MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma
L39375
MolDx will provide limited coverage for molecular DNA/RNA assays to assist in diagnosing equivocal primary cutaneous melanocytic neoplasms when ordered by a board-certified or board-eligible dermatopathologist, the specimen is primary (non-metastatic, non-re-excision) and includes a representative suspicious area, and standard histopathology and ancillary tests remain non-diagnostic. Coverage requires that the patient has not previously had the same or a similar assay on the same lesion and that the assay is validated (demonstrates analytical and clinical validity and clinical utility) and has passed a MolDx technical assessment; assays with equivalent or superior performance may also be considered. Tests not meeting these criteria (e.g., metastatic or re-excision specimens, prior same-assay testing, lack of validation or MolDx TA, or ordered by non-dermatopathologists) are not covered.
"Coverage is provided when the molecular DNA/RNA assay is ordered by a board-certified or board-eligible dermatopathologist to assist in distinguishing melanoma from non-melanoma."