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

Vaccines: Starting in 2023, Medicare Part D will cover all adult vaccines approved by the Advisory Committee on Immunization Practices (“ACIP”) without any deductible or coinsurance. In return for providing the MFP, manufacturers of selected drugs do receive coverage, but high utilization drugs are certain to have coverage anyway.

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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. The Part B rebate would exclude vaccines as well. Subtitle E is a slightly modified version of H.R. 3, the Elijah E.

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Doctors for America

APRIL 29, 2025

We hope that Commissioner Makary will utilize his experience to help ensure FDA puts patients over politics throughout his tenure. Both Secretary Kennedy and Commissioner Makary have proposed strategies to mitigate the “revolving door” between the government and the industries they regulate.

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