Tuesday, January 5, 2021

Very Brief Blog: Final NCD for Colorectal Screening Liquid Biopsy: January 14, 2021?

A quick note to remind us that last fall, CMS announced a proposed national coverage decision on colorectal cancer screening tests.  In the proposed decision - CAG-00454N - CMS will cover blood-based biomarker tests for colorectal cancer if they are FDA-approved and have performance of 74% sensitivity (picking up 3/4 of actual cancers) and specificity of 90% (1 in 10 results are a false positive).   See the proposal here.

According to CMS regulations and proposal tracking sheet, the final decision is slated to appear on January 14, 2020.  Historically, CMS nearly always nailed these due-dates, although in the last couple years, several of them have lagged by several months (e.g. the CAR-T decision).   

There are a number of ins-and-outs to the proposal, for example, annual and biannual test intervals can interact with the sensitivity/specificity statistics, and some tests might be better at picking up advanced adenomas, which don't seem to be counted as the NCD defines tests in terms of cancer metrics.   Nonetheless, if the final decision is more or less in the format of the proposal, it will provide clear measures and accelerated coverage to the multiple colorectal blood tests that are in, or will soon enter, FDA pipelines.   


Generally, CMS only adopts new preventive benefits if they are authorized as line items by Congress or if they are adopted via NCDs after they are endorsed by the US Preventive Services Task Force.   Due to nuances of Medicare law, CMS has authority to create new preventive benefits in two areas, colorectal cancer and prostate cancer, based on its direct and de novo assessment of the preventive test technology.  It's unlikely, though, it would review a preventive test prior to FDA approval, and the proposal currently in play is designed to be triggered only after FDA approval.


Epigenomics, the named test in the proposed NCD, issued a Euro5M convertible bond in January (here).