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.

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.

As part of its Modernization Initiative, the Department of Health and Human Services’ Office of Inspector General (OIG) recently published its first industry-segment specific Compliance Program Guidance, which focuses on skilled nursing facilities (SNFs) (SNF ICPG). Since 1998, the OIG has issued voluntary compliance program guidance documents, each tailored to a specific segment of the health care industry and providing important insights on specific risk areas and tips for implementing an effective compliance program.  In April 2023, the OIG announced a long overdue modernization of these compliance program guidance documents and rolled out its General Compliance Program Guidance the following November.  

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.

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. 

The government’s continued dedication of resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs appears to have borne fruit according to the results of the COVID-19 Fraud Enforcement Task Force’s (CFETF) report released on April 9, 2024. The CFETF, which represents a concerted effort across numerous federal agencies to investigate pandemic-related fraud, has, according to its 2024 report, succeeded in prosecuting over 3,500 defendants in criminal enforcement matters, in bringing civil enforcement actions resulting in more than 400 civil settlements and judgments, and in securing more than $1.4 billion in seizures and forfeitures. The report itself is a showcase of the CFETF’s COVID-19 fraud enforcement efforts to date.

Lawyers for Good Government, in partnership with the American College of Obstetricians and Gynecologists, initiated a vital project known as The Policy Resource Hub in 2022.

The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. In addition to civil False Claims Act settlements, there were a number of criminal enforcement matters, including some involving politicians, government employees, and those with connections to gangs and transnational crime networks.

The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance documents (CPGs) since 2008 and advancing OIG’s Modernization Initiative first announced in a September 2021 Request for Information.