The PBM Policy and Legislative Update — Spring 2025 edition builds upon prior issues and summarizes activity from January through March (2025) that affects the PBM industry. It highlights federal activities, state activities, and other noteworthy events and trends affecting the PBM industry.

Over the past few years, Congress has attempted to pass “federal PBM reform.” Members of Congress have held numerous hearings related to PBMs and introduced numerous bills seeking to regulate PBMs (we regularly track these federal actions through our quarterly PBM Policy and Legislative Updates). Despite the rhetoric in Washington about bipartisan support to regulate PBMs, Congress has not been able to pass meaningful PBM reform.  This brings us to the One Big Beautiful Bill (Reconciliation Bill), which includes some PBM measures but remains  far from the sweeping reform Congress previously introduced and  from what we are seeing at the state level. The House passed the Reconciliation Bill on May 22, 2025, with a slim margin of 215 to 214.  The Reconciliation Bill will now move to the Senate, where the Senate will need to approve it with a simple majority for it to become law. 

President Trump issued his “Delivering Most-Favored Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order) this week.  The Executive Order seeks to reduce the price of drugs by requiring manufacturers to offer the United States most-favored-nation pricing, or in other words, the lowest price offered to any “comparably developed” foreign country that pays for the same drugs. 

The Final Rule provides our first insight into how the new Administration may approach Medicare Advantage (MA) and Part D policies. We have summarized key provisions adopted in the Final Rule and those the Trump administration expressly declined to adopt.

Over the past few weeks, we have been closely following the Trump Administration’s restructuring of the Department of Health and Human Services (HHS), the major reduction in the department’s workforce (RIF), and its broader deregulation strategy. A recently leaked Office of Management and Budget (OMB) Budget “passback” memorandum to HHS, which outlines proposed amounts for the President’s HHS budget request for fiscal year 2026 (the “Leaked Budget”) as well as departmental restructuring plans, provides additional insights into the Administration’s priorities for HHS and the agencies under its purview. In addition, on May 2, 2025, the Administration submitted to the Senate Committee on Appropriations the President’s “skinny” FY 2026 budget request (the “Skinny Budget”), which will be followed in the coming weeks by a more complete FY 2026 federal budget request. 

It’s no secret that President Trump, his Cabinet, and other executive branch leaders are prioritizing deregulatory activities over more historical federal governance approaches. Indeed, one of President Trump’s earliest executive orders – issued on January 31, 2025 – is entitled “Unleashing Prosperity Through Deregulation” and states that for each new regulation issued, at least ten prior regulations must be identified for repeal (and it defines the term “regulation” broadly to include memoranda, guidance documents, and policy statements, among others). In addition to this new 10-for-1 directive, on February 19, 2025, President Trump issued executive order 14219, “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (EO 14219). The president’s order directs all executive agency heads, in coordination with the Director of the Office of Management and Budget (OMB) and its Department of Government Efficiency (DOGE) Team Lead, to review all existing regulations for “consistency with law and Administration policy” and, within 60 days, to identify regulations that fall under certain categories.

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.

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.

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.