Gene Expression Profiling for Cancer Indications - Medicare Advantage

This Humana Medicare Advantage medical coverage policy summarizes when gene expression profiling (GEP) tests for cancer indications may be considered medically reasonable and necessary, deferring to applicable CMS NCDs/LCDs/LCAs and the MolDX technical assessment or FDA labeling where CMS guidance is absent. It lists covered cancer indications (notably multiple breast cancer assays with explicit AJCC/ER/HER2/node/tumor-size criteria, CUP testing, prostate classifiers, bladder, melanoma, pancreatic, lung, hematologic and other uses), statutory exclusions, and documentation requirements that tests be ordered by the treating physician and used to inform management. This document chunk contains AJCC TNM staging definitions and notes and NCCN clinically localized prostate cancer risk group definitions (including AJCC prognostic groups and Grade Group definitions). The text provides staging criteria, numerous staging notes/limitations, and a change log showing the policy was created 01/01/2024 and updated through 12/01/2025, but it does not contain explicit Medicare coverage 'Indications' or documentation requirements for gene expression profiling.