Update: I didn't know, until September, there was a press release from CareDx discussing this on August 16. It makes my point - MolDx insisted (in writing) that the draft version 2 LCD was an editorial update only, and made no change in coverage. Yet CareDx insists, also in writing, that the draft version 2 LCD would have changed and limited coverage. My only conclusion: The LCD text cannot be clear [discussion below].
##### Original Article:
Where I live, in Hollywood, we talk about scripts being "in turnaround." According to a new CMS press release today, MolDx's LCD for transplant genomic tests is "in turnaround," too.
Find the CMS press release here:
https://www.cms.gov/newsroom/press-releases/moldx-local-coverage-determination-statement
See coverage at 360Dx. According to 360Dx, CareDx CEO John Hannah "cheered the decision."
History
Back in Spring 2023, there was a tsunami of news (and stock price impacts) regarding nuances of policy and billing practices around transplant genomics. Principally, these are tests from CareDx and Natera that detect when sick transplant organs have dying cells that are releasing their non-native DNA.
In Summer 2023, MolDx released a slightly edited version of the LCD "for clarification only" but I found the rules confusing at best.
Could the LCD be Way More Clear? Yes.
The LCD could be far more clear, as I pointed out in a July 7 blog. MolDx now uses multiplex Z codes for specific covered clinical scenarios, like "test for cause" versus "test for surveillance." Why not simply rewrite the LCD on the same lines? As I wrote in July, it would be something like this:
We cover these donor DNA tests under two situations, "for cause" and "replacing surveillance." For "For cause" coverage, the patient and situation will meet these four rules. (1,2,3,4) For "For surveillance" coverage, the patient and situation will meet these other five rules (5,6,7,8,9).
As I remarked then, the structure of the LCD would become clear, if it just mapped and matched to the structure of the Z codes that MolDx already has.
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Wall Street Journal
I quote from my July blog:
Over the past year, there have been debates in the WSJ about MolDx's coverage regarding donor DNA testing (the saga started in March 2023 and reached WSJ September 10, September 22, September 26, February 22, April 18) and along the way, see also at least one CMS press release (February 29). See also brand new WSJ Op Ed on August 21, 2024 (here).
The Draft That's NOT Being Finaled
I quote again from my July blog, here giving links to redlines of the old and proposed LCD. For even more detail, see an August 10, 2023, blog by me.
MolDx issued a revision of the LCD (DL38568) on August 10, 2023, currently pending finalization. I posted a cloud-copy redline of the draft compared to the prior active version - here. The effective coverage rules are intertwined and reach circa 900 words long in the proposal. MolDx noted in August 2023 that the various revisions (here) were "clarity" only and that "no change in coverage" was implied by the new text and definitions and rules (stated as "synopsis of changes" in DL38568).
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| DL38568 (click to enlarge). Changes for clarity only (per MolDx own synopsis). |
