Kathleen Peterson

Hogan Lovells

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Latest Posts › Manufacturers

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CMS Issues Final Guidance on IRA 2027 Drug Price Negotiation Program, 2026-27 MFP Effectuation

On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more

10/8/2024 / Centers for Medicare & Medicaid Services (CMS) , Drug Pricing , Final Guidance , Inflation Reduction Act (IRA) , Manufacturers , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

7/30/2024 / Biosimilars , Centers for Medicare & Medicaid Services (CMS) , Manufacturers , Medicare Part B , OIG , Pharmaceutical Industry , Popular , Prescription Drugs

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

Medicaid Drug Rebate Program: CMS addresses authorized generics, drug category narrow exception in manufacturer releases 112 and...

The Centers for Medicare & Medicaid Services (CMS) recently issued two manufacturer releases. The first provides further information regarding the treatment of sales of authorized generic drugs in the Average Manufacturer...more

6/10/2020 / Centers for Medicare & Medicaid Services (CMS) , Generic Drugs , Manufacturers , Medicaid , Medicaid Drug Rebate Program

To the Spoiler Go the Spoils: OIG Approves Limited Product Replacement Program

A perennial question for manufacturers of drugs and biologicals that require specialized handling, storage, or reconstitution is how to handle circumstances in which the product is spoiled, breaks, or otherwise becomes...more

8/31/2017 / Biologics , Manufacturers , OIG , Patient Safety , Pharmaceutical Industry

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