MolDX: Melanoma Risk Stratification Molecular Testing

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: Melanoma Risk Stratification Molecular Testing L37725 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 L37725 LCD Title MolDX: Melanoma Risk Stratification Molecular Testing Proposed LCD in Comment Period N/A Source Proposed LCD DL37725 Original Effective Date For services performed on or after 12/03/2018 Revision Effective Date For services performed on or after 06/26/2025 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date 05/19/2022 Notice Period End Date 07/02/2022 CPT codes, descriptions, and other data only are copyright 2025 American Medical Association. All Rights Reserved. Fee schedules, relative value units, conversion f

Molecular diagnostic tests used to assist in risk stratification of melanoma patients are covered when ALL of the following are true: The patient has a personal history of melanoma AND: Either: Has Stage T1b and above OR Has T1a with documented concern about adequacy of microstaging Is undergoing workup or being evaluated for treatment, AND Does not have metastatic disease AND Presumed risk for a positive Sentinel Lymph Node Biopsy (SLNB) based on clinical, histological, or other information is >5% AND Has a disease stage, grade, and Breslow thickness (or other qualifying conditions) within the intended use of the test The TEST has demonstrated, as part of a Technical Assessment: Clinical validity of analytes tested in predicting metastatic disease (or the absence of metastatic disease) in peer-reviewed scientific literature Utility beyond clinical, histological, and radiographical factors in the ability to accurately stratify patients into risk groups to manage patient care, such by precluding unnecessary sentinel lymph node biopsies Appropriate analytical validity Performance characteristics equivalent or superior to other covered, similar tests