On the October 21, 2026, Abbott earnings call, there were some remarks on the pricing of Cologuard 2.0 in 2027 and forward.
I'll show the dialog, from Motley Fool transcript, and then some screen shots of the CMS pricing data and its sources.
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....Our next question will come from Vijay Kumar from Evercore ISI. Your line is open.
- Vijay Kumar: Hi, Robert. Good morning, and thank you for taking my question. I have 2 questions. Maybe I'll ask both of them upfront. One, a follow-up on this Exact. Did Cologuard 2.0, the next-gen Cologuard, did the reimbursement get cut, Robert? And what's the ASP for this blood test? It feels like Exact should accelerate. My second question was FY 2027. Thanks for the color on top line, but should we still be aiming for double-digit EPS growth? Thank you.
- Robert Ford: Yeah, sure. Let's talk about your first question regarding Cologuard Plus and getting a reimbursement cut. Listen, Cologuard Plus is a new test, so the process for setting CMS reimbursement is a little bit different versus tests that have been on the market for a while. We've been in active discussions with CMS. Conversations have been very productive.
- I'll just say the following. I find it very hard to imagine that when the process is done, that the reimbursement rate for Cologuard Plus would go down, and I'm just going to leave it at that. It is an interesting process, very different, I would say, from NCDs and some of the MedTech kind of process.
- So it's a little bit of a new process for us. But like I said, I'd be very surprised if that were to happen. [next topic] I think you [also] asked about the price of our blood test. Yeah, I'm not going to divulge that because for obvious competitive reasons. There's somewhat of a price that's been set by the market right now
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Cologuard Plus (aka "2") is PLA code 0464U, dating from July 1, 2024. It was FDA approved in October 2024.
In the summer of 2024, CMS initially proposed to crosswalk the 0464U price to that of older Cologuard 81528. But public comment followed, and in the final rates of November 2024, effective January 2025, the Cologuard price was set at $592 by crosswalk of 81327 x 3 (plus 82274). That's 81327 x 3 or $192 x 3.
PAMA currently surveyed paid prices in 1H2025, as reported to CMS in June-July 2026. 0464U was one of the codes that had NO reported PAMA pricing. You can see this on the master spreadsheet of PAMA results, because 0464U has its current price and no further data... no PAMA survey data.
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Since 0464U has no PAMA survey data to set the 2027 2028 2029 price, CMS had to crosswalk it or gapfill it. Since it had previously been crosswalked at 3 x 81327, CMS repeats that. You can see the currently proposed 2027 price - a crosswalk x 3 - in the next screen shot.
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You can see in the "recommendations" box, a lot of other crosswalks were suggested along the journey, besides 81327 x 3. Like 0433U, 0005U, 0399U, 81528, and gapfill.
The Fly in the Ointment
So far, you see that 0464U was crosswalked [mostly] to 81327 in Fall 2024, and lacking any other PAMA price, CMS is happy to repeat that for 2027. (In fact, they are retrieving and reusing over a hundred old crosswalks in this way).
The problem is, as shown in the next screenshot, PAMA has dutifully deflated the price of code 81327 from $192 down to $126 (when fully worked in).
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81327 Deep Dive
This is the distribution of 81327 PAMA data. Per CMS, 12 TINS reported. There were 66 events at 39 price levels from $33 to $461. No payments aggregated at the CMS rate of $192. Most specific prices occured only once or twice in the 66 events.
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ADLT
As far as I know, as a sole source FDA test Cologuard Plus could be converted to ADLT pricing, which would kick off at the lowest list price on the first date it was marketed to the public.
##Median = 34th event of 66 events
