Ofatumumab (Arzerra) — CPB 0794 | AETNA Coverage Update

Aetna modified CPB 0794 for ofatumumab (Arzerra), effective October 25, 2025. Here's what billing teams need to know.

Aetna, a CVS Health company, updated its ofatumumab coverage policy under CPB 0794 Aetna system, narrowing covered indications to chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) only. The policy directly affects claims billed with HCPCS J9302 (ofatumumab, 10 mg) and infusion administration codes CPT 96413 and 96415. If your oncology or infusion center bills Arzerra for any other diagnosis, expect a claim denial.

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Quick-Reference Table

Field	Detail Copy
Payer	Aetna
Policy	Ofatumumab (Arzerra) — CPB 0794
Policy Code	CPB 0794
Change Type	Modified
Effective Date	October 25, 2025
Impact Level	High
Specialties Affected	Hematology/Oncology, Infusion Centers, Hospital Outpatient
Key Action	Audit all active Arzerra claims and prior authorizations against CLL and SLL diagnoses before billing post–October 25, 2025

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Aetna Ofatumumab Coverage Criteria and Medical Necessity Requirements 2025

The Aetna ofatumumab coverage policy under CPB 0794 sets two — and only two — covered indications. Aetna considers ofatumumab medically necessary for:

#	Covered Indication Copy
1	Chronic lymphocytic leukemia (CLL)
2	Small lymphocytic lymphoma (SLL)

That's the entire approved list. No other indications qualify for reimbursement under this policy.

For initial approval, your prior authorization request needs to document one of those two diagnoses clearly. Aetna doesn't specify a line-of-therapy requirement in the current policy language, so first-line, relapsed, and refractory CLL or SLL all appear eligible — but your prior auth submission should still include treatment history to support medical necessity.

Continuation of therapy follows a straightforward standard. Aetna covers ongoing ofatumumab when there is no evidence of unacceptable toxicity and no disease progression on the current regimen. Document this explicitly in your clinical notes at each authorization renewal. If a patient progresses or develops intolerable toxicity, Aetna will not continue coverage — and that's clinically appropriate.

The policy cross-references CPB 0314 (Rituximab) and CPB 0764 (Alemtuzumab/Campath). If your patient is on a combination regimen involving those agents, check those policies separately. Prior authorization requirements and coverage criteria can differ, and billing errors on combination infusion claims are common.

When billing J9302 for an Aetna member, make sure your ICD-10 diagnosis code maps to CLL (C91.1x range) or SLL. The policy lists 246 ICD-10-CM codes in the associated code set, including a large block of Hodgkin lymphoma codes (C81.xx series) — but those fall outside the two covered indications. Don't let a broad code set mislead you into thinking Hodgkin lymphoma is covered here. It is not.

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Aetna Ofatumumab Exclusions and Non-Covered Indications

Aetna is direct about this. Every indication outside of CLL and SLL is experimental, investigational, or unproven under CPB 0794.

Historically, ofatumumab has been studied in relapsed/refractory follicular lymphoma, diffuse large B-cell lymphoma, Waldenström's macroglobulinemia, and multiple sclerosis (under a different formulation, Kesimpta). None of those indications are covered under this policy.

If a provider submits a prior auth for ofatumumab in a Hodgkin lymphoma patient — and the ICD-10 code table attached to this policy includes dozens of C81.xx Hodgkin codes — that's a denial waiting to happen. The code appearing in the policy's associated list does not mean it's a covered indication. The covered indications are defined in the criteria section, not the code table. This is a distinction billing teams miss constantly, and it causes expensive write-offs.

If your team fields requests for off-label Arzerra use, loop in your compliance officer before submitting. Billing experimental indications without a clear payer approval path creates both financial and compliance exposure.

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Coverage Indications at a Glance

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Aetna Ofatumumab Billing Guidelines and Action Items 2025

The effective date of October 25, 2025 is already here. If your team hasn't acted yet, start today.

Copy Action Items

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CPT, HCPCS, and ICD-10 Codes for Ofatumumab (Arzerra) Under CPB 0794

Covered HCPCS Codes (When Selection Criteria Are Met)

Code	Type	Description Copy
J9302	HCPCS	Injection, ofatumumab, 10 mg [Arzerra]

CPT Administration Codes Related to CPB 0794

These codes support ofatumumab infusion billing. They are not inherently covered or excluded — coverage depends on the drug being approved and the administration being medically necessary.

Other HCPCS Codes Referenced in CPB 0794

Code	Type	Description	Coverage Group Copy
J3245	HCPCS	Injection, tildrakizumab, 1 mg	Other HCPCS codes related to the CPB (not a covered ofatumumab code)

Note on J3245: Tildrakizumab is a dermatology agent (Ilumya). Its presence in this CPB's code set is likely for cross-reference or administrative purposes. Do not bill J3245 for ofatumumab. If you see this code on an Arzerra claim, it's an error.

Key ICD-10-CM Diagnosis Codes

The policy includes 246 ICD-10-CM codes. Below are the codes present in the provided data. Covered diagnoses are CLL and SLL only. The Hodgkin lymphoma codes below appear in the associated code set but are not covered indications under CPB 0794.

The full policy code set includes 166 additional ICD-10-CM codes not shown here. Verify the complete list in the source policy at CPB 0794 on Aetna's policy portal before updating your billing guidelines. CLL codes in the C91.1x range and SLL codes are the only diagnoses that will support a covered claim.

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