Drug Pricing Digest — Quantity 59

Inflation Reduction Act, Healthcare Reform, and General Developments

CMS ANNOUNCES VOLUNTARY PAYMENT MODEL TO IMPLEMENT MFN PRICING IN MEDICAID

On November 6, 2025, the Centers for Medicare & Medicaid Services (CMS) issued a press release asserting the voluntary “GENErating cost Reductions fOr U.S. Medicaid (GENEROUS)” payment model, which is able to implement most favored nation (MFN) pricing in Medicaid. The publication of this fee mannequin got here on the identical day because the announcement of two additional producer pricing offers.

According to the press launch, “State Medicaid programs that choose to participate … will be able to purchase drugs included in the pilot at prices aligned with those paid in select other countries.” Further, “Launching in 2026, the model allows CMS to negotiate with participating manufacturers for lower prices, while states adopting the model will implement uniform, transparent coverage criteria.” The mannequin will “run for five years and is voluntary for manufacturers and states.”

The CMS web site explains that producers “would report to CMS the international net unit price for the covered outpatient drug and supplemental rebates would be invoiced to manufacturers by states on a quarterly basis, consistent with the calculation of the statutory Medicaid rebates.” The state would invoice the producer quarterly for supplemental rebates for the medicine which are topic to the mannequin, and “the supplemental rebate amount would reflect the international pricing for the covered outpatient drug.”

CMS additionally issued a Request for Applications (RFA) for producers involved in taking part within the mannequin. 

Reportedly, an MFN fee mannequin for Medicare can also be in preparation. That mannequin is predicted to increase Medicare protection for sure medicine of producers which have entered into pricing agreements with the Trump administration.

Sources: BloombergLaw, InsideHealthCoverage (first, second), The Hill, StatNews (first, second, third), PoliticoPro.

CMS made a revision to the RFA shortly after initially releasing it.

Source: Pink Sheet.

TWO ADDITIONAL MANUFACTURERS ENTER INTO DRUG PRICING AGREEMENTS

Two extra US pharmaceutical producers introduced on November 6, 2025, that they’ve entered into drug pricing agreements with the Trump administration (see here and here). The White House once more issued a fact sheet accompanying the bulletins. This brings the full variety of producers which have entered into such agreements to 5. Like the prior agreements, which we mentioned in points No. 56 and No. 57 of this digest, the brand new agreements stay confidential, and the producers agreed to take part within the TrumpRx web site.

Sources: PoliticoPro (first, second, third), StatNews (first, second, third, fourth), Scrip (first, second), InsideHealthPolicy, Pink Sheet, BloombergLaw (first, second), BioWorld (first, second), 340B Report.

Additional producers are reportedly additionally concerned in ongoing negotiations with the Trump administration which will result in extra agreements. 

Source: Scrip (first, second).

STAKEHOLDERS CONTINUE TO DISCUSS MFN DEAL CONFIDENTIALITY

Commenters once more famous that no significant particulars have been disclosed relating to the phrases of the agreements that 5 producers have entered into with the Trump administration.

Source: InsideHealthPolicy.

LEGISLATION TO IMPOSE MFN PRICING REMAINS PENDING

MFN coverage discussions and developments have been centered on government motion, both by the offers with producers or by fee fashions and proposed regulation. Meanwhile, numerous payments have been launched in Congress that will impose MFN pricing by legislation, however their likelihood of passage stay unclear. 

Source: InsideHealthPolicy.

STAKEHOLDERS DISCUSS INTERNATIONAL MFN IMPACTS

Stakeholders proceed to debate the potential impacts of the MFN drug pricing coverage, together with on ex-US markets.

Source: BioWorld.

FDA AWARDS SIX ADDITIONAL NATIONAL PRIORITY REVIEW VOUCHERS

On November 6, 2025, coordinated with the announcement of additional producer pricing offers, FDA introduced six extra awards underneath the Commissioner’s National Priority Voucher (CNPV) program. As with the primary award of vouchers, which we mentioned in problem No. 57 of this digest, recipients embrace producers which have entered into pricing agreements with the Trump administration.

Sources: InsideHealthPolicy, StatNews, Scrip, Bloomberg.

Tune in to the most recent episode of the Latham Drug Pricing Podcast, the place Washington, D.C. companion Chris Schott and counsel Monica Groat discover the voucher awards intimately and talk about how the accelerated assessment interval may have an effect on launch methods, whether or not corporations with no voucher will likely be deprived, and potential dangers and considerations.

CMS RELEASES 2026 PHYSICIAN FEE SCHEDULE FINAL RULE

The 2026 Physician Fee Schedule (PFS) ultimate rule, which CMS launched on October 31, 2025, was printed within the Federal Register on November 5, 2025. We mentioned the PFS proposed rule in problem No. 51 of this digest and the preliminary launch of the PFS ultimate rule in problem No. 58 of this digest.

Among different issues, the PFS ultimate rule addresses the interaction between necessities of the Inflation Reduction Act (IRA) and Medicare.

• Part D inflation rebates and 340B items: CMS finalized a claims-based “Prescriber Pharmacy Methodology” to exclude 340B items from Part D inflation rebates starting January 1, 2026, as required by the IRA, with enhancements to raised seize lined entity affiliations (e.g., NPI/MPN mapping and use of OPAIS “Shipping Addresses”). CMS additionally finalized a voluntary 340B claims information repository to start gathering submissions in 2026 for potential future use; CMS didn’t undertake an estimation strategy.
• Part B inflation rebate baseline information: CMS finalized its strategy to determine a fee quantity benchmark quarter when information are lacking through the use of the third full calendar quarter after project of a billing and fee code. If a broadcast fee restrict is unavailable for that quarter, CMS calculates the benchmark fee quantity for that quarter utilizing constructive Average Sales Price (ASP) or Wholesale Acquisition Cost (WAC) figures from the ASP reporting system or, if unavailable, WAC from different public sources.
• Maximum Fair Price (MFP) and ASP: CMS finalized its strategy that items offered at MFP are included in producers’ ASP calculations, efficient January 1, 2026.

The PFS ultimate rule addresses different matters as properly, together with:

• Bona Fide Service Fees (BFSFs): CMS didn’t finalize the proposed new honest market worth (FMV) methodology, reassessment cadence, or third-party valuation requirement and didn’t finalize an inventory of price examples. CMS did finalize new ASP submission necessities: Manufacturers should submit their cheap assumptions, together with their FMV methodology utilized within the BFSF evaluation (starting with Q1 2026 submissions, that are due on April 30, 2026), and acquire and report certification letters from recipients of BFSFs confirming that the price just isn’t handed on.
• Bundled sale definition: CMS finalized adopting a definition of “bundled arrangement” for functions of the ASP calculation that largely tracks the long-standing Medicaid definition.

The Hospital Outpatient Prospective Payment System (OPPS) ultimate rule, sometimes on the identical publication schedule because the PFS ultimate rule, has not but been launched.

Sources: InsideHealthCoverage (first, second, third, fourth, fifth, sixth), StatNews, 340B Report.

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

REBATE MODEL IMPLEMENTATION BEGINS

The contractor retained by the Health Resources & Services Administration (HRSA) to manage the 340B rebate mannequin has published the permitted implementation plans of the eight producers which are taking part within the mannequin. 

Source: 340B Report (first, second).

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

Drug producer litigation difficult the 340B legal guidelines enacted by numerous states continues.

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

Medicare Part B

No developments to report.

Medicare Part D

No developments to report.

State Law Developments

MANUFACTURER CHALLENGE TO COLORADO PDAB LAW CONTINUES

Litigation difficult Colorado’s Prescription Drug Affordability Board (PDAB) statute continues. The Colorado PDAB not too long ago turned the primary within the nation to impose an higher fee restrict (UPL), which we mentioned in problem No. 56 of this digest.

Source: BloombergLaw (first, second).

STAKEHOLDERS EXPECT VIRGINIA TO RECONSIDER PDAB BILL

Stakeholders count on {that a} Virginia legislation to implement a PDAB, which was vetoed beforehand, will likely be reintroduced with a higher likelihood of passage after Virginia elected a Democratic governor and Democrats management each state chambers.

Source: InsideHealthPolicy.