Throat Neck 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 an Afirma gene expression classifier for evaluation of the enrollee, who was diagnosed with follicular thyroid lesion. Findings: Three physician reviewers found that the patient presented with thyroid nodules, sized at 1.5 and 1.3 cm in diameter. The patient has past history of left breast ductal carcinoma. Thyroid biopsy was performed in two nodules. The cytopathology diagnosis was consistent with atypia of undetermined significance (AUS) in both nodules. The specimen was then sent to genetic expression classifier (GEC). The Afirma GEC result was suspicious. The patient requested reimbursement for Afirma gene expression classifier test. Per the Health Plan, the services at issue were investigational for evaluation of the patient’s medical condition.

Where the denial was upheld

Physician 1: This patient is a 42-year-old male with a previous diagnosis of myoepithelial sarcoma of the paranasal sinus. He has apparently been treated with surgery, radiation, and multiple chemotherapeutic agents including Cisplatin, Ifosfamide, Taxol, Carboplatinum, Adriamycin, and Temodar. He has also been treated with Cyberknife radiotherapy. The patient’s tumor was found positive for the epithelial growth factor (EGF) receptor and it is proposed that he be treated with Erbitux. The provider’s request for authorization of Erbitux was denied by the Health Plan citing the experimental nature of the therapy.Erbitux is one of a new class of drugs that inhibits the EGF receptors on a cancer cell and presumably interferes with angiogenesis. Erbitux has been approved by the FDA for use, along with chemotherapy, in the treatment of colon cancer.

Physician 1: The patient is a 74-year-old female who was apparently first diagnosed with adenoid-cystic carcinoma of the nasopharynx in 1999. She was initially treated with radiation therapy and a recurrence in 2001 was also treated with surgery and radiation therapy. She was noted in January of 2004 to have lung metastases. In December of 2004 she was noted to have recurrence in the neck. A biopsy of her disease again revealed adenoid-cystic carcinoma, which was EGFR positive. It is now recommended she be treated with radiation therapy to her neck, along with Erbitux. The patient’s clinician has requested authorization for treatment with Erbitux. The Health Plan has denied the request citing the investigational nature of the medication in this clinical context.Erbitux is a new drug, which acts by inhibiting the epidermal growth factor receptor (EGFR).

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 throat neck, then check the rights and deadlines that apply to your plan.