Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Afirma gene expression classifier test performed.Findings:  The physician reviewer found that the patient with a 1.3 cm right thyroid nodule. According to the medical notes, the patient had a prior biopsy which was consistent with undetermined significance. The patient underwent a follow up biopsy that also returned atypia of undetermined significance. The specimen was sent for Afirma gene expression classifier testing, which returned a benign result. The Health Plan has declined reimbursement for this test. A specimen was subsequently sent for Afirma gene expression classifier test performed.  The Health Plan denied reimbursement noting the services at issue were investigational for evaluation of this patients medical condition. The cytopathology of the 1.3 cm right thyroid nodule was consistent with atypia of undetermined significance (AUS) twice. The medical literature indicate that the risk of malignancy is between 5 to 15 percent in these nodules but increases after a second AUS biopsy. The Bethesda System recommends a repeat thyroid biopsy in this clinical setting. The 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 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. The American Thyroid Association also recommends taking the patient's history, ultrasound appearance and other clinical factors, including the institutions rate of malignancy, in consideration in order to make medical and surgical decisions. Studies have shown that after a second AUS biopsy, the incidence of malignancy is higher. Therefore, gene expression classifier (GEC) is useful to determine next steps. In this patients case, the ordering provider, in consideration of this patients condition and the second AUS, made the decision to order the Afirma GEC test in this nodule to determine management. The benign result prevented the risks of an additional biopsy or diagnostic surgery. This approach is supported by clinical studies related to Afirma GEC and is recommended for management and to avoid unnecessary procedures or diagnostic thyroidectomy. As such, the Afirma gene expression classifier test performed.was likely to have been more effective than any available standard therapy for the evaluation of this patient. Final Result: The reviewers, all three determined that the services at issue were likely to be more beneficial for the evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1,2 & 3 are board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.