MolDX: Non-Next Generation Sequencing Tests for the Diagnosis of BCR-ABL Negative Myeloproliferative Neoplasms

This LCD provides limited coverage for non-NGS single-gene and multi-gene panel testing for the diagnostic evaluation of suspected BCR-ABL-negative myeloproliferative neoplasms when performed per WHO/ICC diagnostic criteria and after assessment of BCR-ABL (except isolated PV suspicion). Tests must be analytically sensitive (e.g., detect JAK2 VAF ≤1% and ~1–3% for CALR/MPL), include minimum necessary genes for the suspected MPN subtype (e.g., JAK2, CALR, MPL; CSF3R for CNL), follow a sequential reflex testing approach with cessation after a positive diagnostic result, and meet validation requirements (AV, CV, CU); NGS testing falls outside this LCD and is governed by L38176.

"Coverage is provided for multi-gene non-NGS panel testing and single-gene testing for the diagnostic workup of patients with suspected BCR-ABL-negative myeloproliferative neoplasms (MPNs)."