MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma

Summary of Evidence Analysis of Evidence General Information Associated Information Sources of Information Bibliography Revision History Information Associated Documents Attachments Related Local Coverage Documents Related National Coverage Documents Public Versions Keywords Local Coverage Determination (LCD) MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma L39345 Expand All | Collapse All  Email Document  Download  Add to basket Contractor Information Contractor Name Contract Type Contract Number Jurisdiction States LCD Information Document Information LCD ID L39345 LCD Title MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma Proposed LCD in Comment Period N/A Source Proposed LCD DL39345 Original Effective Date For services performed on or after 08/06/2023 Revision Effective Date N/A Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 06/22/2023 Notice Period End Date 08/05/2023 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion factors and/or related

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.