Health Care Enforcement Trends & 2025 Outlook

In our annual report, we examine health care enforcement trends, predict how health care enforcement may evolve, and offer practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

A Letter From the Chair

Mintz’s Health Care Enforcement Defense practice group is proud to present the latest issue of EnforceMintz, our regular newsletter analyzing current events, highlighting trends, and predicting future developments related to health care fraud enforcement. EnforceMintz reports on qui tam cases brought under the False Claims Act (FCA), other government enforcement actions, and significant regulatory developments and court decisions.

As in past years, this installment reflects on health care enforcement trends and predicts how health care enforcement may evolve and where enforcement authorities will focus their efforts and resources in years to come. We also offer practical guidance about what these trends and predictions mean for health care providers, payors, and other stakeholders.

While the Trump administration redux is expected to pursue sweeping changes in various areas, one constant is likely to be health care fraud enforcement. As we observed in 2021, in President Trump’s first term, the total volume of FCA cases actually increased, which was the result of an increase in government-initiated enforcement actions. Similarly, overall FCA recoveries from 2017 to 2020 remained relatively constant, and, in each year, the health care industry was the main source of overall recoveries. Perhaps for that reason, health care fraud enforcement efforts generally have bipartisan support, and monetary recoveries help to fill the Medicare program’s coffers, which could in turn help President Trump fulfill his campaign promise to reduce government spending without cutting Medicare or Social Security.

Pamela Bondi, President Trump’s nominee for attorney general, is no stranger to health care fraud enforcement. She is the former attorney general for the State of Florida, which is a hotbed of government health care program fraud, but neither she nor President-elect Trump has expressed whether health care fraud enforcement will be a DOJ priority this time around. At her Senate confirmation hearing, Bondi stated that she would “defend the constitutionality” of the FCA and committed to ensuring that DOJ had sufficient staffing and resources to “properly support and prosecute” FCA cases, including those brought by qui tam relators.

Even if health care enforcement efforts slow under a second Trump administration, state-level enforcement may accelerate. Regardless, qui tam relators continue to drive the vast majority of FCA enforcement activities, and they show no signs of slowing down, so we anticipate that these matters will continue to reflect the trends and issues we have been following, as well as emerging theories of liability.

In this issue, we discuss 2024’s areas of enforcement focus and our predictions for 2025. Some of the 2024 developments we analyze represent long-standing enforcement priorities while others signal emerging trends. We also cover regulatory policy developments, including DOJ’s continued focus on cooperation and self-disclosure, and case law developments from 2024 that are expected to come to a head in 2025.

On January 15, 2025, DOJ released its annual report of FCA enforcement activity. In the last fiscal year, FCA settlements and judgments exceeded $2.9 billion, $1.67 billion of which related to matters involving the health care industry. DOJ handled 1,402 new FCA matters and qui tam relators filed 979 of those cases, a record number for a single year.

The next edition of EnforceMintz — our annual False Claims Act Statistical Year In Review — will analyze trends in FCA cases using data compiled by Mintz in its Qui Tam Database and dive into the data from DOJ’s annual report.

Karen Lovitch
Chair, Health Care Enforcement Defense Practice

Read Our Annual EnforceMitz Report

Subscribe To Viewpoints

Authors

Karen advises industry clients on regulatory, transactional, operational, and enforcement matters. She has deep experience handling FCA investigations and qui tam litigation for laboratories and diagnostics companies.

Samantha advises clients on regulatory and enforcement matters. She has deep experience handling violations of the federal ant-kickback statute and FCA investigations for clinical laboratories and hospitals.

Keshav Ahuja is an attorney at Mintz who focuses his practice on complex commercial litigation, securities litigation, class actions, and other litigation matters.

Eóin P. Beirne is co-chair of Mintz’s White Collar Defense and Government Investigations group. He guides clients from a wide range of industries through federal and state investigations and enforcement proceedings.

Grady R. Campion is a Mintz attorney who focuses his practice on complex commercial litigation and white collar matters. He represents clients in a variety of industries, including financial services.

Daniel A. Cody is a Member at Mintz who represents clients across the health care and life sciences sectors, including the digital health industry, providing strategic counseling and leading civil fraud and abuse investigations. His practice encompasses a broad range of complex regulatory, compliance, privacy, and transactional matters.

Tara advises managed care organizations, pharmaceutical services providers such as PBMs, and integrated delivery systems, and companies that invest in them, on matters relating to compliance with federal health care program regulations, federal and state fraud, waste and abuse laws and plan benefits.

As a former official in the Civil Fraud Section of the U.S. Department of Justice, Larry has deep experience handling FCA investigations and qui tam litigation for industry leading health care clients across the country.

Hope regularly defends health care companies in governmental investigations and ensuing cases, conducts internal investigations, and advises providers and manufacturers regarding enforcement issues.

Jane Haviland's practice focuses primarily on health care enforcement defense. Jane defends laboratories, physicians, and other clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act, the federal anti-kickback statute, the Stark law, and similar state laws.

Nicole represents clients in complex litigation matters across a variety of areas including health care enforcement defense, white collar defense, construction law, and general commercial litigation in state and federal court. Her practice focuses on defending companies against government investigations of alleged violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS), conducting internal investigations, and litigating qui tam FCA cases.

Caitlin A. Hill is a Mintz attorney who practices complex litigation including contract disputes, commercial and business litigation, complex tort and product liability litigation, and construction law. She advises contractors, owners, developers, and public authorities in all stages of litigation.

Robert G. Kidwell is a Mintz attorney who counsels clients on business strategies, regulatory matters, policymaking and lobbying, compliance issues, privacy, and litigation. He defends clients in class action and competitor litigation, and guides transactions through merger reviews.

Nick A. LaPalme is an Associate at Mintz who focuses his practice on white collar defense, internal investigations, and complex commercial litigation matters. He works with clients across a variety of industries, including financial services.

Scott T. Lashway is a globally recognized privacy and cybersecurity disputes attorney who servers as Co-chair of Mintz’s Privacy & Cybersecurity Practice. He guides clients through high-stakes incident response and breach investigations, complex and bet-the-company litigation, government investigations, and enforcement actions and provides strategic counsel on privacy, cybersecurity, data governance, and AI issues. Scott primarily represents clients in the health care, financial services, technology, artificial intelligence, and media and adtech sectors.

Kevin is a member of the firm's Health Care Enforcement Defense Group and has significant experience representing health care–related entities in a variety of litigation matters, including contract, regulatory, False Claims Act and class action lawsuits. Kevin's health care industry clients have included pharmacies, PBMs, hospitals, clinical laboratories, diagnostic imaging providers, pharmaceutical companies and managed care organizations.

Payton T. Thornton is an Associate at Mintz who focuses his practice on antitrust and competition matters, including antitrust compliance, merger review, and government investigations. He primarily advises clients in the health care sector.

Matthew MK Stein is a Special Counsel at Mintz who advises organizations and individuals on data privacy, data governance, and cybersecurity issues. He leverages experience in private practice and as in-house counsel at a global financial institution to litigate, lead investigations, and provide strategic guidance. He represents clients in various industries, including technology, artificial intelligence, financial services, blockchain, and the adtech and martech sectors.

Rachel Yount is a Mintz attorney who focuses her practice on health care industry transactions. Her clients include hospitals, health systems and plans, physician organizations, and pharmacy benefit managers.

A Letter From the Chair

Published

Viewpoint Topics

Professionals

Share

Related Practices

Authors

Chair, Health Law Practice & Chair, Health Care Enforcement Defense Practice

Of Counsel

Associate

Member / Co-chair, White Collar Defense and Government Investigations Practice

Associate

Member

Member

Member

Member

Associate

Associate

Member

Member

Associate

Member / Co-Chair, Privacy & Cybersecurity Practice

Member / Co-chair, Class Action Practice

Associate

Special Counsel

Of Counsel