This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS). We also review a recent advisory opinion issued by the Office of the Inspector General (OIG) pertaining to a medical-device manufacturer’s proposal to subsidize certain Medicare cost-sharing obligations in the context of a clinical trial. Finally, we examine other notable healthcare regulatory and legislative updates.
