MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies

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: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies L38047 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 L38047 LCD Title MolDX: Next-Generation Sequencing Lab-Developed Tests for Myeloid Malignancies and Suspected Myeloid Malignancies Proposed LCD in Comment Period N/A Source Proposed LCD DL38047 Original Effective Date For services performed on or after 02/10/2020 Revision Effective Date For services performed on or after 03/28/2024 Revision Ending Date N/A Retirement Date N/A Notice Period Start Date N/A Notice Period End Date N/A CPT codes, descriptions, and other data only are copyright

This policy describes and clarifies coverage for Lab-Developed Tests (LDTs) and Food and Drug Administration (FDA)-approved or cleared clinical laboratory tests utilizing Next-Generation Sequencing (NGS) in cancer as allowable under the National Coverage Determination (NCD) 90.2, under section D describing Medicare Administrative Contractor (MAC) discretion for coverage, as well as for use of NGS in suspected myeloid neoplasms. This policy’s scope is specific for myeloid malignancies and suspected malignancies, and is exclusive of solid tumor testing, circulating tumor DNA (ctDNA) testing, and other cancer-related uses of NGS, such as in germline testing.