Monday, July 19, 2021

Calendar Watch: MolDx LCDs for LBx MRD, and Hereditary Risk Genes


MolDx has had several very high-visibility LCDs recently, and I'll summarize quickly here.

Transplant Liquid Biopsy - Finalized in June

MoLDx brought out a general purpose LCD for the use of liquid biopsy (e.g. circulating donor DNA) in transplant management.  LCD L38568 was finalized in April, and became effective on June 5, 2021. Here.

Tumor Liquid Biopsy for Recurrence, Response - Waiting for September 23

MoLDx has a very important draft LCD for minimal disease detection, by liquid biopsy, in cancer.  It will cover both solid tumors and hematopoietic tumors, and use cases for both recurrence monitoring and for treatment response monitoring.  The comment period opened on September 24, 2020, so I believe the final must be issued online by September 23, 2021.  Read the draft DL38779 here.

Note this is a separate LCD from the one for detection of oncogene, driver genes, CDx genes by Lbx.

Hereditary Risk Genetic Testing - Comment Period Extended to July 31

This summer, MolDx proposed an unusual and far-reaching LCD for all types of inherited cancer syndrome genetic testing.   Coverage for specific genes and diseases would be specified by later articles released by the MAC on a rolling basis at its discretion.  The comment period has been EXTENDED by popular demand and runs to July 31, 2021.  Here.  DL38966.  MolDx remarks, "The extension is at the request of the provider community to allow additional time to gather and submit comments."

The MolDx (Palmetto) LCD home page is here.