Aetna Updates Breyanzi (Lisocabtagene Maraleucel) Coverage Policy CPB 0986 — What Billing Teams Need to Know
Aetna, a CVS Health company, has modified Clinical Policy Bulletin CPB 0986 governing coverage of lisocabtagene maraleucel (Breyanzi), effective March 12, 2026. This CAR-T cell therapy policy covers a broad range of B-cell malignancies, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL), and carries strict prior authorization requirements through Aetna's dedicated Gene-based, Cellular & Other Innovative Therapies (GCIT®) review team. Revenue cycle teams at oncology practices and infusion centers billing HCPCS Q2054 need to review updated eligibility criteria before submitting any precertification requests.
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Lisocabtagene Maraleucel (Breyanzi) — CPB 0986 |
| Policy Code | CPB 0986 |
| Change Type | Modified |
| Effective Date | 2026-03-12 |
| Impact Level | High |
| Specialties Affected | Hematology/Oncology, Bone Marrow Transplant, Infusion Services, RCM/Revenue Cycle |
| Key Action | Audit all pending and upcoming Breyanzi prior auth requests against updated eligibility criteria before submitting to NME at 877-212-8811. |
Aetna Breyanzi Coverage Criteria 2026: What Changed in CPB 0986
Breyanzi is classified under Aetna's GCIT® program, meaning every authorization request—commercial and Medicare—routes to a specialized review team rather than standard utilization management. That distinction matters: standard PA workflows won't apply here. All participating Aetna providers must contact National Medical Excellence (NME) at 877-212-8811 to initiate precertification. There is no exception for any plan design where Breyanzi is a covered benefit.
The updated policy reflects the therapy's expanding FDA-approved indications and real-world clinical use. Billing teams should treat this as a full re-review of criteria, not a minor administrative update.
Aetna Breyanzi Medical Necessity Criteria: Who Qualifies
Adult B-Cell Lymphomas (Age 18+)
Aetna considers Breyanzi medically necessary for adult B-cell lymphoma patients under three distinct clinical pathways:
Pathway 1 — Two or more prior lines of systemic therapy with any of the following diagnoses:
- Diffuse large B-cell lymphoma (DLBCL), including DLBCL NOS, follicular lymphoma grade 3, and DLBCL arising from indolent lymphomas
- High-grade B-cell lymphoma (including double/triple hit lymphoma with MYC and BCL2/BCL6 translocations)
- Primary mediastinal large B-cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
- HIV-related B-cell lymphomas (including primary effusion lymphoma, HHV8-positive DLBCL NOS, and plasmablastic lymphoma)
- Monomorphic post-transplant lymphoproliferative disorder (B-cell type)
Pathway 2 — Relapsed/refractory disease after first-line chemoimmunotherapy with any of the following:
- DLBCL (including NOS, grade 3 follicular, and indolent-derived)
- High-grade B-cell lymphoma
- Primary mediastinal large B-cell lymphoma
- HIV-related B-cell lymphomas
- Monomorphic post-transplant lymphoproliferative disorder (B-cell type)
Pathway 3 — Relapsed/refractory mantle cell lymphoma after prior treatment with a covalent Bruton tyrosine kinase (BTK) inhibitor. Covered BTK inhibitors referenced in the policy include acalabrutinib (Calquence), ibrutinib (Imbruvica), and zanubrutinib (Brukinsa).
Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
The policy also addresses CLL/SLL indications—review the full CPB 0986 text for complete criteria, as this section was truncated in the source document. Confirm current criteria directly at the Aetna CPB 0986 source before submitting any CLL/SLL authorization.
Aetna Breyanzi Exclusions: Who Does NOT Qualify
Aetna will deny coverage if any of the following conditions apply—these are hard exclusions, not rebuttable with clinical documentation:
- Primary central nervous system lymphoma
- Previous treatment with Breyanzi or any other CD19-directed CAR-T cell therapy
- ECOG performance status ≥ 3
- Inadequate or unstable kidney, liver, pulmonary, or cardiac function
- Active hepatitis B or hepatitis C
- Any active uncontrolled infection
- Active graft versus host disease
- Active inflammatory disorder
The re-treatment exclusion is particularly significant for billing teams: if a patient has received any prior CD19-directed CAR-T—not just Breyanzi—they are categorically ineligible under this policy. Document the patient's CAR-T treatment history explicitly in precertification requests.
| Previous Version | Current Version |
|---|---|
| Coverage is considered experimental and investigational for all indications | Coverage is considered medically necessary when specific criteria are met |
| Prior authorization is not required | Prior authorization is required for initial treatment |
| Documentation must include clinical history | Documentation must include clinical history |
| Re-review every 24 months | Re-review every 12 months with updated clinical documentation |
Affected Codes
Covered HCPCS Code
| Code | Type | Description |
|---|---|---|
| Q2054 | HCPCS | Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures |
Representative ICD-10-CM Diagnosis Codes
The full policy references 324 ICD-10-CM codes. Key covered diagnosis codes include:
| Code | Description |
|---|---|
| C82.0–C82.9 | Follicular lymphoma (various stages and sites) |
| C82.10–C82.19 | Follicular lymphoma, grade I |
| C82.20–C82.29 | Follicular lymphoma, grade II |
| C82.30–C82.39 | Follicular lymphoma, grade III, unspecified |
| C82.40–C82.49 | Follicular lymphoma, grade IIIa |
| C82.50–C82.59 | Follicular lymphoma, grade IIIb |
Note that codes spanning A00.0–B99.9 (certain infectious and parasitic diseases) appear in the policy as exclusion indicators—active uncontrolled infections in this range support denial. Verify the complete ICD-10 list in the full policy document before coding.
What Your Billing Team Should Do
| # | Action Item |
|---|---|
| 1 | Update your precertification intake forms immediately. Add fields capturing prior CAR-T therapy history (any CD19-directed agent), ECOG performance status, current infection status, and hepatitis B/C serology results. Missing any of these will likely result in denial. |
| 2 | Route all Breyanzi auths exclusively through NME at 877-212-8811. Do not submit through standard Aetna PA channels—Breyanzi is a GCIT product and requires dedicated review. Confirm this routing with your Aetna provider relations contact and document the NME reference number for every case. |
| 3 | Audit any pending authorizations against updated exclusion criteria before March 12, 2026. If a patient has an active inflammatory disorder, active hepatitis, or prior CD19 CAR-T therapy, withdraw and rework the case before submission. A denial on a CAR-T case is expensive to appeal and delays time-sensitive treatment. |
| 4 | Map your ICD-10 codes carefully against the full 324-code list. With diagnoses spanning DLBCL, follicular lymphoma, marginal zone lymphoma, CLL/SLL, and mantle cell lymphoma, a single digit transposition can result in a non-covered diagnosis denial. Pull the complete code list from CPB 0986 and build it into your charge capture workflow. |
| 5 | Train your oncology authorization team on the BTK inhibitor prior therapy requirement for mantle cell lymphoma. Coverage for relapsed/refractory MCL requires documented prior treatment with a covalent BTK inhibitor. That clinical detail must be in the auth request—not just the diagnosis. |
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