I was interested in how many LCDs the different MACs produce for lab diagnostics (MolDx, Novitas, Wellpoint Federal [former NGS MAC].)
To my surprise, Chat GPT was able to follow instructions, search the CMS database for different parameters, and produce clean tables as output. It could also volunteer insights along the way.
You can see my long dialog with Chat GPT in a PDF, and also get Excel tables for MolDx, Novitas, Wellpoint, in this cloud zip file.
https://drive.google.com/file/d/1ASG_aO-28uEDD8qiujrb4OzUTqFitxlx/view?usp=sharing
MolDx
For a 3-year period, it pulled 7 LCDs, although only one or two (L39583, Squamous Risk Stratification) were for wholly new tests. Some LCDs brought older coverage under one new foundational policy. A couple were for well-known guideline hereditary genes e.g. L39953, genes for thoracic aorta designs. These are important LCDs, but if YOUR test is some "wholly novel idea," you'd be asking, how many such LCDs they put out, not which genes are covered for aortic aneurysms.
Of course, MolDx specializes in broad "foundational" LCDs, so new tests from new labs are added on a rolling basis via Z code activation.
Regarding timelines, request received to LCD draft released, shows ~800 days was typical (range, 724-1494 days).
Novitas
At Novitas, Chat GPT followed the same template and found just one new diagnostics LCD, L39365 which non covers 9 or 9 proprietary LDT oncology tests.
There was no request-to-final time, as it was internally generated. However, the record does show it dragged through comment and revisions for about 30 months, a kind of timeline check.
Wellpoint
Chat GPT tallied 3 LCDs at Wellpoint, l39611 for urine drug testing, L39995 for PGx (very similar to MolDx LCD for PGx0, and l39726 for "KidneyIntelX." Only the third, KidneyIntelX, would be of interest as a "wholly novel test" LCD.
As to timeline, none listed a formal request-letter of record. However, clever AI reports that Renalytix publicly stated it had submitted an LCD request in October 2022, and the LCD was finaled in June 2024, so we can infer about 20 months from request to final LCD.
There was a CAC along the way, in August 2023. Code 0407U for KidneyIntelX had about 250 CMS payments in 2024. RENX 2018-2025 raised about $220M for a current market cap of $15M.
Take Home Lesson for Innovators
In the three years studied, Chat GPT (working on its own) reports 9 LDT non coverage decisions at Novitas (1 LCD); 1 novel test LCD at Wellpoint, and several novel LCDs (like one on squamous cancer MAAA) at MolDx. As noted, counting at MolDx was more complex; guideline-matching hereditary gene coverage probably is not germane for someone with a new-out-of-the-box creation.
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