A few days ago, I published a long blog article that inferred and pieced together some apparent rules about how MolDx operates, and why and how some Noridian coverage is presented in different formats than can be found at any other MolDx MAC (here).
Today, I was checking progress of the CareDx Allosure LCD which was proposed in draft from in Fall 2019. DL38255 is the proposed policy, and it shows on CMS as being still in the (E)Edit (review) phase, not released to final. CMS link here, today's screen shot next:
However, if you click on the DL38255 link at CMS, you get the proposed LCD, with a recently appended comment that DL38255 was "Released to Final" on 8/12/2020. Link here, screen shot next. I'm told that in this use case, "released to final" is a CMS LCD term of art, and only means the LCD has entered a final edit process.
OK, no major surprises so far.
Surprises Are Tucked Into 150-Page Palmetto MAC PDF
Later, I was reviewing the new October 2020 150-page Provider Bulletin PDF on the Palmetto website, and it DID hold a few surprises. Find the October Bulletin here. Cloud copy here. (See upper right hand down-arrow to download).
In the October Bulletin, you can find information concerning the AlloSure policy that is not yet released at CMS.gov. See page 122 of the PDF.
Specifically, we can read that the new title will be, "MolDx: AlloSure OR EQUIVALENT Cell Free DNA Testing for Kidney and Heart Allografts," the number remaining L38255. L38255 will be accompanied by an article (shown in the PDF, but not yet on the CMS website), A58387, with billing instructions to submit code 81479 and the correct Z code. (As of today, A58387 isn't on the CMS website yet.)
DL 38255 (quick covers AlloSure Heart & Kidney) is stated to replace the much older, single purpose AlloSure Kidney LCD, L37266.
Finally, Palmetto via this PDF publishes the public comments received during the open comment period for DL38255. There were two, and we can read them on pages 124-128 of the Palmetto PDF.
- The first comment asks that the LCD be finalized as covering both AlloSure "OR EQUIVALENTS" - as Palmetto has done.
- The second comment is a lengthy comment from the CareDx company, running 3 pages. Palmetto provides a brief response noting that some of the CareDx remarks cite unpublished evidence, which Palmetto will evaluate in the future as it is published.
Analysis
The proposed LCD was for AlloSure test alone. The final policy is edited to become an "umbrella" or "foundational" policy for the class of DNA tests used in transplant rejection. Thus, this is another data point that validates theories in my "MolDx Mysteries" article a few days ago here.
For example, if you are entering the market with a DNA graft rejection test, you might be able to get coverage in a few weeks based on proving "equivalent" to AlloSure, whereas a few years ago, you might have had to wait a year or more for your own LCD, or a revision in the LCD itself that discusses your test. In "umbrella" or "foundational" Palmetto LCDs, the new tests are added by a coding/billing article, and no change is required in the text of the LCD itself.
It's not immediately obvious how this policy L38255 for "Allosure or equivalent tests" will interact with a separately- and more recently-proposed policy (April 2020) for "Liquid biopsies [no brand stated] for solid organ transplantation" which is Palmetto LCD DL38779.
