Thyroid Nodule 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 gene test received. Findings: The physician reviewers found that there are multiple peer reviewed scientific articles indicating the benefits of the genetic test in thyroid nodules. The test is ordered by providers after analysis of the patient’s 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. This is the patient’s second biopsy of the 2 cm thyroid nodule. According to the Bethesda system and American Thyroid Association (ATA) guidelines, the risk of malignancy in FLUS is up to 15%.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for gene testing services (ThyraMIR, and ThyGenX). In this case, the submitted documentation does not support that the services in issue were medically necessary. First, molecular tests do not perform well on Hurthle cells. The patient’s biopsy of the suspicious right nodule noted that the specimen was sparsely cellular and that most follicular cells seen had Hurthle cell changes. The reading pathologist further commented that the sample in question may not have been representative of the targeted lesion and that the material collected for ThyGenX testing may not be sufficient. Therefore, it was questionable whether the molecular test was done on an adequate sample, thereby raising the question of whether its results can be trusted.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for BRAF mutation analysis gene panel testing.Findings: Two of the three physician reviewers found that the medical evidence has not demonstrated the superior effectiveness of the services at issue. Per the literature, BRAF mutation analysis gene panel testing (Afirma Thyroid FNA Analysis) was not likely to have been superior to cytology interpretation of pathologic thyroid specimens. A study reported that the rate of malignancy in thyroid nodules suspicious by Afirma was 18.3% while the rate of malignancy in nodules suspicious for neoplasm on cytology interpretation was 31.2%, resulting in a false positive rate of 56%. The authors concluded that cytology interpretation has a higher rate of predicting malignancy when compared with the Afirma test, by almost twofold.

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 thyroid nodule, then check the rights and deadlines that apply to your plan.