Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Xiphoid-junctional dysplastic nevus with atypical feature and inferior thoracic spine-malignant melanoma

Treatment: Decision DX Melanoma Assay 

The insurer denied coverage for Decision DX Melanoma Assay. The denial was upheld.

This patient is a male with a diagnosis of xiphoid-junctional dysplastic nevus with atypical feature and inferior thoracic spine-malignant melanoma, measuring approximately 0.5 millimeters in thickness, with regression in the papillary dermis, in association with a nevus, as noted on the Dermatopathology Report.  According to the Decision DX-Melanoma Result, the patient has a designation of Class 1 Sub-class: 1A.

The insurer has denied coverage for Decision DX Melanoma Assay as not medically necessary.

Decision DX Melanoma Assay is not medically necessary for this patient. The patient had a biopsy of the inferior thoracic spine with a diagnosis of malignant melanoma 0.5 mm in thickness.  According to the Decision DX-Melanoma gene expression profile test, this is a class 1A, which has the lowest risk of metastatic spread within five years.  The provider is requesting plan approval for the Decision DX-Melanoma gene expression profile test.
The Decision DX Melanoma assay that was performed in early 2019 was not medically necessary in this case. The Decision DX 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. However, more recent studies are showing promise for the usefulness and prognostic values for treating certain populations of melanoma patients.  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. According to Trotter, S. C., et al. (2013), "The stage at presentation of melanoma has a significant impact on the course of the disease.  Most melanoma patients present with localized disease 82 to 85 percent of the time, followed by regional involvement 10 to 13 percent of the time, and distant metastatic disease 2 to 5 percent of the time.  The staging of melanoma holds prognostic value and dictates the recommendation in treatment. Staging is determined by the tumor, node, and metastasis (TMN) system developed by the American Joint Committee on Cancer (AJCC)"

In this case, the Decision DX Melanoma assay was not known to be effective 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. Furthermore, based on the results of the original biopsy and clinical findings, this testing would not be of value in treatment planning for this patient.  Therefore, the Decision DX Melanoma assay on the date of service was considered in this case not medically necessary.                                                         

The health care plan did act reasonably and with sound medical judgment and in the best interest of the patient.      

The carrier's denial of coverage for Decision DX Melanoma Assay is upheld.  The medical necessity is not substantiated.