Single Gene and Molecular Biomarker Testing for Solid Tumors - Medicare Advantage

This Medicare Advantage policy covers single-gene and molecular biomarker testing for solid tumors — including companion diagnostics, comprehensive genomic profiling, IHC, germline PARP-related testing, pharmacogenomics, and DNA specimen provenance assays — for patients with solid tumors (e.g., breast, colon, lung, ovarian/fallopian tube/primary peritoneal, salivary gland metastatic/recurrent/unresectable, ampullary adenocarcinoma, esophageal/GEJ cancer, GIST, and others) to guide targeted therapy and clinical trial eligibility. Coverage and any specific limits (frequency, age, prior-treatment requirements, test-specific inclusion/exclusion) are determined by the applicable MolDX/MAC Local Coverage Determinations and referenced LCD/Article IDs and apply only within each MAC’s jurisdiction.

"Refer to the referenced MolDX LCDs (L38335, L38337, L38394, L38435) for required clinical documentation, test reports, and justification for medical necessity."