Healthcare & Life Sciences: Drug Pricing Digest — Number 78

Inflation Reduction Act, Healthcare Reform, and General Developments

US CUSTOMS AND BORDER PROTECTION ISSUES SECTION 232 TARIFF GUIDANCE

On July 30, 2026, US Customs and Border Protection (CBP) issued guidance regarding Section 232 tariffs on pharmaceutical imports. We discussed the Section 232 tariffs in issue No. 69 of this digest.

Sources: Law360, InsideHealthPolicy.

STAKEHOLDERS CONTINUE TO DISCUSS MFN IMPLICATIONS

Stakeholders continue to discuss the implications of the most favored nation (MFN) drug pricing policy, including the treatment of orphan drugs under Globe and Guard, and impacts on ex-US markets.

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

Medicaid Drug Rebate Program (MDRP)

No developments to report.

340B Program

HRSA RELEASES REBATE PILOT MODEL NOTICE

The Health Resources & Services Administration (HRSA) has published a Federal Register notice “to announce the availability of a revised 340B Rebate Model Pilot Program” that “provides a rebate mechanism through which qualifying drug manufacturers may effectuate the 340B ceiling price for certain drugs.” HRSA previously sought to implement a rebate model beginning this year but abandoned its approach following litigation from covered entities.

The pilot will commence on January 1, 2027, and is limited to “selected drugs for initial price applicability year 2026 and 2027 during their price applicability periods.” These are drugs that have a Maximum Fair Price (MFP) in effect following mandatory negotiation under the Inflation Reduction Act (IRA). Manufacturers of such drugs must apply by August 24, 2026, to enroll in the pilot.

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

LAWMAKERS IN CONGRESS CONSIDER 340B REFORM

A group of bipartisan senators has released proposed 340B reform legislation. This follows the release by Senator Bill Cassidy, M.D., chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, of his 340B draft legislation, which we discussed in issue No. 75 of this digest.

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

MANUFACTURER CLAIMS DATA REQUIREMENT FOR IN-HOUSE PHARMACY DISPENSES

As discussed in issue No. 64 of this digest, a growing number of manufacturers have begun requiring covered entities to submit claims-level data for all their 340B dispenses, including dispenses from in-house pharmacies. A second covered entity hospital has filed litigation to challenge one manufacturer’s policy, and stakeholders continue to discuss these policies and the litigation.

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

MANUFACTURER CHALLENGES TO STATE 340B LAWS CONTINUE

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

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

Medicare Part B

CMS PUBLISHES UPDATED ASP DATA COLLECTION SYSTEM USER GUIDES

The Centers for Medicare & Medicaid Services (CMS) updated its Average Sales Price (ASP) Education & Outreach website by posting updated ASP Data Collection System submitter and certifier user guides.

Medicare Part D

PART D REDESIGN SUBSIDIES TO END

On July 28, 2026, CMS announced the termination, at the end of this year, of the Part D Premium Stabilization Demonstration, the “voluntary demonstration for standalone prescription drug plans implemented in CY 2025 to address volatility and variation in standalone premiums following benefit changes” mandated by the IRA. The outgoing Biden administration had initiated this demonstration to reduce costs to Part D plans (and beneficiaries) resulting from the IRA’s redesign of the Part D benefit.

Sources: BloombergLaw (first, second, third), InsideHealthPolicy, PoliticoPro, StatNews, PinkSheet, 340B Report.

State Law Developments

COLORADO PDAB LEGAL CHALLENGE

Litigation challenging Colorado’s Prescription Drug Affordability Board (PDAB) upper payment limit (UPL) remains ongoing.

Sources: InsideHealthPolicy, Colorado Politics.