Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2:

The patient has a medical history of cutaneous melanoma, Breslow Depth 0.5 mm. The request for coverage of the DecisionDx melanoma assay is under review.

This 31 gene assay for predicting future recurrence of melanoma is still in funding stages and not yet FDA approved.  Lacking FDA approval, this tool cannot be covered as a standard of care treatment for melanoma.  To date, results remain inconclusive regarding the efficacy of this tool for improving health outcomes on a large scale.  As such, it cannot be covered by insurance at this time.  Additionally, this tool is not for treating an active disease nor would any of its prognostics change the plan of care for this patient. As such, utilization of this medical device constitutes an elective procedure.  The patient is diagnosed with malignant melanoma, Breslow Depth 0.5mm. Melanoma is a deadly cancer, the American Joint Committee on Cancer (AJCC) divides melanoma into four stages, which takes into account tumor thickness and anatomical level of involvement (localized cutaneous disease) for stages I and II.  Stage III involves local regional lymph nodes and stage IV includes distant metastasis (skin, subcutaneous tissue, nodal, visceral, and skeletal or CNS) (National Comprehensive Cancer Network, 2017).

Sondak & Messina indicate, "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 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."

The NCCN  Guidelines state that "Prognostic gene expression profiling(GEP) to differentiate melanomas at low versus high risk for metastasis may provide information on individual risk of recurrence, as an adjunct to standard AJCC staging. However, the currently available prognostic molecular techniques should not replace pathologic staging procedures, and the use of GEP testing according to specific melanoma stage (before or after SLNB) requires further prospective investigation in large contemporary data sets of unselected patients"

CPT code 81599 [Unlisted multianalyte assay with algorithmic analysis] provided on is not the best available treatment for this patient at this time.  The requested testing is not likely to be more beneficial than any other standard treatment or procedure.

The carrier's denial of coverage for Current Procedural Terminology (CPT) code 81599 [Unlisted multianalyte assay with algorithmic analysis] provided should be upheld.