Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Left shin melanoma
 
Treatment: 81599-Unlisted chemistry procedure-DecisionDx-Melanoma

The insurer denied coverage for 81599-Unlisted chemistry procedure-DecisionDx-Melanoma. The denial is upheld. 

Reviewer#1

This patient is a female with a history of melanoma, 1.1 mm in greatest depth. The requested test is the DecisionDx-Melanoma.  This was denied as there was not enough evidence to support that this testing was beneficial to the patient's condition. This decision is being appealed.

DecisionDx-Melanoma is a gene expression profile test that is used to stratify risk of metastasis in patients with melanoma.  Gene expression profiling like that undertaken by this treating provider has not yet been accepted as standard of care in treating cutaneous melanoma patients.  The American Joint Committee on Cancer (AJCC) and National Comprehensive Cancer Network (NCCN) guidelines for clinical decision making and follow-up for patients with cutaneous melanoma do not currently incorporate gene expression profiling. In fact, at the NCCN Guidelines for Melanoma V.1.2018 Panel Meeting on 06/28/2017, 22/22 dermatologists voted not to include Decision-DX in the NCCN guidelines.  Given that these assays are not recommended in clinical guidelines, and the data pertaining to this assay's use is not yet accepted, the information gleaned from the assay itself would not materially or appropriately affect the treatment or follow-up approach of most practicing dermatologists.  The limited data on Gene Expression Profile (GEP) for melanoma have not yet been extensively vetted and validated by the dermatology or oncology research community. Thus, inclusion of these assays in the evaluation of patients with melanoma is not considered standard of care.

According to Sondak, V. K., & Messina, J. L. (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 SLNB) is not recommended outside of a clinical study (trial)..."" 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)." The American Academy of Dermatology Melanoma Guidelines published in 2019 does not support the use of gene expression profiling.
As mentioned previously the NCCN and the American Academy of Dermatology guidelines do not support the use of DecisionDx-Melanoma.  The DecisionDx-Melanoma has not shown in peer reviewed literature to change clinical management of patients with melanoma, and is not recommended by any regulatory body; therefore, the patient is not a good candidate for the DecisionDx-Melanoma.     

Therefore, 81599 Unlisted chemistry procedure-DecisionDx-Melanoma is not the best available treatment for this patient at this time and is not likely to be more beneficial than any standard treatment or procedure, such as an excision and a sentinel lymph node biopsy.                                                    

The carrier's denial of coverage for 81599-Unlisted chemistry procedure-DecisionDx-Melanoma should be upheld.