BRAF V600 Variant Testing
BRAF V600 variant testing of tumor tissue to select individuals for immune checkpoint inhibitor therapy may be considered medically necessary in the following circumstances:
Individuals with unresectable or metastatic melanoma.
AND
The individual does not have any U.S. Food and Drug Administration (FDA)-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.
Analysis of tumor tissue for the somatic BRAF V600 variant to select individuals for immune checkpoint inhibitor therapy is considered investigational in all other situations.
Mismatch Repair/Microsatellite Instability Testing
Mismatch repair/microsatellite instability (MMR/MSI) testing of tumor tissue to select individuals for immune checkpoint inhibitor therapy may be considered medically necessary in the following circumstances:
Individuals with advanced or metastatic colorectal cancer; OR
Individuals with advanced endometrial carcinoma who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation; OR
Individuals with unresectable or metastatic solid tumors who have progressed following prior treatment and who have no satisfactory alternative treatment options.
AND
The individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.
Mismatch repair/microsatellite instability testing to select individuals for immune checkpoint inhibitor therapy is considered investigational in all other situations.
Programmed Cell Death Ligand-1 Testing
Programmed cell death ligand protein-1 (PD-L1) testing of tumor tissue to select individuals for immune checkpoint inhibitor therapy may be considered medically necessary in the following circumstances:
Individuals with metastatic non-small cell lung cancer (NSCLC); OR
Individuals with metastatic or unresectable, recurrent head and neck squamous cell carcinomas; OR
Individuals with locally advanced or metastatic esophageal or gastroesophageal junction carcinoma that is not amenable to surgical resection or definitive chemoradiation after 1 or more prior lines of systemic therapy for patients with tumors of squamous cell histology; OR
Individuals with persistent, recurrent, or metastatic cervical cancer; OR
Individuals with locally recurrent unresectable or metastatic hormone receptor-negative/HER2-negative (triple negative) breast cancer.
AND
The individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label.
PD-L1 testing of tumor tissue to select individuals for immune checkpoint inhibitor therapy is considered investigational in all other situations.
Tumor Mutational Burden Testing
Tumor mutational burden (TMB) testing of tumor tissue to select individuals for immune checkpoint inhibitor therapy is considered investigational.
