MolDX: Next-Generation Sequencing for Solid Tumors

This policy allows Medicare coverage for NGS-based testing of solid tumors when performed as an LDT or an FDA-cleared/approved clinical laboratory test and when allowable under NCD 90.2 Section D (MAC discretion). The policy is limited to solid tumor testing and explicitly excludes hematologic malignancies, circulating tumor DNA (ctDNA) testing, and germline genetic testing related to cancer.

"Medicare may cover next-generation sequencing (NGS) testing for solid tumors when performed as a lab-developed test (LDT), or as an FDA-cleared or FDA-approved clinical laboratory test, when allowa..."

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