CMS Proposes New Rules on How It Will Implement the IRA

I’m to my eyeballs, quite literally, in moving boxes, but all of my possessions are now -- somewhere, theoretically -- inside my new home. The dog is adjusting. My back hurts. And I have several hours of furniture assembly ahead of me. 

A pox on hex wrenches. 

So today is briefer than it would otherwise be, and I’ll have some catching up to do over the next couple of days. Bear with me. 

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I didn’t want to take today off, because there was some fairly significant news that dropped right as I was about to pull into Interstate 80 on Friday: CMS released its guidance for how it will implement the IRA for selected drugs in the 2027 cycle (these are the medicines that will be announced next February). 

The guidance itself is 136 pages (there is also a fact sheet that has a nice timeline but is otherwise of questionable utility). I’m guessing there is a noteworthy revelation (or two!) on every page, and I imagine we’ll get some good analyses as the experts have a chance to really interrogate the document. But right now, commentary has been limited.* 

All that to say: I’m not being comprehensive below.** But I do think there are at least three things that matter to communicators: 

• CMS wants to revamp how it gets patient feedback. I’ve been pretty vocal that they did a crap job of it last time around, and there’s no shortage of opinions on how they can do it better. CMS isn’t saying exactly what they want, but Page 89 of the guidance gets at the current thinking over there, and it’s … better? Still, CMS is waffling a bit on how public and transparent the process should be, so I’m withholding judgment. 

• CMS isn’t ready to hold PBMs accountable. The big way that the whole IRA experiment could go off the rails for proponents is if prices get whacked … and patients don’t see any benefit. It’s not difficult to imagine why that might happen: PBMs will lose access to rebating on price-controlled drugs, depriving them as a tool to drive revenue and flexibility. That might prompt them to discourage use of the price-controlled products. So lots of folks have asked CMS to make some rules to prevent that behavior. CMS said it’s not willing to commit to actual standards around formulary placement, etc., but it did seem to recognize the issue and define some of the behavior that might prompt it to act. (Page 123) Still, it feels like CMS is making threats, not promises. 

• 340B is going to be a mess. IRA is going to interact with 340B in ways that are complex, with the actual price that the government pays varying based on 340B discounts and status. But CMS disavowed responsibility for “deduplicating discounts between the 340B ceiling price and [IRA maximum prices].” This is all still fairly technical and wonky, and the communications pull-through here is that frustration with technical and wonky things is only going to further raise the profile of 340B and amplify calls for reform.

None of this is set in stone, and comments are being accepted through July 2. Looking forward to poring over those as they’re made public. Because I suspect a lot of people will have a lot of opinions. 

And if you see some good thoughts here, let me know, and I’ll make sure they get seen.

* Even though this is a pretty important document -- “noteworthy” is probably underselling it -- coverage has been minimal. Bloomberg Law has a good piece that you should read. 

** Part of “not being comprehensive” means that I don’t have a hot take on one of the important bits of the guidance, which is discussed a bit in the aforementioned Bloomberg Law piece: the “Medicare Transaction Facilitator” that will ensure, like, everyone gets paid. The technical bits there are not scintillating, and the communications implications aren’t clear yet, but that doesn’t mean it’s not going to be really, really important.

Header image via Flickr user Aart van Bezooijen.