Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for gene test DecisionDX-Melanoma performed.  Findings:  The physician reviewer found that the patient is diagnosed with cutaneous melanoma on the mid-upper back. Histopathologically, the tumor was Clark level III and extended to the Breslow depth of 0.4 mm. The DecisionDX-Melanoma assay performed  showed class 1 molecular signature, which is associated with a low risk of near term (within five years) metastatic disease. The patient requested reimbursement for the DecisionDX-Melanoma assay performed. The Health Plan denied reimbursement for the testing and noted that the services at issue were considered investigational for evaluation of the patients cutaneous melanoma. There is a lack of support in the medical literature for the services at issue in this clinical setting. While the majority of clinical stage I patients will be disease free at five years, some stage I patients will develop advanced disease. Prognosis for clinical stage II and III cases by tumor, node, metastasis (TNM) is highly variable, as evidenced by a five year survival rate of 53% to 82% for stage II patients and a five year survival rate of 22% to 68% for stage III patients. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin and clinical examinations. There is rarely any systemic surveillance imaging, further lymph node interrogation or recommendation for adjuvant therapy. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. The DecisionDX-Melanoma gene expression profile (GEP) test is an expression assay designed to predict distant metastasis in stage I and stage II melanoma patients. DecisionDX-Melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as class 1 (i.e., low risk of metastasis) or class 2 (i.e., high risk of metastasis). The result of the analysis for this patients melanoma performed with DecisionDX-Melanoma, classified the tumor as class 1, with a low risk of near-term (within 5 years) metastatic disease, such as 97% metastasis free rate. While melanoma prognostic assay may be a useful tool in as a predictor of metastasis risk, there is a lack of peer reviewed published studies confirming this hypothesis. As such, DecisionDX-Melanoma assay performed was not likely to have been more effective than standard options in evaluating this patients medical condition. Final Result: The reviewers determined that the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2 & 3 are board certified in dermatology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.