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Alice Valder Curran

Jul 30, 2026

4:19
So let's talk about that.
4:21
Sure.
4:22
So the, the news here is really a redo of what CMS tried to do in the guidance for 2028.
4:29
So as a reminder, CMS identifies selected drugs.
4:34
They, they start by saying, "What is a qualifying single source drug?" And then they rank the qualifying single source drugs based on Medicare spend, and then the top spend drugs they, they pick, um, for negotiation, in air quotes.
4:46
Um, CMS continues to define a qualifying single source drug by reference to an active moiety, in the case of a small molecule NDA product or active ingredient, for purposes of BLA or biologics products.
5:01
And CMS's definition in particular says that all drugs that share an active moiety with the, even if in multiple NDAs or share active ingredient, even if it's multiple BLAs, where all of those NDAs or BLAs are held by the same manufacturer, are going to be considered a single QSSD, qualifying single source drug, for selection and negotiation purposes.

13 MINS LATER

18:42
There's even newer stuff

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