DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities

The Trump administration recently announced the renewal of a cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the new DOJ-HHS False Claims Act Working Group (the Working Group). Deputy Assistant Attorney General (DAAG) of the Commercial Litigation Branch Brenna Jenny; Acting General Counsel of the HHS Sean Keveney; and Acting Chief Counsel to the HHS Office of the Inspector General Susan Edwards will jointly lead the Working Group. It will also include members from the Centers for Medicare & Medicaid Services Center for Program Integrity and Offices of the United States Attorneys.

The FCA Working Group’s Cross-Agency Priorities

The Working Group announced the following specific priority areas, some familiar and some more novel, in which the HHS and DOJ will coordinate their efforts to combat potential False Claims Act (FCA) violations:

• “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” (DOJ Office of Public Affairs)

The announcement also highlights certain of the Working Group’s procedural priorities: (1) potential imposition of Medicare payment suspensions, when there is reliable information of an overpayment or a credible allegation of fraud; (2) consideration of whether the DOJ should move to dismiss certain qui tam complaints; and (3) encouraging whistleblowers to report any potential violations of the FCA, specifically in the priority areas identified. The group’s focus on these tools indicates that its approach to healthcare fraud enforcement may be to broadly solicit potential FCA violations from whistleblowers but selectively pursue the strongest cases within the priority areas identified.

The Administration’s Continued Emphasis on Healthcare Fraud Enforcement 

The announcement follows months of emphasis by the Trump administration on its intention to pursue healthcare fraud enforcement. In February 2025, Michael Granston (then DAAG) stated that the DOJ would continue to “aggressively” enforce the FCA. Following that statement, the DOJ demonstrated that commitment, touting successes in the form of trials won, settlements reached, and complaints filed to combat healthcare fraud.

The establishment of the Working Group reflects DAAG Jenny’s experience in senior positions at the DOJ and HHS, as well as perspectives she has gained as a private sector lawyer defending FCA actions against healthcare entities. With a new DAAG and the establishment of this Working Group, we may expect to see changes based on new priorities and perspectives on various issues that arise in FCA cases, especially those involving HHS programs.

Finally, days before the announcement of the Working Group, the DOJ announced the results of its 2025 National Health Care Fraud Takedown. This takedown reflects continuity as the latest in a long series of similar coordinated actions across many administrations. It is particularly notable, though, due to its size and areas of focus. The DOJ reported that the more than $14.6 billion in alleged fraud in this takedown is more than double the prior record. The action resulted in “criminal charges against 324 defendants, including 96 doctors, nurse practitioners, pharmacists, and other licensed medical professionals, in 50 federal districts and 12 State Attorneys General’s Offices,” in addition to civil and administrative actions.

Looking Ahead

With the advent of this administration’s DOJ-HHS False Claims Act Working Group, we can expect it will continue to pursue FCA enforcement and work to combat healthcare fraud with the goal of recouping significant funds. This may lead to an increase in qui tam actions brought to the government’s attention by whistleblowers in the priority areas previously noted in this alert. While many of these priorities signal continuity from past administrations, others, such as drug, device, or biologics pricing and barriers to patient access to care, are more novel areas of focus. Healthcare and life sciences companies should be aware of these priority areas and consult counsel, as their regulatory and compliance programs may face increased scrutiny and potential enforcement activity.

Goodwin’s Healthcare; Life Sciences Regulatory & Compliance; and Government Investigations, Enforcement & White Collar Defense lawyers will continue to monitor enforcement developments in these areas and their potential impact on healthcare and life sciences companies. Please contact the Goodwin team with any questions related to the DOJ-HHS False Claims Act Working Group and its enforcement objections.

This informational piece, which may be considered advertising under the ethical rules of certain jurisdictions, is provided on the understanding that it does not constitute the rendering of legal advice or other professional advice by Goodwin or its lawyers. Prior results do not guarantee similar outcomes.