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

This policy covers Next-Generation Sequencing (NGS) lab-developed tests (LDTs) and FDA-approved/cleared NGS clinical tests for evaluation of myeloid malignancies and suspected myeloid neoplasms, when consistent with NCD 90.2 and any applicable MAC discretion. It explicitly excludes solid tumor testing, circulating tumor DNA (ctDNA) testing, germline testing, and other non-myeloid cancer uses of NGS.

"Coverage is provided for Next-Generation Sequencing (NGS) lab-developed tests (LDTs) and FDA-approved or -cleared clinical laboratory NGS tests when used to evaluate myeloid malignancies."

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