CMS issues some minor revisions to the CLIA operations manual. Most seem to focus on mult-site locatons under one CLIA certificate, but review all changes closely.
https://www.cms.gov/files/document/r230soma.pdf
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BREAST CANCER DCIS
MolDx brings out a biomarker LCD for risk stratification in DCIS (breast cancer in situ). The LCD appears to distinguish between "rhetorical proof" and "enough data."
For LCD DL40142 The request letter appears to be from June 10, 2020, for DCISionRT. It gives conditions under which a test COULD be covered, but if I read it correctly, no existing test meets that bar yet. MolDx writes,
"While it is desirable to have a tool that identifies a population with no relative risk reduction from RT (claimed lack of response to RT) for decision making and for supporting such decisions as a rhetorical proof, we conclude that there is insufficient data currently to convincingly support the assertion that any current biomarker test has demonstrated it can identify such a population, nor does this contractor believe this is a reasonable nor a necessary requirement for a useful test. This was a central rationale presented at the CAC by SMEs for use of such tests, yet this assertion is most easily explained by a failure to identify statistical significance of RT use in the low-risk groups by an underpowered data set from which such conclusions could not be drawn."
MolDx appears to cite lack of proof of improved performanced and outcomes with molecular testing. Writing,
"clinicopathologic risk assessments have demonstrated the ability to identify sufficiently low-risk patients and can be accessed by anyone. The advancement of newer technologies must come with direct comparison to the current best options available and be founded on the best-available evidence. To date, the only published direct comparisons of a biomarker test to one of these clinicopathologic risk assessments (in a Medicare-relevant population) has not demonstrated a significant difference in risk stratification[55] or improved performance.[54]
My conclusion that the LCD doesn't cover any current DCIS test is supported by the lack of any coding or billing article. And the non-coverage conclusion was also the reading of Chat GPT AI. See AI article here. I also ask Chat GPT what the heck the term "rhetorical proof" means.
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SOLID ORGAN TRANSPLANT
MolDx also rolls out Molecular Testing for Solid Organ Graft Rejectiion, L40058. It's based in part on a 11/2022 CAC meeting. If I'm reading it correctly, it is presented as a new LCD and not a revision.
It will be important to closely compare this proposal to the existing graft rejection LCD. Topics like coverage of "surveillance" testing have been under discussion for several years. MolDx had an original LCD, then an updated LCD that lingered a year before being canceled (including a CMS presss release!), and then a promise that "someday" a new revised LCD would appear. So that "someday" seems to be today, July 17. Meanwhile, in the field of transplant as well as the field of MRD, MolDx has been tucking more and more key information into the text of families of Z codes rather than into LCDs or billing articles - here.
The draft LCD specifically refers to "surveillance" timepoints as 4 per year 1 (Kidney), 12 per year 1 (heart, lung), and 2 per year thereafter.
Here are the full transplant LCD rules, as well as an AI structured re-rewrite of the LCD rules.
https://brucedocumentblog.blogspot.com/2025/07/ai-explains-moldx-transplant-lcd.html
CareDx Market Cap Falls
In early trading on July 17, CareDx was down about 40%, from around $20 to $12.
