HHS and DOJ Revive FCA Working Group

In a July 2, 2025 press release (the Press Release), HHS and DOJ’s Civil Division announced that the agencies are reinvigorating the DOJ-HHS False Claims Act Working Group (the Working Group), “strengthening” the agencies’ “ongoing collaboration to advance priority enforcement areas” and combat healthcare fraud. The Working Group will include leadership from the HHS Office of General Counsel, CMS’s Center for Program Integrity, the Office of Counsel to HHS-OIG, and DOJ’s Civil Division.

The agencies initially established the Working Group in December 2020 to target potential fraud involving federal support provided in response to COVID-19. The reinvigorated Working Group will meet monthly beginning in July 2025 to focus on several longstanding and new priority enforcement areas.

Working Group Activities

The Press Release highlights three key components of the Working Group’s coordination work.

First, HHS intends to “make referrals to DOJ of potential violations of the FCA that reflect Working Group priorities.” These include the priorities announced by Brett Shumate, the Assistant Attorney General of DOJ’s Civil Division, in a memo dated June 11, 2025 (DOJ Civil Division Enforcement Priorities Memo),¹ as well as the following priority areas relating specifically to healthcare fraud:

• 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 health care 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.”

Second, to “expedite ongoing investigations” in the above priority areas and “identify new leads,” the Working Group intends to “leverag[e] HHS resources through enhanced data mining and assessment of HHS and HHS-OIG report findings.”

Third, the Working Group intends to “discuss considerations bearing on whether HHS should implement a payment suspension pursuant to 42 U.S.C. § 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.”

Take-Aways

Over the past months, the Trump Administration has issued numerous directives that have caused a general shift in the DOJ Civil Division’s enforcement priorities.² That shift raised the question of whether traditional FCA enforcement areas, such as combating health care fraud and abuse, would remain an agency priority. Based on the Press Release, the answer appears to be a resounding “yes.”

The Press Release is notable not only for confirming that health care fraud and abuse remains an FCA enforcement priority, but also for highlighting potentially new fraud and abuse focus areas. For example, while some of the priority areas highlighted in the Press Release—including Medicare Advantage and kickbacks—have been longstanding areas of focus for FCA enforcement, others—such as compliance with network adequacy requirements—appear to reflect relatively new priorities.

The Press Release also suggests that the DOJ Civil Division may not be content to rely mainly on qui tam complaints to identify potential health care fraud and abuse. Rather, the Working Group’s goal of leveraging HHS resources to “identify new leads” suggests that there may be an uptick in agency-initiated investigations, at least in the priority areas identified in the Press Release.

Of course, the precise scope of the Working Group’s work remains to be seen. But the revival of the Working Group is a clear message that FCA enforcement in the health care space isn’t going away any time soon.

1. The DOJ Civil Division Enforcement Priorities Memo includes the following five enforcement areas: (i) combatting discriminatory practices and policies; (ii) ending antisemitism; (iii) protecting women and children; (iv) ending sanctuary jurisdiction; and (v) prioritizing denaturalization. With respect to the third enforcement area (protecting women and children), the Memo states that DOJ’s Civil Division will pursue investigations under the FCA related to gender-affirming care.
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2. Examples of those directives are included in the DOJ Civil Division Enforcement Priorities Memo. ↩︎