Health Care and False Claims Act

This article is part of Looking Back and Moving Forward: Top Issues Shaping White Collar Law in 2026. Click here to read the full newsletter.

Health care remained the focal point of federal FCA enforcement in 2025, with DOJ securing significant settlements, litigating high-stakes cases through verdict, and announcing expanded interagency enforcement priorities that will shape investigations in 2026.

Recent Matters

Several high-profile settlements underscored DOJ’s continued focus on health care fraud:

• Unlawful Kickbacks: Gilead Sciences (approximately $202 million)
  Gilead resolved whistleblower allegations that it paid unlawful kickbacks to induce prescriptions of certain HIV medications, reinforcing DOJ’s continued focus on pharmaceutical marketing and physician engagement practices. United States, et al., ex rel. Bellman v. Gilead Sciences, Inc., No. 16-cv-6228-PAE (S.D.N.Y.), ECF No. 32 (April 30, 2025).
• Medicare Advantage Risk Adjustment Settlements (approximately $62 million)
  In March 2025, DOJ resolved allegations involving improper diagnosis coding and inflated risk scores submitted to Medicare Advantage plans, highlighting sustained enforcement attention on risk adjustment practices. United States, et. al., ex rel. Pew v. Seoul Medical Group, Inc., et al., No. 2:20-cv-05156 (C.D. Cal.).
• Improper Medical Device Reimbursement (approximately $37 million)
  In September 2025, a device manufacturer and distributor settled claims that Medicare was billed for testing products for arterial disease that allegedly failed to meet program requirements. United States, et al., ex. rel. Kane v. Semler Scientific, Inc., No. 3:16-cv-1516 (M.D. Fla.).

Looking Ahead to 2026 and Beyond

On July 2, 2025, DOJ and the Department of Health and Human Services (HHS) formally renewed and expanded the DOJ-HHS False Claims Act Working Group, announcing enforcement priorities that will guide FCA referrals and investigations going forward into 2026 and beyond. The Working Group is designed to enhance data sharing, accelerate referrals, and coordinate enforcement across DOJ, HHS, and HHS-OIG.

Looking ahead to 2026, providers, payors, pharmacies, and life sciences companies should expect continued scrutiny across billing, coding, referral relationships, and compliance practices. Health care FCA enforcement in 2026 is expected to intensify in several key areas targeted by the DOJ-HHS False Claims Act Working Group:

• Medicare Advantage, including risk score inflation and unsupported diagnoses
• Pharmacy benefit managers, especially practices around rebates, pricing, and formulary decisions for drugs and devices
• Kickbacks involving drugs, devices, durable medical equipment, and other reimbursed items
• Barriers to patients’ access to care, such as network adequacy violations
• Materially defective medical devices raising safety or efficacy concerns
• Electronic health record manipulation, including documentation practices used to justify medically unnecessary services

Clients in the health care space should assess compliance programs with these priorities in mind, focusing on coding accuracy, referral arrangements, pricing practices, and documentation integrity. The combination of large financial settlements, coordinated enforcement initiatives, and clearly articulated DOJ-HHS priorities signal that health care FCA risk remains high. Proactive compliance reviews and early issue identification will be critical as enforcement momentum carries into 2026.

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