Aetna modified CPB 0986 for lisocabtagene maraleucel (Breyanzi), effective February 14, 2026. Here's what billing teams need to do.
Aetna, a CVS Health company, updated CPB 0986 — its coverage policy for lisocabtagene maraleucel (Breyanzi) — on February 14, 2026. This CAR-T cell therapy policy covers HCPCS code Q2054 and procedure codes 38225 through 38228 for the full CAR-T workflow, from T-cell harvesting to infusion. The update expands the covered indications and tightens the exclusion criteria that your precertification submissions must address.
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Lisocabtagene Maraleucel (Breyanzi) — CPB 0986 |
| Policy Code | CPB 0986 |
| Change Type | Modified |
| Effective Date | February 14, 2026 |
| Impact Level | High |
| Specialties Affected | Hematology/Oncology, BMT programs, Hospital Outpatient, Infusion Centers |
| Key Action | Submit precertification through National Medical Excellence (NME) at 877-212-8811 before any Breyanzi infusion billed under Q2054 |
Aetna Breyanzi Coverage Criteria and Medical Necessity Requirements 2026
The Aetna Breyanzi coverage policy designates Breyanzi as a GCIT® (Gene-based, Cellular & Other Innovative Therapies) product. That means dedicated review by the Aetna GCIT team — not a standard utilization management queue. Plan for longer review timelines and more detailed clinical documentation than you'd send for conventional chemotherapy.
Precertification is required. No exceptions for Aetna participating providers. Contact National Medical Excellence (NME) at 877-212-8811 before you harvest T-cells under CPT 38225. The prior authorization clock starts before the manufacturing process — not at infusion.
Adult B-Cell Lymphomas (Age 18+)
This is where most of your volume will fall. Aetna considers Breyanzi medically necessary for adult B-cell lymphomas in three distinct pathways:
Pathway 1 — Two or more prior lines of systemic therapy. The member must have relapsed or refractory disease and one of these subtypes:
| # | Covered Indication |
|---|---|
| 1 | Diffuse large B-cell lymphoma (DLBCL), including DLBCL NOS, follicular lymphoma grade 3, and DLBCL arising from indolent lymphomas |
| 2 | High-grade B-cell lymphoma, including double/triple hit lymphoma with MYC and BCL2 and/or BCL6 translocations |
| 3 | Primary mediastinal large B-cell lymphoma |
| 4 | Follicular lymphoma — ICD-10 codes C82.0 through C82.9A (confirmed in source data) |
| 5 | Marginal zone lymphoma |
| 6 | HIV-related B-cell lymphomas, including primary effusion lymphoma, HHV8-positive DLBCL NOS, and plasmablastic lymphoma |
| 7 | Monomorphic post-transplant lymphoproliferative disorder (B-cell type) |
Pathway 2 — First-line chemoimmunotherapy followed by relapsed/refractory disease. This is the second-line indication that expands Breyanzi's reach beyond heavily pretreated patients. Covered subtypes here include DLBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, HIV-related B-cell lymphomas, and monomorphic post-transplant lymphoproliferative disorder. Follicular lymphoma and marginal zone lymphoma are NOT covered under this pathway — only under Pathway 1.
Pathway 3 — Relapsed/refractory mantle cell lymphoma after a covalent BTK inhibitor. The member must have received prior treatment with acalabrutinib (Calquence), ibrutinib (Imbruvica), or zanobrutinib (Brukinsa). Note: the source policy lists "zanobrutinib" — verify against the full CPB 0986 text, as the standard drug name is zanubrutinib (Brukinsa). Document the specific BTK inhibitor, dates of therapy, and reason for discontinuation in your precertification package.
Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL)
The policy summary was truncated at the CLL/SLL section, but this indication exists in CPB 0986. If your program treats CLL or SLL patients with Breyanzi, pull the full policy from Aetna's site before submitting. The medical necessity criteria for CLL/SLL likely include specific prior therapy requirements — don't assume the B-cell lymphoma pathways apply.
One-Dose Treatment Rule
Every indication in this coverage policy specifies "one dose treatment." Bill Q2054 once per treatment course. A second infusion — even for a different indication — will deny. Aetna explicitly excludes members who have received a previous treatment course with Breyanzi or any other CD19-directed CAR-T therapy.
Aetna Breyanzi Exclusions and Non-Covered Indications
Aetna excludes members from Breyanzi coverage if any single exclusion criterion is met. This is an OR list — one disqualifier is enough for denial.
| Exclusion Criterion | What to Document |
|---|---|
| Primary central nervous system lymphoma | Confirm diagnosis type before submission |
| Prior Breyanzi or any CD19-directed CAR-T therapy | Full prior oncology treatment history |
| ECOG performance status ≥ 3 | Current ECOG score from treating physician (see Appendix in full CPB 0986 for ECOG definitions) |
| Inadequate or unstable kidney, liver, pulmonary, or cardiac function | Current organ function labs and clinical notes |
| Active hepatitis B, active hepatitis C, or any active uncontrolled infection | Infectious disease clearance documentation |
| Active graft versus host disease | Transplant history and current GVHD status |
| Active inflammatory disorder | Rheumatology or relevant specialist notes |
The ECOG exclusion is the one that gets overlooked most often. If your clinical team is considering Breyanzi for a debilitated patient, get the ECOG score in writing before you invest in precertification. A denial here wastes everyone's time — and delays care.
Active infections are a hard stop. Document infectious disease clearance explicitly. Don't assume an Aetna reviewer will infer it from lab values.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| DLBCL (2+ prior lines) | Covered | Q2054, 38225–38228 — see full CPB 0986 ICD-10 list | One dose; prior auth required |
| DLBCL (relapsed/refractory after 1st-line chemoimmunotherapy) | Covered | Q2054, 38225–38228 — see full CPB 0986 ICD-10 list | Second-line pathway; one dose |
| High-grade B-cell lymphoma, incl. double/triple hit (2+ prior lines) | Covered | Q2054, 38225–38228 | One dose; prior auth required |
| High-grade B-cell lymphoma (relapsed/refractory after 1st-line) | Covered | Q2054, 38225–38228 | One dose |
| Primary mediastinal large B-cell lymphoma (2+ prior lines or relapsed/refractory after 1st-line) | Covered | Q2054, 38225–38228 | One dose |
| Follicular lymphoma (2+ prior lines only) | Covered | Q2054, C82.0–C82.9A | NOT covered under 1st-line relapse pathway |
| Marginal zone lymphoma (2+ prior lines only) | Covered | Q2054, 38225–38228 | NOT covered under 1st-line relapse pathway |
| HIV-related B-cell lymphomas (2+ prior lines or relapsed/refractory after 1st-line) | Covered | Q2054, 38225–38228 | Includes primary effusion lymphoma, plasmablastic lymphoma, HHV8+ DLBCL |
| Monomorphic post-transplant lymphoproliferative disorder, B-cell type | Covered | Q2054, 38225–38228 | Covered under both prior-therapy pathways |
| Mantle cell lymphoma (relapsed/refractory after covalent BTK inhibitor) | Covered | Q2054, 38225–38228 | Requires documented BTK inhibitor history |
| CLL / SLL | See full policy | Q2054 | Summary truncated — pull full CPB 0986 |
| Primary CNS lymphoma | Not Covered | — | Absolute exclusion |
| Second course of any CD19-directed CAR-T | Not Covered | — | Absolute exclusion |
| ECOG ≥ 3 | Not Covered | — | Absolute exclusion |
Aetna Breyanzi Billing Guidelines and Action Items 2026
Lisocabtagene maraleucel billing is not standard oncology billing. The entire episode — from leukapheresis to infusion — runs through multiple CPT codes, and each step requires documentation that supports the original precertification.
| # | Action Item |
|---|---|
| 1 | Call NME at 877-212-8811 before leukapheresis. Precertification must happen before CPT 38225 (T-cell harvesting). If you bill 38225 without an approved auth number, the entire claim sequence is at risk — not just the infusion. Document the auth number in every subsequent claim in the episode. |
| 2 | Map your charge capture to the full CPT sequence. Your billing team should confirm all four CAR-T procedure codes are in your charge master: 38225 (harvesting), 38226 (preparation and cryopreservation), 38227 (receipt and preparation for administration), and 38228 (autologous CAR-T administration). Missing any of these is a reimbursement leak. |
| 3 | Bill Q2054 for the Breyanzi product itself. This is the HCPCS code for lisocabtagene maraleucel — up to 110 million autologous anti-CD19 CAR-positive viable T cells. Confirm your system maps Q2054 correctly and doesn't crosswalk it to a generic drug administration code. |
| 4 | Include bridging chemotherapy codes if used. CPT codes 96413, 96414, 96415, 96416, and 96417 cover chemotherapy administration for lymphodepletion or bridging therapy. These are separate from the CAR-T codes. Bill them on the appropriate service dates with correct modifier usage — don't bundle them into the infusion day. Note: CPB 0986 lists these codes as "Chemotherapy administration" without further description. The extended descriptions in the code table below are from the CPT code set, not from CPB 0986 — verify against your current CPT manual. |
| 5 | Document the pathway explicitly in your precertification. Aetna needs to know which coverage pathway you're using — two or more prior lines, first-line relapse, or BTK inhibitor failure. A vague "relapsed/refractory DLBCL" submission will get a request for additional information that delays your approval and the patient's leukapheresis date. |
| 6 | Verify ECOG status and organ function before submitting. Pull current labs for kidney, liver, pulmonary, and cardiac function. Document ECOG score (see Appendix in full CPB 0986 for ECOG definitions). Get infectious disease clearance in writing. Aetna will ask for this — have it ready at initial submission, not as a follow-up. |
| 7 | Flag any CLL/SLL patients separately. The policy summary was cut off before the CLL/SLL criteria. Pull the full CPB 0986 from Aetna's site and review the complete criteria before submitting for any CLL or SLL patient. Don't apply the B-cell lymphoma pathways to CLL/SLL without confirming coverage. |
If your program is new to CAR-T billing or you're seeing unexpected claim denials on this episode type, loop in your compliance officer and a billing consultant who specializes in cell therapy before the next submission.
| 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 |
CPT, HCPCS, and ICD-10 Codes for Lisocabtagene Maraleucel Under CPB 0986
Covered HCPCS Codes (When Selection Criteria Are Met)
| 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 |
CPT Codes Related to CPB 0986
The descriptions below for 96413–96417 are from the CPT code set, not from CPB 0986. The source policy lists all five codes as "Chemotherapy administration" without further detail. Verify against your current CPT manual.
| Code | Type | Description |
|---|---|---|
| 38225 | CPT | CAR-T therapy; harvesting of blood-derived T lymphocytes for deve[lopment of genetically modified cells] — description truncated in source policy; verify against full CPB 0986 |
| 38226 | CPT | Preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage) |
| 38227 | CPT | Receipt and preparation of CAR-T cells for administration |
| 38228 | CPT | CAR-T cell administration, autologous |
| 96413 | CPT | Chemotherapy administration |
| 96414 | CPT | Chemotherapy administration |
| 96415 | CPT | Chemotherapy administration |
| 96416 | CPT | Chemotherapy administration |
| 96417 | CPT | Chemotherapy administration |
Key ICD-10-CM Diagnosis Codes
The full policy includes 324 ICD-10-CM codes. Below are the diagnosis code ranges confirmed in the available policy data. Pull the complete list from the full CPB 0986 policy before finalizing your claims.
| Code Range / Code | Description |
|---|---|
| C82.0–C82.9A | Follicular lymphoma (all grades and sites) — confirmed in source data |
| A00.0–B99.9 | Certain infectious and parasitic diseases — listed as exclusion codes (active, uncontrolled infection) |
| C00.0–C82.39 | Malignant solid tumors (range) |
| C82.50–C82.9A | Malignant solid tumors (range continuation) |
For DLBCL, mantle cell lymphoma, marginal zone lymphoma, CLL, and SLL diagnosis codes, refer to the full 324-code ICD-10 list in CPB 0986. These codes are not confirmed in the available policy excerpt. Do not bill a diagnosis code on assumption — a missing or mismatched code is a fast path to a claim denial.
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