Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Cutaneous melanoma  

Treatment: Current Procedural Terminology (CPT) code 81599 [Unlisted multianalyte assay with algorithmic analysis]

The insurer denied coverage for Current Procedural Terminology (CPT) code 81599 [Unlisted multianalyte assay with algorithmic analysis]. The denial is upheld. 

Reviewer #1:

This patient is a male with cutaneous melanoma. The dermatopathology report indicated a Breslow depth of 0.5mm, Clark level III, and background dysplastic nevus. A Decision Dx was ordered.

According to Weiss, et al., "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 [66, 113].  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."

Per Abbasi, et al., "Clearly, the greatest potential benefit is in those patients with intermediate risk melanomas (Stage I and II) as there is no consensus on how to manage them. In a study conducted by Pedram Gerami, MD, Associate Professor in Dermatology, Pathology, and Pediatrics-Dermatology at Northwestern University Feinberg School of Medicine, as compared to having a high-risk AJCC [American Joint Committee on Cancer] score a Class 2 GEP score has been shown to be 1.5 times more likely to have a poor outcome.  This means these patients could receive life-saving preventive therapies..."

According to Boland & Gershenwald, "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..."

The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. Decision Dx Melanoma has not had sufficient testing prospectively and in a randomized controlled study to make it standard of care. The CPT code 81599 [Unlisted multianalyte assay with algorithmic analysis] provided is not the best available treatment for this patient at this time.     
  
There is no evidence that the test is better than standard of care.  Therefore, the requested service is not likely to be more beneficial than any of the standard treatments/procedures for this patient.                                                    

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