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

This policy covers non-NGS multigene panels and limited single-gene testing for diagnosing BCR-ABL-negative myeloproliferative neoplasms when performed according to WHO/ICC diagnostic criteria and after assessment of BCR-ABL (except when only PV is suspected). Covered tests must include required genes for the suspected MPN subtype (e.g., JAK2 V617F/exon12, CALR, MPL; CSF3R for CNL), demonstrate analytical sensitivity (minimum VAF ~4%), have established clinical validity/utility, and be used for diagnosis only (not MRD or test-of-cure).

"Multigene non-NGS panel testing is covered for diagnostic evaluation of suspected BCR-ABL-negative myeloproliferative neoplasms (MPNs) when all policy criteria are met."

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