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DOJ and HHS Reestablish False Claims Act Working Group, Delineate Healthcare Enforcement Priorities

By Michael J. Podberesky, Brett Barnett, Maura Naehr, Timothy Fry & Edwin O. Childs on July 11, 2025
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On July 2, 2025, the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) announced the reestablishment of the DOJ-HHS False Claims Act Working Group.  Originally formed in December 2020 at the tail end of the first Trump Administration, this partnership focuses on advancing enforcement of the False Claims Act (FCA) as a primary tool to combat healthcare fraud.  While some may view the announcement as merely formalizing long-existing cooperation between DOJ and HHS, the announcement is still significant in that it signals the Administration’s commitment to investigating and prosecuting individuals and entities that commit healthcare fraud.  This reinvigoration of the FCA Working Group aligns with President Trump’s plans to “aggressively” enforce the FCA, as detailed in our earlier February 24, 2025 alert.

Working Group Priorities

The recent announcement establishes specific areas of healthcare for priority enforcement including: (1) Medicare Advantage; (2) barriers to patient access to care; (3) kickbacks; (4) materially defective medical devices; (5) manipulation of electronic record systems; and (6) drug, device, or biologics pricing.  In addition, the Working Group will continue to focus on the priority FCA enforcement areas the Assistant Attorney General of the Civil Division announced on June 11, 2025.  Those priorities include unlawful discrimination in the private sector, civil rights law violations by federal fund recipients, and impermissible claims and bills submitted to federal healthcare programs for non-covered services.  With respect to civil rights law violations, as highlighted in in our earlier May 20, 2025 alert regarding the Civil Rights Fraud Initiative, the Trump Administration intends to use FCA enforcement to combat civil rights violations.

Working Group Functions & Membership

The FCA Working Group will be led by HHS General Counsel, Chief Counsel to HHS Office of Inspector General, and the Deputy Assistant Attorney General of the Commercial Litigation Branch.  Membership will include leaders of HHS and DOJ’s Civil Division, which prosecutes False Claims Act cases, along with designees to represent U.S. Attorneys’ Offices.

Through cross-agency collaboration, HHS will continue to refer potential FCA violations to the DOJ for investigation, especially if the alleged misconduct occurs in one of the enforcement priority areas delineated in the announcement (described in the section above).  Both HHS and DOJ will work together to advance ongoing investigations and the Working Group will jointly consider whether HHS should suspend payments to providers (pending the investigation) under 42 C.F.R. § 405.370, and whether the DOJ should move to dismiss a whistleblower (qui tam) complaint pursuant to 31 U.S.C. § 3730(c)(2)(A).

Potential Implications

In isolation, the language of this announcement appears to create a novel group, but this is not the first time DOJ and HHS have partnered, formally and informally, in fighting healthcare fraud.  That said, the reestablishment of the FCA Working Group sends another clear warning that this Administration seeks to prioritize healthcare enforcement.  As such, contractors, manufacturers, recipients of federal funds, and healthcare providers should continue to be vigilant in ensuring compliance with governing laws and program rules to reduce the risk of potential enforcement action.  Further, by centralizing certain FCA-related decisions such as considering proactively dismissing whistleblower complaints, the healthcare industry may get additional guidance and consistency in this DOJ tool to reduce frivolous FCA actions.

Backed by the firm’s nationally recognized government investigations and white collar litigation practice and healthcare compliance, regulatory & policy practice, McGuireWoods LLP advises clients across diverse sectors—including defense, intelligence, technology, healthcare, and energy—on everything from day-to-day compliance to complex litigation, bid protests, investigations, and regulatory enforcement involving federal agencies and law enforcement.  For questions about this announcement, the FCA Working Group, or the False Claims Act generally, contact the authors, your McGuireWoods contact, or a member of the firm’s False Claims Act Investigations & Litigation or Healthcare Litigation & Enforcement Practice Groups.

Special thanks to summer associate Emily Belanger for her significant contributions to this legal alert. She is not licensed to practice law.

Photo of Michael J. Podberesky Michael J. Podberesky

Michael Podberesky, a former federal prosecutor in the U.S. Department of Justice’s Civil Fraud Section, is a partner in the firm’s nationally recognized Government Investigations and White Collar Litigation Department and co-leader of the firm’s Healthcare Litigation and Enforcement Practice Group. Employing his…

Michael Podberesky, a former federal prosecutor in the U.S. Department of Justice’s Civil Fraud Section, is a partner in the firm’s nationally recognized Government Investigations and White Collar Litigation Department and co-leader of the firm’s Healthcare Litigation and Enforcement Practice Group. Employing his extensive experience with False Claims Act cases in the healthcare and defense sectors, Michael represents clients confronting high-stakes government investigations and litigation arising from allegations of healthcare and procurement fraud and also counsels clients regarding compliance issues.

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Photo of Brett Barnett Brett Barnett

Brett is the co-leader of McGuireWoods’ False Claims Act Investigations & Litigation Practice Group. He focuses his practice on representing clients in high-stakes False Claims Act matters, healthcare fraud and abuse investigations, and complex commercial litigation across the country. Brett routinely leads internal…

Brett is the co-leader of McGuireWoods’ False Claims Act Investigations & Litigation Practice Group. He focuses his practice on representing clients in high-stakes False Claims Act matters, healthcare fraud and abuse investigations, and complex commercial litigation across the country. Brett routinely leads internal and government-facing investigations involving the U.S. Department of Justice and other federal and state agencies, and defends clients in civil FCA litigation, often involving parallel proceedings and regulatory scrutiny.

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Photo of Timothy Fry Timothy Fry

Tim resolves clients’ thorny compliance and regulatory issues that make or break healthcare transactions and operations. He delivers practical, business-oriented solutions that clear obstacles, close deals, and protect enterprise value.

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Photo of Edwin O. Childs Edwin O. Childs

As a leader of the firm’s Defense, National Security and Government Contracting industry team, Ned Childs is a government contract and investigations and enforcement attorney who represents companies across a wide range of sectors, including the defense, services, technology, and aerospace industries. His…

As a leader of the firm’s Defense, National Security and Government Contracting industry team, Ned Childs is a government contract and investigations and enforcement attorney who represents companies across a wide range of sectors, including the defense, services, technology, and aerospace industries. His practice, spanning more than a decade in Washington, encompasses a broad array of legal services, including government contract investigations, disclosures, and regulatory enforcement actions; bid protests and government contract disputes; government contract counseling; export licensing and enforcement; prime contractor-subcontractor disputes; corporate ownership and acquisition issues; and election law investigations and enforcement matters.

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  • Posted in:
    Health Care and Life Sciences
  • Blog:
    The FCA Insider
  • Organization:
    McGuireWoods LLP
  • Article: View Original Source

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