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. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees indeterminate thyroid nodule. Findings:  The physician reviewer found that The patient is diagnosed with a 3.5 cm nodule in left thyroid lobe. Thyroid biopsy cytopathology was consistent with atypia of undetermined significance (AUS). The specimen was then sent for molecular testing resulting in suspicious results. The patient has requested reimbursement for the Afirma gene expression classifier. The Health Plan denied reimbursement and noted that the gene testing was investigational for the evaluation of this patient. There are multiple peer reviewed scientific articles indicating the benefits of the genetic test in thyroid nodules. The test is ordered after analysis of the patients cancer risk based on clinical data, diagnostic imaging features and cytology report. The test is in vitro, which confers no physical risk to the patient. The sample is obtained at the same time of the fine needle aspiration biopsy, and no additional procedure is needed. The test 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 result of the Afirma gene expression classifier was suspicious for malignancy. This increases the patients risk of malignancy to 40%. This information was important to determine the decision whether to perform thyroidectomy or not. All told, Afirma gene expression classifier provided was likely to have been more effective than other standard options for the evaluation of this patient.  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.