Aetna modified CPB 1072 for obecabtagene autoleucel (Aucatzyl), effective February 14, 2026. Here's what billing teams need to know before submitting claims.

Aetna, a CVS Health company, updated its CAR-T cell therapy coverage policy under CPB 1072 Aetna system to define medical necessity criteria for obecabtagene autoleucel (Aucatzyl). The primary billing code is Q2058, covering up to 400 million CD19 CAR-positive viable T cells, alongside CAR-T procedure codes CPT 38225–38228. If your team bills for cell therapy at a center treating adult ALL, this policy directly controls your reimbursement and prior authorization pathway.


Quick-Reference Table

Field Detail
Payer Aetna, a CVS Health company
Policy Obecabtagene Autoleucel (Aucatzyl)
Policy Code CPB 1072
Change Type Modified
Effective Date February 14, 2026
Impact Level High
Specialties Affected Hematology/Oncology, Bone Marrow Transplant Programs, Hospital Revenue Cycle
Key Action Confirm CD19-positive status, ECOG score, and prior CAR-T history before submitting precertification to National Medical Excellence (NME)

Aetna Obecabtagene Autoleucel Coverage Criteria and Medical Necessity Requirements 2026

The Aetna obecabtagene autoleucel coverage policy is narrow and precise. Aucatzyl is covered for one indication only: relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) in adults. Every other use is experimental, investigational, or unproven.

Precertification is required for all Aetna participating providers and members in applicable plan designs. Contact National Medical Excellence (NME) directly at 877-212-8811 before infusion. This is not optional — missing prior authorization on a therapy that costs several hundred thousand dollars is a claim denial your facility will not recover from easily.

Aucatzyl is classified under Aetna's Gene-based, Cellular & Other Innovative Therapies (GCIT®) program. That means a dedicated GCIT team reviews every case, not a standard utilization management desk. Expect more scrutiny than a routine prior auth, and document accordingly.

Medical Necessity Criteria for Initial Approval

To meet medical necessity for initial approval, the member must satisfy all of the following:

1. No prior CAR-T or CD19-directed therapy (with one exception).
The member cannot have received a previous course of Aucatzyl, any other CD19-directed CAR-T therapy, or any prior CD19-directed therapy — except blinatumomab (J9039). If your patient received a different CAR-T previously, Aetna considers them ineligible. Full stop.

2. Philadelphia chromosome-negative OR Philadelphia chromosome-positive disease, each with its own sub-criteria.

For Ph-negative disease, the member must meet at least one of these:

#Covered Indication
1Primary refractory disease
2First relapse with remission of 12 months or less
3Relapsed or refractory after at least two prior lines of systemic therapy
+ 1 more indications

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For Ph-positive disease, the member must meet at least one of these:

#Covered Indication
1Relapsed or refractory after at least two different tyrosine kinase inhibitors (TKIs) — such as bosutinib, dasatinib, imatinib (S0088), nilotinib, or ponatinib — or at least one second-generation TKI
2Intolerance to TKI therapy, or TKI therapy is contraindicated

3. Morphological bone marrow disease. The member must have ≥5% blasts in the bone marrow at the time of treatment.

4. CD19-positive disease. Confirm this in the documentation before submitting. If you can't show CD19 positivity, the claim will not pass medical necessity review.

Aetna bills this as a one-split dose treatment. There is no separate continuation of therapy approval pathway beyond the dosage and administration guidance — which means your initial auth request needs to capture the complete treatment plan.


Aetna Aucatzyl Exclusions and Non-Covered Indications

Seven absolute exclusions make a member ineligible for Aucatzyl under this coverage policy. If any one of these applies, Aetna will not cover the therapy.

Exclusion Clinical Description
Age < 18 years Pediatric patients are excluded entirely
ECOG ≥ 3 Not ambulatory, confined to bed/chair >50% of waking hours
Inadequate organ function Kidney, liver, pulmonary, or cardiac insufficiency (unstable)
+ 4 more exclusions

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The real issue here is that several of these exclusions overlap with the patient population most likely to receive CAR-T. A post-allo-SCT patient with even low-grade graft versus host disease is automatically excluded. Document the absence of these conditions explicitly in your prior auth package — don't assume the reviewing clinician will infer it from the treatment history.

All indications outside of adult relapsed/refractory B-cell precursor ALL/LL are considered experimental, investigational, or unproven. Aetna does not provide reimbursement for off-label Aucatzyl use under this policy.


Coverage Indications at a Glance

Indication Status Relevant Codes Notes
Adult R/R B-cell precursor ALL/LL — Ph-negative, primary refractory Covered Q2058, C91.00, C91.02 Prior auth required via NME; CD19+ required
Adult R/R B-cell precursor ALL/LL — Ph-negative, first relapse ≤12 months Covered Q2058, C91.00, C91.02 Prior auth required; ≥5% bone marrow blasts required
Adult R/R B-cell precursor ALL/LL — Ph-negative, ≥2 prior systemic therapies Covered Q2058, C91.00, C91.02 Prior auth required
+ 7 more indications

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This policy is now in effect (since 2026-02-14). Verify your claims match the updated criteria above.

Aetna Obecabtagene Autoleucel Billing Guidelines and Action Items 2026

This policy was modified with an effective date of February 14, 2026. If you treat adult ALL patients at a cell therapy center and bill Aetna commercial plans, act on these now.

#Action Item
1

Add Q2058 to your charge capture with a mandatory prior auth flag. Q2058 is the primary HCPCS code for Aucatzyl. Every claim for this code must link to an active prior auth obtained through NME (877-212-8811). Build that verification into your pre-infusion workflow, not your post-infusion billing review.

2

Pull the CD19 positivity documentation before submitting the precertification. Aetna requires confirmed CD19-positive disease. If the pathology report isn't in the chart or isn't clearly documented in the prior auth package, expect a denial. Don't submit without it.

3

Document the full prior treatment history for CAR-T and TKI therapy. Aetna's criteria hinge on what the patient received previously. For Ph-positive patients, list each TKI tried, the dates, and the reason for discontinuation. For all patients, confirm no prior CD19-directed CAR-T was given. One missing line in the treatment history can flip a covered claim to a denial.

+ 4 more action items

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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 Obecabtagene Autoleucel Under CPB 1072

Covered HCPCS Code (When Selection Criteria Are Met)

Code Type Description
Q2058 HCPCS Obecabtagene autoleucel, 10 up to 400 million CD19 CAR-positive viable T cells, including leukapheresis

Key ICD-10-CM Diagnosis Codes

Code Description
C91.00 Acute lymphoblastic leukemia not having achieved remission (B-cell precursor)
C91.02 Acute lymphoblastic leukemia, in relapse (B-cell precursor)
C83.50 Lymphoblastic (diffuse) lymphoma, unspecified site
+ 14 more codes

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Additional ICD-10 codes in CPB 1072 cover active infections (A00.0–B99.9), inflammatory conditions (K50.00–K52.9, M04.1–M04.9, M05.00–M1A.9XX1, M35.81), abnormal organ function studies (R94.1–R94.9), and post-procedure infection complications (T80.211A–T86.832). These codes primarily support the exclusion documentation — use them to code any active conditions that may disqualify a member.


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