DOJ and HHS Launch FCA Working Group: Heightened Enforcement Risk for Health Care Entities

On July 2, 2025, the U.S. Department of Justice (DOJ) Civil Division and the U.S. Department of Health and Human Services (HHS) jointly announced the formation of a False Claims Act (FCA) Working Group. This new initiative underscores a coordinated federal enforcement strategy focused on identifying and addressing fraud in federally funded health care programs, particularly Medicare Advantage and Medicaid managed care. The announcement comes days after Matthew R. Galeotti, Head of DOJ’s Criminal Division, announced the results of the “largest coordinated health care fraud takedown in the history of the Department of Justice”  and the creation of a “Health Care Fraud Data Fusion Center” comprised of data specialists that will “break down information silos, using coordinated data analysis to enable our investigative teams to quickly identify and dismantle emerging fraud schemes.” Taken together, these announcements demonstrate the DOJ’s effort—in both civil and criminal divisions—to strengthen its collaboration with HHS to investigate and prosecute health care fraud.

Overview of the Working Group

The FCA Working Group is composed of leadership from:

• HHS Offices of General Counsel and Inspector General
• Centers for Medicare & Medicaid Services Center for Program Integrity, and
• DOJ Civil Division and designees from the U.S. Attorney’s Offices

The cross-agency collaboration reflects DOJ and HHS’s intent to enhance and maximize investigative capacity through inter-agency referrals and coordinated litigation strategies. The Working Group will also leverage HHS resources through enhanced data mining and assessment of HHS and HHS-OIG report findings. The Working Group’s information sharing means that health plans, providers, and vendors should expect more focused civil and administrative investigations, often running concurrently.

Priority Enforcement Areas

The agencies linked their announcement to the “priority FCA matters” laid out by Assistant Attorney General Brett Shumate in his June 11 memorandum on Civil Division Enforcement Priorities. The FCA Working Group is expected to focus on:

• 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

Notably, HHS leadership emphasized during a July 2 American Health Law Association panel that network adequacy and access violations will be a continued focus. This area has gained traction in both FCA and state enforcement actions. Key risk areas include inaccurate provider directories; misstatements in CMS submissions and marketing materials regarding network access; and failure to meet state or federal appointment wait-time and geographic access standards. False or misleading attestations concerning network sufficiency may result in FCA exposure if they lead to improper reimbursement or induce beneficiary plan selection. 

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.

Health care entities—including Medicare Advantage plans, Medicaid managed care entities, provider groups, life science companies and delegated vendors—should take proactive steps to strengthen their compliance programs in light of the DOJ and HHS’s coordinated focus on FCA enforcement. This includes building and maintaining robust programs that ensure accurate risk adjustment coding, truthful network adequacy attestation, and effective oversight of delegated entities and downstream vendors. Organizations must monitor DOJ policy updates, HHS enforcement trends, and FCA-related guidance to stay ahead of government scrutiny and effectively address concerns raised in whistleblower actions.