Decision Dx-melanoma Assay denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested genetic testing Decision Dx melanoma assay for evaluation of his medical condition. Findings: The physician reviewer found that review of the submitted documentation and relevant literature demonstrates the medical necessity of the services at issue. Decision Dx melanoma assay is utilized to help predict future metastatic risk of his invasive melanoma. In this case, the patient was diagnosed with an invasive melanoma, which requires excision for definitive treatment. Subsequent follow-up is aimed at identifying recurrences or the development of distant metastases. Once metastatic, treatment of melanoma is very challenging and not very successful.

Nature of Statutory Criteria/Case Summary: An enrollee has requested DecisionDx Melanoma Assay testing for evaluation of his medical condition. Findings: Three physician reviewers found that the current medical evidence supports the services at issue in this clinical setting. Uveal melanomas are rare, and up to 50% are at risk for metastases. Among the most important risk factors are chromosomal markers in the tumor identified by use of the Decision DX Melanoma Assay test. Using samples of primary uveal melanomas obtained by fine needle biopsy, tumors are classified as having low or high metastatic potential, depending on the expression of 15 genes. DecisionDx Melanoma Assay testing is a standard of care for determining prognosis and need for more aggressive therapy and is superior to other testing available.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for DecisionDx melanoma assay provided for evaluation of the enrollee’s malignant melanoma. Findings: The 3 physician reviewer found that the staging and prognosis of cutaneous malignant melanoma is classically determined by the system as discussed by the American Joint Committee on Cancer (AJCC). As per this system, this patient would have been stage 1b, with an expected 10-year survival of at least 83%. DecisionDx is a study of 31 genes in melanoma cells which classifies the particular melanoma as either Class 1 with a five year distant-disease free survival of 73%, or Class 2 with five year disease-free survival of 46%. Colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx classification in patients who had sentinel node biopsy.

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for a Decision Dx-Melanoma assay.Findings: Three out of three physician reviewers found that the Decision Dx-Melanoma assay at issue was not likely to have been more beneficial than any other available standard treatments for the patient’s medical condition.NCCN Clinical Practice Guidelines do not currently recommend the Decision Dx test for cutaneous melanoma. There is no literature to support its use in the care of patients with thin melanomas to effect health outcomes. While there is literature to suggest that it may be beneficial for patients with melanomas to predict whether there is risk for metastasis based on phenotype, there is no current data to determine what to do with the information provided by the test.

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 Decision Dx-melanoma Assay, then check the rights and deadlines that apply to your plan.