Gemtuzumab Ozogamicin (Mylotarg) — CPB 0922 | AETNA Coverage Update

Aetna modified CPB 0922 for gemtuzumab ozogamicin (Mylotarg), effective September 26, 2025. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its gemtuzumab ozogamicin coverage policy under CPB 0922. This change affects claims billed with HCPCS code J9203 (injection, gemtuzumab ozogamicin, 0.1 mg) and chemotherapy administration codes CPT 96413 through 96417. If your practice or infusion center treats CD33-positive AML, acute promyelocytic leukemia, or myeloid sarcoma, this policy governs your reimbursement under commercial Aetna plans.

Quick-Reference Table

Aetna Gemtuzumab Ozogamicin Coverage Criteria and Medical Necessity Requirements 2025

The core of the Aetna gemtuzumab ozogamicin coverage policy under CPB 0922 Aetna system is medical necessity documentation tied to specific diagnoses. J9203 — the billing unit for Mylotarg at 0.1 mg per injection — is covered when selection criteria are met. That phrase does real work here: Aetna won't pay on diagnosis alone.

The covered ICD-10 diagnoses fall into three main leukemia categories. CD33-positive acute myeloid leukemia (AML) is the primary indication. That maps to ICD-10 codes C92.60, C92.61, C92.62 (AML with 11q23-abnormality), and C92.A0, C92.A1, C92.A2 (AML with multilineage dysplasia). Acute promyelocytic leukemia — C92.40, C92.41, C92.42 — and myeloid sarcoma — C92.30, C92.31, C92.32 — round out the leukemia coverage.

The CD33-positive designation is not incidental. Gemtuzumab ozogamicin is an antibody-drug conjugate that targets CD33. Your documentation must establish CD33 positivity. If you're submitting claims for AML without CD33 status confirmed in the medical record, expect a claim denial.

Acute lymphoblastic leukemia (ALL) also appears in the ICD-10 code set under this policy — C91.0, C91.1, C91.2. This reflects emerging data on Mylotarg in ALL, particularly CD33-positive ALL. Medical necessity criteria for this indication may be narrower, so make sure prior authorization is in place before treatment begins.

For commercial plans, prior authorization is the standard expectation for a drug in this class. Mylotarg carries a per-dose cost that routinely triggers prior auth review. Don't assume an authorization from six months ago covers a new cycle. Verify active authorization status before each course of therapy.

Medicare criteria are handled separately. If you bill Medicare Advantage or Medicare Part B, Aetna directs you to its Medicare Part B step criteria — not CPB 0922. Billing under the wrong policy set is a fast path to a claim denial that's hard to unwind.

Aetna Gemtuzumab Ozogamicin Exclusions and Non-Covered Indications

The ICD-10 code list attached to CPB 0922 includes diagnoses beyond hematologic malignancies — and that's where the real exposure sits for billing teams.

The policy lists codes for small cell lung cancer (C34.90, C34.91, C34.92), mesothelioma (C45.0–C45.9), malignant neoplasm of the breast (C50.011–C50.929), ovarian cancer (C56.1–C56.9), glioblastoma (C71.9), and non-Hodgkin lymphoma (C85.80–C85.99). These appear in the code data without a "covered" group label. That's telling.

These diagnoses likely represent investigational or off-label uses of gemtuzumab ozogamicin. Aetna's standard position on investigational use is non-coverage. Billing J9203 against any of these diagnoses on a commercial plan will almost certainly result in a claim denial unless you have an explicit prior authorization documenting medical necessity under a clinical trial or exception pathway.

The real issue here is the ICD-10 code list's breadth. It can look like a covered-indications list. It isn't. Codes in the "other HCPCS codes related to the CPB" group — J9100 (cytarabine, 100 mg) and J9151 (daunorubicin citrate, liposomal, 10 mg) — are related context codes, not separately covered under CPB 0922 criteria. These are combination chemotherapy agents often used alongside Mylotarg in AML regimens. Bill them on their own medical necessity documentation, not on CPB 0922's coverage criteria.

If your oncology team is using Mylotarg in a solid tumor trial, talk to your compliance officer before submitting claims. The path to reimbursement in those cases runs through your payer's clinical trial policy, not through CPB 0922.

Coverage Indications at a Glance

Aetna Gemtuzumab Ozogamicin Billing Guidelines and Action Items 2025

The effective date of September 26, 2025 is already live. These are the steps your billing team needs to take now.

CPT, HCPCS, and ICD-10 Codes for Gemtuzumab Ozogamicin Under CPB 0922

Covered HCPCS Codes (When Selection Criteria Are Met)

Chemotherapy Administration CPT Codes (Related to CPB 0922)

Key ICD-10-CM Diagnosis Codes