On Wednesday, July 2, 2025, HHS and DOJ announced a new working group focused on enforcement of the False Claims Act (“FCA”). According to the announcement, the DOJ-HHS False Claims Act Working Group (“Working Group”) is a collaboration between the two agencies to combat healthcare fraud. The Working Group is the second iteration of a similar effort established during the first Trump Administration. According to the DOJ press release, the Working Group will prioritize both new and familiar areas of enforcement to the healthcare industry, leverage enhanced data mining for purposes of FCA investigations, and consider possible changes to agency policies concerning payment suspension and qui tam complaints.
Membership in the Working Group will include leadership from the HHS Office of General Counsel, CMS Center for Program Integrity, the Office of Counsel to the HHS-OIG, and DOJ’s Civil Division, with designees representing U.S. Attorneys’ Offices. The group will be jointly led by the HHS General Counsel, Chief Counsel to HHS-OIG, and the Deputy Assistant Attorney General of the Commercial Litigation Branch.
In addition to the subject areas prioritized in a June 11, 2025 memorandum by the Assistant Attorney General of the Civil Division, the Working Group’s announcement identified the following priority areas for FCA enforcement in the healthcare industry:
- 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 Records systems to drive inappropriate utilization of Medicare covered products and services.
The announcement explains that the Working Group will include cross-agency efforts to expedite ongoing investigations in the above priority areas and identify new leads, including “by leveraging HHS resources through enhanced data mining and assessment of HHS and HHS-OIG report findings.”
The announcement also notes that the Working Group will discuss considerations bearing on whether HHS should implement a payment suspension pursuant to 42 C.F.R. § 405.370 et seq. or whether DOJ shall move to dismiss a qui tam complaint under 31 U.S.C. § 3730(c)(2)(A), consistent with Justice Manual Section 4-4.111.
Finally, the announcement states that the Working Group encourages whistleblowers to identify and report violations of the federal FCA involving priority enforcement areas. The Working Group’s announcement is silent regarding the pending decision by the Eleventh Circuit concerning the constitutionality of the qui tam provision of the FCA, discussed here.
