Screening for Colorectal Cancer - Blood-Based Biomarker Tests

CMS NCA document | source_status=Closed | review_type=New | public_comment_open=False | document_id=CAG-00454N

The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to cover a blood-based biomarker test as an appropriate colorectal cancer screening test once every 3 years for Medicare beneficiaries when performed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, when ordered by a treating physician and when all of the following requirements are met: The patient is: age 50-85 years, and, asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and, at average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer). The blood-based biomarker screening test must have all of the following: FDA market authorization with an indication for colorectal cancer screening; and proven test performance characteristics for a blood-based screening test with both sensitivity greater than or equal to 74% and specificity greater than or equal to 90% in the detection of colorectal cancer compared to the recognized standard (accepted as colonoscopy at this time), based on the pivotal studies included in the FDA labeling. The currently available Epi proColon® test does not meet the criteria for an appropriate blood-based biomarker CRC screening test. Based on the evidence at this time, we will non-cover the Epi proColon® test. See Appendix B for the draft manual language.