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Justice Department Reports Record $6.8 Billion in False Claims Act Recoveries for 2025

The Department of Justice announced unprecedented enforcement results under the False Claims Act (FCA) for fiscal year 2025, with settlements and judgments exceeding $6.8 billion – the highest annual total since the statute’s inception. Healthcare-related matters accounted for $5.7 billion of these recoveries, reflecting the government’s aggressive stance on fraud in the medical sector.

The record-breaking year also saw 1,297 qui tam lawsuits filed by whistleblowers, the most in any single year, while the DOJ independently initiated 401 new investigations. Since Congress strengthened the FCA in 1986, total recoveries have surpassed $85 billion.

In a press release, the DOJ emphasized the FCA’s role as a “powerful weapon” against fraud and acknowledged Senator Charles Grassley’s instrumental role in the 1986 amendments that transformed the Civil War-era statute into a cornerstone of federal enforcement.

Healthcare enforcement focused heavily on improper marketing practices and unlawful remuneration. Pharmaceutical manufacturer Gilead Sciences agreed to pay $176 million after admitting to paying high-volume prescribers substantial honoraria, meals, and travel expenses to promote HIV medications. The DOJ also intervened in a qui tam lawsuit against three major national insurers for allegedly paying kickbacks to brokers to induce plan enrollment.

Patient support programs came under scrutiny when QOL Medical and its CEO agreed to pay $47 million to resolve allegations that free breath testing services were offered as unlawful inducements for claims on its drug Sucraid, despite the test’s limited diagnostic value.

Medicare Advantage fraud remained a priority for enforcement, with Independent Health Association agreeing to pay up to $98 million to resolve allegations involving unsupported diagnosis codes. Similarly, Seoul Medical Group and affiliates settled for over $60 million regarding allegedly false diagnosis codes for spinal conditions. In January 2026, Kaiser Permanente affiliates resolved similar allegations for $556 million, further underscoring this enforcement priority.

The DOJ has expanded its focus to include cybersecurity and digital health. Health Net Federal Services (Centene) paid $11.2 million for allegedly false cybersecurity certifications in a contract for military health benefits, while Illumina settled for $9.8 million over claims it sold genomic sequencing systems with cybersecurity vulnerabilities. These cases demonstrate the DOJ’s willingness to pursue FCA liability for technology compliance failures, even without a data breach.

Quality of care issues also featured prominently, with Vohra Wound Physicians agreeing to pay $45 million for allegedly overbilled and unnecessary wound care services, reinforcing the DOJ’s focus on medical necessity.

The enforcement patterns from 2025 suggest several ongoing trends for healthcare stakeholders to monitor. First, FCA enforcement continues to expand aggressively, particularly in healthcare and life sciences. Second, Medicare Advantage and risk adjustment remain central to enforcement actions. Third, Anti-Kickback Statute violations continue to draw significant attention.

The convergence of regulatory and fraud theories is evident in the DOJ’s approach to device quality, data integrity, and cybersecurity. An increase in FCA trials and relator-led litigation signals a more contentious enforcement environment, while state-level enforcement and scrutiny of private equity ownership structures continue to gain momentum.

For healthcare organizations navigating this complex landscape in 2026 and beyond, several practical measures are advisable. Strengthening AI and technology controls with human oversight and regular audits can reduce risk. Enhanced cybersecurity compliance, aligned with NIST and ISO standards, is increasingly critical. Organizations should implement real-time analytics for billing and documentation, rather than relying solely on retrospective audits.

Companies should also review speaker programs, broker arrangements, and digital platform value transfers to mitigate kickback risks. Documentation showing compliant intent should be preserved as part of a unified compliance program. Finally, organizations should monitor state-level developments and cross-border risks, particularly for private equity-backed entities.

The record enforcement results of 2025 confirm that healthcare fraud enforcement is becoming more aggressive and complex. Organizations that prioritize compliance, particularly around emerging risk areas like AI, cybersecurity, and remuneration structures, will be better positioned to withstand increased scrutiny.

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9 Comments

  1. Elizabeth Hernandez on

    The Gilead Sciences settlement is a prime example of the DOJ’s willingness to hold even large pharmaceutical companies accountable for unlawful practices. This sends a strong message to the industry.

    • Yes, the hefty $176 million penalty shows that the DOJ will not hesitate to pursue substantial recoveries against companies that violate the False Claims Act, regardless of their size or influence.

  2. The DOJ’s focus on healthcare-related matters, which accounted for over 80% of the recoveries, is understandable given the significant taxpayer funding involved. Ensuring proper use of government funds in this sector is critical.

    • Absolutely, with billions of dollars at stake, the government has a responsibility to aggressively pursue any instances of fraud or misuse of public healthcare funds.

  3. Isabella P. Rodriguez on

    Wow, the DOJ’s record-breaking recoveries under the False Claims Act show they’re really cracking down on healthcare fraud. It’ll be interesting to see if this enforcement trend continues in the coming years.

    • Yes, the aggressive stance on improper marketing and remuneration practices is clearly paying dividends. Rooting out fraud in the medical sector is crucial for protecting patients and taxpayers.

  4. Elizabeth Miller on

    It’s encouraging to see the DOJ’s commitment to strengthening the False Claims Act over the years. The record-breaking recoveries demonstrate the law’s effectiveness as a deterrent and enforcement tool.

  5. The surge in qui tam lawsuits filed by whistleblowers is a positive sign that the public is engaged and willing to help the government identify fraudulent activities. This should serve as a deterrent for would-be offenders.

    • Patricia Williams on

      I agree, the False Claims Act is an important tool for incentivizing whistleblowers to come forward. Their role in exposing fraud is invaluable.

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