NEW YORK – Medicare Administrative Contractor Palmetto GBA released a final local coverage determination for ctDNA tests detecting minimal residual disease in patients with Stage II to Stage III colon cancer, focusing specifically on Natera's Signatera test.
Limited coverage of minimal residual disease testing in cancer will be provided if the patient has advanced cancer, plans on being treated for said cancer, and has not previously been tested with the same test for the same genetic content; if the patient has a personal history of colorectal, the type and staging of which is within the intended use of the test; the identification of progression of disease within the intended use population of the test is identified in National Comprehensive Cancer Network guidelines as a condition requiring a definitive change in patient management; the test identifies recurrence or progression before there is clinical evidence and demonstrates sensitivity and specificity comparable with radiographical evidence; and the test completes a technical assessment to confirm analytical and clinical validity of the test.
The two intended uses covered are for patient risk stratification after surgical resection to inform adjuvant treatment decisions and for recurrence monitoring in patients with a previous cancer diagnosis but no ongoing evidence of disease, Natera said in a statement. Palmetto previously released a draft coverage decision for the test last year.
The LCD covers minimal residual testing in cancer that meets these requirements, but the evidence review was focused on the Signatera test. According to the LCD, "the analytical validity and clinical validity of minimal residual disease testing using cell-free DNA, and Signatera in particular, appears to be well established."
Although general evidence suggests patients with Stage II colorectal cancer will likely not have a recurrence, a substantial minority still do, and there are no good clinical or pathologic markers to identify which patients will have a recurrence, Palmetto said.
The MAC continued that recurrence risk prognostication is at the core of managing patients with colorectal cancer and that evidence shows MRD detection with Signatera is a more sensitive and specific determinant of recurrence than CEA testing, the traditional method for detecting recurrence. Palmetto added that it expects future revisions to the coverage decision as science and standards of care evolve.
The policy is effective for services performed on or after Oct. 18. In an analyst note, Steven Mah at Piper Sandler said reimbursement is still being determined but it could be between $3,000 and $4,000 based on other oncology tests, or $1,800 if it is crosswalked to Adaptive Biotechnologies' ClonoSeq test.
Last month, Natera received CE marking for the test.