MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules

Molecular diagnostic testing for thyroid nodules is covered when the index nodule has not previously been tested with the same or a similar assay and the nodule is indeterminate (Bethesda III–IV) or Bethesda V when molecular stratification would inform malignancy type. Coverage requires documentation of cytology (Bethesda category), evidence that test results will inform surgical decision-making after clinical/radiographic/cytologic review, and that the performing laboratory/test demonstrates appropriate analytical and clinical validation, peer‑reviewed clinical utility, independent algorithm validation if applicable, and a satisfactory technical assessment; NGS for samples already classified as malignant is excluded from this policy.

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

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