Healthcare & Life Sciences: Drug Pricing Digest — Number 71

Inflation Reduction Act, Healthcare Reform, and General Developments 

MOST FAVORED NATION LEGISLATION

The Trump administration is continuing its push to enact the most favored nation (MFN) drug pricing policy through Congress.

Source: InsideHealthPolicy (first, second, third).

SEVENTEENTH MANUFACTURER ANNOUNCES DRUG PRICING AGREEMENT

In July 2025, President Trump sent identical letters to 17 pharmaceutical company executives demanding that the companies agree to MFN pricing for their drugs. We discussed the letters in issue No. 52 of this digest. On April 23, 2026, the last of the 17 manufacturers announced that it had entered into a drug pricing agreement with the Trump administration.

Sources: InsideHealthPolicy, PinkSheet, PoliticoPro, Scrip, StatNews.

CMS EXTENDS GENEROUS APPLICATION DEADLINE

The Centers for Medicare & Medicaid Services (CMS) extended the application deadline for manufacturers seeking to participate in the Generous payment model. The application deadline for manufacturers is now June 11, 2026.

Source: InsideHealthPolicy.

STAKEHOLDERS CONTINUE TO ANALYZE TRUMP TARIFF PROCLAMATION

Stakeholders continue to analyze the implications of the proclamation President Trump issued on April 2, 2026, stating that the Secretary of Commerce has completed an investigation under Section 232 of the Trade Expansion Act of 1962. We discussed the proclamation in issue No. 69 of this digest.

Source: Law360.

Check out Latham’s recent Client Alert that discusses the recent Trump executive order regarding accelerated access to psychedelic drugs for mental illness.

IRA LEGAL CHALLENGES CONTINUE

Drug manufacturer litigation against the Inflation Reduction Act (IRA) drug pricing-negotiation program continues.

Source: Law360.

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

REBATE MODEL DEVELOPMENTS

The comment period for the 340B rebate model closed on April 20, 2026. The Health  Resources & Services Administration (HRSA) has reportedly received more than 5,500 comments on its request for information (RFI). At the same time, members of Congress continue to evaluate the 340B rebate concept, most recently resulting in two contradicting letters.

Source: 340B Report (first, second).

LOUISIANA ATTORNEY GENERAL DISCUSSES 340B ENFORCEMENT ACTIONS

Louisiana Attorney General Liz Murrill noted in recent remarks that “I am in the process of preparing enforcement actions as we speak. I’ve had multiple complaints about a whole slew of manufacturers engaging in conduct that directly violates our [340B contract pharmacy] statute. Since I am the enforcer on that under that statute, I’m the party that needs to take action, and I do intend to do that.”

Source: Law360.

MANUFACTURER CHALLENGE TO HRSA CERTIFICATION PRACTICES CONTINUES

Litigation brought by manufacturers challenging the 340B eligibility of certain sexually transmitted disease (STD) clinics continues. The manufacturers allege that HRSA permitted these STD clinics to participate in the 340B program and certified their eligibility without satisfying all statutory requirements. We discussed this litigation in issues No. 43 and No. 69 of this digest.

Source: BloombergLaw.

MANUFACTURER CLAIMS DATA REQUIREMENT FOR IN-HOUSE PHARMACY DISPENSES

As discussed in issue No. 64 of this digest, some manufacturers have begun requiring covered entities to submit claims-level data for all their 340B dispenses, including dispenses from in-house pharmacies. Stakeholders continue to discuss these requirements. 

Sources: InsideHealthPolicy, 340B Report (first, second).

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

Drug manufacturer litigation challenging the 340B laws enacted by various states continues.

Sources: BioWorld, BloombergLaw, Law360 (first, second), 340B Report (first, second, third, fourth, fifth).

Medicare Part B

No developments to report. 

Medicare Part D

State Law Developments  

PDAB DEVELOPMENTS IN VIRGINIA AND COLORADO

The Virginia General Assembly has adopted legislation that would establish a Prescription Drug Affordability Board (PDAB) and rejected Governor Abigail Spanberger’s attempt to delay certain provisions of the legislation.

Meanwhile, in Colorado, the legislature postponed consideration of legislation that would exempt orphan drugs from the state’s PDAB requirements. As we discussed in issue No. 56 of this digest, the Colorado PDAB is the first to impose an upper payment limit (UPL).

Source: StatNews.