CMS Considers Covering DNA Stool Test For Colorectal Cancer
This article was originally published in The Gray Sheet
Executive Summary
CMS is considering national coverage for aDNA stool test as an alternative to a colonoscopy or sigmoidoscopy for colon cancer screening, the agency announced Aug. 1
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Warning letter blocks DNA stool test coverage
CMS says Jan. 30 it will not cover Exact Science's PreGen-Plus assay as a screening alternative to colonoscopy because the test is no longer on the market. CMS decided to open a national coverage decision on the DNA stool test in August at Exact Science's request, but in October the firm received a 1warning letter from FDA stating that PreGen-Plus does not qualify as a lab-developed test and needs to undergo regulatory review (2"The Gray Sheet" Aug. 6, 2007, p. 9). In December, Exact Science asked CMS if it could withdraw its coverage request. "After a commercially available stool DNA test is cleared or approved by the FDA, a request for reconsideration would be anticipated," CMS says. The agency has until May to finalize its decision