Palmetto MolDx Posts Five New Molecular LCDs - Plus Urine Drug Testing

On April 23, 2020, Palmetto Jurisdiction M, the home jurisdiction for MolDx, published five new MolDx-branded LCDs, plus a sixth LCD of interest to the lab community, on urine drug testing.

Comment periods started April 23, run to June 6.   Palmetto will hold a public meeting, I believe, but is no longer required to hold a former Contractor Advisory Committee meeting. 

The MolDx LCDs should propagate to other MolDx contractors - CGS, WPS, Noridian. 

I'm not sure if the UDT test, which is not branded "MolDx," will be picked up by other contractors; it's possible.

• DL38566 - Phenotypic Markers in Circulating Tumor Cells
• DL38558 - Liquid Biopsies in Solid Organ Transplant
• DL37264 - Endopredict Test in Breast Cancer
• DL37794 - BCI Test in Breast Cancer
• DL38576 - Predictive, Prognostic Tests in Bladder Cancer
• DL38557 - Urine Drug Testing

To see the LCD proposals and check for updates, I recommend you go to the Palmetto LCD policy page (here)  and at the bottom, click on Proposed LCD Status Report.  This will send you to the CMS web page; note the relevant LCDs may be on one or more CMS web pages (click next-page).

Making Your Life Easier:

I've put the diagnostic LCDs in one open access zip file in the cloud - here.

Liquid Biopsy in Solid Transplants

MolDx already has a two-year-old LCD for CareDx AlloSure Test based on circulating donor DNA.  MolDx also produced an LCD last year for the Natera Prospera based on circulating donor DNA.  Eurofins also has a donor DNA transplant test, and there may be other companies entering this space in the future.

MolDx, since August 2019, has started to exhibit a strong preference for writing "umbrella" LCDs wherever possible, to avoid writing 2,3,4 or more individual single-brand LCDs.   That seems to be the intention with the "Liquid Biopsy Solid Transplant" test.   Typically it takes literally most of a year for a MolDx LCD to propagate among the several MolDx independent MACs and get finalized (I've got the data to back up that "almost a year" point, as long as you include the word "typically.")  It's unclear if MolDx would have concurrent brand-specific LCDs in this space a year from now, or shift to one umbrella LCD, once it is finalized and in place.

 CTC for Phenotypic Markers

This LCD has a broad title but the content is restricted to Her-2-neu CTC detection.