Afirma Gene Expression Classifier denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Afirma gene expression classifierfor evaluation of the enrollee’s 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 patient’s 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.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Afirma gene expression classifier testing for evaluation of the enrollee’s 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 Association’s 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.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Afirma gene expression classifier for the evaluation of his indeterminate thyroid nodules. Findings: Three physician reviewers found that Fine Needle Aspiration (FNA) is a well established procedure in determining if a thyroid nodule is malignant or benign with good sensitivity for a papillary thyroid cancer. This testing is supposed to help in planning future intervention. The negative predictive value is higher in this test but the literature has shown that the positive predictive value is low. The Afirma gene expression classifier potentially can improve the net health outcome by providing an alternative to diagnostic thyroid surgery.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the Afirma Gene Expression Classifier (GEC) genetic testing. When FNA cytopathology is indeterminate, repeat FNA and or thyroid surgery are the standard options to obtain a definitive pathological diagnosis. In this patient’s case, the initial FNA cytology was as indeterminate. Thus, FNA could have been repeated, and if cytology was still indeterminate, surgical resection should have been considered.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Afirma Gene Expression Classifier, then check the rights and deadlines that apply to your plan.