MolDX: Phenotypic Biomarker Detection in Circulating Tumor Cells

Limited coverage is provided for assays that detect biomarkers from circulating tumor cells (CTCs) when the patient has cancer, the cancer has an associated biomarker with established clinical utility in peer-reviewed literature, and at least one documented clinical reason for CTC testing exists (e.g., not previously tested, metastatic lesion not tested, progression, or suspected treatment resistance). Coverage requires that the CTC-based test complete MolDX Technical Assessment demonstrating AV, CV, and CU with clinical validation equivalent or superior to tissue-based testing; only one test per patient encounter is allowed unless a documented adjunct second test meeting all criteria is reasonable and necessary, and duplicate testing of the same biomarker from the same sample type for the same indication using different methodologies is not covered.

"Patient has a diagnosis of cancer."