Thursday, April 22, 2021

MolDx Finalizes Broad Coverage of LBx cfDNA for Transplant Rejection

Several years ago, the MolDx program provided coverage of the CareDx test AlloSure, which detects leakage of donor organ DNA to recognize transplant rejection.

On April 22, 2021, MolDx released a revised policy that's notable for several reasons.  

First, it's not a policy for one branded test, but for a family of tests with a common indication.  MolDx calls these "foundational" policies (I think of them as "categorical" or "umbrella" policies).  

Second, the scope isn't limited to liquid biopsy cfDNA tests, but includes gene expression tests as well.   Thus, either technology may be covered under this LCD, as long as they serve the common purpose of organ transplant rejection diagnostics.  This is an expansion of scope; the original LCD was proposed as "Liquid Biopsies for Organ Transplant Rejection."  

Consistent with the expansion of scope, the final LCD is heavily redlined (some parts are about 80% redline, 20% original).   This is in contrast to quite a few LCDs, which have minimal changes from draft to final.

The LCD has 37 references.  The policy took nearly a year to finish; the release date in the draft is listed as 4/23/2020.

  • See the new MolDx policy here.
    • L38568; effective 6/6/2021.
    • Helpfully, we already have a billing and coding article, A58010, here.
    • There's a Q&A of comments submitted, A58675, here.  
    • >> Some interesting comments in there.
  • See a single cloud zip file with the draft, final LCDs, and the articles and the redline here.
  • See an article on the policy's release, at Genomeweb, here.
  • See CareDx press release here.
    • CareDx did not move much today, but its share price of $76 is near-high, and about double the average price ($20-35) the last couple years.  
    • The stock tripled from $21 on March 1, 2020, to $68 on March 1, 2021.

The final policy was extensively redlined.