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
1Diffuse large B-cell lymphoma (DLBCL), including DLBCL NOS, follicular lymphoma grade 3, and DLBCL arising from indolent lymphomas
2High-grade B-cell lymphoma, including double/triple hit lymphoma with MYC and BCL2 and/or BCL6 translocations
3Primary mediastinal large B-cell lymphoma
+ 4 more indications

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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)
+ 4 more exclusions

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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
+ 11 more indications

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This policy is now in effect (since 2026-03-12). Verify your claims match the updated criteria above.

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 more action items

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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.


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 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
+ 6 more codes

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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)
+ 1 more codes

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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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