The July 2, 2025, press release encourages whistleblowers to identify and report potential violations of the FCA involving the above priority enforcement areas.
The U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) announced on July 2, 2025, the creation of a DOJ-HHS False Claims Act Working Group. The working group is intended to strengthen HHS and DOJ’s “ongoing collaboration to advance priority enforcement areas” of the Trump administration.
The announcement reinforces the administration’s ongoing intention to rely on the False Claims Act (FCA) as a key tool to advance its policy agenda and to combat alleged fraud, waste and abuse across federal programs, and follows a steady FCA drumbeat by the administration. The Commercial Litigation Branch’s then Deputy Assistant Attorney General Michael Granston’s February 2025 remarks to the qui tam bar emphasized the FCA’s central role in combatting fraud and abuse—and addressing alleged “nonmonetary harms.” Deputy Attorney General Todd Blanche’s May 19, 2025, memorandum—following a string of executive orders indicating as much—announced the DOJ’s clear intention to utilize the FCA to address the administration’s focus on allegedly unlawful “diversity, equity and inclusion” practices and antisemitism.
The DOJ-HHS False Claims Act Working Group will be jointly led by the HHS general counsel, chief counsel to HHS-OIG and the deputy assistant attorney general of the DOJ’s Commercial Litigation Branch. The working group will be comprised of leaders from the HHS Office of General Counsel, the Centers for Medicare & Medicaid Services’ Center for Program Integrity, the Office of Counsel to the HHS-OIG and the DOJ’s Civil Division.
As part of the working group, HHS will make referrals to the DOJ regarding potential violations of the FCA that reflect the following priorities:
- 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 working group will also follow the priority enforcement areas announced by the assistant attorney general of the Civil Division on June 11, 2025:
- Combatting discriminatory practices and policies;
- Ending antisemitism;
- Protecting women and children;
- Ending sanctuary jurisdictions; and
- Prioritizing denaturalization.
Although DOJ and HHS have a “long history of partnering,” the creation and composition of the working group is designed to:
[M]aximize cross-agency collaboration to expedite ongoing investigations in these 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 role of CMS program integrity officials (in addition to OIG) in this working group may indicate an appetite and effort by HHS and DOJ to identify some potential FCA cases earlier. The July 2, 2025, press release encourages whistleblowers to identify and report potential violations of the FCA involving the above priority enforcement areas. Nevertheless, the focus on data-driven, early identification of FCA referrals, taken together with the direction that the working group will provide input on “whether DOJ shall move to dismiss … qui tam complaint[s] under 31 U.S.C. § 3730(c)(2)(A), the Working Group’s effort may indicate an appetite to reduce the Government’s reliance on relator-initiated FCA cases.”
The administration is making clear that it views the FCA as a key enforcement tool for combatting waste, fraud and abuse, particularly in the healthcare and life sciences industries. Companies in those industries with federal contracts should evaluate their compliance with the FCA and monitor for further updates from the DOJ and HHS regarding key enforcement areas.
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