MolDX: Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy

Coverage is limited to molecular tests used to aid diagnosis or exclusion of lung cancer in patients with an indeterminate pulmonary nodule after a non-diagnostic bronchoscopy, when results will meaningfully inform management per consensus guidelines and no alternate diagnostic method can or will be performed prior to test results. Covered tests must be used in the intended population, not previously performed for the same indication, demonstrate analytical and clinical validity and utility (including independent algorithm validation when applicable), meet high rule-in or rule-out performance standards, and successfully complete the MolDX technical assessment; NGS for malignant samples is out of scope.

"Beneficiary underwent bronchoscopy for an indeterminate pulmonary nodule and the bronchoscopy was non-diagnostic (failed to provide a specific histopathologic diagnosis)."