Health Care Enforcement & Investigations

On May 14, 2025, Fresno Community Hospital and Medical Center d/b/a Community Health System (CHS) and its technology partner, Physicians Network Advantage, Inc. (PNA), agreed to pay $31.5 million and enter into a Corporate Integrity Agreement to settle allegations of violating the federal anti-kickback statute (AKS) and physician self-referral law (Stark Law) under the False Claims Act (FCA). The alleged conduct at issue revolved around CHS’s plan beginning in 2013 to assist local area physicians in their adoption of the electronic health records (EHR) platform used by CHS and its establishment of PNA to support that goal. For decades, the government has strongly promoted the adoption of interoperable EHR platforms by physician practices (e.g., Meaningful Use payments), given that EHR systems allow for better care coordination, increased efficiency, and improved patient experience. Moreover, as described in more detail below, the Department of Health and Human Services (HHS) adopted an AKS safe harbor and Stark Law exception that allowed certain entities, including hospitals, to donate EHR technology and services to physicians if certain conditions are satisfied. However, CHS’s and PNA’s alleged conduct exceeds what is permissible under the relevant safe harbor and exception.

Amid ongoing policy shifts in Washington, the federal government’s interest in pursuing civil cyber-fraud cases appears to be here to stay.  

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for” causation.  As we previously reported, the Sixth Circuit and the Eighth Circuit have also held that the stricter “but-for” causation standard applies to AKS-based FCA claims.

Read about how a win in the Fifth Circuit and the end of Chevron deference could breathe new life into the Medicare Drug Price Negotiation Program challenges despite continued losses in federal court.

Mintz’s annual report on False Claims Act case activity analyzes data from DOJ and the firm’s Health Care Qui Tam Database, and explores the 2024 record high in FCA case activity, the moderate increase in health care–related activity.

Our 2025 edition of EnforceMintz reflects on health care enforcement trends, predicts how health care enforcement may evolve, and offers practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

Over the past two years, the Department of Justice has actively incentivized companies to voluntarily self-disclose potential civil and criminal violations. This article explores the DOJ’s new policies, the benefits of self-disclosure, and the challenges companies face in complying with these initiatives.

In 2024, federal courts issued significant False Claims Act decisions for the health care and life sciences industries. These decisions further develop the FCA scienter standard addressed by the Supreme Court in its 2023 SuperValu decision and reexamine the constitutionality of the FCA’s qui tam provisions. A circuit split on the interpretation of “causation” for FCA suits based on alleged violations of the Anti-Kickback Statute (AKS) has also emerged.

In 2024, DOJ and the OIG expanded telehealth enforcement beyond traditional telefraud schemes, addressing compliance with state corporate practice and telehealth-specific billing codes. Two cases, including the first criminal telemedicine prosecution, signal a trend of heightened regulatory scrutiny for the maturing telehealth industry.

Following the Supreme Court’s decision in Securities and Exchange Commission v. Jarkesy, holding that the Seventh Amendment entitles defendants to a jury trial when the SEC seeks to impose civil monetary penalties for a securities fraud violation, parties are starting to assert Jarkesy-based arguments in appealing administrative actions of the Department of Health and Human Services.

As opioid-related enforcement efforts continued across the opioid supply chain in 2024, the government pursued criminal charges in two matters that resulted in significant settlements. Additionally, a number of recent cases against pharmacies involve a common theory of liability based on the Controlled Substances Act, which served as the basis for civil liability under the False Claims Act.

In 2024, DOJ resolved several noteworthy False Claims Act cases against hospitals and health systems, obtaining numerous large recoveries in cases where Stark Law and federal Anti-Kickback Statute violations served as a predicate for FCA claims.

In 2024, the Department of Justice ramped up cybersecurity enforcement under the Civil Cyber-Fraud Initiative (CCFI), targeting entities that failed to safeguard PHI and PII in federally funded contracts. Key cases highlight trends in False Claims Act litigation and underscore the importance of cybersecurity compliance heading into 2025.

In 2024, the Department of Justices and Centers for Medicare & Medicaid Services intensified enforcement in Medicare Advantage and Part D, with a focus on risk adjustment audits and Star Ratings disputes. Key developments, including litigation and regulatory changes, signal heightened scrutiny for MAOs, PDP Sponsors, and their vendors in 2025.

Government scrutiny of value-based care (VBC) health care delivery models is expected to increase as VBC adoption grows. In 2024, the DOJ announced a large FCA settlement with a VBC primary care practice, and HHS’s Office of Inspector General issued a Special Fraud Alert focusing on VBC business arrangements.

In 2024, the HHS Office of Inspector General added the University of Colorado Health d/b/a/ UCHealth, an established provider, to the Heightened Scrutiny list after UCHealth settled an FCA case for $23 million, without an admission of wrongdoing.

In 2024, the FTC and state attorneys general pursued various theories of liability against a diverse array of entities offering health care or health care–related services, and employed numerous different enforcement tools and partnerships. We expect that the agencies will continue developing these strategies in 2025.

In 2024, the COVID-19 Fraud Enforcement Task Force, in conjunction with five COVID Fraud Enforcement Strike Forces and other government agencies, has resolved many significant criminal and civil pandemic fraud cases. More civil pandemic fraud enforcement actions and continuing criminal actions are expected in 2025.

Our 2025 edition of EnforceMintz reflects on health care enforcement trends, predicts how health care enforcement may evolve, and offers practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

On September 23, 2024, the Criminal Division of the United States Department of Justice (“DOJ” or the “Department”) revised its Evaluation of Corporate Compliance Programs guidance (the “ECCP”). This article focuses on significant revisions detailed in the most recent installment of the guidance.