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

Coverage is limited to validated molecular tests used to risk‑stratify indeterminate pulmonary nodules after a non‑diagnostic bronchoscopy when results will meaningfully inform guideline‑directed management and alternate diagnostic methods are not feasible. Tests must be used in the intended population, demonstrate analytical and clinical validity and utility (including algorithm validation and appropriate rule‑in/rule‑out performance), have not been previously performed for the same indication, and must complete a MolDX technical assessment. NGS for identifying variants in samples already classified as malignant is outside the scope of this policy.

"Beneficiary underwent bronchoscopy for an indeterminate pulmonary nodule (IPN)."

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