DOJ’s record-breaking 2025 False Claims Act recoveries and key healthcare fraud enforcement trends

On January 12, 2026, the Department of Justice (DOJ) announced that False Claims Act (FCA) settlements and judgments exceeded $6.8 billion in fiscal year 2025—the highest annual total in the history of the statute.¹ Over $5.7 billion of these recoveries related to healthcare matters. The outcomes highlighted in the DOJ’s press release confirm the trends described in our 2025 healthcare fraud year in review, including the government’s aggressive posture, expanding enforcement priorities, and evolving theories of liability across the healthcare and life sciences sectors.

This alert summarizes the DOJ’s latest enforcement results, highlights key settlements and judgments, and discusses practical takeaways for healthcare innovators, investors, and stakeholders navigating this dynamic enforcement environment.

I. 2025: An historic year in False Claims Act enforcement

The DOJ’s 2025 FCA enforcement statistics are unprecedented:

• $6.8 billion in total FCA settlements and judgments, which is the highest annual recovery the DOJ has ever reported
• $5.7 billion from healthcare-related matters, inclusive of settlements and of trial judgments obtained by the DOJ and qui tam relators currently on appeal
• 1,297 qui tam lawsuits filed, which is the most filed in any year
• 401 new government investigations opened, reflecting a sustained year-over-year trend of the DOJ initiating its own investigations independent of qui tam relators
• Over $85 billion recovered since Congress strengthened the FCA in 1986

DOJ leadership emphasized that the FCA remains a “powerful weapon” against fraud and that enforcement will continue to be aggressive and focused. The DOJ also highlighted the critical role of whistleblowers, with qui tam actions comprising a significant percentage of cases and yielding over $5.3 billion in recoveries this year alone. In a gesture by the DOJ to the strong support for FCA enforcement on Capitol Hill, the press release briefly recounted the critical role that Senator Charles Grassley played in the adoption of the 1986 FCA amendments that transformed the Civil War-era statute into its present status as a staple of federal enforcement.

II. Key enforcement trends and priorities

a. Marketing, patient support, and remuneration

The DOJ’s 2025 enforcement activity demonstrates a sustained and expanding focus on improper marketing practices, unlawful remuneration, and patient support programs that risk injecting financial motivations into clinical decision-making. The government’s actions targeted a wide range of actors—including insurers, pharmaceutical manufacturers, pharmacies, and healthcare providers—whose conduct the DOJ and whistleblowers alleged resulted in false claims to federal healthcare programs.

• Speaker programs: The DOJ resolved significant cases against pharmaceutical manufacturers for using speaker programs and honoraria payments to induce prescriptions. For example, Gilead Sciences agreed to pay the federal government $176 million after admitting it paid high-volume prescribers tens or hundreds of thousands of dollars in honoraria, meals, and travel expenses to promote certain HIV drugs.²
• Kickbacks to Brokers and Enrollment Incentives: The DOJ intervened in a qui tam lawsuit alleging that three major national insurers compensated brokers with marketing payments that were effectively kickbacks to induce plan enrollment.
• Patient Support and Co-Pay Assistance: DOJ enforcement extended to patient support programs, where benefits such as free product assistance, travel expenses, and laboratory testing were alleged to constitute unlawful inducements. QOL Medical and its CEO agreed to pay $47 million to resolve allegations that free breath testing services were offered to induce claims for its drug Sucraid, despite the test’s limited diagnostic value.³ 

b. Managed care

The DOJ continued its intense focus on Medicare Advantage (MA) and managed care fraud, reflecting the program’s growing size and fiscal impact. Major 2025 cases included:

• Independent Health Association: up to $98 million to resolve allegations of unsupported and invalid diagnosis codes submitted for MA enrollees, including retrospective chart reviews and physician queries to add purportedly improper diagnoses.⁴ In a recent resolution not reflected in the DOJ’s 2025 recoveries, Kaiser Permanente affiliates settled similar allegations for $556 million in January 2026, further reflecting the DOJ’s enforcement priority in this area.
• Seoul Medical Group and Affiliates: over $60 million to resolve allegations of false diagnosis codes for spinal conditions, with a related $2.35 million settlement by a radiology group for allegedly conspiring to create false supporting reports.⁵

c. Expanding theories: cybersecurity, digital health, and hybrid FDCA-FCA cases

The DOJ’s 2025 enforcement results confirm the expansion of FCA liability into areas such as cybersecurity and digital health:

• Health Net Federal Services (Centene): $11.2 million for allegedly false cybersecurity certifications in a contract for military health benefits.⁶
• Illumina: $9.8 million for selling genomic sequencing systems with cybersecurity vulnerabilities and misrepresenting compliance with security standards.⁷

These cases confirm the trend of DOJ using the FCA to enforce cybersecurity obligations, even absent a data breach, and increasing scrutiny of software, security, and data integrity practices in digital health and device companies. The government’s focus on misrepresentation and certification in government contracting aligns with the trend toward a theory of FCA liability for technology-enabled compliance failures.

d. Substandard care

The DOJ resolved significant cases involving overbilling, unnecessary admissions, and substandard care, including a settlement with Vohra Wound Physicians of $45 million for overbilled and unnecessary wound care services.⁸ This and other cases reflect the DOJ’s continued focus on medical necessity and quality of care.

III. How 2025 enforcement trends inform predictions for healthcare fraud enforcement

The enforcement trends and results from 2025 serve as the foundation for the predictions outlined in our 2025 healthcare fraud year in review. Key observations include:

• Aggressive and expanding enforcement: The DOJ’s record-breaking recoveries and case volume demonstrate escalating enforcement, especially in healthcare and life sciences.
• Focus on managed care and risk adjustment: Major settlements and ongoing litigation in Medicare Advantage and broker arrangements underscore the centrality of risk adjustment and MA to FCA activity.
• Kickbacks and remuneration: The government’s pursuit of speaker programs, broker incentives, and digital health marketing highlights the perennial emphasis on AKS enforcement and the importance of compliance controls.
• Hybrid FDCA-FCA theories: The DOJ’s use of the FCA to address device quality, data integrity, and cybersecurity failures illustrates the convergence of regulatory and fraud theories.
• Cybersecurity as a fraud issue: Settlements in the digital health and device sectors reflect the emergence of cybersecurity misrepresentations as an FCA theory affecting the healthcare and life sciences industries.
• Increased trials and litigation risk: The rise in FCA trials and relator-led litigation, with varied outcomes, signals a continued transition of FCA practice into a more contentious and trial-heavy enforcement environment.
• State-level and private equity scrutiny: While not a headline in the DOJ’s press release, the ongoing shift toward state enforcement and scrutiny of ownership structures remain important trends for 2026.

These developments provide a clear roadmap for anticipating future enforcement priorities and preparing effective compliance strategies.

IV. Practical takeaways for 2026 and beyond

Given the DOJ’s priorities and the trends confirmed by the 2025 enforcement results, healthcare stakeholders should:

• Strengthen AI and technology controls: Implement human-in-the-loop safeguards, audit AI-driven processes, and document compliance decisions.
• Enhance cybersecurity compliance: Conduct privileged “attestation dry runs,” inventory vendor access, and align with NIST and ISO standards.
• Review billing, pricing, and documentation: Replace retrospective audits with real-time analytics, validate documentation integrity, and audit digital marketing claims.
• Mitigate kickback and remuneration risks: Review MSO, broker, and speaker program arrangements, and audit value transfers in digital platforms.
• Prepare for litigation: Design and implement a unified compliance program, and preserve contemporaneous records showing compliant intent in real time.
• Monitor state and global enforcement: Track state-level developments and cross-border risks, especially for private equity-backed and multinational organizations.

Conclusion

The DOJ’s 2025 FCA enforcement results confirm that the healthcare fraud landscape is more aggressive, complex, and interconnected than ever. Companies that invest in forward-looking compliance—particularly around AI, cybersecurity, documentation integrity, pricing transparency, and remuneration structures—will be best positioned to withstand increased scrutiny and differentiate themselves through trust and operational excellence.
 

<sub>1. United States Department of Justice, “False Claims Act Settlements and Judgments Exceed $6.8B in Fiscal Year 2025,” https://www.justice.gov/opa/pr/false-claims-act-settlements-and-judgments-exceed-68b-fiscal-year-2025; United States Department of Justice, “Fact Sheet,” https://www.justice.gov/opa/media/1424126/dl
2. United States Department of Justice, “U.S. Attorney Announces $202 Million Settlement With Gilead Sciences For Using Speaker Programs To Pay Kickbacks To Doctors To Induce Them To Prescribe Gilead’s Drugs,” https://www.justice.gov/usao-sdny/pr/us-attorney-announces-202-million-settlement-gilead-sciences-using-speaker-programs
3. United States Department of Justice, “QOL Medical and Its CEO Agree To Pay $47 Million for Allegedly Paying Kickbacks To Induce Claims for QOL’s Drug Sucraid,” https://www.justice.gov/usao-ma/pr/qol-medical-and-its-ceo-agree-pay-47-million-allegedly-paying-kickbacks-induce-claims
4. United States Department of Justice, “Medicare Advantage provider Independent Health to pay up to $98m to settle False Claims Act suit,” https://www.justice.gov/usao-wdny/pr/medicare-advantage-provider-independent-health-pay-98m-settle-false-claims-act-suit
5. United States Department of Justice, “Medicare Advantage Provider Seoul Medical Group and Related Parties to Pay Over $62M to Settle False Claims Act Suit,” https://www.justice.gov/opa/pr/medicare-advantage-provider-seoul-medical-group-and-related-parties-pay-over-62m-settle; United States Department of Justice, “Fact Sheet,” https://www.justice.gov/opa/media/1424126/dl
6. United States Department of Justice, “Health Net Federal Services, LLC and Centene Corporation Agree to Pay Over $11 Million to Resolve False Claims Act Liability for Cybersecurity Violations,” https://www.justice.gov/opa/pr/health-net-federal-services-llc-and-centene-corporation-agree-pay-over-11-million-resolve
7. United States Department of Justice, “llumina Inc. to Pay $9.8M to Resolve False Claims Act Allegations Arising from Cybersecurity Vulnerabilities in Genomic Sequencing Systems,” https://www.justice.gov/opa/pr/illumina-inc-pay-98m-resolve-false-claims-act-allegations-arising-cybersecurity
8. United States Department of Justice, “Vohra Wound Physicians and its Owner Agree to Pay $45M to Settle Fraud Allegations of Overbilling for Wound Care Services,” https://www.justice.gov/opa/pr/vohra-wound-physicians-and-its-owner-agree-pay-45m-settle-fraud-allegations-overbilling</sub>

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