Further demonstrating its interest in ramping up anti-fraud enforcement in the health care and life sciences industries, on July 2, 2025, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) announced the formation of a “False Claims Act Working Group” (FCA Working Group). The FCA Working Group includes the HHS Office of General Counsel, the Centers for Medicare & Medicaid Services (CMS) Center for Program Integrity, the Office of Counsel to the HHS Office of Inspector General (HHS-OIG), and DOJ’s Civil Division, with representatives from U.S. Attorneys’ Offices. This initiative aims to strengthen collaboration among these agencies to identify and combat health care fraud in priority areas, and possibly at an earlier stage, including through the use of data mining and HHS-OIG reports and analyses.
Through the FCA Working Group, HHS will refer to DOJ potential violations of the FCA in priority areas of enforcement, 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, such as violations of network adequacy requirements
- Kickbacks related to drugs, medical devices, durable medical equipment, and other products paid for by federal health care programs
- Materially defective medical devices that impact patient safety
- Manipulation of Electronic Health Records systems to drive...
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