2024 U.S. Health Care Fraud, Waste & Abuse Trends (Part II): Guidance on Clinical Laboratory Arrangements

This podcast, the second in a three-part series, features a discussion between multiple speakers—Michael Lampert, Andrew O'Connor, and a host—regarding recent developments in fraud, waste, and abuse, specifically focusing on clinical laboratory and specimen collection arrangements. The speakers analyze the implications of these arrangements under the kickback statute, civil monetary penalties law, and advisory opinions issued by the HHS-OIG in 2023, including advisory opinion 2306. They delve into the OIG's skepticism towards per-specimen arrangements, highlighting factors that contribute to fraud and abuse risks, such as the inadequacy of federal carve-outs and fair market value considerations. The podcast further explores the legal perspectives of advisory opinions, their impact on potential enforcement actions by the DOJ, and the risk of False Claims Act cases brought by relators. The discussion sets the stage for the next podcast, which will focus on enforcement actions in the healthcare space.