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CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. Non-applicable drugs (e.g., of the total expenditures for all Part D drugs in 2021.

Labelling 105
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NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

Putting Patients First Blog

The NHC remains concerned about the effects that the aggregation of drugs with the same active moiety or active ingredient in the selection process could have on subsequent research. Without appropriate guardrails, CMS’ broad definition of drugs eligible for negotiation may discourage these types of improvements.