DOJ, HHS Announce Revamped False Claims Act Working Group

Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs.

On July 2, 2025, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) jointly announced that they will be strengthening their collaboration to advance priority enforcement areas through a DOJ-HHS False Claims Act Working Group (“FCA Working Group”). Originally formed in December 2020 during President Trump’s first term, the FCA Working Group is now being reestablished with renewed vigor to address key FCA enforcement priorities.

As we report annually, FCA settlements and judgments return billions of dollars to the federal treasury, with the health care and life sciences sectors accounting for the majority of those recoveries. While health care FCA statistics dipped last year, we predicted in January a “continued focus”—particularly given that the first Trump administration saw DOJ file a record number of health care-related FCA cases in a single year.

The relaunch of the FCA Working Group signals that the federal government, aided by whistleblowers, will continue to rely heavily on the FCA for health care fraud and abuse enforcement, with HHS continuing to refer potential violations to DOJ. The July 2 announcement identified six priority areas:

• Medicare Advantage;
• Drug, device, and 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.

The agencies also linked their announcement to the “priority FCA matters” laid out by Assistant Attorney General Brett Shumate in a June 11 memorandum (discussed in our June 20 blog post). These included broader DOJ Civil Division priorities such as using the FCA to enforce antidiscrimination laws and investigating claims for noncovered services (such as gender affirming care) to federal health care programs. HHS leadership further emphasized during a July 2 American Health Law Association panel that network adequacy violations that impede patient access will be a continued focus.

In each case referred to the FCA Working Group, DOJ and HHS will assess two threshold questions:

1. Should HHS suspend Medicare payments under 42 U.S.C. § 405.370 et seq. based on a credible allegation of fraud?
2. Should DOJ decline to intervene and seek dismissal of a qui tam suit under 4-4.111 of the Justice Manual?

The FCA Working Group will include leadership from the HHS Office of the 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 DOJ’s Civil Division, with representation from U.S. Attorneys’ Offices nationwide. The group will be jointly led by the HHS General Counsel, Chief Counsel to HHS-OIG, and the Deputy Assistant Attorney General of the Civil Division’s Commercial Litigation Branch.

The announcement follows the DOJ and HHS-OIG’s June 30 announcement of the Criminal Division’s 2025 Health Care Fraud Takedown, the largest to date, which included both criminal and civil FCA recoveries.

While the U.S. Court of Appeals for the Eleventh Circuit has yet to decide whether the FCA’s qui tam provisions are unconstitutional, the FCA Working Group continues to encourage whistleblower reports in high-priority enforcement areas. The FCA Working Group also urges companies to consider voluntary disclosure, cooperation, and remediation in line with § 4-4.112 of the Justice Manual.

In short, health care and life sciences companies—particularly federal contractors—should remain vigilant about both traditional FCA risks (e.g., overbilling, billing for services that are not medically necessary, etc.) and emerging theories (e.g., civil rights violations), as we noted in May and June. Although FCA elements like scienter and materiality continue to serve as significant defenses, the “first line” of defense lies in building and maintaining a strong compliance infrastructure: robust internal audits, responsive remediation, and legal counsel well-versed in FCA enforcement. Organizations should also monitor DOJ policy updates as well as HHS enforcement signals in real time. Just as important, fostering a corporate culture that promotes compliance, transparency, and internal reporting can reduce the risk of whistleblower-initiated litigation before it begins.

Epstein Becker Green Staff Attorney Ann W. Parks contributed to the preparation of this post.