Biomarkers for Oncology

Medicare covers oncology biomarker testing when biomarkers have demonstrated clinical validity and clinical utility and when test results are used to inform patient management; combination panels require peer-reviewed evidence showing individual contributor value. Specific molecular and proteomic tests (enumerated per tumor type, e.g., KRAS/NRAS/BRAF/MSI in colorectal cancer, EGFR/BRAF in NSCLC, Prosigna for ER+ breast cancer per FDA label, ThyraMIR/ThyGeNEXT/Afirma/RosettaGX/ThyroSeq for indeterminate thyroid FNA) are covered as indicated, subject to limits including NCD 90.2 for NGS and general once-in-a-lifetime restrictions unless clinical documentation justifies repeat testing (exceptions for monitoring certain fusions up to 4 times/year and select relapse scenarios).

"Biomarker testing is covered when the biomarker has demonstrated clinical validity and clinical utility (CVU) and the test result is accepted into and used to inform patient management decisions."