Health Care

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) released its 2025 Marketplace Integrity and Affordability Proposed Rule (Proposed Rule), proposing a number of enrollment and eligibility policies impacting both Federal and State Exchanges. While CMS frames these policies as necessary to combat fraud and abuse, the impact will be a reduction in enrollment in the ACA Marketplace – with the Proposed Rule estimating that between 750,000 and 2 million fewer individuals enroll in health insurance plans on the Exchanges in 2026. 

This blog outlines the major provisions of the Proposed Rule, followed by a discussion of their potential impact on plans participating in the ACA Marketplace.

On March 12, 2025, in one of the Trump Administration’s first actions with respect to the Center for Medicare and Medicaid Innovation (CMMI), CMMI announced that it would prematurely terminate four alternative payment model (APM) demonstration models by December 31, 2025. CMMI’s decision was not entirely unexpected. In response to a 2021 report from a Congressional advisory committee recommending that CMMI “streamline” its portfolio of demonstrations, the Biden Administration initiated a 10-year “strategic refresh” of CMMI. Similarly, a critical report from the Congressional Budget Office (CBO) about the net cost initiated a wave of criticism from Republicans. Combined with the Trump Administration’s hyperfocus on reducing government spending (based on CMMI’s estimation, terminating the demonstrations early will save the federal government $750 million), it is not particularly surprising that CMMI was targeted for some cuts.

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase out the agency’s historical approach of enforcement discretion towards such tests (see here, here, here, and here). However, one infrequently considered regulatory compliance issue for LDTs is their reliance on separate specimen collection devices or convenience kits. All LDTs require the use of some form of biological specimen, such as blood or saliva, which may be collected by health care professionals in a clinical setting or by consumers in their homes before being submitted to a laboratory for testing. 

The following is a summary comparison between the currently passed NY HIPA and WA MHMDA.

In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The National Strategy called for creating more accessible food labeling practices to empower consumers to make healthier choices, among other laudable public health-focused goals. Prior to the January 2025 transition from the Biden to the Trump administration, the Food and Drug Administration (FDA) took concrete steps to address this particular National Strategy priority through both formal rulemaking and informal guidance. This blog post summarizes FDA's actions at the end of the Biden administration intended to modernize food labeling practices and move them forward in today’s more consumer-focused marketplace.   

In United States v. Regeneron Pharmaceuticals, Inc., the First Circuit joined the emerging majority view that False Claims Act (FCA) claims based on violations of the Anti-Kickback Statute (AKS) require a showing of “but-for” causation.  As we previously reported, the Sixth Circuit and the Eighth Circuit have also held that the stricter “but-for” causation standard applies to AKS-based FCA claims.

Governor Kathy Hochul released the proposed Fiscal Year 2026 New York State Executive Budget on January 21, 2025 (FY 26 Executive Budget). The FY 26 Executive Budget contains an amendment to Article 45-A of New York’s Public Health Law (hereinafter, the Disclosure of Material Transactions Law), which has been in effect since August 1, 2023. The law currently requires parties to a “material transaction” to provide 30 days pre-closing as well as post-closing notice to the New York State Department of Health (DOH). Since the law has taken effect, DOH has received notice of 9 material transactions, the details of which are listed on its website. If enacted, the amendment will change the reporting parties’ notice requirement, extend waiting periods, and increase DOH’s oversight of material health care transactions.

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.

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.

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.

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.

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 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.

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.

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.