Next Generation Sequencing (NGS)

Medicare nationally covers NGS diagnostic testing for somatic cancers in patients with recurrent/relapsed/refractory/metastatic disease or advanced stage III/IV disease and who plan to seek further treatment, and for germline testing limited to patients with breast or ovarian cancer who have a clinical indication and risk factors for hereditary disease. Coverage requires testing in a CLIA-certified laboratory, an order from the treating physician, FDA approval/clearance as specified (companion IVD for somatic tests), delivery of results via a report template to the treating physician, and no prior testing with the same NGS test for the same genetic content; MACs may make local coverage determinations for certain other scenarios.

"NGS is nationally covered for somatic (acquired) cancer when performed in a CLIA-certified laboratory, ordered by the treating physician, the patient has recurrent, relapsed, refractory, metastatic..."