Healthcare & Life Sciences: Drug Pricing Digest — Number 79

Inflation Reduction Act, Healthcare Reform, and General Developments

LITIGATION CHALLENGING THE IRA CONTINUES

Drug manufacturer litigation against the drug pricing negotiation program established under the Inflation Reduction Act (IRA) continues. Most recently, the US District Court for the District of Columbia upheld a lower court opinion that had ruled against a manufacturer’s challenge, but remanded one issue to the lower court for further consideration. That issue relates to the standard the Centers for Medicare & Medicaid Services (CMS) applies to determine whether a generic drug is marketed.

Sources: BloombergLaw, Law360, InsideHealthPolicy, BioWorld.

IRA NEGOTIATION DEVELOPMENTS

The comment period for CMS’s proposed rule that would apply to the IRA negotiation program beginning in 2029 closed on August 17, 2026. We discussed the proposed rule in issue No. 74 of this digest. More than 11,000 comments were submitted.

Meanwhile, a white paper examines patient access to medications that are subject to a Maximum Fair Price (MFP), noting that “in Q1 2026, after the coverage requirement for IPAY 2026-selected drugs took effect, nearly a quarter (24%) of first fill attempts for these drugs were initially rejected, the same rate as in 2025, indicating a lack of material improvement for patient access.”

Source: InsideHealthPolicy (first, second).

STAKEHOLDERS CONTINUE TO DISCUSS MFN AND TARIFF IMPLICATIONS

Stakeholders continue to discuss the implications of the most favored nation (MFN) drug pricing policy and pharmaceutical tariffs.

Sources: InsideHealthPolicy (first, second, third), PinkSheet (first, second), Generics Bulletin.

TRUMPRX DEVELOPMENTS

Multiple pharmacy benefit managers (PBMs) have agreed to publish drug prices that are available on TrumpRx on their patient portals. Meanwhile, stakeholders are discussing the savings TrumpRx provides.

Source: InsideHealthPolicy (first, second).

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

CHALLENGE TO STD CLINIC CHILD SITE STATUS CONTINUES

As discussed in issue No. 53 of this digest, there are two lawsuits related to Health Resources & Services Administration (HRSA) policies for certifying sexually transmitted disease (STD) clinics as “child sites” eligible for the 340B program, one brought by manufacturers (as discussed in issue No. 69 of this digest) and the other brought by covered entities (as discussed in issue No. 72 of this digest).

In the challenge brought by manufacturers, the US District Court for the District of Columbia has now held that HRSA improperly certified the STD clinics as child sites because “any funding the clinics received was through [the parent entity], not a state or local government, rendering them statutorily ineligible for 340B certification as covered entities.”

Sources: BloombergLaw, 340B Report.

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.

Source: 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.

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

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

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

Medicare Part B

No developments to report. 

Medicare Part D

COURT SIDES WITH CMS IN DENYING PHASE-IN STATUS

The US District Court for the District of Columbia upheld a lower court opinion that had ruled against a manufacturer in its suit against CMS. The manufacturer had sought to obtain a different designation for purposes of the phase-in of manufacturer discounts under the IRA’s Part D manufacturer discount program.

Source: BloombergLaw.

State Law Developments

No developments to report.