Medicare, Medicaid and Commercial Coverage & Reimbursement

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.

In the latest episode of Health Law Diagnosed, Of Counsel Bridgette Keller is joined by Associate Hassan Shaikh for a discussion on noteworthy developments relating to the IRA and drug pricing.

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.

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

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.

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

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

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

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.

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

On May 12, 2025, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for the third cycle of the IRA’s Medicare Drug Price Negotiation Program (Negotiation Program).

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

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.

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

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.

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.