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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Afirma gene expression classifier testing for evaluation of the enrollees follicular lesion of undetermined significance. Findings:  2/3 of the physician reviewers found that there are multiple peer reviewed scientific articles supporting the benefits of genetic testing in thyroid nodules. The cytopathology result of the 5.0 cm thyroid nodule was consistent with AUS. The risk of malignancy is 5-15% in AUS. The American Thyroid Associations guidelines state that for nodules with AUS 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. If the genetic test is suspicious, the risk of malignancy increases to 40%. The risk of malignancy decreases to less than 6% with benign findings by GEC. In this case, the patients thyroid nodule had worrisome features by ultrasound due to its size and microcalcifications. The provider determined the submission to GEC after obtaining the AUS result, and consulting with a second provider, which is appropriate. In this case, the result of the Afirma GEC was suspicious for malignancy. This information was important to determine the decision whether to perform thyroidectomy and the extent of surgery. This test is also included in the algorithm for diagnosis of thyroid nodules by the National Comprehensive Cancer Network (NCCN) guidelines. Therefore, the Afirma gene expression classifier testing was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: 2/3 of the reviewers determined that the testing at issue was likely to be more beneficial for 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.