MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules

Molecular testing for thyroid nodules is covered for indeterminate cytology (Bethesda III–IV) and select Bethesda V nodules to aid surgical decision making when the index nodule has not been previously tested with the same or a similar assay and the test is analytically and clinically validated for the intended population. Laboratories must document intended population/indication, validation data, and supporting peer‑reviewed evidence; algorithm‑based tests require independent validation cohorts. NGS for samples already classified as malignant and repeat testing with the same/similar assay for the same indication are excluded under this policy.

"Molecular diagnostic testing is covered for an index thyroid nodule that has not been previously tested with the same or a similar assay for the same clinical indication."

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