For individuals who have thyroid nodules without strong clinical or radiologic findings suggestive of malignancy in whom surgical decision making would be affected by test results, the use of either of the following types of molecular marker testing or gene variant analysis in fine needle aspirates of thyroid nodules with indeterminate cytologic findings (ie, Bethesda diagnostic category III [atypia/follicular lesion of undetermined significance] or Bethesda diagnostic category IV [follicular neoplasm/suspicion for a follicular neoplasm]) may be considered medically necessary:
Afirma® Genomic Sequencing Classifier; or
ThyroSeq®.
The use of any of the following types of molecular marker testing or gene variant analysis in fine needle aspirates of thyroid nodules with indeterminate findings (Bethesda diagnostic category III [atypia/follicular lesion of undetermined significance] or Bethesda diagnostic category IV [follicular neoplasm/suspicion for a follicular neoplasm]) or suspicious findings (Bethesda diagnostic category V [suspicious for malignancy]) to rule in malignancy to guide surgical planning for initial resection rather than a 2-stage surgical biopsy followed by definitive surgery may be considered medically necessary:
ThyroSeq;
ThyraMIR® microRNA/ThyGenX®;
Afirma BRAF after Afirma Genomic Sequencing Classifier; or
Afirma MTC after Afirma Genomic Sequencing Classifier.
Gene expression classifiers, genetic variant analysis, and molecular marker testing in fine needle aspirates of the thyroid not meeting criteria outlined above, including but not limited to use of RosettaGX Reveal and single-gene TERT testing, are considered investigational.
