This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal Anti-Kickback Statute (AKS). We also discuss several criminal and civil enforcement actions pertaining to healthcare fraud, including alleged violations under the False Claims Act (FCA), AKS and Physician Self-Referral Law (Stark Law). We then review several US Department of Health and Human Services (HHS) agency actions, including several HHS Office of Inspector General (OIG) audits regarding Provider Relief Fund spending and diabetes drug and opioid prescriptions, as well as an upcoming OIG study of vertical integration of prescription drug pharmacy benefits managers. We also cover other government activities, including a multi-agency request for information about the involvement of private equity in the healthcare system and a proposed rule concerning compounding drugs.
