Health Care Enforcement & Investigations

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.

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.

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.

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.

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, 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, 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 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, 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.

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.

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.

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.

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 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.

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.

On September 30, 2024, a federal district court judge held that the qui tam provisions of the False Claims Act (FCA) violate the Appointments Clause of Article II of the Constitution.  U.S. ex rel. Zafirov v. Fla. Med. Assocs., LLC, C.A. No. 8:19-cv-01236-KKM, 2024 U.S. Dist. LEXIS 176626 (M.D. Fla. Sept. 30, 2024) (“Zafirov”).  While Zafirov’s holding is novel, the constitutional issue raised in that decision is not.

Read about DOJ recent scrutiny of private equity deals, its initiatives aimed at increasing acquirer oversight of M&A transactions, and best practices for private equity sponsors in the current enforcement landscape.

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the relator, Adam Hart, a former McKesson employee, filed a petition for certiorari seeking Supreme Court review of a Second Circuit decision that upheld the dismissal of relator’s complaint asserting claims under the civil False Claims Act (FCA) premised on alleged violations of the AKS. U.S. ex rel. Hart v. McKesson Corp., 96 F.4th 145 (2d Cir. 2024). A violation of the AKS requires as the scienter element that the defendant "knowingly and willfully" offered or paid remuneration to induce the recipient of the renumeration to purchase goods or items for which payment may be made under a federal health care program. 42 U.S.C. § 1320a-7b(b)(2). The Second Circuit held that a defendant does not act “willfully” within the meaning of the AKS unless that defendant “act[s] knowing that his conduct is unlawful.” United States ex rel. Hart, 96 F.4th at 154.

Acting U.S. Attorney Joshua Levy discussed the enforcement priorities for the Massachusetts U.S. Attorney’s Office (USAO) during a Q&A session on May 29, 2024, and made clear that the historical focus of the office remains the top priority: detecting and combating health care fraud, waste, and abuse.