Naxitamab-gqgk (Danyelza) (CPB 0984, reviewed 2026-01-13)

Before 2026-01-13: Billing and clinical teams must implement precertification workflow for all Danyelza (naxitamab-gqgk, HCPCS J9348) claims. (1) Update billing system to flag all J9348 claims as requiring precertification before claim submission. (2) Establish referral process: providers must contact Aetna at (866) 752-7021 or fax (888) 267-3277 with Statement of Medical Necessity (SMN) form for each patient. (3) Train front-desk and clinical staff on precertification requirements and contact information. (4) Update encounter templates to ensure providers document: patient age (≥1 year), disease status (relapsed or refractory), disease location (bone or bone marrow), and prior therapy response (partial response, minor response, stable disease, or progressive disease). (5) For continuation therapy, establish reauthorization protocol requiring documentation of absence of unacceptable toxicity or disease progression. Failure to obtain precertification will result in claim denial. This policy applies to Aetna commercial medical plans only; refer to Medicare Part B Criteria for Medicare beneficiaries.