Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Skin Disorders. 
Treatment: Cancer Screening. 

The insurer denied Decision DX Melanoma testing. The denial is upheld in whole. 

The patient is a female who was diagnosed with malignant melanoma involving the skin of her left calf. The pathology report indicated that this was an invasive, malignant melanoma measuring 0.3 millimeter (mm) in Breslow depth, Clark's level II, not ulcerated, with less than 1 mitosis per square millimeter, T1a, stage Ia. Her tumor was sent for the Decision DX Melanoma gene expression profile test. The health plan denied the claim for this study on the basis that it was not medically necessary. The question at hand is whether or not the Decision DX Melanoma gene expression profile test is medically necessary. 

The health plan's determination is upheld in whole. 

The Decision DX gene expression profile test for melanoma is not considered the standard of care by the surgical and medical oncology community. Therefore, it is not medically necessary. 

The Decision DX Melanoma gene expression profile test evaluates 28 discriminating gene targets and 3 endogenous control genes within primary melanoma specimens. The resulting gene expression profiles are used to identify patients who are at increased risk of recurrence or metastasis (Class II result), versus those at lower risk (Class I result) than what would be predicted by the current American Joint Committee on Cancer (AJCC) staging system. The prognostic accuracy of this test has been validated and published in peer-reviewed journals. (1,2) 

In order for this test to be incorporated into our staging and risk stratification schema for melanoma patients, there will need to be evidence to show that specific interventions for patients with class II results provide a clinical benefit. At the present time, it is not clear that the results of this test provide clinically meaningful information for patients. The argument has been made that patients with a high-risk result could benefit from more intensive clinical surveillance, imaging surveillance and/or administration of adjuvant therapy. There is currently no evidence showing that more intensive clinical surveillance provides a benefit to patients with melanoma. Even for patients known to be at high risk for recurrence/metastasis as defined by our current criteria, the use of routine surveillance imaging is controversial because of its low yield and the significant incidence of indeterminate findings unrelated to melanoma. Similarly, the use of adjuvant interferon (the only Food and Drug Administration [FDA] approved adjuvant therapeutic agent that would be available for this patient given her stage of disease) for patients with known high-risk resected melanoma is controversial because of its toxicity and lack of proven overall survival benefit (although there is a 10% improvement in disease-free survival). Finally, the National Comprehensive Cancer Network clinical practice guidelines for melanoma (3) state that "It remains unclear whether this gene expression profile (GEP) is reliably predictive of outcome across the risk spectrum of melanoma. Prospective validation studies (as have been performed in breast cancer) are required to more accurately define the clinical utility of molecular testing prior to widespread implementation of GEP for prognostication of cutaneous melanoma, and in particular to determine its role in guiding surveillance imaging, sentinel lymph node biopsy, and adjuvant treatment decisions".