on Clinical Trial Remuneration and Fraud & Abuse Laws

AdvaMed submitted comments to the HHS Office of Inspector General (OIG) in response to its Request for Information on the application of the Federal Anti-Kickback Statute (AKS) and Beneficiary Inducements Civil Monetary Penalty (CMP) provisions to clinical trial participant remuneration.

AdvaMed urged OIG to modernize and provide greater regulatory clarity by establishing a clinical trial-specific AKS safe harbor and related guidance to protect reasonable remuneration and participant-support arrangements provided in connection with bona fide clinical research.

AdvaMed highlighted the need for a flexible, risk-based framework that supports patient access to clinical trials while maintaining appropriate safeguards against fraud and abuse. AdvaMed emphasized that appropriate participant support can help reduce financial and logistical barriers to clinical trial participation, improve enrollment and retention, and promote clinical research more representative of the intended use population