MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules

Molecular diagnostic testing for thyroid nodules is covered when the index nodule (thyroid) has not previously been tested with the same or similar assay and is indeterminate (Bethesda III–IV) or is Bethesda V where testing will aid malignancy stratification; concurrent testing of multiple nodules is allowed if each meets criteria. Coverage requires documentation of cytology (Bethesda category), clinical and radiographic consideration for surgical decision-making, and robust test evidence including analytical/clinical validation, independent algorithm validation (if applicable), peer‑reviewed clinical utility, and successful technical assessment; NGS to identify variants in malignant samples is outside the scope of this policy.

"Index thyroid nodule has not been previously tested with the same or a similar assay for the same clinical indication."

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