This Medicare contractor will provide limited coverage for ctDNA tests that detect minimum residual disease (MRD) in patients with a personal history of colorectal cancer.
Specifically, the enclosed evidentiary review is focused on the Signatera molecular residual disease assessment test, from here on called “Signatera,” (Natera, Inc, San Carlos, CA). Other tests that demonstrate equivalent analytical and clinical validity as part of a comprehensive technical assessment (TA) will similarly attain coverage for indications that are supported by the evidence and intended use within scope of this policy.
This Contractor provides limited coverage for MRD testing in colorectal cancer when:
- The conditions set by NCD 90.2 are fulfilled if NGS methodology is utilized (summarized: the patient has advanced cancer; plans on being treated for said cancer, and has not been previously been tested with the same test for the same genetic content) or are not applicable (the patient does not have cancer as defined below);
- The patient has a personal history of colorectal cancer, the type and staging of which is within the intended use of the MRD test;
- The identification of recurrence or progression of disease within the intended use population of the test is identified in the NCCN Guidelines as a condition that requires a definitive change in patient management;
- The test is demonstrated to identify recurrence or progression before there is clinical or radiographical evidence of recurrence or progression; and demonstrates sensitivity and specificity comparable with radiographical evidence of recurrence. For colorectal cancer, it must have a sensitivity at least equivalent to and specificity that is significantly better than serial CEA monitoring OR demonstrate equivalence with another ctDNA MRD test that has demonstrated this measuring the same analytes. Test performance must be similar to established MRD tests including Signatera
- The test satisfactorily completes a technical assessment that will review and confirm the analytical and clinical validity of the test.
MRD testing often requires two types of assays to be performed as part of the service. First, a sample is taken from tumor diagnostic material to establish a baseline tumor signature as defined by the test methodology. This is followed by a series assays run on blood to detect the presence or recurrence of tumor based on the measured biomarkers, expression, or other analytes over various timepoints. This series of assays comprises a single test when the patient is known to have cancer.
When the patient is NOT known to have cancer (specifically when there is no clinical, radiographical, or other biological evidence that tumor cells remain post treatment and subsequently the patient is no longer being subjected to therapeutic interventions for cancer), a second kind of test may exist wherein a single additional timepoint may constitute a single test.
The evidentiary review is available upon request.
