A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the IRA’s Drug Negotiation Program.

On April 15, 2025, President Trump issued an Executive Order instructing federal agencies to implement a variety of drug pricing reforms. The Executive Order addresses drug pricing from several different angles, including pharmacy benefit manager (“PBM”) competition and transparency, Medicare and Medicaid drug pricing, international importation, and drug manufacturer competition (the “Executive Order”).

The Executive Order, which is the first significant action taken by the current Administration to address drug prices, echoes initiatives and policy statements announced during the first Trump Administration. However, most of the drug pricing reforms announced during the first Administration were never fully implemented. It is unclear how many of the proposals in this Executive Order will ultimately be implemented, but it does provide the clearest outline yet of the Administration’s policy priorities regarding drug prices.

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.

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.

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.

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.

Building upon prior issues and summarizing activity from July through September, the Fall 2024 PBM Update highlights federal legislative activity and oversight, state legislative activity and oversight, and other noteworthy events and trends affecting the PBM industry.

On November 12, 2024, the drug manufacturer Johnson & Johnson (J&J) filed a lawsuit against the Health Resources and Services Administration (HRSA) in the U.S. District Court for the District of Columbia. The lawsuit relates to J&J’s proposal to require certain 340B covered entities – specifically, disproportionate share hospitals (DSH) – that purchase J&J’s drugs Stelara and Xarelto under the 340B Drug Pricing Program to do so under a rebate model. J&J is challenging HRSA’s threatened enforcement action against the drug maker.

On September 26, 2024, the Centers for Medicare & Medicaid Services (CMS) released a final rule implementing changes to the Medicaid Drug Rebate Program (MDRP). While not the focus of the agency’s rulemaking, stakeholders used the opportunity to comment on the proposed rule to air concerns and grievances related to the 340B Drug Pricing Program (340B Program). Although CMS acknowledged the flood of 340B Program comments, the agency ultimately punted on responding to stakeholders because the comments were outside the scope of the rulemaking. The response from CMS is understandable, but the numerous comments from stakeholders add to the growing calls for additional guidance and improvements to the 340B Program.