Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Afirma gene expression classifierfor evaluation of the enrollees thyroid nodule. Findings:  The physician reviewer found that the cytopathology of the 1.6 cm thyroid nodule was consistent with atypia of undetermined significance (AUS).  There are multiple peer reviewed scientific articles indicating the benefits of the genetic test in thyroid nodules. This type of testing is also included in the algorithm for diagnosis of thyroid nodules by the National Comprehensive Cancer Network (NCCN) 2016 guidelines. In this patients case, the cytopathology of the 1.3 cm thyroid nodule was consistent with a FLUS. The risk of malignancy is 5-15% in FLUS. The Bethesda System recommends a repeat biopsy for this type of nodule. The 2015 American Thyroid Associations guidelines state that 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. If the genetic test is suspicious, the risk of malignancy increases to approximately 40%. In this patients case, the patients thyroid nodule had worrisome features by ultrasound (size, hypoechoic). The medical studies have shown that 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 result of the Afirma GEC was suspicious for malignancy. This information was important to determine the decision whether to perform thyroidectomy or not, and the extent of surgery if so (hemithyroidectomy versus total thyroidectomy). All told, 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 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 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 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.