Healthcare & Life Sciences: Drug Pricing Digest — Number 62

Inflation Reduction Act, Healthcare Reform, and General Developments

CMS PUBLISHES GLOBE AND GUARD PROPOSED RULES THAT WOULD IMPLEMENT MFN PRICING IN MEDICARE PARTS B AND D 

On December 19, 2025, the Centers for Medicare & Medicaid Services (CMS) published two proposed rules: the Global Benchmark for Efficient Drug Pricing (Globe) Model, which relates to Medicare Part B, and the Guarding U.S. Medicare Against Rising Drug Costs (Guard) Model, which relates to Medicare Part D. The comment period for both proposed rules ends on February 23, 2026.

The Globe and Guard proposed rules would each implement a mandatory payment model under the waiver authority of the Center for Medicare & Medicaid Innovation (CMMI), which is tasked with testing innovative payment and service delivery models. Both models would impose a rebate on relevant drugs based on most favored nation (MFN) pricing metrics.

The Globe model “would have a 7-year test period that includes 5 performance years, beginning October 1, 2026, and ending September 30, 2031, and 7 payment years, beginning October 1, 2026, and ending September 30, 2033.”

The Guard model’s “period of performance would begin on January 1, 2027, and end on December 31, 2033, and the payment period for the model would begin on January 1, 2027, and end on December 31, 2035.”

Both models would interact with the existing rebates that were imposed by the Inflation Reduction Act (IRA) and involve complicated benchmark and rebate calculations, making it advisable for organizations to carefully evaluate the scope and applicability of the models to specific drugs, as well as the financial and strategic implications of the models.

CMS previously announced the Generous voluntary payment model that applies MFN pricing in Medicaid, which we discussed in issue No. 59 of this digest.

Sources: BioWorld, InsideHealthPolicy, StatNews, BloombergLaw (first, second), In Vivo, PoliticoPro.

NINE ADDITIONAL MANUFACTURERS ENTER INTO DRUG PRICING AGREEMENTS

Coinciding with the release of the Globe and Guard proposed rules, nine additional US pharmaceutical manufacturers announced on December 19, 2025, that they have entered into drug pricing agreements with the Trump administration. The White House again issued a fact sheet accompanying the announcements. This brings the total number of manufacturers that have entered into such agreements to 14. Like the prior agreements, which we discussed in issues No. 56, No. 57, and No. 59 of this digest, the new agreements remain confidential, and the manufacturers agreed to participate in the TrumpRx website.

Also on December 19, 2025, FDA announced that it has awarded two vouchers to one of the nine manufacturers under the Commissioner’s National Priority Voucher (CNPV) program.

Sources: BloombergLaw, InsideHealthPolicy (first, second, third), SmartBrief, PinkSheet, StatNews (first, second), Scrip.

IRA LEGAL CHALLENGES CONTINUE

Drug manufacturer litigation against the IRA drug-pricing negotiation program continues.

Source: BloombergLaw (first, second).

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

PRELIMINARY INJUNCTION HALTS 340B REBATE MODEL

On December 29, 2025, the US District Court for the District of Maine issued a preliminary injunction halting the implementation of the 340B rebate model nationwide. The rebate model was scheduled to commence on January 1, 2026. The ruling came in response to litigation brought by hospital groups.

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

Medicare Part B 

No developments to report.

Medicare Part D

No developments to report. 

State Law Developments

DRUG DISTRIBUTOR CHALLENGE TO CONNECTICUT PRICE CAP LAW CONTINUES

Litigation challenging Connecticut’s price cap law continues. We discussed the litigation in issue No. 57 of this digest.

Sources: BloombergLaw, Law360.