The FDA granted the test Breakthrough Device designation in September 2019, and CMS announced Jan. 12, the test would receive Medicare coverage through a new pathway approved by the FDA.
The Medicare Coverage of Innovative Technology final rule is automatically providing devices with Breakthrough designation Medicare coverage once they receive market authorization.
The swab-collected stool sample test detects microbial genomics biomarkers which are strongly tied to specific stages of colorectal cancer progression. Upon receipt of a positive test, patients must undergo a colonoscopy to confirm and remove the adenomas.
The need for an additional colonoscopy presents a financial burden for some patients, as Medicare will only cover one test annually. It is the same issue other at-home alternatives suffer from. However, the consensus remains to be the best screening test is the one that gets done.
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