There's a Sherlock Holmes story where a dog barked at every stranger. Since the murder was committed on a night the dog didn't bark, Holmes concluded the murderer was someone known to the household.
Here, I'm putting together some puzzle pieces from recent CMS (and FDA) decisions.
Background Facts
In July proposed rulemaking, CMS proposed to take existing whole slide imaging codes, priced on the CMS clinical lab fee schedule and falling under its Clin Lab policies like Date of Service rule, ADLT rule, etc. And take those codes OFF the clinical lab fee schedule, and price them differently (temporarily on APCs in the OPPS setting, and by "contractor price" elsewhere.)
For me, the natural position was that those WSI tests - including advanced computational results from H&E - were CLIA tests, and simply had to go on the Clin Lab Fee Schedule - nothing to talk about.
For example, see a position paper from Digital Pathology Association on validation of AI "in the clinical lab" - a CLIA lab. Here, here. (Link 2, the paper, is open access, but you might need to enter from Link 1).
But CMS has pulled a range of WSI based codes (whether H&E or IHC) from the CLFS in its proposed rules, while skipping quite a few similar codes in the PLA system. (See Valar comment to CMS, link in this blog.)
Back to the Non Barking Dog
So anyway, here's my point about that non-barking dog.
When FDA approves lab tess (including big sole-lab tests like FMI Foundation One), it classifies them for CLIA.
FDA explains how it classifies IVDs in CLIA levels
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations
CLIA explains how this is FDA's job
https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/cartegorization
FDA clia database is here
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
If you search that database for Foundation Medicine, you'll find a number of tests. But look for Artera's tests - including their prostate test from 2025 based on H&E algorithm - and you won't find it.
So long before CMS proposed to knock H&E WSI algorithmic tests off the CLFS - which would require they "not" be CLIA tests - FDA was NOT putting them into the national FDA-CLIA database of FDA tests that were classed by FDA as "CLIA" tests.
It's just an isolated finding but I found it intriguing.
Hiding in plain sight - like the dog that didn't bark. There's apparently been some hesitation since 2025 whether H&E WSI tests - although for FDA "medical devices," might not also be "CLIA tests" in the CLIA database.
in contrast, for example, at the FDA-CLIA portal search "Dako," you'll get 81 hits. Search "Abbott" and you'll max-out the system at 500 hits.
