Healthcare & Life Sciences: Drug Pricing Digest — Number 58

Inflation Reduction Act, Healthcare Reform, and General Developments

CMS CALLS ON MANUFACTURERS TO ALIGN ON MFN PRICING

John Brooks, a deputy administrator and the chief policy and regulatory officer with the Centers for Medicare & Medicaid Services (CMS), discussed the most favored nation (MFN) policy during remarks at a recent industry conference. He called on pharmaceutical manufacturers to work together to implement MFN pricing and highlighted efforts by the Trump administration to pressure ex-US countries to increase drug prices.

Source: Pink Sheet (first, second).

STAKEHOLDERS CONTINUE TO DISCUSS IMPLICATIONS OF THE MFN DEALS

Stakeholders continue to discuss and evaluate the possible impacts of the MFN deals announced so far by the Trump administration, including the absence of meaningful details regarding their implementation and concerns regarding the TrumpRx direct-to-consumer platform.

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

Meanwhile, the Trump administration is considering further pharmaceutical tariffs and is reportedly negotiating with various countries regarding their drug pricing frameworks.

Sources: BloombergLaw (first, second), Pink Sheet, Reuters.

MANUFACTURER WITHDRAWS FROM MDRP, 340B PROGRAM

A major manufacturer announced that it is withdrawing from the Medicaid Drug Rebate Program (MDRP) and the 340B program, leading commenters to question whether additional manufacturers will follow the same course.

Sources: StatNews, Pink Sheet.

CBO REVISES SCORE FOR IRA’S EXPANDED ORPHAN DRUG EXCLUSION

As discussed in issue No. 50 of this digest, President Trump’s signature healthcare policy legislation, H.R. 1, expanded the orphan drug exclusion from forced negotiations by amending under the Inflation Reduction Act (IRA). The Congressional Budget Office (CBO) has issued a revised estimate, often referred to as a score, of the financial impact of this change to the IRA negotiation program.

Sources: PoliticoPro, Pink Sheet, StatNews (first, second), 340B Report.

STAKEHOLDERS CONTINUE TO DISCUSS PRIORITY REVIEW VOUCHERS

Stakeholders continue to review the FDA’s grant of nine vouchers under the Commissioner’s National Priority Voucher (CNPV) program, which we discussed in issue No. 57 of this digest.

Sources: AP News, InsideHealthPolicy, StatNews, BloombergLaw. 

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

HRSA APPROVES EIGHT REBATE MODEL PLANS

On October 30, 2025, the Health Resources & Services Administration (HRSA) updated its website to show that the agency has approved eight “plans for participation in the 340B Rebate Model Pilot Program with a January 1, 2026, start date.” We discussed the initial release of the rebate model guidance in issue No. 52 of this digest.

Sources: BloombergLaw, 340B Report.

SENATE HELP COMMITTEE HEARING DISCUSSES 340B

On October 23, 2025, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing regarding the 340B program. A bipartisan group of senators is reportedly working on proposed legislation that would reform the 340B program.

Sources: PoliticoPro, Pink Sheet, InsideHealthPolicy (first, second), 340B Report (first, second, third).

COVERED ENTITIES SUE HRSA, ALLEGING UNREASONABLE ADR DELAYS

A group of covered entities has filed suit against HRSA in connection with Administrative Dispute Resolution (ADR) petitions that the covered entities submitted in November 2023. The litigation alleges that HRSA has failed to act on the petitions, which relate to a manufacturer’s contract pharmacy policy.

Source: 340B Report.

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

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

Sources: Law360, 340B Report (first, second).

Medicare Part B

CMS RELEASES 2026 PHYSICIAN FEE SCHEDULE FINAL RULE

On October 31, 2025, CMS released the 2026 Physician Fee Schedule (PFS) final rule. It is scheduled to be published in the Federal Register on November 5, 2025. We discussed the PFS proposed rule in issue No. 51 of this digest.

As we evaluate the PFS final rule, we want to highlight that CMS did not adopt the proposed definition of bona fide service fee, which would have included detailed requirements regarding the determination of fair market value. 

But CMS did adopt additional reporting requirements, effective January 1, 2026, which include submitting “reasonable assumptions for calculations of the manufacturer’s ASP… and its customary business practices including documentation of the methodology used to determine fair market value,” as well as a “certification letter from the recipient of a bona fide service fee as evidence that the fee is not passed on in whole or in part to a client or customer of the recipient of the fee, whether or not the entity takes title to the drug.”

The Hospital Outpatient Prospective Payment System (OPPS) final rule, typically on the same publication schedule as the PFS final rule, has not yet been released.

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

Medicare Part D

No developments to report.

State Law Developments

DRUG DISTRIBUTORS 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: Law360, Generics Bulletin, StatNews.