Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Afirma gene expression classifier test for evaluation of the enrollees indeterminate thyroid nodule.Findings:  The physician reviewer found that The patient was diagnosed with a 1.5 cm right sided thyroid nodule.  A fine needle aspiration (FNA) biopsy yielded atypia of undetermined significance.  A specimen was subsequently sent for Afirma gene classifier analysis. The patient has requested reimbursement for the Afirma gene expression classifier test. The Health Plan denied reimbursement on the basis that the services at issue were investigational for the evaluation of this patient. While 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 indeterminate (Alexander, et al). Until recently, studies have shown that the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Ibrahim, et al). The Afirma gene expression classifier test helps determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick, et al). Therefore, Afirma gene expression classifier was likely to have been more beneficial for the evaluation of this patient than any available standard therapy. Final Result: Two of three reviewers 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 reviewer number one is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert 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.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert 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.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert 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.