Decision Dx-melanoma Gene 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 reimbursement for the DecisionDx-Melanoma Gene Assay. For cutaneous melanoma stage I-II measuring 0.3 mm, the DecisionDx-Melanoma Gene Assay has been validated as an accurate predictor of five-year metastatic risk. Treatment plans for cutaneous melanoma, including possible adjuvant therapy use, are based upon the individual patient’s risk of recurrence. The alternative testing for recurrence risk and treatment decision-making is a sentinel lymph node biopsy (SLNB). Low-risk results from the DecisionDx-Melanoma Gene Assay identifies patients who could avoid invasive SLNB. In this case, cutaneous metastases would be difficult to detect from full-body skin screening examination surveillance due to the absence of pigmentation in the tumor.

An enrollee has requested reimbursement for a DecisionDx-Melanoma gene assay. A study found the use of gene expression profiling in patients with stage 1-2 melanomas as a risk stratification tool in patients with melanomas with high risk features. In this patient’s case, the records document melanoma with a thick Breslow depth transected at initial biopsy, negative surgical margins on wide local excision, and negative sentinel lymph node biopsy. Based on the initial pathology report, the patient appeared to have an increased risk of cancer recurrence. The DecisionDx-Melanoma gene test assesses the risk of recurrence based on the genetic expression profile. In this patient’s case, the DecisionDx-Melanoma gene test showed a lower risk profile and, therefore, changed management to include less frequent skin examinations and surveillance imaging.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has reimbursement for DecisionDX-melanoma gene assay that was performed for evaluation of the enrollee’s cutaneous melanoma. Findings: The 3 physician reviewers found that the staging and prognosis of cutaneous melanoma is classically determined. As per this system, this patient would have been staged as pT3aN1 (Stage IIIa). This has an expected ten year survival of about 63%. DecisionDX is a study of 31 genes in melanoma cells. It then classifies that melanoma as either high or low risk for recurrence. The National Comprehensive Cancer Network (NCCN) guidelines state there is interest in these newer genetic profiles, but only in the context of a clinical trial.

Nature of Statutory Criteria/Case Summary: A 61-year-old female enrollee has requested reimbursement for Decision Dx Melanoma Gene Assay for evaluation of the enrollee’s melanoma. Findings: The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on Decision Dx Melanoma Gene Assay has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers.

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 Gene Assay, then check the rights and deadlines that apply to your plan.