Proposed LCD - MolDX: Molecular Assays for the Diagnosis of Cutaneous Melanoma (DL39389)

CMS National Coverage PolicyTitle XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary42 CFR 410.32(a) Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: ConditionsCMS Internet-Only Manual, Pub. 100-02, Medicare Policy Manual, Chapter 15, 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests, 80.1.1 Certification ChangesCoverage Indications, Limitations, and/or Medical NecessityThe 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 molecularDeoxyribonucleic 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 dermatopathologistThe 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 malignancyThe patient may be subjected to additional intervention, such as re-excision and/or sentinel lymph node biopsy, as a result of the diagnostic uncertaintyThe patient has not been tested with the same or similar assay for the same clinical indicationThe test is validated for use in the intended-use population and is performed according to its stated intended-useThe test demonstrates Analytical and Clinical Validity (AV and CV) and Clinical Utility (CU) and undergoes a technical assessment (TA) by MolDxto demonstrate compliance of the service with this policyTests that demonstrate similar indicated uses and equivalent or superior performance to covered tests may similarly be covered under this policy.General InformationAssociated InformationN/ASources of InformationN/ABibliographyAmerican Cancer Society. 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