Introduction
The U.S. Department of Justice (“DOJ”) has doubled down on eliminating healthcare fraud in government programs, including through the launch of new inter-agency groups in both the Civil and Criminal Divisions, and a recent spate of high-profile, high-dollar criminal prosecutions. Considering 2024 marked another banner year for False Claims Act (“FCA”) enforcement—netting the federal government $2.9 billion in fiscal year 2024, with the highest number of qui tam suits filed in a single year to date (979)—all signs point to continued vigorous enforcement in the coming years.[1]
Formation of the False Claims Act Working Group
On July 2, 2025, DOJ and the U.S. Department of Health and Human Services (“HHS”) announced their collaboration in creating the DOJ-HHS False Claims Act Working Group (the “FCA Working Group”).[2] The FCA Working Group will be led by the HHS General Counsel, Chief Counsel to HHS Office of Inspector General (“HHS-OIG”), and the Deputy Assistant Attorney General of the Commercial Litigation Branch. The FCA Working Group will also have representation from the Centers for Medicare & Medicaid Services Center for Program Integrity and designees from various U.S. Attorneys’ Offices.[3] The FCA Working Group will also use enhanced data mining and findings of HHS and HHS-OIG reports both to identify new instances of fraud and expedite current investigations.[4] HHS will refer potential new fraud cases to DOJ.[5]
The purposes of the FCA Working Group are to increase coordination among federal agencies affected by healthcare fraud and focus on the enforcement of the following key areas, as stated in the press release announcing the initiative:
- 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, DME, 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[6]
In addition to these enforcement priorities, the Group will also focus on investigations that further the healthcare-related FCA enforcement priorities that Assistant Attorney General Brett Shumate enumerated in his recent memorandum.[7] Relevant areas of enforcement priority overlap include submitting false claims for non-covered services for puberty blockers and sex hormones and submitting false diagnosis codes for gender dysphoria.[8]
The FCA Working Group will also examine factors that CMS considers in deciding whether to suspend payments from Medicare contractors to providers or suppliers of care.[9] And it will determine whether to move to dismiss cases brought under the FCA’s qui tam provisions that permit whistleblowers to bring suit on behalf of the federal government.[10]
While the FCA Working Group centralizes strategy and decision making on FCA cases already brought to the government’s attention, it does not replace or eliminate the current mechanisms for reporting healthcare fraud. The HHS tipline for whistleblowers remains active,[11] as does the DOJ guidance on voluntarily self-disclosure of false claims,[12] and the Criminal Division’s relatively recently established whistleblower pilot program, which creates an incentive for the reporting of healthcare fraud involving private insurers (as opposed to federal payors) that is not otherwise within the scope of the FCA.[13]
Health Care Fraud Data Fusion Center
In parallel with the establishment of the FCA Working Group for civil enforcement, the DOJ’s Criminal Division, Fraud Section, Health Care Fraud Unit Data Analytics Team, HHS-OIG, and the Federal Bureau of Investigation (“FBI”) have recently formed the Health Care Fraud Data Fusion Center.[14] The Data Fusion Center is part of a broader effort in the executive branch to “break down information silos” between agencies to enhance their data collection and analysis capabilities.[15]
Illustrative of the recent success of the Criminal Division’s data analytics efforts is Operation Gold Rush, which resulted in charges against 19 defendants across the country.[16] The scheme allegedly involved a network of straw owners who bought up medical supply companies in the United States under false identities.[17] The supply companies then purportedly used stolen identities of Medicare beneficiaries to submit claims to Medicare for durable medical equipment,[18] which, as noted above, is one of the FCA Working Group’s enforcement priorities. In total, $4.45 billion in fraudulent claims were submitted to Medicare as part of this scheme, the majority of which the federal agencies stopped pre-payment thanks to “proactive data analytics” detecting irregular billing patterns.[19]
Operation Gold Rush was part of a broader announcement by DOJ, on June 30, 2025, of the results of its nationwide healthcare fraud takedown, in which 324 defendants were charged in connection with over $14.6 billion in fraud.[20]
Conclusion
The FCA Working Group is designed to fast-track meritorious claims and direct valuable agency resources toward finding and correcting fraudulent practices among individuals and entities that provide healthcare funded by the government. Similar efforts in the Criminal Division, notably the Data Fusion Center, have already resulted in successful investigations and enforcement actions of nationwide scope. The launch of these initiatives underscores the emphasis of the current administration on detecting and addressing fraud, waste, and abuse. We anticipate this focus will continue, and will continue to share relevant updates with clients and friends of the Firm.
[1]See Press Release, False Claims Act Settlements and Judgments Exceed $2.9B in Fiscal Year 2024, U.S. Dep’t of Justice (Jan. 15, 2025), available at https://www.justice.gov/archives/opa/pr/false-claims-act-settlements-and-judgments-exceed-29b-fiscal-year-2024 (last visited July 21, 2025).
[3]See id.
[4]See id.
[5]See id.
[6]See id.
[7] Memorandum of Assistant Attorney General Brett Shumate to Department Employees on Civil Division Enforcement Priorities (June 11, 2025), available at https://www.justice.gov/civil/media/1404046/dl?inline (last visited July 21, 2025).
[8]See id.
[9]See 42 C.F.R. § 405.370; see also Press Release, supra note 2.
[10]See 31 U.S.C. § 3730(c)(2)(A); see also U.S. Dep’t of Just., Just. Manual § 4-4.111 (2021); Press Release, supra, note 1 ("The Working Group shall discuss considerations bearing on . . . whether DOJ shall move to dismiss a qui tam complaint under 31 U.S.C. § 3730(c)(2)(A), consistent with Justice Manual Section 4-4.111”).
[11]See Press Release, supra note 2.
[12]See U.S. Dep’t of Just., Just. Manual § 4-4.112 (2021).
[14]See Press Release, National Health Care Fraud Takedown Results in 324 Defendants Charged in Connection with Over $14.6 Billion in Alleged Fraud, U.S. Dep’t of Justice (June 30, 2025), available at https://www.justice.gov/opa/pr/national-health-care-fraud-takedown-results-324-defendants-charged-connection-over-146 (last visited July 7, 2025).
[15]See Exec. Order. No. 14,243, 90 Fed. Reg. 13681 (Mar. 20, 2025); see also Press Release, supra note 14.
[16]See Press Release, supra note 14.
