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
- 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.