Medicare has blown past a number of statutory NCD deadlines in the past year, something that never occurred in the previous decade. Missing of deadlines began in 2018 or 2019, before the current pandemic.
The agency missed another one on August 28. On February 28, 2020, CMS opened an NCD on the Epigenomics Epi proColon blood test, and FDA approved/PMA test screening for colorectal cancer. The opening was based on a nearly-year-old, April 2019 letter from Epigenomics to CMS (here). ( don't know, but I'm guessing, company communications with CMS likely started after the 2016 FDA approval.) 67 public comments are available (here).
CMS missed its six month statutory deadline to produce a draft NCD after the close of the 30-day, March 2020 public comment period. We'll keep on watch for the draft NCD.
Separately, AHRQ is in the midst of a broad assessment of all uses of liquid biopsy, from cancer gene detection for companion diagnostics to screening to minimal residual disease [relapse] detection. Here.
