Endocrine
Genetic Testing

Diagnosis: Thyroid Nodule
Treatment: Genetic testing
The insurer denied the genetic testing. The health plan's determination is upheld.

This is a male who underwent a hemithyroidectomy with isthmusectomy. A fine needle aspiration was performed on a nodule on the left side. Pathology demonstrated papillary carcinoma (classic), with papillary micro carcinoma with Hurtle cell carcinoma. ThyraMIR gene classifier testing was recommended and is under review.

The Genetic Testing: ThyraMIR is not medically necessary for this patient.
According to Bose et al, fine needle aspiration biopsy is able to distinguish benign from malignant nodules with high sensitivity and specificity; however, 20% to 30% of nodules are diagnosed as indeterminate with a risk of malignancy varying from 10% to 75% based on the 2017 revision of the Bethesda System for Reporting Thyroid Cytopathology.
In a review of the literature by Liu, the authors concluded that over half of nodules with gene classifier-suspicious results still require further validation like molecular markers, diagnostic surgery, or long follow-up, which limits its use in future clinical practice. In a study by Marti et al, there were wide variations in the gene classifier-benign call rate across two tertiary referral cancer centers which had differing rates of malignancy in indeterminate thyroid nodules.
In a review of the literature by Duh, the authors concluded that the quality of gene classifier methods has not been rigorously examined. and future studies should define and assign a "true negative" label to gene classifier-benign nodules that do not develop malignant signs or symptoms during a pre-specified period of follow-up, and these nodules should be included in calculations of diagnostic accuracy.

Therefore, based upon the peer reviewed medical literature, the Genetic Testing: ThyraMIR is not medically necessary.