Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Melanoma. 
Treatment: DecisionDx Melanoma Test, code 81599. 

The insurer denied coverage for DecisionDx Melanoma Test, code 81599. 

The denial is upheld. 

This is a male patient who has a melanoma that was selected for testing by the Castle DecisionDx - Melanoma. The patient's lesion on the left upper back that was noted as a melanoma was 0.5 millimeters (mm) in thickness. It was excised. 

According to Weiss, 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). Definitive assessment of the sensitivity and specificity of this test should be conducted in prospective analyses of patients who are representative of the general primary melanoma patient population. Moreover, guidance on interpretation of DecisionDx results is of critical importance. Clinicians may suggest that patients predicted by this test to be at high risk for metastasis undergo more frequent clinical evaluations and surveillance imaging, particularly in patients who have negative sentinel lymph node biopsies. However, in settings in which adjuvant therapies are either contraindicated or not available, this categorization may increase patient anxiety without real benefit to the patient." 

Boland & Gershenwald (2016) states, "The revisions to the American Joint Committee on Cancer (AJCC) melanoma staging system over time reflect changes in our understanding of the biology of the disease. Since the 1st edition, where tumor thickness was defined anatomically by its relationship to the reticular or papillary dermis (Clark level) as well as tumor thickness (Breslow thickness), there have been significant strides in our use of clinicopathological variables to stratify low- versus high-risk patients. Management of the regional nodal basin has also changed dramatically over time, impacted by techniques such as lymphatic mapping and sentinel lymph node biopsy (SLNB) and changes in pathological evaluation of the regional lymph nodes. Additionally, stratification of distant metastases has evolved as survival outcomes have been shown to vary based upon anatomic site of metastases and serum lactate dehydrogenase levels. The variables in use in the current (7th edition) AJCC staging system are surrogate markers of biology with validated impact of survival outcomes." 

The National Comprehensive Cancer Network (NCCN) states, "Prognostic gene expression profiling (GEP) to differentiate melanomas at low risk for metastasis may provide information on individual risk of recurrence, as an adjunct to standard [the American Joint Committee on Cancer (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 [sentinel lymph node biopsy (SLNB)])requires further prospective  investigation in large, contemporary data sets of unselected patients."                                             

Based on the review of the medical record and literature, there is insufficient evidence to support the requested testing as appropriate, as the test lacks evidence of efficacy. The DecisionDx Melanoma assay has not had sufficient testing prospectively and in a randomized controlled study to make it standard of care. 

The health plan acted reasonably with sound medical judgment, and in the best interest of the patient. 

The medical necessity for the DecisionDx Melanoma Test, code 81599 is not substantiated. The insurer's denial should be upheld.