CMS recently announced a proposed Medicare coverage decision on non-invasive biomarker colorectal cancer screening tests. CMS proposes to automatically cover any test once every three years when both certain “patient” and “test criteria” are met.
The full proposal is available on the CMS website, but here is a summary of the criteria:
Patient Criteria
- Age 45 to 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 (gFOBT) or fecal immunochemical test (FIT)); 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).
Test Criteria
- The test must be Food and Drug Administration (FDA) market authorized and indicated for colorectal cancer screening; and,
- The test must achieve the requirements of the FDA-required post-approval study as specified in the Safety and Effectiveness Data (SSED) to continue coverage; and
- The test must be processed in a CLIA certified laboratory; and,
- The test must demonstrate performance characteristics that meet a sensitivity of greater than or equal to 90% and a specificity greater than or equal to 87%, OR, a sensitivity of greater than or equal to 79% and a specificity of 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 FDA labeling.
ACG’s Comments
ACG urged CMS to reconsider this proposal, encouraging the agency to emphasize CRC prevention versus detection.
The proposal, as outlined, provides blanket coverage at the same intervals for tests meeting criteria related to colorectal cancer detection, regardless of the data or characteristics of individual tests. ACG is concerned that the proposal provides minimal incentive for non-invasive biomarker tests to improve prevention, as part of maintaining Medicare coverage.
ACG’s full comments are included here, and you can review all public comments on the CMS website.
ACG organizes our comments by the “evidence questions” guiding the agency’s analysis and review. These questions include:
Question 1: Is the evidence sufficient to determine that screening for colorectal cancer with non-invasive biomarker tests is reasonable and necessary for the prevention or early detection of illness or disability?
ACG Comments to Question 1:
We appreciate that CMS has recognized colorectal cancer prevention as well as early detection. The goal of colorectal cancer screening is best directed towards prevention. However, the proposed sensitivity/specificity criteria are for colorectal cancer detection. The criteria do not appear to include non-advanced or advanced adenomas, and do not contain any performance thresholds for precancer or advanced precancerous lesion (APL) sensitivity. CMS should acknowledge that APLs, such as advanced adenomas and adenoma with high grade dysplasia, are important targets for noninvasive tests. Thus, CMS should deem non-invasive tests of higher value if detection of APL is better for a certain test. CMS should also strongly consider adding thresholds for adenoma with high grade dysplasia, as these lesions are closest to colorectal cancer. There must be a focus on cancer prevention. Without such focus, test developers and manufacturers have no incentive for improving APL detection if these tests receive automatic Medicare coverage under proposed criteria. These criteria, as proposed, are not “reasonable and necessary” for colorectal cancer prevention under this question.
Question 2: Is the evidence sufficient to determine that screening for colorectal cancer with non-invasive biomarker tests is appropriate for Medicare beneficiaries?
ACG Comments to Question 2:
It is unclear whether this proposal includes guidance on including Medicare-age beneficiaries in any post-market study requirement. Without such data, it is difficult to answer this question. ACG also urges CMS to provide data supporting the three-year interval between tests for Medicare beneficiaries. While ACG does not oppose the three-year interval per se, the correct interval should be based on the characteristics of each specific test. CMS should at least acknowledge the need for more data and more studies on this interval period.
Other ACG Comments:
ACG recommends including patients without iron deficiency or amenia in the patient criteria for “average-risk.”
ACG urges CMS to convene a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) for additional expert input on the evidence and analysis in the proposed coverage decision.