Lexology March 8, 2023
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal Anti-Kickback Statute (AKS), physician self-referral law (Stark Law) and False Claims Act (FCA). This issue also discusses recent regulatory developments more broadly.
NOTABLE ENFORCEMENT ACTIONS SUPREME COURT DENIES CERTIORARI IN FCA CASE
On January 9, 2023, the Supreme Court of the United States denied a petition for a writ of certiorari filed by a pharmaceutical manufacturer seeking to establish that liability in AKS cases requires proof of corrupt intent. This case arose from the manufacturer’s challenge to a negative US Department of Health and Human Services (HHS) Office of Inspector General advisory...