Aetna modified CPB 0919 for inotuzumab ozogamicin (Besponsa), effective January 29, 2026. Here's what billing teams need to know.

Aetna, a CVS Health company, updated its inotuzumab ozogamicin coverage policy under CPB 0919 to expand frontline treatment criteria for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma. The primary billing code is J9229 (injection, inotuzumab ozogamicin, 0.1 mg), administered with chemotherapy administration codes in the 96365–96450 range. This change affects oncology and hematology practices billing Aetna commercial plans — and the criteria are specific enough that missing one checkbox will cost you a clean claim.


Quick-Reference Table

Field Detail
Payer Aetna, a CVS Health company
Policy Inotuzumab Ozogamicin (Besponsa) — CPB 0919
Policy Code CPB 0919
Change Type Modified
Effective Date January 29, 2026
Impact Level High
Specialties Affected Hematology, Medical Oncology, Infusion Centers
Key Action Update prior authorization requests to include CD22-positive confirmation, Philadelphia chromosome status, and planned combination regimen before billing J9229

Aetna Inotuzumab Ozogamicin Coverage Criteria and Medical Necessity Requirements 2026

The Aetna inotuzumab ozogamicin coverage policy divides approval into two distinct clinical scenarios: frontline therapy and relapsed/refractory disease. Both require prior authorization. Call (866) 752-7021 or fax (888) 267-3277 to precertify — don't wait until after the first infusion.

Frontline (Induction/Consolidation) Therapy — All five criteria must be met:

#Covered Indication
1B-cell precursor ALL or lymphoblastic lymphoma diagnosis
2CD22-positive tumor confirmed by testing
3Philadelphia chromosome-negative disease
+ 2 more indications

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This is the more restrictive path. Philadelphia chromosome-positive patients don't qualify for frontline coverage under this policy. That's a hard stop — document Ph status in the medical record before you submit.

Relapsed or Refractory Disease — All five criteria must be met:

#Covered Indication
1B-cell precursor ALL or lymphoblastic lymphoma
2CD22-positive tumor confirmed by testing
3Philadelphia chromosome-positive or Philadelphia chromosome-negative disease (both qualify here)
+ 2 more indications

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The six-cycle cap applies to both paths. Aetna won't approve beyond that under any circumstances listed in this policy.

Continuation of Therapy requires reauthorization. Aetna approves continuation when there's no evidence of unacceptable toxicity or disease progression. That means your reauthorization documentation needs to show treatment response — not just that the patient is still on therapy.

Prior authorization is required for all Aetna participating providers and members in applicable plan designs. Submit a Statement of Medical Necessity (SMN) form available at Aetna's Specialty Pharmacy Precertification page. Missing or incomplete documentation is the fastest path to a claim denial.


Aetna Inotuzumab Ozogamicin Exclusions and Non-Covered Indications

Aetna considers all indications outside of ALL and lymphoblastic lymphoma to be experimental, investigational, or unproven. This is a blanket exclusion. If your treatment team is exploring Besponsa for any off-label use outside these specific diagnoses — follicular lymphoma, diffuse large B-cell lymphoma, or anything else — Aetna won't cover it under this coverage policy.

The ICD-10 code list in this policy does include follicular lymphoma codes (C82.x series), but those appear in the broader code set associated with the policy, not as approved indications. Don't let a code appearing in the policy file make you think it's covered. The clinical criteria are what control approval.


Coverage Indications at a Glance

Indication Status Key Codes Notes
B-cell precursor ALL/lymphoblastic lymphoma — frontline (induction/consolidation), Ph-negative, CD22+, mini-hyper-CVD ± blinatumomab Covered J9229, J9039, J9370, J9100 Max 6 cycles; Ph+ not eligible for frontline
B-cell precursor ALL/lymphoblastic lymphoma — relapsed/refractory, Ph-positive or Ph-negative, CD22+ Covered J9229, J9039, J9370 Single agent, TKI combo (Ph+), or mini-hyper-CVD ± blinatumomab; max 6 cycles
Continuation of therapy (reauthorization) Covered J9229 No disease progression; no unacceptable toxicity; up to 6 cycles total
+ 1 more indications

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This policy is now in effect (since 2026-01-29). Verify your claims match the updated criteria above.

Aetna Inotuzumab Ozogamicin Billing Guidelines and Action Items 2026

Inotuzumab ozogamicin billing under CPB 0919 has enough moving parts that a checklist approach pays off. Here's what your team needs to do before January 29, 2026 — and at every authorization cycle after.

#Action Item
1

Verify CD22-positive status is documented before submitting any prior auth. Aetna requires confirmation by testing or analysis. A note that says "B-cell ALL" without CD22 testing results will not clear precertification. Pull the lab report and attach it.

2

Document Philadelphia chromosome status for every patient. Ph-negative status is required for frontline coverage. Ph-positive and Ph-negative both qualify for relapsed/refractory coverage, but which TKI combination you're using matters — confirm that plan-specific documentation matches the drug combination you're billing.

3

Verify the planned regimen matches an approved combination. If your oncologist is using mini-hyper-CVD, document each component: cyclophosphamide (J9071–J9076 depending on manufacturer), vincristine (J9370), dexamethasone (J1094, J1100, or J8540 depending on route), methotrexate (J8610, J9255, or J9260), and cytarabine (J9100). Every drug in the combination should appear in the treatment plan and in your charge capture.

+ 4 more action items

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If your patient population has an unusual mix of Ph-positive frontline cases or off-label requests, talk to your compliance officer before the effective date. The coverage policy draws sharp lines, and edge cases here carry real financial exposure.


Sample Version Diff Line-by-line changes
Previous VersionCurrent Version
Coverage is considered experimental and investigational for all indicationsCoverage is considered medically necessary when specific criteria are met
Prior authorization is not requiredPrior authorization is required for initial treatment
Documentation must include clinical historyDocumentation must include clinical history
+ 1 more action items

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CPT, HCPCS, and ICD-10 Codes for Inotuzumab Ozogamicin Under CPB 0919

Key HCPCS Codes

Code Type Description
J9229 HCPCS Injection, inotuzumab ozogamicin, 0.1 mg (primary drug code — covered per CPB 0919)
J9039 HCPCS Injection, blinatumomab, 1 microgram
J9071 HCPCS Injection, cyclophosphamide (Auromedics), 5 mg
+ 15 more codes

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Chemotherapy Administration CPT Codes

These codes cover administration of inotuzumab ozogamicin and combination chemotherapy agents. Bill the appropriate code based on route, drug, and administration time.

Code Type Description
96365 CPT IV infusion, therapy/prophylaxis/diagnosis — initial
96366 CPT IV infusion — each additional hour
96401–96450 CPT Chemotherapy administration (full range)

Note: The policy lists CPT codes 96401 through 96450 as related codes. Select the specific code that matches the administration method and sequence for each drug in the regimen.

Key ICD-10-CM Diagnosis Codes

The following codes appear in the CPB 0919 policy. Coverage is driven by the clinical criteria above — confirm each patient's diagnosis maps to an approved indication before billing J9229.

Code Description
C82.0 Follicular lymphoma
C82.1 Follicular lymphoma
C82.10 Follicular lymphoma
+ 7 more codes

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The full ICD-10 code set in CPB 0919 includes 145 codes. The complete list is available at the Aetna CPB 0919 source page. Verify that your primary diagnosis code maps to an ALL or lymphoblastic lymphoma indication — not just that it appears in the broader code set.


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