CMS Seeks Feedback on Yet Another Round of Bureaucratic Forms
Published Date: 11/24/2025
Notice
Summary
The Centers for Medicare & Medicaid Services (CMS) wants your feedback on their plan to collect info from the public. This helps make sure the questions they ask aren’t too much work and actually useful. If you have thoughts, you’ve got until December 24, 2025, to speak up—no cost to comment, just your time!
Analyzed Economic Effects
2 provisions identified: 0 benefits, 1 costs, 1 mixed.
Medicare drug price caps in 2028
If you have Medicare Part B or Part D, maximum fair prices (MFPs) for up to 15 high‑expenditure, single‑source drugs will apply beginning in the initial price applicability year 2028. The negotiation period for those 2028 prices begins on the earlier of the date the Primary Manufacturer signs a Medicare Drug Price Negotiation Program Agreement or February 28, 2026.
Manufacturers must submit negotiation data
If you are a Primary Manufacturer (the NDA/BLA holder) of a selected drug, you must submit required negotiation data (including non‑Federal average manufacturer price and information tied to the negotiation factors) using Form CMS‑10849. CMS estimates 405 respondents, a one‑time submission frequency, and a total annual burden of 47,620 hours for this collection.
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