Tuesday, March 24, 2020

Reminder: CMS Accepting Comments on Colorectal Screening NCD til March 29, 2020

February 28 seems like a long time ago - four weeks in the COVID era seems like four years in regular time.

Recall that on February 28, 2020, CMS announced it would be undertaking an NCD this year on the Epigenomics Epi proColon blood-based colon cancer screening test.   The test was FDA PMA approved in 2016, and the NCD opening request letter was filed by Epigenomics in April 2019.  (However, investor calls of the publicly-held company show it was negotiating with CMS well before 2019). 

The NCD opening followed fairly quickly after a favorable health economics study in December 2020 - press here, article by D'Andrea et al. here.

My original blog is here.   The CMS webpage is here.  The CMS comments page is here - see the orange box that says, "COMMENT."   There were 38 comments through March 24.   Often, commenters show up on the last day - submit your comment by March 29.

Epigenomics has the first FDA-approved blood test for colorectal cancer screening.  Multiple other companies have announced they are developing tests in this category.

Note that CMS views colorectal cancer screen by stool or blood as an intermediate test is is concerned whether the patient is "lost to followup" when positive and never gets a colonoscopy.   (An earlier lost-to-followup step is never turning in the blood or fecal test material itself).    The D'Andrea modeling study focuses on this.   

In other news, in 2019, recall a CMS-sponsored study was highly critical of the covered stool nucleic acid test Cologuard, which is circa $500 per test (Naber et al., PLOS, 2019).   Exact Sciences has market cap of about $9B, 2019 revenue around $800M,  2019 operating loss around $200M.  In 2018, The Exact Sciences Cologuard test was about 20% of Medicare's $1B in molecular spending, the highest paid single test.