Thursday, December 19, 2019

Very Brief Blog: Guardant Announces Expanded Coverage of G360 LBx Test from MolDx

CMS generally releases new proposed and new final LCDs on Thursdays.

According to a press release from Guardant on 12/19/2019, MolDx has finalized a proposed LCD, from earlier in the year, giving expanded coverage across cancer types for its Guardant360 assay.

See the press release here.

See a link to the LCD at CMS here.  I've put a cloud PDF copy here.


Last March, the LCD was released as DL38043 (Palmetto MAC).  At least for Jurisdiction J, the comment period closed June 20, giving exactly 6 months from the comments-close to the appearance of the final LCD (which is effective in +45 days from now).   It may be a lesser net time lag if some MolDx MACs ran a later comment cycle that Jurisdiction J.   MolDx may have been waiting for the release of a draft revised NCD for the national CMS NGS NCD, which appeared about October 28.

The "response to comments" document is online here (A57866).