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PACER filings: 340B drug pricing · October 14, 2026 · Primary source

AMERICAN HOSPITAL ASSOCIATION v. KENNEDY

Score 75PRIMARYregulatoryFederal court

Summary

This is Exhibit A to a filing in American Hospital Association v. Kennedy (D. Me., No. 26-cv-00515-LEW), consisting of AbbVie's 340B Rebate Model Pilot Plan for IMBRUVICA (ibrutinib). The exhibit connects AbbVie's rebate model proposal to the IRA Medicare Drug Price Negotiation program, with CMS identifying Pharmacyclics LLC as the primary manufacturer for IRA purposes. The document was filed October 14, 2026 in support of plaintiffs' motion in a case challenging HHS policy affecting 340B covered entities.

What this may mean

The exhibit surfaces the intersection of the IRA negotiated drug pricing framework and the 340B program, specifically how a manufacturer's rebate model pilot interacts with 340B covered entities' acquisition costs and discounts for IMBRUVICA. Hospitals and FQHCs participating in the 340B program that purchase IMBRUVICA face potential changes to their discount structure if a rebate-based model displaces the current upfront discount model.

Informational only. Not legal, medical, financial, or other professional advice. Always consult a qualified professional familiar with your specific facts before relying on any item.

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