MolDX: Molecular Testing for Risk Stratification of Thyroid Nodules

Coverage is allowed for molecular testing of index thyroid nodules that are indeterminate (Bethesda III–IV) or select Bethesda V nodules when results will aid surgical decision-making, provided the index nodule has not already been tested with the same or similar assay. The performing laboratory must specify the intended population/indication and submit evidence of analytical and clinical validation (including independent algorithm validation and peer-reviewed clinical utility) and a technical assessment demonstrating performance at least as good as currently covered services. Next-generation sequencing to identify variants in samples already classified as malignant is excluded from this policy.

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