Healthcare & Life Sciences: Drug Pricing Digest — Number 70

Inflation Reduction Act, Healthcare Reform, and General Developments 

IRA LEGAL CHALLENGES CONTINUE

Drug manufacturer litigation against the Inflation Reduction Act (IRA) drug pricing-negotiation program continues, with the US Supreme Court currently weighing whether to grant certiorari.

Source: Law360.

STAKEHOLDERS CONTINUE TO DISCUSS GLOBE AND GUARD PAYMENT MODELS, MFN IMPLICATIONS

Stakeholders continue to discuss the implications of the most favored nation (MFN) policy and the recent presidential proclamation regarding Section 232 tariffs, which we discussed in issue No. 69 of this digest.

Sources: InsideHealthPolicy, PoliticoPro, NBC News, Pink Sheet (first, second, third, fourth, fifth), BioWorld.

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

MANUFACTURER CHALLENGES “PATIENT” DEFINITION

A major pharmaceutical manufacturer has filed litigation in the US District Court for the District of Columbia, challenging the definition of “patient” under the 340B program. The current definition was issued by the Health Resources & Services Administration (HRSA) in the form of guidance in 1996, and subsequent attempts to update the definition have failed. The patient definition was previously challenged by a covered entity in the context of a HRSA audit finding of diversion, as discussed in issue No. 31 of this digest.

Sources: BloombergLaw, Law360, InsideHealthPolicy, Pink Sheet, 340B Report.

MANUFACTURER CLAIMS DATA REQUIREMENT FOR IN-HOUSE PHARMACY DISPENSES

A third manufacturer is requiring covered entities to submit claims-level data for all their 340B dispenses, including dispenses from in-house pharmacies. We discussed these manufacturer requirements in issue No. 64 of this digest.

Sources: BloombergLaw, 340B Report.

CMS EXTENDS COST SURVEY DEADLINE

In the 2026 Outpatient Prospective Payment System (OPPS) final rule, which we discussed in issue No. 60 of this digest, the Centers for Medicare & Medicaid Services (CMS) announced that the agency will conduct an OPPS hospital drug acquisition cost survey with the intent to use the results to potentially modify the reimbursement amount for drugs purchased under the 340B program. CMS extended the deadline for 340B covered entities to respond to the survey to April 7, 2026.

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, 340B Report (first, second, third).

After siding with manufacturers in their challenge to West Virginia’s contract pharmacy law, as discussed in issue No. 69 of this digest, the US Court of Appeals for the Fourth Circuit has now also issued a similar opinion with respect to a Maryland contract pharmacy statute.

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

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.

Medicare Part B

No developments to report. 

Medicare Part D

State Law Developments  

VIRGINIA CONTINUES TO DISCUSS PDAB BILL

Discussion continues in Virginia regarding a bill that would establish a Prescription Drug Affordability Board (PDAB). We discussed the legislation in issue No. 64 of this digest.

Source: InsideHealthPolicy.

MARYLAND PDAB IMPLEMENTATION CONTINUES

The Maryland PDAB has proposed an upper payment limit (UPL) for one drug. If implemented, Maryland would be the second state to impose a UPL.

Sources: BloombergLaw, StatNews.