CMS Proposes Coverage of Colorectal Cancer DNA Test
An easier colorectal screening method may be reimbursed by Centers for Medicare & Medicaid Services (CMS) related programs if support for a proposed decision memo succeeds. CMS is proposing coverage of the Cologuard™ DNA stool test once every three years for beneficiaries who meet particular criteria.
Cologuard was recently approved by the Food and Drug Administration (FDA). Research supports the test, which detects molecular markers of the altered DNA contained in cells shed by colorectal cancer and pre-malignant colorectal epithelial neoplasia. The test identifies three specific markers, the first being epigenetic changes, the second detecting specific point mutations, and the third identifying human fecal hemoglobin.
The test will be a relief for most adults between ages 50 and 85 years. Additional criteria beyond age include:
- Asymptomatic (No signs or symptoms of colorectal disease including gastrointestinal pain, blood in stool, positive guaiac fecal occult blot test or fecal immunochemical test.)
- Average risk (No history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease (IBD), Crohn’s disease, ulcerative colitis. No family history of colorectal cancer or adnomatous polyp, familial adenomatous polyposis, or hereditary nopolyposis colorectal cancer).
CMS seeks comments on the proposed decision by September 11.
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