Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #3:

The dermatopathology report notes the patient is a male with a listed diagnosis of invasive malignant melanoma located on the skin, left posterior thigh.  Per a final report from the DecisionDx-Melanoma test, the patient had Class 1 Sub-class:1A. 

The insurer has denied coverage for CPT code 81599 [Unlisted multianalyte assay with algorithmic analysis] provided as experimental/investigational.  
In a letter of medical necessity the dermatologist affirmed that the patient had been diagnosed with cutaneous melanoma and asserted that the information from the DecisionDX-Melanoma gene expression test would help to determine the most appropriate management plan for the patient.  
The scientific evidence in peer-reviewed literature does not support a result of improvement in health outcome. The results of the DecisionDX Melanoma test revealed the patient as class 1A, which suggests a very low risk of metastatic potential.  Furthermore, based on the results of the original biopsy and clinical findings, this testing would not be of value in treatment planning for this claimant.  The DecisionDX Melanoma assay was not known to be effective at the time it was performed, based on a lack of scientific evidence showing that the results will accurately guide patient care and health outcomes.  In this case, the testing would not have been considered effective or useful in treatment planning.  The initial evaluation for risk of metastasis in patients with cutaneous melanoma uses the American Joint Committee on Cancer (AJCC) staging criteria, which includes Sentinel Lymph Node status.

Cirenajwis, H., et al, state, "Cutaneous malignant melanoma (CMM) is the most lethal form of skin cancer and its incidence has increased faster than that of any other cancer, rendering it a major public health problem worldwide.  In order to provide clinicians and patients with accurate prognostic information about the disease, a correct staging system is fundamental.  Since 1998, the American Joint Committee on Cancer (AJCC) melanoma staging system has served as a foundation for clinical classification and it was recently updated to the 7th edition after adding more tumor intrinsic factors with prognostic significance."

Swetter, et al., indicate "Routine molecular testing, including GEP, for prognostication is discouraged until better use criteria are defined. The application of molecular information for clinical management (eg, sentinel lymph node eligibility, follow-up, and/or therapeutic choice) is not recommended outside of a clinical study or trial." 

In this case, the DecisionDX Melanoma assay was not known to be effective on date of reading based on a lack of scientific evidence showing that the results would accurately guide patient care and health outcomes, and the use of this testing was not supported by scientifically based guidelines of national medical research or governmental agencies.   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 Current Procedural Terminology (CPT) code 81599 [Unlisted multianalyte assay with algorithmic analysis] provided should be upheld.