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

NGS-based lab-developed tests and FDA-approved/cleared NGS clinical laboratory tests are covered for evaluation of myeloid malignancies and suspected myeloid neoplasms as allowable under NCD 90.2 (MAC discretion, Section D). The policy is limited to hematologic/myeloid disease indications and explicitly excludes solid tumor testing, circulating tumor DNA (ctDNA) testing, and germline NGS uses; follow MAC/local requirements for documentation and prior authorization.

"NGS-based lab-developed tests (LDTs) and FDA-approved or -cleared clinical laboratory NGS tests are covered for evaluation of myeloid malignancies and suspected myeloid neoplasms when allowable und..."

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