Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Melanoma.

Treatment: DecisionDX-Melanoma gene expression profiling test.

The insurer denied the DecisionDX-Melanoma gene expression profiling test.

The denial was upheld.

This is a female patient with a diagnosis of a 0.38 mm deep superficial spreading malignant cutaneous melanoma, stage T1A.  DecisionDX-Melanoma gene expression profiling test was performed.

Per Sondak & Messina (2016), "The clinical value of this test remains unclear, and the National Comprehensive Cancer Network (NCCN) Guidelines for Melanoma state "while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low- versus high-risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas (before or following [sentinel lymph node biopsy (SLNB)]) is not recommended outside of a clinical study (trial)." This admonition seems sound, particularly if we apply the same stringent criteria for validation that Mahar et al. applied to clinical prognostic tools that also claim to demonstrate independent prognostic value. Nevertheless, practicing surgical oncologists are encountering patients with clinically localized invasive melanomas who have already undergone this test at the time of referral. For the time being, until far more detailed data derived from prospective evaluations are available, there is insufficient evidence to propose that routine clinical management, including decision making regarding SLNB, should be altered by the results of gene expression profiling, although to reassure patients who have already received and are concerned about a "high-risk" determination, more intensive surveillance may be justified.

Similarly, according to 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)."

Swetter SM, et al. (2019) affirms, "Current evidence does not support increased surveillance imaging as a result of available prognostic [gene expression profiling (GEP)] tests, particularly in node-negative patients who are not yet eligible for newer, more effective adjuvant therapies. Similarly, the frequency of clinical follow-up and indications for imaging in patients with [cutaneous melanoma (CM)] are unlikely to be modified by a prognostic GEP result until prospective studies have confirmed a benefit and adjuvant therapy has demonstrated a meaningful impact in earlier-stage disease."                                                         

Based on the review of the medical record and literature, DecisionDX-Melanoma gene expression profiling test is not considered medically necessary for this patient. For stage 1 melanoma there is no additional testing that needs to be done. The risk of metastasis for this thin melanoma is small. The National Comprehensive Cancer Network (NCCN) guidelines do not recommend any additional workup for T1 melanomas, outside of an excision with 1 cm margins. Therefore, the request is not medically necessary. 

The health plan acted reasonably with sound medical judgement, and in the best interest of the patient. DecisionDX-Melanoma gene expression profiling testing is used to stratify risk of metastasis in patients with melanoma. Gene expression profiling like that undertaken by this provider has not yet been accepted as standard of care in treating cutaneous melanoma patients.      

Based on the above, the medical necessity for DecisionDX-Melanoma gene expression profiling test is not substantiated.  The insurer's denial should be upheld.