Legal Update, July 2023

Legal Update

Lawsuits on Implementation of Medicare Drug Pricing Negotiation
by Elizabeth “Issie” Karan, Hemophilia Alliance Legal Counsel

In recent weeks, pharmaceutical manufacturers, including Merk, Bristol-Myers Squibb, and PhRMA, and the Chamber of Commerce have filed a slew of lawsuits challenging the Medicare Drug Price Negotiation Program authorized by the Inflation Reduction Act. Merck argued before the DC District Court that the law unfairly forces companies to participate in Medicare’s “price-setting,” and compared the program to “when a regime forces political prisoners to accept responsibility at show trials before they are shipped to the gulag.” Now the Chamber of Commerce has filed a motion for a preliminary injunction, requesting a halt to the agency’s drug price negotiation program while the group’s legal challenge proceeds.

Medicare price negotiations are set to take place over the course of 2023 and 2024, with the established prices not expected to go into effect until the start of 2026. However, these lawsuits could delay that timeline. Importantly for HTCs, Medicare Drug Pricing Negotiations only implicates Part D medications at first, which would not include treatments for bleeding and clotting disorders.

Also in this Issue…

Notes from Joe
· Gene Therapy is Here, Now What?

Notes from the Community
· First Hemophilia Patient to Receive Gene Therapy Outside Clinical Trials

Alliance Update
· Gene Therapy Update Webinar
· Alliance Member Needs Assessment
· Order Your Printed Product Guide NOW!

Payer Update
· Hemophilia Alliance Welcomes Kollet Koulianos
· What the Data Shows on Copay Accumulator Adjustment Programs

Advocacy Update
· Washington, DC’s HOT July

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