The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group. The announcement emphasized high-priority enforcement areas including:
- Medicare Advantage
- drug, device or biologics pricing, including arrangements for discounts, rebates, service fees, and formulary placement and price reporting
- barriers to patient access to care, including violations of network adequacy requirements
- kickbacks related to drugs, medical devices, durable medical equipment and other products paid for by federal healthcare programs
- materially defective medical devices that impact patient safety
- manipulation of electronic health records systems to drive inappropriate utilization of Medicare-covered products and services
These priority areas were noted to be in addition to the DOJ's Civil Division enforcement priorities highlighted by Assistant Attorney General Brett A. Shumate in his June 11, 2025, memorandum to all DOJ Civil Division employees, which focused on combating discriminatory practices, ending antisemitism, protecting women and children, ending sanctuary jurisdictions and prioritizing denaturalization.
The revitalization of the Working Group's coordination and cross-agency collaboration signals an increased focus on healthcare-related False Claims Act (FCA) investigations and enforcement actions.
The Working Group plans to leverage data mining and HHS Office of the Inspector General (OIG) report findings and discuss implementation of payment suspensions in accordance with 42 C.F.R. § 405.370 et seq., which may be implemented based on credible allegations of fraud.
Industry stakeholders should take note and implement proactive compliance measures focused on the above-noted priority areas in light of this increased focus on FCA investigations and enforcement actions.
