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 |
|---|---|
| 1 | Primary refractory disease |
| 2 | First relapse with remission of 12 months or less |
| 3 | Relapsed or refractory after at least two prior lines of systemic therapy |
| 4 | Relapsed or refractory after allogeneic stem cell transplant (allo-SCT) |
For Ph-positive disease, the member must meet at least one of these:
| # | Covered Indication |
|---|---|
| 1 | Relapsed 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 |
| 2 | Intolerance 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) |
| Active hepatitis B or C | Or any active uncontrolled infection |
| Active inflammatory disorder | Including autoinflammatory syndromes (M04.1–M04.9) |
| CNS pathology | Clinically relevant history or active CNS disease |
| Active graft versus host disease | Coded under D89.810–D89.813 |
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 |
| Adult R/R B-cell precursor ALL/LL — Ph-negative, post allo-SCT relapse | Covered | Q2058, C91.00, C91.02 | Active GVHD is an absolute exclusion — verify first |
| Adult R/R B-cell precursor ALL/LL — Ph-positive, ≥2 TKIs or second-gen TKI failure | Covered | Q2058, J9039, S0088, C91.00, C91.02 | Document specific TKIs tried and dates |
| Adult R/R B-cell precursor ALL/LL — Ph-positive, TKI intolerant/contraindicated | Covered | Q2058, C91.00, C91.02 | Document clinical basis for intolerance or contraindication |
| Lymphoblastic lymphoma (adult, relapsed/refractory) | Covered | Q2058, C83.50–C83.59 | Same criteria as ALL; CD19+ and ≥5% blasts required |
| All other diagnoses or indications | Not Covered (Experimental/Investigational) | — | No reimbursement under CPB 1072 |
| Pediatric patients (age < 18) | Not Covered | — | Absolute exclusion regardless of clinical criteria |
| Prior CAR-T recipients (non-blinatumomab CD19 therapy) | Not Covered | — | Previous blinatumomab (J9039) is the only exception |
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 | Flag ECOG performance status in every auth request. ECOG ≥ 3 is an absolute exclusion. Your clinical team knows this. Your billing team needs to verify it's documented before the prior auth goes out — not after the claim comes back denied. |
| 5 | Verify the absence of active GVHD for post-allo-SCT patients. This is the trap that will catch billing teams off guard. Post-transplant patients are one of the covered populations (Ph-negative, relapsed after allo-SCT), but active GVHD disqualifies them. Get a written attestation or clinical note confirming GVHD status before proceeding. |
| 6 | Use CPT 38225–38228 correctly for the CAR-T procedure itself. These codes cover the CAR-T therapy administration. Q2058 covers the product. Both sets of codes will appear on a typical claim, and they need to be supported by the same prior auth. Confirm your facility's charge capture maps both groups to CPB 1072 documentation requirements. |
| 7 | Treat this as a GCIT case, not a standard PA. The Aetna GCIT team reviews these. Standard utilization management timelines may not apply. Build in extra lead time before the scheduled infusion date — two to four weeks minimum is prudent for a first 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 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 |
| C83.51 | Lymphoblastic (diffuse) lymphoma, head, face and neck |
| C83.52 | Lymphoblastic (diffuse) lymphoma, intrathoracic lymph nodes |
| C83.53 | Lymphoblastic (diffuse) lymphoma, intra-abdominal lymph nodes |
| C83.54 | Lymphoblastic (diffuse) lymphoma, lymph nodes of axilla and upper limb |
| C83.55 | Lymphoblastic (diffuse) lymphoma, lymph nodes of inguinal region and lower limb |
| C83.56 | Lymphoblastic (diffuse) lymphoma, intrapelvic lymph nodes |
| C83.57 | Lymphoblastic (diffuse) lymphoma, spleen |
| C83.58 | Lymphoblastic (diffuse) lymphoma, lymph nodes of multiple sites |
| C83.59 | Lymphoblastic (diffuse) lymphoma, extranodal and solid organ sites |
| D89.810 | Acute graft-versus-host disease |
| D89.811 | Chronic graft-versus-host disease |
| D89.812 | Acute on chronic graft-versus-host disease |
| D89.813 | Graft-versus-host disease, unspecified |
| T86.03 | Bone marrow transplant infection |
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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