FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Vaccine”: Because vaccines are excluded from the MDRP, CMS proposes to define them solely for purposes of the MDRP.

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FDA Law Blog

AUGUST 14, 2022

Medicare Part D redesign: The IRA changes Medicare Part D starting in 2025 by lowering the patient out-of-pocket (“OOP”) limit to $2,000, adjusted annually in subsequent years. Much has been written in the press and by analysts about the impact that these provisions will have on drug innovation, drug manufacturer revenues, and patient access.

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FDA Law Blog

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. Under all of these programs, patient co-insurance would be calculated based on the MFP so that patients receive the benefit of that price. The Part B rebate would exclude vaccines as well.

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Doctors for America

APRIL 29, 2025

The president and his cabinet’s decisions directly impact how we practice and care for our patients. However, this assessment comes with alarm – essential services our patients rely on and that we as clinicians need to provide high-quality, evidence-based care have been obliterated by seemingly haphazard decision-making.

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