MolDX: Next-Generation Sequencing for Solid Tumors

Medicare coverage under this policy applies to Next-Generation Sequencing (NGS) clinical laboratory tests (LDTs, FDA-cleared, or FDA-approved) for solid tumors, consistent with NCD 90.2 section D and subject to Medicare Administrative Contractor discretion. The policy explicitly excludes hematologic malignancies, circulating tumor DNA (ctDNA) testing, and germline testing for cancer patients. Coverage determinations and required documentation follow NCD 90.2 and applicable MAC/local policies.

"Coverage is allowed for Next-Generation Sequencing (NGS) clinical laboratory tests (Lab-Developed Tests, FDA-cleared, or FDA-approved) for solid tumors as allowable under NCD 90."

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