I had really hoped that nothing was going to happen over the latter half of last week so that we could all ease into the end-of-year sprint. But it turns out there were a lot of interesting items leading into the long weekend. So …
I won’t get to everything today — there’s a bunch of papers and opinion pieces that I’m triaging — but I’ll catch up over the course of the week.
The best way I can think of to kick off the rest of the year is by documenting the items that I’ll be waiting for over the remainder of 2024. Some of these are expected and probably won’t create waves. Others could create seismic changes.
Here’s what my list looks like:
The FTC lawsuit over insulin/rebates
This was promised back in July, and it still hasn’t emerged. I have no particularly compelling hypothesis for what the hold-up, but this feels like one where the FTC is way too invested not to move forward.
Finalization of march-in rights rules
Reuters, back in May, said this was coming “within days.” I have an elaborate, conspiracy-minded theory on what’s going on with the delay that I won’t share here because of my high editorial standards, but I still wake up every morning wondering if today is the day.
340B legislation drops
We already have two competing bills around 340B percolating, but the big one — backed by a group of six Senators — hasn’t dropped yet. That’s supposedly an any-day-now thing, but there are big Charlie-Brown-kicking-the-football vibes here. Every time the bill’s introduction is promised, it gets pushed back. Turns out this stuff is hard, but it feels like there’s been too much hype for the Senators not to do something.
Appeals court decision in the PhRMA IRA suit
Oral arguments in the PhRMA case happened back in May, but the appellate system is not known for expediency. I think the conventional wisdom is that the odds are against industry, even on appeal, but all it takes is one decision to swing the whole thing to the Supreme Court (maybe).
More NYT PBM revelations
When the New York Times dropped its front-page takedown on PBMs, it promised that the piece would be “the first article in a series.” And yet — 10 weeks later — we’ve yet to see the rest of the series. It’s hard to imagine that the NYT doesn’t have at least a couple more Pulitzer-bait pieces lined up that need to run by the end of the year.
PBM reform legislation in the lame-duck session
It’s generally a sucker’s bet to wager on Congress doing anything, but there does seem to be rare, bipartisan consensus that the time has come for PBM reform. I’m not a Beltway guy, at least not anymore, so I don’t dare handicap this. But even if it doesn’t happen in 2024, it’s going to happen, and it’s going to generate plenty of ink along the way.
Final guidance for the 2027 IRA cycle
The general assumption, I think, is that the final guidance for 2027 will look like the draft guidance for 2027, which, in turn, looks a lot like the final guidance for 2026. CMS has its story, and it’s sticking to it. But it’s hard to rule out a CMS curveball.
Decisions in the Merck and Novo Nordisk IRA cases
There’s probably not a lot of drama about the outcomes here, but actual rulings will keep the IRA in headlines. In conjunction with speculation about the 2027 selected drugs, these are likely to keep the topic of exactly how coercive negotiations are — or could be — top of mind.
PDAB action in Maryland/Colorado
The process of creating state-level drug price controls is not a quick one, but the process continues to crawl forward in Maryland and Colorado, which are the states with the most advanced efforts. These are hugely process-driven endeavors, which makes it hard to track for those with short attention spans, but we’re getting ever closer to those states slapping prices on the meds.
***
That’s only a sampling. I expect there’s a handful of other milestones we can guess at something something smoothing, maybe some details on the Medicare Transaction Facilitator, and the next shoe (shoes) to drop in the battle over 340B policies following J&J’s gambit.
What are you all looking out for?
I don’t know if Rep. James Comer really wants to throw PBM leaders in jail, as the headlines suggest, but his effort to highlight questionable PBM practices — notably whether consumers are steered toward PBM pharmacies — is certainly having its intended effect, PR-wise.
The JNJ 340B move last month — pushing a rebate model for certain drugs and certain providers — remains a huge deal. J&J’s Blasine Penkowski gave the most complete view of the company’s thinking last week in a must-read LinkedIn post.
CAP NEWS: AARP, through an Avalere analysis, estimated that just over 3 million Medicare beneficiaries will benefit from the $2,000 out-of-pocket cap next year. About 1.4 million will see savings of more than $1,000. That’s great news for the most vulnerable, but — reality check — there are 56 million with a Medicare drug plan, so most Americans won’t notice.
MORE CAP NEWS: Bloomberg Law has a really good summary of the dispute over the CMS’ “stabilization” effort to keep Part D plans afloat in light of the costs imposed by the $2,000 cap. It includes an American Action Forum estimate for the size of the CMS investment here: $7.2 billion.
EVEN MORE CAP NEWS: Milliman released a report reminding everyone that most seniors won’t even have to spend $2,000 to hit the OOP cap because the cap isn’t calculated on actual out-of-pocket spending but rather what spending would be under the standard benefit. Makes sense to me. Makes sense to you, probably. Going to confuse the h*ck out of seniors. At least this will be a pleasant surprise for most.
“MTF” is a candidate for abbreviation of the year. Bloomberg Law — which has been on fire lately — has a nice piece about the “Medicare Transaction Facilitator” (which exists now most as a theory, not a functioning system) and the possibility of a real shitshow around how money flows through the system, post IRA.
Man, there are a lot of highly speculative numbers flying around about the financial burden of covering GLP-1 meds. A new study by the Harvard PORTAL folks suggested that the CV indications for the medicines could boost Medicare spending to as much as $145 billion. That’s the number in all the headlines, though the authors concede later in the paper that, with a narrower definition around CV and some real-world assumptions around use, the number might be closer to $10 billion a year. That’s both a) a lot of money, and b) a lot less than $145 billion.
Thanks for reading this far. I’m always flattered when folks share all or part of Cost Curve. All I ask is for a mention or tag. Bonus points if you can direct someone to the subscription page.
