Mahmud Brifkani

Hogan Lovells

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Latest Posts › Food and Drug Administration (FDA)

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CMS Issues Revised Medicare Part B and Part D Inflation Rebate Guidance

On December 14, 2023, the Centers for Medicare & Medicaid Services (CMS) published two “revised” guidance documents implementing the Medicare Part B and Part D inflation rebate provisions of the Inflation Reduction Act of...more

12/19/2023 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Food and Drug Administration (FDA) , Manufacturers , Medicaid Drug Rebate Program , Medicare , Medicare Part B , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS issues initial guidance on Drug Price Negotiation Program

On March 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued initial guidance on the Drug Price Negotiation Program, which was established under the Inflation Reduction Act (IRA) on August 16, 2022. The Drug...more

3/20/2023 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Food and Drug Administration (FDA) , Inflation Reduction Act (IRA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

Senate Passes Drug Pricing Legislation

On August 7, 2022, the Senate passed the proposed Inflation Reduction Act of 2022, which includes a number of significant drug pricing-related provisions. The bill generally revives many of the drug pricing provisions...more

8/8/2022 / Drug Pricing , Food and Drug Administration (FDA) , Health Care Providers , Life Sciences , Medicare , Pharmaceutical Industry , Prescription Drugs

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