MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms
L39927
Limited coverage is provided for non-NGS single-gene or multi-gene molecular testing for diagnosis of BCR-ABL-negative MPNs (e.g., PV, ET, PMF, CNL, CEL-NOS) when testing follows consensus diagnostic criteria and BCR-ABL assessment, uses assays with specified VAF sensitivity (≤1% for JAK2; 1–3% for CALR/MPL), and includes minimum necessary genes for the suspected subtype (JAK2, CALR, MPL; CSF3R for CNL). Single-gene testing must follow a sequential reflexive algorithm (stop after a positive diagnostic result unless further testing is clinically required); NGS testing is outside the scope of this LCD and may be used subsequently only when non-NGS testing is negative and NGS adds non-duplicative, guideline-supported mutations. Coverage requires documented analytical and clinical validity, completion of a technical assessment demonstrating AV/CV/CU, and evidence of equivalent or superior performance when compared to accepted standards.
"Patient is being evaluated for a BCR-ABL-negative myeloproliferative neoplasm (including PV, ET, PMF, CNL, CEL-NOS) according to national or international consensus diagnostic criteria (e."