Thursday, September 1, 2022

MolDx Releases Draft LCD for Molecular Therapy Selection in Arthritis (Doesn't Like It)

MolDx has released a brand new LCD for public comment, under the title, MolDX: Molecular Biomarker Testing to Guide Targeted Therapy Selection in Rheumatoid Arthritis, LCD DL39242.

Find the listing of newly released draft LCDs here.  Open DL39424 here.  Comment runs until October 15. 

When you click on the link, you get both the LCD page and, for me, a pop open window that floats on top that gives a summary with the issue, the requestor (if any), and links to documents.  Note that the issue description is terse:  "This LCD outlines non coverage for this service with specific details." 

The request is a two-page cover sheet to a submitted dossier (not provided).  The two-page cover sheet here gives a table of contents of what was submitted, but not the actual content.  For example, we don't know what indication or intended use was requested.  (See *) The cover sheet is also undated, so we don't know the time lag between the LCD request and the execution (so to speak).   The requested coverage is for the PrismRA test.  We do read here, in the new cover materials, there was a contractor advisory meeting back on December 7, 2021.

While the request was from PrismRA, the non coverage is broader, "Current molecular biomarker tests to guide targeted therapy selection in Rheumatoid Arthritis (RA) are non-covered by this contractor."  Note that MolDx now only directs itself to molecular tests, so a proteomic RA test would be out of scope.

The LCD has 88 citations.

The contractor meeting for this topic, and others in the past two years, are posted here:

Note that the December 7, 2021 meeting is listed in order under its "posting date" which was 1/13/2022.  I wrote about it a bit, at the time.  

No billing article is attached.  (A billing article could be pro forma, even with a non coverage LCD, such as "for denials and appeals, bill this way."  However, such a draft article wouldn't attract much public comment.)

I wasn't able to identify a CPT (or PLA) code for PrismRA, suggesting it doesn't yet have a defined Medicare price.  The website for the test is here:

The parent company appears to be in Waltham MA, so it isn't immediately clear why there is a MolDx LCD, since MolDx doesn't process Massachusetts claims.   The parent company SCIPHER raised $110M six months ago - here.

In contrast, I found a different LCD, related to melanoma, that had a full 14-page LCD request letter as an attachment.  That could be a useful model for readers, unlike the LCD request in this article today, which is basically redacted til only a table of contents is left.