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The Government Strikes Back: HHS' Drops Its First Briefs in the Litigation Over the IRA

And insurance companies are refusing to cover Leqembi

The story of the lawsuits over the IRA’s price control provisions has largely been one-sided: we’ve heard from the companies and organizations suing the government to stop the program, but other than some anodyne quotes from the Biden administration, there hasn’t been a good sense of how HHS will respond to the suits.

But at midnight on Friday, that changed: HHS filed two briefs in the U.S. Chamber of Commerce lawsuit.

One was a formal opposition to the Chamber’s motion for a preliminary injunction to shut the whole price-control regime down until the legal issues are resolved. The other was the government’s motion to dismiss the suit altogether. (Bloomberg Law covered behind a paywall. I haven’t seen any other coverage.)

I wrote over the weekend about one fascinating argument that the government made: maybe price controls won’t be so bad. Maybe they’ll even lead to higher revenue. It’s a strange position for HHS to be taking, but all’s fair in love and litigation, I guess.

On the core legal issues, I saw two major takeaways.

On the specifics of the Chamber case, HHS leaned heavily into issues around standing. The government doesn’t think that the organization has the legal right to sue them.

The other takeaway is that the government is going to make a big deal about the price-control regime being “voluntary” because companies can refuse to take part by exiting government health programs. This is going to come across as absurd to industry, which knows that leaving Medicare is not financially viable or responsible from a patient-centricity standpoint.

So it sounds like the next great semantic battle will be over the word “voluntary.”

The other element here that caught my eye was a lack of much analysis of some of the core constitutional elements in the HHS briefs. The First Amendment claim, for example, pushed by the Chamber and all four drugmakers to file suit, wasn’t mentioned a single time in either of the HHS filings.

(As a reminder: I’m not a lawyer, and my decision not to enroll in law school a quarter-century ago looks foolish on mornings like this. Not legal advice. Caveat emptor. Etc.)

quick turns
  • The Association Press has found at least three insurance companies that are already on the record as refusing to cover the Leqembi Alzheimer’s treatment, with others -- including United Healthcare -- unwilling to comment. I’m trying to think of any other examples where a fully approved, novel med was out-and-out uncovered at full approval. Let me know what I’m missing.

  • Endpoints has some of the details on how Novo is expanding its lobbying efforts as it pushes for Medicare coverage of obesity drugs. I’m quoted, too, trying to distill down a week’s worth of thinking into a pithy sound bite.

  • Last month, the FTC made a big show of disavowing some of their old, pro-PBM arguments in an effort to get the PBM industry to stop referencing them. The PBMs didn’t want to listen, apparently.

  • A lot of patients who were treated with Novartis’ $2 million-plus gene therapy, Zolgensma, are still requiring treatment with existing chronic therapies, according to this Reuters piece showcasing how Novartis, patients and doctors are moving from a “potentially curative” language to a “one-time treatment” frame. Courtney Rice’s LinkedIn page has some worthwhile commentary on the piece.

  • I don’t think there is anything new in this Axios piece about the state of PBM reform, but it’s a nice summary. (It’s also the kind of story that strains Axios’ “Smart Brevity” format. Seventeen bullet points? Really?)

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