On July 2, 2025, the U.S. Department of Justice (DOJ) announced the formation of a new working group in collaboration with the U.S. Department of Health and Human Services (HHS) focused on the enforcement of the False Claims Act (FCA). The DOJ-HHS False Claims Act Working Group will include leadership from the DOJ's Civil Division and various HHS offices.
As part of the working group's coordination, HHS will make referrals to DOJ regarding potential FCA violations in certain priority areas. These referrals will reflect the new enforcement priorities, in addition to long-standing enforcement areas previously announced by Assistant Attorney General Brett Shumate on June 11, 2025.
The priority enforcement areas include:
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Medicare Advantage.
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Drug, device, or biologics pricing, including arrangements for discounts, rebates, service fees, and formulary placement and price reporting.
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Barriers to patient access to care, including violations of network adequacy requirements.
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Kickbacks related to drugs, medical devices, durable medical equipment, and other products paid for by federal health care programs.
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Materially defective medical devices that impact patient safety.
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Manipulation of Electronic Health Records systems to drive inappropriate utilization of Medicare-covered products and services.
Monthly meetings will commence in July, focusing on identifying new leads by utilizing HHS resources such as enhanced data mining and assessment of HHS and HHS-OIG report findings to creatively address unchecked fraud, waste, and abuse. The working group will also consider whether HHS should suspend payments to Medicare providers and suppliers based on a credible allegation of fraud, and whether DOJ should use its statutory authority to move to dismiss qui tam complaints.
Companies operating in the targeted sectors should anticipate increased scrutiny and enforcement actions. It is advisable for businesses to review their compliance programs and ensure robust measures are in place to prevent and detect potential FCA violations. Enhanced enforcement may lead to an increase in FCA investigations and litigation. Organizations should be prepared to respond promptly to any inquiries or actions from the DOJ and ensure they have legal strategies in place to address potential claims.
