Health Care

This article discusses challenges related to laws prohibiting manufacturers from paying rebates on drugs dispensed to 340B eligible patients, known as nonduplication, how nonduplication is linked to implementation of the Maximum Fair Price, and stakeholder concerns with successfully navigating these new requirements.

Mintz’s Pharmacy Benefits and PBM Contracting Practice is pleased to present the ‘Fourth Edition: Q1 2025’ of our Mintz IRA Update, a regular publication that delves into developments of the Inflation Reduction Act of 2022 (IRA) and their impact on pharmaceutical supply chain stakeholders.

The PBM Policy and Legislative Update — Winter 2025 edition builds upon prior PBM Policy and Legislative Updates and summarizes activity from October through December (2024) that affects the PBM industry. It highlights (i) federal activities, (ii) state activities, and (iii) other noteworthy events and trends affecting the PBM industry.

Host Of Counsel Bridgette Keller invites the Mintz Health Law team to reflect on what they’re grateful for as they prepare for the year ahead. Hear from a dynamic group of Members, Of Counsel, and Associates as they share their perspectives on what’s coming up over the horizon.

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.

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically targeting PBMs. Signed into law by Governor Healey on January 9, 2025, the comprehensive bill, titled “An Act Relative to Pharmaceutical Access, Costs and Transparency” (the Act), introduces a multifaceted approach that aims to reduce prescription drug costs, enhance data transparency, and impose stronger oversight of PBMs and pharmaceutical manufacturers.

In this Special Edition of the PBM Policy and Legislative Update, the Mintz Health team partnered with our Antitrust colleagues to analyze the FTC’s Second Report titled Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers.

On January 13, 2025, California Attorney General Rob Bonta (the California AG) issued two Legal Advisories regarding the utilization of artificial intelligence (AI). The first Legal Advisory provides guidance to consumers and entities developing, selling, and using AI describing their rights and obligations under California law. The second Legal Advisory, entitled Application of Existing California Law to Artificial Intelligence in Healthcare (the Health Care Legal Advisory), is expressly directed at health care providers, insurers, vendors, investors, and other health care entities who develop, sell, and use AI and other automated decision-making tools.

New York employers are – once again – required to provide employees with notice regarding New York’s reproductive health decision making protections.  The U.S. Court of Appeals for the Second Circuit vacated a lower court’s permanent injunction of a New York law that requires employers to include a notice in their employee handbooks regarding the State’s prohibition of discrimination based on reproductive health choices. 

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.

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.

Host Of Counsel Bridgette Keller is joined by Alex Hecht, ML Strategies Executive Vice President & Director of Operations, Washington, DC, as they dive into potential health care policy changes on the horizon following the 2024 election and what stakeholders can expect in 2025.

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.