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A Pivotal Week for Pharmaceutical Policy: Trump Administration Advances Tariff and Drug Pricing Initiatives

October 7, 2025 | Blog | By Theresa Carnegie, Stephnie John, Hassan Shaikh, Attiya S. Khan, Grace Callander, Sneha Shenoy

The first week of October 2025 marked a significant shift in U.S. drug pricing policy as the Trump administration unveiled a series of sweeping actions to deliver on his promise to lower drug prices. From President Trump’s announcement of a 100% tariff on imported branded drugs to the Trump administration’s landmark pricing deal with Pfizer and the rollout of the TrumpRx.gov direct-to-consumer (DTC) platform, last week marked an escalation in the White House’s efforts to drive down prescription drug costs and bring pharmaceutical manufacturing back to U.S. soil. Below, we provide an overview of the Trump administration’s new policies and the stakeholder responses already reshaping the broader pharmaceutical landscape.

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Mintz IRA Update — Still Undefeated: Government Notches Three More Victories in Negotiation Program Lawsuits

September 15, 2025 | Article | By Theresa Carnegie, Mitchell Clough, Xavier Hardy, Hassan Shaikh

Federal courts continue to uphold the Medicare Drug Price Negotiation Program, with multiple rulings emphasizing the voluntary nature of manufacturer participation. Key legal challenges from AstraZeneca, Boehringer Ingelheim, PhRMA, and others face setbacks as the government remains undefeated.

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Mintz IRA Update — 340B Roundup: States and Manufacturers Continue to Battle over 340B Contract Pharmacies

September 15, 2025 | Article | By Lauren Moldawer, Xavier Hardy, Abdie Santiago, Jordyn Flaherty

States and manufacturers clash over 340B contract pharmacy laws as litigation mounts and courts weigh in on the future of pharmacy access protections.

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Mintz IRA Update — Medicare Part B Physician Fee Schedule Guidance and Its Potential Implications for Medicare Part D

September 15, 2025 | Article | By Theresa Carnegie, Tara E. Dwyer, Rachel Yount, Hassan Shaikh

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare Part B drugs.

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Mintz IRA Update — 340B Roundup: CMS Proposes Steeper OPPS Clawbacks, Launches Drug Cost Survey with Public Comment

September 15, 2025 | Article | By Lauren Moldawer, Xavier Hardy, Abdie Santiago, Jordyn Flaherty

CMS proposes OPPS payment cuts and a drug cost survey, signaling major 340B reimbursement shifts and renewed scrutiny of hospital payment rates.

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Mintz IRA Update — Redesigning Part D for CY 2026

September 15, 2025 | Article | By Tara E. Dwyer, Samantha Hawkins

CMS finalizes 2026 Medicare Part D changes under the IRA, including new cost limits, subsidy guidance, and updated creditable coverage rules.

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PhRMA’s 2025 agenda pushes back on drug pricing reforms, calling for innovation-friendly policies, 340B reform, and PBM accountability.

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Mintz IRA Update — The Uncertain State of Affairs for GLP-1s

September 15, 2025 | Article | By Theresa Carnegie, Hassan Shaikh, Samantha Hawkins

GLP-1 receptor agonists (GLP-1s) such as semaglutide, and dual agonists like tirzepatide, are transforming obesity treatment and reshaping the US health care landscape.

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Mintz IRA Update — 340B Roundup: Senate HELP Committee’s Long-Awaited 340B Report Highlights Ongoing Problems but Provides Few Solutions

September 15, 2025 | Article | By Lauren Moldawer, Xavier Hardy, Abdie Santiago, Jordyn Flaherty

Senate HELP Committee releases 340B report urging transparency, oversight, and reforms amid uncertainty over future federal legislative action.

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Mintz IRA Update — IRA Medicare Drug Price Negotiation Program Updates for Q3 2025

September 15, 2025 | Article | By Rachel A. Alexander, Stephnie John, Samantha Hawkins, Hassan Shaikh

On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for the third cycle of the IRA’s Medicare Drug Price Negotiation Program (Negotiation Program).

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Mintz IRA Update — Under Pressure: The Trump Administration’s Drug Pricing Executive Orders

September 15, 2025 | Article | By Theresa Carnegie, Xavier Hardy, Hassan Shaikh, Abdie Santiago

President Trump issues executive orders and letters to curb drug costs, promote MFN pricing, and reform Medicare’s Negotiation Program.

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Mintz IRA Update — Disrupting the Pharmaceutical Supply Chain: The Era of the DTC Model

September 15, 2025 | Article | By Theresa Carnegie, Stephnie John

While the pharmaceutical industry has reacted negatively to President Trump’s May 12 “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients” Executive Order (Executive Order), manufacturers appear to be leveraging one of Trump’s directives in the Executive Order, accelerating the industry’s shift toward a new model of drug delivery: direct-to-consumer (DTC) programs.

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Mintz IRA Update — 340B Roundup: HRSA Launches 340B Rebate Model Pilot Program Amid Ongoing Legal and Regulatory Shifts

September 15, 2025 | Article | By Lauren Moldawer, Xavier Hardy, Abdie Santiago, Jordyn Flaherty

HRSA launches 340B rebate pilot tied to Medicare drug negotiations, signaling major program shifts amid legal rulings and stakeholder concerns.

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Federal Court Blocks Arkansas PBM Ownership Law, Citing Constitutional Violations

August 6, 2025 | Blog | By Theresa Carnegie, Samantha Hawkins

In a significant legal development, a federal judge has temporarily blocked Arkansas from enforcing Act 624. Act 624 prohibits pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state, effectively forcing vertically integrated companies to divest or shut down their Arkansas pharmacy operations. However, on July 28, 2025, U.S. District Judge Brian Miller granted a preliminary injunction to several major PBMs and affiliated entities, halting the law’s implementation pending final resolution of the case.

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Health Law Diagnosed: PBM Update Spring 2025

June 10, 2025 | Podcast | By Bridgette Keller, David Gilboa

Host, Bridgette Keller is joined by Associate, David Gilboa to break down the highlights from our Spring 2025 PBM Policy and Legislative Update. In just five minutes, we cover the most impactful federal and state developments shaping the PBM landscape this season.

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PBM Policy and Legislative Update — Spring 2025

June 10, 2025 | Blog | By Rachel A. Alexander, Theresa Carnegie, Tara E. Dwyer, Lauren Moldawer, Bridgette Keller, Pamela Polevoy, Madison Castle, David Gilboa, Xavier Hardy, Samantha Hawkins, Stephnie John, Alison H. Peters, Abdie Santiago, Hassan Shaikh, Sophia Temis, Payton Thornton

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.

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PBMs Sue Arkansas over Restrictive PBM Ownership Law

June 9, 2025 | Blog | By Theresa Carnegie, Hassan Shaikh, Samantha Hawkins, Mitchell Clough

On April 16, 2025, Arkansas enacted Act 624 (the Act), an unprecedented law prohibiting pharmacy benefit managers (PBMs) from owning or operating pharmacies in the state. As we discussed in our May 2025 blog post, the law’s passage has already resulted in market disruptions, and PBMs with vertically integrated business models have cautioned that the law will limit patients’ access to drugs and cost many local jobs. 

Now, two of the nation’s largest PBMs, CVS Health and Cigna’s Express Scripts (ESI), have filed federal lawsuits seeking to block implementation of the Act on the grounds that the Act is unconstitutional, preempted by federal law, and harmful to Arkansans. 

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Mintz IRA Update — The Future of the Medicare Drug Price Negotiation Program

February 13, 2025 | Article | By Samantha Hawkins, Matthew Tikhonovsky

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.

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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.

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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.

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