On July 2, 2025, the Department of Justice ("DOJ") and the Department of Health and Human Services ("HHS") announced a joint DOJ-HHS False Claims Act Working Group (the "Working Group") that will focus on enhanced enforcement of the False Claims Act ("FCA") to combat healthcare fraud. The Working Group announced six priority enforcement areas and outlined additional areas of focus that the Working Group will explore. The announcement of the Working Group is notable both in underscoring the Administration's continued prioritization of FCA healthcare enforcement and in setting forth priority areas in addition to those identified in the Civil pision's June 11, 2025 memorandum, which the Working Group announcement references.1
The Working Group will look to expedite ongoing investigations in the identified priority areas, including through an increased use of data mining. The six priority areas are:
- 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.
The Working Group will also consider HHS's payment suspension authority for "credible allegations of fraud." The Centers for Medicare & Medicaid Services currently defines a credible allegation of fraud broadly as "an allegation from any source, including ... (1) [f]raud hotline tips verified by further evidence; (2) [c]laims data mining; and (3) [p]atterns identified through provider audits, civil false claims cases, and law enforcement investigations." Allegations are considered credible when they have "indicia of reliability." Although HHS has exercised its payment suspension authority in the past, participants in federal healthcare programs will want to monitor whether the Working Group identifies additional considerations bearing on when HHS should exercise this authority, as well as whether there is an uptick in payment suspensions going forward.
The Working Group will also discuss the factors that DOJ should consider in determining whether to dismiss qui tam complaints. When discussing the Working Group, Deputy Assistant Attorney General ("DAAG") Brenna Jenny of DOJ's Civil pision—who will co-lead the Working Group—explained that one focus will be on streamlining investigations, including "assessing early whether novel legal theories are viable and supported by leadership."2 Under the DOJ Justice Manual, the merits of a claim are just one of several factors that can serve as the basis for dismissal; others include considering whether an action duplicates a preexisting government investigation, interferes with an agency's policies or programs, interferes with the government's litigation prerogatives, or implicates classified information and national security interests.3 While the DOJ and HHS announcements still welcome qui tam complaints, this shift announced by DAAG Jenny could have implications for largely unfounded complaints that in the past have resulted in multi-year investigations. Upcoming Working Group meetings may provide more details. The Working Group will meet on a monthly basis, starting in July.
Footnotes
1. WilmerHale has provided additional analysis on the June 11, 2025 memorandum, which is available here: DOJ Civil pision Issues Enforcement Priorities Memorandum (June 13, 2025).
2. American Health Law Association, Annual Meeting (July 2, 2025).
3. U.S. Department of Justice, Justice Manual § 4-4.111 (updated Oct. 2021).
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