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 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.

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.

This Q&A with John Koss, Managing Director of Mintz’s E-Data Consulting Group, delves into the work of the group along with the benefits, challenges, and emerging issues related to using AI in e-discovery.

Since May 2023, federal legislators have introduced more than 50 bills focused on issues related to AI technologies, with patient privacy, the role of clinicians, and health equity emerging as areas of focus. In addition, the Biden administration released an Executive Order focused on promoting AI safety in October 2023.

An uptick in DOJ cybersecurity enforcement in 2023, includes two FCA settlements, an unsealed qui tam complaint, and significant regulatory activity that could pose future enforcement risk.

Health care companies using algorithms and AI applications face increased compliance risks. Previous technology-related enforcement suggests how relators and enforcement agencies might use AI to detect potential fraud and develop allegations based on how the technology is being used.

Government enforcement activities focused on tele-fraudsters remained active in 2023, with most enforcement actions focusing on fraud schemes involving medically unnecessary durable medical equipment or genetic testing, or both.

In 2023, the DOJ amplified compliance-related incentives for companies under criminal investigation (including health care companies), while the OIG has substantially revised and modernized previously issued compliance guidance and resources applicable to health care companies and providers.

Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase of the technical component (TC) of anatomic pathology (AP) services (Proposed Arrangement) could generate prohibited remuneration under the federal Anti-Kickback Statute (AKS) and thus be grounds for the imposition of sanctions.  As we discuss below, this AO was notable because the OIG’s decision seems to be driven by its views on the (lack of) commercial reasonableness of the arrangement and its skepticism regarding arrangements that “carve out” federal health care program business.