MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma

Coverage is provided for molecular DNA/RNA assays to assist dermatopathologists in distinguishing melanoma from non-melanoma for primary cutaneous melanocytic neoplasms when multiple specific conditions are met, including ordering by a board-certified/board-eligible dermatopathologist, an equivocal diagnosis after standard-of-care and ancillary tests, a representative specimen area suspicious for malignancy, and potential for additional clinical intervention. Tests must be validated for the intended-use population, demonstrate Analytical and Clinical Validity and Clinical Utility, not be a repeat assay on the same lesion, and must undergo MolDx technical assessment to be covered.

"Test must be ordered by a board-certified or board-eligible dermatopathologist."

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