Molecular Pathology Procedures

This LCD covers molecular pathology procedures (Tier 1 and Tier 2) only when there is no definitive alternative test or alternatives are equivocal, a clinically valid assay exists, the assay demonstrates analytical validity/clinical utility, results directly affect treatment/management, panels are limited to genes necessary for therapeutic decisions, and diagnostic genetic testing has not been previously performed (generally once per lifetime). Numerous gene- and disease-specific tests (e.g., EGFR, KRAS, BRAF, BRCA1/2, JAK2, FLT3, MSI, HLA, CFTR, TP53, etc.) are listed as medically necessary for specific clinical indications; several tests and broader panel uses (e.g., certain Tier 2 genes, MTHFR, F2/F5, Ceramides, broad 5–50 gene solid tumor panels outside NSCLC) are explicitly considered not medically necessary. Documentation must demonstrate clinical validity/utility, laboratory analytical validity for LDTs, physician-authored interpretations when applicable, and may be subject to prepayment or post-payment medical review.