The Trump administration recently announced the renewal of a new cross-agency collaboration between the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) in the form of the DOJ-HHS False Claims Act Working Group. The Working Group will be jointly led by Deputy Assistant Attorney General (DAAG) of the Commercial Litigation Branch Brenna Jenny, HHS Acting General Counsel Sean Keveney, and HHS Office of Inspector General Acting Chief Counsel Susan Edwards, and will include the Centers for Medicare & Medicaid Services (CMS) Center for Program Integrity and U.S. Attorneys' Offices.
The FCA Working Group's Cross-Agency Priorities
The Working Group announced specific priority areas in which HHS and DOJ will coordinate their efforts to combat potential False Claims Act (FCA) violations in the following enforcement areas, some familiar and others more novel:
- 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 announcement also highlights certain of the Working Group's procedural priorities: (1) potential imposition of Medicare payment suspensions, where there is reliable information of an overpayment or a credible allegation of fraud; (2) consideration of whether 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, Michael Granston (then DAAG) stated that DOJ would continue to "aggressively" enforce the FCA. Following that statement, 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 Brenna Jenny's experience in senior positions at DOJ and HHS, as well as perspectives she has gained as a private sector attorney 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, 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. DOJ reported that the $14 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 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 that the administration 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 noted above. 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 should consult with counsel as their regulatory and compliance programs may face increased scrutiny and potential enforcement activity.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
