Health Care

As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s workforce by a reported 10,000 employees and started the process of restructuring the organization as a whole. Now that the dust is starting to settle, we are beginning to analyze the RIFs and how they could impact key health care stakeholders, including Medicare Advantage Plans, providers, and biopharmaceutical and medical device manufacturers. This post provides a brief overview of the restructuring to date, HHS’s reduction in workforce, and their potential impacts. We will continue to monitor these developments and provide future updates to Mintz clients and friends. 

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology, in the Eastern District of Texas to determine whether the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits the agency to regulate laboratory developed tests (LDTs) is a complete victory for clinical laboratories. The U.S. district judge’s decision, issued on March 31, 2025, vacated the May 2024 final rule through which FDA sought to specify that LDTs are agency-regulated in vitro diagnostic products (IVDs) and to describe a plan for phasing-in enforcement of existing medical device regulations for such products over four years (see our previous posts on the LDT final rule here and here). In adopting the plaintiffs’ arguments wholesale, however, the judge created some incongruities in the relevant regulatory frameworks, as well as several quandaries for FDA and the clinical laboratory industry going forward. These inconsistencies could have greater consequences down the road if the Trump administration decides not to appeal the ruling.

The first quarter of 2025 has been eventful for New York’s Disclosure of Material Transactions Law. As discussed in our recent blog post, the proposed Fiscal Year 2026 New York State Executive Budget (FY 26 Executive Budget) contains an amendment that would alter reporting parties’ notice requirements, extend waiting periods, and increase oversight of material health care transactions by the New York State Department of Health (DOH). Now, nearly a year and a half after the Disclosure of Material Transactions Law took effect, DOH has published Public Health Law Article 54-A, Material Transactions Frequently Asked Questions (FAQs) on its website. The law currently requires “health care entities” engaged in a “material transaction” to provide written notice of the transaction to DOH at least 30 days before the transaction closing as well as notice to DOH upon the transaction closing. With the FAQs, DOH seeks to “provide responses to common questions the Department has received to date” and clarify health care entities’ obligations under the Disclosure of Material Transactions Law. The FAQs expand on the statute’s language, providing guidance on what “health care entities” are subject to the law, what constitutes a “material transaction,” how a transaction’s impact will be assessed, and the ability to comment on a proposed transaction.

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. 

Host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is joined by Member Deb Daccord, Of Counsel Cassie Paolillo, and Of Counsel Kate Stewart, who share their insights on the law’s far-reaching implications.

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.

Read about recent changes made by CMS to the Medicare Drug Price Negotiation Program following the first round of negotiations, manufacturers’ reactions to CMS’s explanations about maximum fair prices, the drugs targeted for the second round of negotiations, and the implications of the Trump administration for the future of the program.

Read about clarification from CMS for Part D Sponsors implementing the IRA’s Medicare Prescription Payment Plan and Medicare Prescription Drug Inflation Rebate Program policies that took effect on January 1, 2025.

Read about how a win in the Fifth Circuit and the end of Chevron deference could breathe new life into the Medicare Drug Price Negotiation Program challenges despite continued losses in federal court.

Read about how Donald Trump’s second presidency and Republican control in the 119th Congress could impact the future of the IRA’s Medicare Drug Price Negotiation Program.

Read about the impact of changes to Medicare Part D’s Part D benefit redesign and other changes that went into effect on January 1, 2025, and additional changes to watch for in 2025.

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.