Aetna Modified CPB 0984 for Naxitamab-Gqgk (Danyelza), Effective January 15, 2026 — Here's What Billing Teams Need to Do

Aetna, a CVS Health company, modified CPB 0984 governing naxitamab-gqgk (Danyelza) coverage for high-risk neuroblastoma, with an effective date of January 15, 2026. This coverage policy update defines the exact criteria your team must satisfy before billing J9348 (injection, naxitamab-gqgk, 1 mg) and the chemotherapy administration codes CPT 96413–96417. If you bill for pediatric oncology or hematology/oncology programs treating relapsed or refractory neuroblastoma, this update directly affects your prior authorization workflow and reimbursement claims.

Quick-Reference Table

Field	Detail Copy
Payer	Aetna, a CVS Health company
Policy	Naxitamab-gqgk (Danyelza) — CPB 0984
Policy Code	CPB 0984
Change Type	Modified
Effective Date	January 15, 2026
Impact Level	High
Specialties Affected	Pediatric Oncology, Hematology/Oncology, Infusion/Chemotherapy Billing
Key Action	Confirm all three initial approval criteria are documented before submitting precertification for J9348

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Aetna Naxitamab-Gqgk Coverage Criteria and Medical Necessity Requirements 2026

The Aetna naxitamab-gqgk (Danyelza) coverage policy applies to commercial medical plans only. Medicare billing teams should check Aetna's Medicare Part B criteria page separately — CPB 0984 does not govern those claims.

Precertification is required for all Aetna participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to start the process. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification portal.

What Aetna Requires for Initial Approval

Aetna considers naxitamab-gqgk (Danyelza) medically necessary for high-risk neuroblastoma only when all three of the following criteria are satisfied simultaneously:

1. Age and disease location. The member must be at least one year old with relapsed or refractory disease in the bone or bone marrow.

2. Prior therapy response. The member must have shown a partial response, minor response, stable disease, or progressive disease with prior therapy. A complete response to prior therapy is not listed as a qualifying response — take note of that distinction.

3. Combination regimen. Danyelza must be used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), billed under HCPCS J2820 (injection, sargramostim/GM-CSF, 50 mcg). A claim for J9348 without documented GM-CSF co-administration is a claim denial waiting to happen.

All three criteria must be met. Missing any single criterion — even if the other two are airtight — results in a denial. Document each criterion explicitly in the medical record before submitting prior authorization.

Continuation of Therapy Requirements

Aetna covers continuation of naxitamab-gqgk therapy when two conditions are met. First, the indication must be one already approved under Section I of the policy. Second, there must be no evidence of unacceptable toxicity or disease progression on the current regimen.

The medical necessity bar for reauthorization is lower than for initial approval, but it's not automatic. Your team needs documented evidence that the patient is tolerating the drug and responding — or at minimum not progressing. Build that documentation into your reauthorization workflow now, before January 15, 2026.

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Aetna Danyelza Exclusions and Non-Covered Indications

Aetna's position is direct: every indication not explicitly listed above is experimental, investigational, or unproven. There is no coverage for Danyelza in any off-label indication under this policy.

This matters for Danyelza billing because the drug has emerging data in other GD2-expressing tumors. None of that evidence is sufficient for Aetna under CPB 0984 as written. If your oncology program is treating neuroblastoma in patients under one year of age, or treating disease that does not involve the bone or bone marrow, expect denial.

If your team sees a clinically compelling off-label case, your path is an individual medical necessity review or appeals process — not a standard claim. Loop in your compliance officer before billing J9348 for any indication outside the three criteria above.

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Coverage Indications at a Glance

Indication	Status	Relevant Codes	Notes Copy
High-risk neuroblastoma, relapsed or refractory, bone/bone marrow involvement, age ≥1 year, with prior therapy response, + GM-CSF combination	Covered	J9348, J2820, CPT 96413–96417, C74.x ICD-10 codes	Precertification required; all three criteria must be met
High-risk neuroblastoma — continuation of approved therapy, no toxicity or progression	Covered (Reauthorization)	J9348, J2820, CPT 96413–96417	Reauthorization required; document tolerability and disease status
Any other indication (off-label use, pediatric patients under age 1, disease outside bone/bone marrow, etc.)	Not Covered — Experimental/Investigational	J9348	Aetna considers all other uses experimental, investigational, or unproven

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Aetna Naxitamab-Gqgk Billing Guidelines and Action Items 2026

The Aetna naxitamab-gqgk coverage policy is narrow and specific. These action items apply directly to what the policy requires.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Naxitamab-Gqgk (Danyelza) Under CPB 0984

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J9348	HCPCS	Injection, naxitamab-gqgk, 1 mg

Chemotherapy Administration CPT Codes Related to CPB 0984

Select the correct administration codes based on actual infusion time and technique. These are not interchangeable — improper code selection on Danyelza claims is a common audit trigger.

Key ICD-10-CM Diagnosis Codes for High-Risk Neuroblastoma Under CPB 0984

The full code set under this policy includes 93 ICD-10-CM codes, all drawn from the C74.x range (malignant neoplasm of the adrenal gland). The table below reflects the codes provided in the policy data.

The policy data notes 13 additional C74.x codes beyond those listed here. Pull the full code list from the CPB 0984 Aetna policy document directly to confirm your complete crosswalk before January 15, 2026.

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