Monday, February 5, 2024

MolDxOlogy: Nodify CDT Test Covered in Press Release; Not Covered in "DEX"

Recently, MolDx published an article that it would make coverage and non-coverage decisions on a certain code set of proteomic tests.  This comes in addition to MolDx's longstanding responsibility for DNA-RNA tests.   See my blog here.   See the MolDx article and code list here.

Some of these  codes step into a complex history.  

Outside of DEX: Medicare and XL2, Medicare and Nodify

For example, there was originally a MolDx LCD on the Biodesix BDX XL2 lung cancer proteomic test; iin the 2021-2022  time period, MolDx stripped the "MolDx" title word off the LCD, but kept the LCD in place.  On the other hand, to my knowledge, there was never an LCD on the Biodesix Nodify test, although there is a press release stating it is covered by Medicare,

Inside of DEX:  XL2 and Nodify

A prominent posting on the MolDx home page refers readers to the DEX Registry for coverage status (here). Let's look up the Nodify test.  Going to the DEX registry, looking up Biodesix, and  selecting the subfield for its Kansas center, the Nodify test is listed, but listed as non covered.  

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This could be a typo; while the MolDx home page article sends readers to DEX to learn coverage status,  the footer on the DEX itself says that this site should not be relied on for coverage status.  It's just one of the complexities I file under "MolDxology."  

Let's try DEX and the XL2 test.  If you go to DEX and click on Biodesix/Seattle, the XL2 test is listed as, "Coverage has not been set."  But we already know, there is an LCD at Noridian (also at Palmetto here) covering XL2.    

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Conclusion? It make take a while for all the connections between local MAC coverage, and the MolDx coverage, and the Proteomics article, and the DEX registry, to sort out.

Another Puzzle - Proteomics Article and Proteomics-on-slides

Another entry point to multiplex proteomics is on-slide immunohistochemistry plus techniques like ML or AI.   I spot checked five or six slide+algorithm codes: just one of them was included on the MolDx article for Proteomics codes that now fall under MolDx.

From my proteomics article blog.

Proteomics on slides.  What about multiplex proteomics on slides - immunohistochemistry plus AI?   I have a quick list of 5 codes that are slides, often with IHC, + imaging + algorithms (ML or AI?).  These are 0220U, 0295U, 0376U, 0414U, 0418U.   (See pricing here).   MolDx seems to have included exactly 1 of these 5 codes in the Proteomics Article.  Why 0295U is included as "proteomics" and some of the others not, I haven't determined yet.


Copy of MolDx's "refer to Dex for coverage" -- here.