NEW YORK – Medicare Administrative Contractors CGS Administrators and Wisconsin Physicians Service Insurance Corporation released final coverage decisions aligning with Palmetto's limited coverage of minimal residual disease testing in patients with colorectal cancer.
The evidence review for the decisions centered specifically on Natera's Signatera test, although other ctDNA tests that meet the requirements would also be covered.
The MACs, which are members of the Centers for Medicare and Medicaid Services MolDx program, will provide limited coverage of MRD testing in stage II to stage III colorectal cancer patients if the patient has advanced cancer, plans on being treated for said cancer, and hasn't previously been tested with the same test for the same genetic content; 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.
According to the LCDs, recurrence risk prognostication is at the core of managing patients with colorectal cancer, and evidence shows MRD detection with Signatera is a more sensitive and specific determinant of recurrence than traditional methods, such as carcinoembryonic antigen testing.
CGS' policy goes into effect for services performed on or after Oct. 19, while WPSIC's goes into effect Oct. 18.
Natera received CE marking for the Signatera test in August.