Healthcare & Life Sciences: Drug Pricing Digest — Number 80

Inflation Reduction Act, Healthcare Reform, and General Developments

WHITE HOUSE ANNOUNCES GENEROUS PARTICIPANTS

On August 31, 2026, the White House announced that nine pharmaceutical manufacturers are voluntarily participating in the Generous payment model. As discussed in issue No. 59 of this digest, the Generous model implements most favored nation (MFN) pricing in Medicaid through the existing supplemental rebate framework. While the terms of the participation agreements remain confidential, it appears that the companies received relief from Section 232 tariffs and waivers from requirements under the mandatory Global Benchmark for Efficient Drug Pricing (Globe) and the Guarding U.S. Medicare Against Rising Drug Costs (Guard) payment models, which would implement MFN pricing in Medicare. The deadline currently posted on the Centers for Medicare & Medicaid Services (CMS) website for states to participate in Generous is September 10, 2026.

CMS has not yet published final regulations to implement the Globe and Guard payment models. Both regulations were initially proposed on December 19, 2025, as discussed in issue No. 62 of this digest.

Sources: InsideHealthPolicy, Law360, PoliticoPro (first, second, third), BloombergLaw (first, second), PinkSheet (first, second), BioWorld, Scrip (first, second), StatNews (first, second, third).

STAKEHOLDERS CONTINUE TO DISCUSS MFN AND TARIFF IMPLICATIONS

Stakeholders continue to discuss the implications of the MFN drug pricing policy and pharmaceutical tariffs.

Sources: PinkSheet (first, second), PoliticoPro, InsideHealthPolicy, Scrip.

INDICATIONS THAT 340B PROGRAM WILL TRANSITION TO CMS

President Trump’s budget proposal for fiscal year 2027, which was issued on April 3, 2026, proposed moving oversight of the 340B program from the Health Resources & Services Administration (HRSA) to CMS. An anonymous source reportedly indicated that the transition will take place in September.

Source: 340B Report.

LITIGATION CHALLENGING THE IRA CONTINUES

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

Sources: BioWorld (first, second), BloombergLaw (first, second, third), Law360 (first, second, third), InsideHealthPolicy (first, second).

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

LITIGATION REGARDING “PATIENT” DEFINITION CONTINUES

Litigation brought by a major pharmaceutical manufacturer to challenge the definition of “patient” under the 340B program is proceeding. We discussed the litigation in issue No. 70 of this digest.

Sources: Law360, 340B Report.

ADDITIONAL STATES ADOPT CONTRACT PHARMACY LAWS

More states have enacted or proposed legislation that would bar drug manufacturers from restricting contract pharmacy access. Some bills would require covered entities to make disclosures regarding 340B discounts. We note that legislative action related to the 340B program may have occurred in other states but has not yet been reported in the trade press.

Source: 340B Report.

FOIA BATTLE OVER CONTRACT PHARMACY AGREEMENTS CONTINUES

In 2021, a pharmaceutical manufacturer submitted a Freedom of Information Act (FOIA) request to HRSA, asking for copies of covered entity agreements with their contract pharmacies. The litigation related to the FOIA request is ongoing.

Source: 340B Report.

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

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

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

Medicare Part B

No developments to report.

Medicare Part D

No developments to report.

State Law Developments

MARYLAND PDAB IS AUDITED

Stakeholders are discussing the operations of the Maryland Prescription Drug Affordability Board (PDAB) after an audit revealed issues with collecting fees. We discussed the Maryland PDAB in issues No. 70 and No. 73 of this digest.

Source: InsideHealthPolicy.