MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules

Molecular diagnostic testing for thyroid nodules is covered when the index nodule is cytologically indeterminate (Bethesda III–IV) or Bethesda V if it will aid malignancy stratification, provided the nodule has not been previously tested with the same or a similar assay and results will inform surgical decision making. Coverage requires that the test be developed for the indicated population, demonstrate analytical and clinical validation (including algorithm validation in a non‑development cohort if applicable), have peer‑reviewed evidence of clinical validity and utility, complete a technical assessment, and show performance at least as good as currently covered services; NGS of samples already classified as malignant is excluded from this policy.

"Molecular testing is covered for an index thyroid nodule that is cytologically indeterminate (Bethesda category III or IV)."