Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Malignant melanoma

Treatment: DecisionDX Melanoma assay 

The insurer denied coverage for DecisionDX Melanoma assay. The denial was upheld.

This patient is a female with a history of a suspicious, irregular, multi-colored lesion of her left upper back. A biopsy of the lesion revealed a diagnosis of invasive malignant melanoma, 0.6mm thick with superficial spreading. Melanoma in-situ extended to the peripheral margin; invasive melanoma was 0.4mm from the peripheral margin and 0.2mm from the deep margin. A DecisionDx-Melanoma Gene Expression Profile test was performed. The results showed Class 1, Sub-class 1A, which is associated with the lowest risk of recurrence within 5 years.

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.

The patient had a biopsy of the back that was diagnosed as malignant melanoma 0.6 mm thickness. It was reported by the DecisionDx-Melanoma gene expression profile test is a Class I A which has an extremely low risk of metastatic spread for at least five years. The provider is requesting plan approval for the DecisionDx-Melanoma gene expression profile test. The DecisionDX Melanoma assay was not known to be effective at the time it was performed, based on a lack of scientific evidence showing that the results will accurately guide patient care and health outcomes. In this case, the testing would not have been considered effective or useful in treatment planning.

Additionally, per Cirenajwis, H., Ekedahl, H., Lauss, M., Harbst, K., Carneiro, A., Enoksson, J., Jonsson, G. (2015), "Cutaneous malignant melanoma (CMM) is the most lethal form of skin cancer and its incidence has increased faster than that of any other cancer, rendering it a major public health problem worldwide. In order to provide clinicians and patients with accurate prognostic information about the disease, a correct staging system is fundamental. Since 1998, the American Joint Committee on Cancer (AJCC) melanoma staging system has served as a foundation for clinical classification and it was recently updated to the 7th edition after adding more tumor intrinsic factors with prognostic significance." Furthermore, per Weiss, S., et al, (2015), "Recently, Castle Biosciences released the DecisionDx Melanoma gene panel which predicts the risk (high (69%) or low (3%)) of distant metastasis at 5 years for stage I-III patients. This panel may be used in clinical practice, however it is not currently recommended by any standard treatment guidelines, including the National Comprehensive Cancer Network (NCCN)" Finally, per Farberg, A. S., Glazer, A. M., Winkelmann, R. R., & Rigel, D. S., et al. (2017), "However, the particular impact for the 31-GEP is still incompletely defined. Other substantial impacts include downstaging of management and prediction of tumor biologic behavior. Such applications will require additional validation by clinical trials with additional CMM samples and long-term clinical follow-up."

In this case, the DecisionDX Melanoma assay was not known to be effective on date of reading based on a lack of scientific evidence showing that the results would accurately guide patient care and health outcomes, and the use of this testing was not supported by scientifically based guidelines of national medical research or governmental agencies. Furthermore, based on the results of the original biopsy and clinical findings, this testing would not be of value in treatment planning for this patient. 

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