Appeal type: Medical necessity
Decision: Upheld

Diagnosis:  Thyroid Nodules
 
Treatment:  Genetic Test

The insurer denied the Genetic Test.  The denial was upheld.

This is a female patient who presented to the clinic with complaints of bilateral thyroid nodules that were found on ultrasound.  A physical examination was performed on her neck that revealed a supple neck, full range of motion, no cervical lymphadenopathy and the thyroid was nonpalpable.  An ultrasound was performed which revealed right lower lobe of the thyroid, isoechoic, hypoechoic, G1, irregular shape, irregular margin, partial halo, measuring 1.2 x 0.876 x 1.31 cm., and homogenous gland.  The thyroid was normal in size and shape.  The right thyroid was one nodule up to approximately 1.3 cm.  The left thyroid was one nodule up to about 0.7 cm.  The diagnosis was nontoxic multinodular goiter, neoplasm uncertain behavior of the thyroid gland.  A fine-needle biopsy was performed that revealed no thyroid cancer mutation detected.

The right thyroid nodule was described by the treating physician as having a 5-15% percent chance of cancer.  The patient reported no family history of thyroid cancer.  A relative had taken thyroid medication only, and another was treated for lymphoma.  The patient's thyroid status has been normal with no treatment for high or low thyroid problems, and she was without any symptoms.  The decision was made to perform a FNA on the right thyroid nodule, the fluid was sent for a Thyroid Cancer Mutation Panel.  The biopsy results were consistent with follicular lesion of uncertain clinical significance Bethesda Category 3, negative for malignant cells, colloid nodule with cystic degeneration and old hemorrhage Bethesda Category 2.  The follow up treatment plan for the patient included follow-up in 6 months with an ultrasound for monitoring.  

According to the 2015 American Thyroid Association Management Guidelines for adult patients with thyroid nodules and differentiated thyroid cancer, the thyroid cancer mutation panel (is reserved for indeterminate FNA specimens.  The treatment tree for thyroid nodule evaluation includes an initial thyroid ultrasound.  Based on the ultrasound results, the treating provider develops a suspicion pattern (high, intermediate, low, very low, benign) patterns.  For this current nodule of 1.3 cm in diameter, the suspicion pattern was low.  The FNA specimen is sent for cytology and graded according to the Bethesda System.  This nodule results included results that were consistent with follicular lesion of uncertain clinical significance, Cat 3.  

Furthermore, an NCCN Tumor Marker Task Force has indicated that the clinical utility of a molecular test should be founded in strong evidence proving that use of the marker improves patient outcomes sufficiently to justify its incorporation into routine clinical practice. It is important to note that longterm outcome data on companion use of molecular marker status to guide therapeutic decision-making is currently lacking; therefore, we do not know if implementation of molecular marker use in routine clinical practice would result in a significant overall benefit in health outcomes in patients with thyroid nodules.

The health plan acted reasonably with sound medical judgment in the best interest of the patient.

Based on the above, the medical necessity for the genetic testing is not substantiated.  The insurer's denial is upheld.