MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms
L39923
This policy provides limited coverage for non-NGS single‑gene or multi‑gene assays to diagnose BCR-ABL‑negative myeloproliferative neoplasms (classical MPNs such as PV, ET, PMF, and select non‑classical MPNs) when testing follows WHO/ICC diagnostic criteria and BCR-ABL assessment (unless only PV is suspected). Covered tests must meet specified analytic sensitivity (VAF ≤1% for JAK2; 1–3% for CALR/MPL), include minimum necessary genes for the suspected subtype (e.g., JAK2, CALR, MPL; CSF3R for CNL), complete required technical assessments and demonstrate clinical validity/utility; NGS testing is outside this LCD and governed by LCD L38123. Testing for monitoring (MRD) or test-of-cure, insufficient gene-content panels, duplicate mutation testing, and myelodysplastic/myeloproliferative neoplasms are not covered.
"Patient is being evaluated for a BCR-ABL-negative myeloproliferative neoplasm (MPN) according to national or international consensus diagnostic criteria (WHO or ICC)."