Thyroid Nodule With Indeterminate Cytology: when insurers say no, reviewers often say yes

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The enrollee has requested reimbursement for the Afirma Gene Expression Classifier (GEC) molecular test for evaluation of the enrollee’s thyroid nodule. Findings: Two of the physician reviewers found that While a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority turn out to be benign. Afirma utilizes a GEC in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for ThyraMir gene test. Findings: The physician reviewers found that the Bethesda System recommends a repeat thyroid biopsy. Moreover, the newest 2015 American Thyroid Association's guidelines state that “for nodules with AUS/FLUS cytology, after consideration of worrisome clinical and sonographic features, investigations such as repeat fine needle aspiration (FNA) or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with a strategy of either surveillance or diagnostic surgery. Informed patient preference and feasibility should be considered in clinical decision-making”.

These outcomes come from California’s external review program — an independent physician panel whose decision binds the insurer. Every state has an equivalent, and internal appeals succeed even more often. If your care for thyroid nodule with indeterminate cytology was denied, the published record says the denial is worth fighting.