Saturday, June 24, 2023

And Then A Miracle Occurs: Veracyte Test 0261U Doubles in Price after Castle Test 0108U Becomes ADLT


Code 0261U was crosswalked to code 0108U when the latter was priced $2350.  Under ADLT rules, 0108U doubled in price to $4950, and so did 0261U.


I'm frequently asked about artificial intelligence and CMS coding - including lab coding.  While many battles are being waged over the CMS valuation  of AI and Machine Learning, a few proprietary lab tests have terms like these in their titles, and are priced through the mechanics of lab test policy.

One of the first to be so priced was code 0108U.   Later, another test, 0261U, was crosswalked to that price.  So far, easy to understand.

Later, code 0108U became an ADLT test - an Advanced Diagnostic Laboratory Test priced under special rules, for three quarters at list price and then, based on its median payor price as reported to CMS.

Under the median price process, 0108U shot up from $2350 to $4950.   And miraculously, code 0261U, which is crosswalked to the price (current price) of 0108U, also doubled in price to $4950.

That's the main story.  Nerdy details below.



Go way back to the June 2019 CLFS meeting, and you'll find a presentation for Cernostics for its "Tissue Cypher" Barrett's esophagus test.   It was sent to the Gapfill process, which in 2020 resulted in a price of $2513.

0108U [Tissue Cypher, Cernostics] Gastroenterology (Barrett’s esophagus), whole slide–digital imaging, including morphometric analysis, computer-assisted quantitative immunolabeling of 9 protein biomarkers (p16, AMACR, p53, CD68, COX-2, CD45RO, HIF1a, HER-2, K20) and morphology, formalin-fixed paraffin-embedded tissue, algorithm reported as risk of progression to high-grade dysplasia or cancer. 

That would seem to be the end of that.

Then, as I noted in a November 2021 blog, new code 0261U was crosswalked by CMS to the 0108U price.  Blog here.

0261U ["Immunoscore," HalioDx] Oncology (colorectal cancer), image analysis with artificial intelligence assessment of 4 histologic and immunohistochemical features (CD3 and CD8 within tumor-stroma border and tumor core), tissue, reported as immune response and recurrence-risk score.

But Wait, There's More

CMS has created a total of 13 "ADLT" tests, presented on a CMS spreadsheet here:

As you can see, the 0108U test (now owned by Castle Bioscience) became an ADLT test in 4/2022 and got a new price, $2350.   This is actually a bit lower than the $2513 price from its crosswalk.  ADLT initial price is meticulously defined by CMS as the lowest price available to to the public on the first day the test was offered to the public.  We can infer, whenever that day was back in 2018 or 2019, its list price was $2350 not $2513.

That list price held from April 1, 2022, for three quarters - until the end of 2022.  Then, by the PAMA regulations, 0108U is assigned a new price, which is the median price of private insurer payments during the three quarters just mentioned.   THAT price was apparently $4950, so the new price is $4950 in CY2023 now.

And that's where the surprise comes from.  The world may have long forgotten that 0261U was crosswalked to the price of 0108U, but CMS computers know that.  And the price of 0261U was therefore upped to $4950.   If look at the current Clin Lab Fee Schedule for Spring 2023, you'll find the current prices of both 0108U and 0261U are $4950.


How long will this price last?  

There's one answer for 0108U and a different answer for 0261U.

Castle would report its ADLT data for 1H2023 (now) to CMS in 1Q2024, and that will set a new price for CY2025 for 0108U.

The next PAMA reporting period for 0261U would reset its OWN price (no longer crosswalked) based on price data from 1H2019.  But 0261U was only first active in Fall 2021, so it won't be part of the PAMA reporting in 1Q2024 based on data from 1H2019.   Therefore, my guess is, 0261U will remain yoked to 0108U until 0261U gets is own (every-three-year) PAMA reporting.   That is scheduled to be 0261U reporting its 1H2025 paymens to CMS in 1Q2026 for a price in 1/1/2027.  Unless 0261U becomes an ADLT on its own.  


AMA Use of "AI"

Note that 0108U describes its method as computer-assisted immunohistochem (plus algorithm) whereas 0261U includes the term "artificial intelligence."  I've heard at AMA meetings that since around 2022 they are avoiding adding the term AI to future coding.   


Ancient 0108U History.  

Four years ago, in June 2019, according to a file copy I have, Cernostics asked CMS to CW 0108U to 81538, which is the Biodesix Veristrat test.  That test was the second of all ADLT tests, from 2018.   81538 current price is $2871, as an ADLT since 2018, and unchanged for several years.  

Veracyte acquired HaldioDx in June 2021.  Veracyte announced in September 2022 it was discontinuing production of Immunoscore CRC test.

Castle acquired Cernostics in October 2021.   0108U became an ADLT in April 2022.

See MOLDX policies for Barrett tests here.

In CY2021, Pt B national utilization data, 0108U paid Part B claims were 18 claims, pmt $45,000.

0261U claims were not shown.


At the June 21, 2023 CLFS new code pricing meeting, Artera asked CMS to crosswalk its new code, 0376U, to one-half the price of 0261U (which in turn, is crosswalked to 0108U).  

0376U code text is, "Oncology (prostate cancer), image analysis of at least 128 histologic features and clinical factors, prognostic algorithm determining the risk of distant metastases, and prostate cancer specific mortality, includes predictive algorithm to androgen deprivationtherapy response, if appropriate."