On January 19, 2021, CMS released a much-anticipated NCD which prospectively covers future tests for colorectal cancer screening when they have FDA approval and meet several pre-specified CMS criteria. Find the full NCD here.
The rules are slightly abbreviated here for easy reading:
- Blood-based liquid biopsy CRC tests are covered once every 3 years
- Patients must be:
- 50-85 years old
- Asymptomatic
- At average risk (no history of polyps, colorectal cancer, family history of colorectal cancer, etc)
- The test must be:
- FDA authorized for CRC screening;
- Sensitivity equal or greater than 74% and specificity equal or greater than 90% vis-a-vis colonoscopy, based on FDA pivotal studies.
No current LBx test meets the criteria. For exact text see NCD link and see also the NCD discussion.
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The criteria mean that if you have cancer, which could be picked up on colonoscopy, the test will pick up 7 cases out of 10. The 90% specificity basically equates to a 10% false positive rate (1 in 10 patients who will go to colonoscopy after the blood test, but will not have cancer).
CMS discussed variable 2-3 year intervals but uses 3; CMS will monitor future tests when they actually are approved and modify if needed. CMS considered beginning at age 45 but will hold to age 50 for now.
CMS removed a proposal that the tests would need BOTH FDA approval AND guideline inclusion. The word guideline appears 77 times in the NCD.
While FDA could approve tests that do not meet the criteria, the criteria are at least close or "ballpark" to what FDA would likely require. For example, FDA would not approve an LBx test that was 50% sensitive and 50% specific in the first place.
There was debate that CMS should consider, or favor, tests with better performance to detect precancerous adenomas. In fact, the word "adenoma" appears 177 times in the NCD. However, CMS rates tests as passing or failing based onlly the performance in so far as it detects colorectal cancer itself.
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In December, legislation was introduced in the House (H.R. 8845) that would allow CMS to cover future FDA-approved multi-cancer screening tests, which would include both blood-based tests and other (e.g. urine) based tests. The NCD here is for blood-based liquid biopsy only. See also S.5051.
