Bass, Berry & Sims attorney Jennifer Michael provided insight for a Law360 article examining a December 2023 opinion issued by the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) relating to a medical device manufacturer’s proposal to pay the cost-sharing obligations for patients participating in a clinical trial. OIG concluded that the clinical trial sponsor will not face sanctions under the Anti-Kickback Statute if the sponsor covers the study participants’ cost-sharing obligations up to a maximum amount of $2,000.

Jennifer, who previously served as Chief of HHS OIG’s Industry Guidance Branch, pointed out that, while OIG has issued a number of favorable opinions on the subject of cost-sharing subsidies in clinical trial settings, Advisory Opinion 23-11 applies only to the requesting clinical trial sponsor. However, she added that “I think [Advisory Opinion 23-11 is] probably giving the industry more comfort … about helping beneficiaries with these types of subsidies.”

The full article “HHS OIG Won’t Levy AKS Fines for Subsidies in Clinical Trial,” was published by Law360 on January 2 and is available online.