MolDX: Next-Generation Sequencing for Solid Tumors

This policy covers next-generation sequencing (NGS) clinical laboratory tests for cancer (LDTs, FDA-cleared, and FDA-approved) for solid tumor testing when allowable under NCD 90.2 Section D and at MAC discretion. It explicitly excludes hematologic malignancies, circulating tumor DNA (ctDNA)/liquid biopsy testing, and germline genetic testing in/for patients with cancer.

"NGS-based clinical laboratory tests for cancer (including Lab-Developed Tests, FDA-cleared, and FDA-approved tests) are allowable for coverage under National Coverage Determination (NCD) 90."

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