MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma

Jurisdiction: JJ Part B. States: Alabama, Georgia, Tennessee. Type: Active LCD

The purpose of this test is to assist dermatopathologists to arrive at the correct diagnosis of melanoma versus non-melanoma when examining skin biopsies. This Medicare contractor will provide limited coverage for molecular Deoxyribonucleic acid (DNA)/ Ribonucleic acid (RNA) assays that aid in the diagnosis or exclusion of melanoma from a biopsy when ALL of the following clinical conditions are met: The test is ordered by a board-certified or board-eligible dermatopathologist The specimen is a primary (non-metastatic, non-re-excision specimen) cutaneous melanocytic neoplasm for which the diagnosis is equivocal/uncertain (i.e., clear distinction between benign or malignant cannot be achieved using clinical and/or histopathological features alone) despite the performance of standard-of-care test procedures and relevant ancillary tests (i.e., immunohistochemical stains) The specimen includes an area representative of the lesion or portion of the lesion that is suspicious for malignancy The patient may be subjected to additional intervention, such as re-excision and/or sentinel lymph node biopsy, as a result of the diagnostic uncertainty The patient has not been tested with the same or similar assay for the same clinical lesion The test is validated for use in the intended-use population and is performed according to its stated intended-use The test demonstrates Analytical and Clinical Validity (AV and CV) and Clinical Utility (CU) and undergoes a technical assessment (TA) by MolDx ® to demonstrate compliance of the service with this policy Tests that demonstrate similar indicated uses and equivalent or superior performance to covered tests may similarly be covered under this policy.