Notes on AI Pathology Pricing at CMS

Here are some quickly collated notes AI Pathology pricing at CMS.

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In May 2023, the Prelude multi-slide AI test, 0295U, won ADLT status, and the price rose to $5435, almost triple the $1897 price that had been set earlier by gapfill by MolDx for it.

https://www.discoveriesinhealthpolicy.com/2023/05/nerd-corner-ihcalgorithm-test-gets-adlt.html   

The ADLT status also flipped its payment status for hospital outpatient specimens to "payable", as I describe in the blog linked above.

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Another slide-AI code, 0108U, is priced as an ADLT at $4950, and this caused the price of a code crosswalked to it (HalioDx 0261U), to also double to $4950 passively.

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In summer and fall 2023, CMS had the chance to price several new PLA codes for slides plus AI, and CMS chose a much cheaper crosswalk, at only about $700.   I'll give the blog link next and then quote it.

https://www.discoveriesinhealthpolicy.com/2023/11/cms-posts-final-prices-for-new-lab.html

3 Slide-AI Codes All $600

There were 3 codes for AI-enhanced slide-based imaging, 0376U (Artera AI Prostate), 0414U (former X084U, LungOI Imagene), 0418U (former X088U, PreciseDX Breast Bx).  Requested prices were as high as the $2500 range (Artera request).   

The expert panel, the CMS proposed  price, and the CMS final price were all crosswalk to 0220U (PreciseDx Breast) at about $700.    (I've noted earlier that if you views "slides + AI" as a category, prices have reached as high as $5435 for ADLT pricing of the Prelude DCISioniRT test 0295U) or $4950 (in the case of 0108U, 0261U).  

Labs in this $700 price group can appeal, meaning the price would be revisited next summer.

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 Category III Digital Pathology Codes

I discussed some of the administrative problems with these codes in an August 2023 blog.

https://www.discoveriesinhealthpolicy.com/2023/08/novitas-publishes-article-on-t-codes.html

The codes are add on codes so they must be on the same claim same day same lab as the primary service.    The codes are unpriced, which usually makes payment very slow and difficult.   The codes are "bundled" in the CMS outpatient setting, where many biopsies originate.   (They are also bundled in the DRG inpatient setting).   Thus, there are many high barriers to use of these codes, some of which can't be overcome (inpatient bundling).

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I covered a CAP TODAY article on digital pathology in December 2023.

https://www.discoveriesinhealthpolicy.com/2023/12/cap-today-continues-rising-coverage-of.html

I also quoted myself in brief, on problems with the Cat III dig path codes:

BQ: There are a couple problems with the Category III codes.  (1) They are structured as add-on (+) codes, so they must be on the same claim same day as the original surg path (or staining) codes.  (2) A huge proportion of relevant specimens originate in hospital outpatient (or inpatient) environments, where CMS has made the codes nonpayable (bundled or packaged).

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In an AI experiment, in July 2023, I dumped 50 new abstracts on digital pathology into Chat GPT and got summaries and discussions about them.

https://www.discoveriesinhealthpolicy.com/2023/07/ai-corner-ai-consolidates-50-new.html