Temozolomide (Temodar) Injection — CPB 0876 | AETNA Coverage Update

Aetna modified CPB 0876 for temozolomide (Temodar) injection, effective September 26, 2025. Here's what billing teams need to do.

Aetna, a CVS Health company, updated its temozolomide injection coverage policy under CPB 0876 to define 12 approved indications for HCPCS J9328. If your team bills chemotherapy administration via CPT 96413 or 96415 for any of these diagnoses, this policy sets the exact criteria that determines whether Aetna pays or denies. Get your charge capture and prior authorization workflows aligned before September 26, 2025.

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Quick-Reference: Aetna CPB 0876 Temozolomide Injection Policy Change 2025

Field	Detail
Payer	Aetna, a CVS Health company
Policy	Temozolomide (Temodar) Injection
Policy Code	CPB 0876
Change Type	Modified
Effective Date	September 26, 2025
Impact Level	High
Specialties Affected	Oncology, Neuro-oncology, Hematology/Oncology, Infusion Centers
Key Action	Confirm all temozolomide injection claims map to an approved indication and supported ICD-10 code before billing J9328

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Aetna Temozolomide Injection Coverage Criteria and Medical Necessity Requirements 2025

The Aetna temozolomide injection coverage policy under CPB 0876 recognizes 12 specific indications as medically necessary. Every indication has conditions attached. "CNS cancer" alone is not enough — the indication type, line of therapy, and combination regimen all matter.

Here's what the policy actually requires for medical necessity approval across the 12 covered indications:

CNS cancers and brain metastases. Aetna covers temozolomide injection for CNS cancers broadly, including brain metastases from solid tumors. This is the widest bucket in the policy. Glioblastoma and anaplastic astrocytoma are the most common diagnoses that fall here.

Solid tumor-specific indications. Several indications carry tight restrictions. Cutaneous melanoma only qualifies as single-agent subsequent therapy for metastatic or unresectable disease — not first-line, not combination. Small cell lung cancer (SCLC) follows the same pattern: single-agent subsequent therapy for relapsed or primary progressive disease only. Uterine sarcoma also requires single-agent subsequent therapy for advanced, recurrent/metastatic, or inoperable disease.

Combination therapy requirements. Two indications require specific drug combinations. Ewing sarcoma requires second-line use in combination with irinotecan (J9206), with or without vincristine (J9370), for relapsed, progressive, or metastatic disease. High-risk neuroblastoma requires a four-drug regimen: temozolomide plus irinotecan (J9206), dinutuximab, and sargramostim (J2820). If the combination isn't documented, expect a claim denial.

Pheochromocytoma/paraganglioma is the only indication where temozolomide injection is covered as first-line therapy — and only as a single agent for unresectable or metastatic disease.

Uveal melanoma is covered for unresectable or metastatic disease as a single agent. This is separate from cutaneous melanoma, so confirm which melanoma subtype is documented in the record before billing.

Aetna requires that continuation of therapy also meets medical necessity. Ongoing treatment is only covered when there's no evidence of unacceptable toxicity or disease progression on the current regimen. If the patient's status changes, the prior authorization needs to reflect it.

For prior authorization requirements specific to your plan, check the member's benefit plan — Aetna's coverage policy sets the criteria, but individual plan documents govern whether prior auth is required for each indication.

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Aetna Temozolomide Injection Exclusions and Non-Covered Indications

Aetna's position is straightforward: any indication not listed in the 12 approved categories is experimental, investigational, or unproven.

That's a broad exclusion. Temozolomide has off-label use in several tumor types that are not on this list. If your oncologist is prescribing it for a diagnosis outside these 12 indications, Aetna will not cover the injection form under CPB 0876. No appeal based on clinical rationale is likely to succeed without significant supporting evidence — and even then, it's an uphill climb.

Also note the oral/injection split. This policy covers only the injectable form of temozolomide (Temodar injection, J9328). Oral temozolomide (J8700, capsules) is governed by Aetna's Pharmacy Clinical Policy Bulletins — a different policy, different criteria, different review pathway. Billing J9328 when the patient received oral temozolomide, or vice versa, creates both a claim denial and a compliance problem.

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Coverage Indications at a Glance

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Aetna Temozolomide Injection Billing Guidelines and Action Items 2025

These are the specific steps your billing team needs to take before the September 26, 2025 effective date.

Copy Action Items

If your patient mix includes rare indications like dinutuximab-combination neuroblastoma or pheochromocytoma/paraganglioma, talk to your compliance officer before the effective date. The policy's note that dinutuximab has no specific HCPCS code listed creates a billing gap that needs a plan-specific resolution before you're sitting on denied claims.

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CPT, HCPCS, and ICD-10 Codes for Temozolomide Injection Under CPB 0876

Covered HCPCS Code (When Selection Criteria Are Met)

Code	Type	Description Copy
J9328	HCPCS	Injection, temozolomide, 1 mg

CPT Administration Codes

Code	Type	Description Copy
96413	CPT	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance
96415	CPT	Chemotherapy administration, intravenous infusion technique; each additional hour (list separately)

Key ICD-10-CM Diagnosis Codes

The full policy includes 450 ICD-10-CM codes. The table above lists the primary groupings and representative codes. Review the complete code list at the Aetna CPB 0876 source document before billing.

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