DOJ and HHS Announce New False Claims Act Working Group
On July 2, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Justice (DOJ) announced that they are forming the DOJ-HHS False Claims Act Working Group to further combat healthcare fraud—an effort which the current administration “is fully committed to supporting.”1 The launch of this working group signals that healthcare fraud – particularly affecting certain listed areas below – is a key focus of the new administration.
Under the False Claims Act, 31 U.S.C. §§ 3729-3733, any person who knowingly submits, or causes to submit, a false claim to the government may be liable for up to three times the government’s damages plus a penalty linked to inflation.2 False claims act liability may arise for other reasons, too, including for knowingly using a false record to avoid paying funds to the government (as may be the case in the underpayment of tariffs).3
For the fiscal year ending September 30, 2024, the DOJ obtained more than $2.9 billion in settlements and judgments from civil cases involving fraud and false claims.4
The DOJ-HHS False Claims Act Working Group will include representatives from the HHS Office of General Counsel, the Centers for Medicare & Medicaid Services Center for Program Integrity, the Office of Counsel to the HHS Office of Inspector General (HHS-OIG), and the DOJ’s Civil Division, with designees representing U.S. Attorney’s Offices. The HHS General Counsel, Chief Counsel to HHS-OIG, and the Deputy Assistant Attorney General of the Commercial Litigation branch will jointly lead the group.
Some of the enforcement areas that the DOJ-HHS False Claims Act Working Group is prioritizing include:
- 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; and
- Manipulation of Electronic Health Record systems to drive inappropriate utilization of Medicare covered products and services.5
Companies in the healthcare sector should prepare for heightened scrutiny of their operations. Some steps to take include: developing robust compliance programs, identifying areas with potential False Claims Act exposure, and curing any deficiencies as soon as possible.
For additional information concerning the government’s announcement or the False Claims Act more generally, please contact your local Quarles attorney or:
- Kirti Vaidya Reddy, Partner: (414) 277-5260 / kirti.reddy@quarles.com
- Kristin C. Foster, Associate: (414) 277-5136 / kristin.foster@quarles.com
END NOTES
1 Office of Public Affairs, U.S. Department of Justice. DOJ-HHS False Claims Act Working Group. (accessed July 3, 2025).
2 Civil Division, U.S. Department of Justice. The False Claims Act. (accessed July 3, 2025).
3 Id.
5 Office of Public Affairs, U.S. Department of Justice. DOJ-HHS False Claims Act Working Group. (accessed July 3, 2025).