Bass, Berry & Sims attorney Jennifer Michael co-authored Chapter 9: “Fraud and Abuse Laws” in the 2021 American Bar Association (ABA) publication, Bringing Medical Devices to Market. This book guides readers through the process of bringing a new medical device from proof-of-concept to the market.

The “Fraud and Abuse Laws” chapter provides an overview of the False Claims Act and the Anti-Kickback Statute, and discusses certain Anti-Kickback Statute safe harbors and Special Fraud Alerts that are particularly relevant to medical device manufacturers. The chapter also highlights other fraud and abuse considerations applicable to medical device manufacturers, as well as steps medical device manufacturers can take to improve compliance and reduce fraud and abuse risks.

More information about the book, Bringing Medical Devices to Market, is available on the ABA website.