Molecular Pathology Procedures

Medicare covers specified molecular pathology tests (e.g., EGFR, KRAS/NRAS, MET, FLT3, JAK2/exon12–13, MPL, NPM1, KIT, MGMT, MSI, HFE, HLA typing, IGH, MYD88, PML/RARA, chimerism, Oncotype/Prosigna, SF3B1, RET, etc.) when used to guide diagnosis or therapy, while IFNL3 (IL28B), F2/F5, MTHFR, Ceramides and routine HPA 1–15 testing are not covered or are limited. Coverage requires documentation of medical necessity and appropriate clinical criteria (e.g., MSI age/Bethesda or pembrolizumab indication, HFE once lifetime with evidence of iron overload), evidence that results will affect management, limits on unnecessary panel genes, and analytic/clinical validity for LDTs with medical-record support for claims.

"Chimerism analysis to identify appropriate donors and monitor engraftment success or disease reoccurrence is medically necessary."

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