Aetna modified CPB 0953 covering onasemnogene abeparvovec (Zolgensma and Itvisma) for spinal muscular atrophy, effective September 26, 2025. Here's what billing teams need to do.
Aetna, a CVS Health company, updated its Zolgensma coverage policy under CPB 0953 to add Itvisma (onasemnogene abeparvovec-brve) as a second covered product alongside Zolgensma. This is a significant structural change — the policy now governs two gene therapy products with separate, distinct medical necessity criteria. If your team bills J3399 for Zolgensma or handles Itvisma claims (currently without a specific HCPCS code), this update changes your precertification workflow, your site-of-care requirements, and your documentation checklist starting September 26, 2025.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Onasemnogene abeparvovec-xioi (Zolgensma) — CPB 0953 |
| Policy Code | CPB 0953 |
| Change Type | Modified |
| Effective Date | September 26, 2025 |
| Impact Level | High |
| Specialties Affected | Pediatric neurology, SMA specialty centers, gene therapy infusion facilities |
| Key Action | Update precertification workflows and documentation checklists for both Zolgensma and Itvisma before September 26, 2025 |
Aetna Zolgensma Coverage Criteria and Medical Necessity Requirements 2025
The real issue with this policy is the volume of simultaneous conditions that must all be met before Aetna will approve either product. This isn't a simple age-based gate — it's an 11-criteria checklist for Zolgensma alone. One missed documentation element kills the claim.
Zolgensma (onasemnogene abeparvovec-xioi) — Medical Necessity Criteria
Aetna considers Zolgensma medically necessary for SMA when all of the following apply:
| # | Covered Indication |
|---|---|
| 1 | Genetic confirmation: Bi-allelic mutations in the SMN1 gene (deletions or point mutations), documented by genetic testing. CPT codes 81329, 81336, or 81337 cover this analysis. |
| 2 | Disease onset before 6 months of age. |
| 3 | Age under 2 years at time of treatment. |
| 4 | No advanced SMA, defined as the absence of all of the following:
|
| 5 | Invasive ventilatory support (tracheostomy — HCPCS E0465) |
| 6 | Non-invasive respiratory assistance (HCPCS E0466) for 16+ hours per day, continuously for 14+ days, outside of acute illness or perioperative ventilation |
This is a one-shot treatment — Aetna will not approve a second administration. Document that clearly in the prior authorization package.
Itvisma (onasemnogene abeparvovec-brve) — Separate Criteria Apply
Itvisma is the second product now covered under this Aetna SMA coverage policy. The criteria share some overlap with Zolgensma but differ in key ways.
Important: The Itvisma criteria in the available source summary are truncated. The full criteria are not completely reproduced here. Do not rely on this post to build your Itvisma prior authorization checklist. Obtain the complete CPB 0953 policy document directly from Aetna before submitting any Itvisma claim. Your compliance officer should review the full criteria before your first submission.
Itvisma currently has no specific HCPCS code assigned. Billing teams handling Itvisma claims should confirm the correct unlisted or miscellaneous code with Aetna during precertification. Do not assume J3399 applies — that code is specific to Zolgensma.
Prior Authorization Requirements
Precertification is required for both products. Call (866) 752-7021 or fax (888) 267-3277. Get Statement of Medical Necessity forms from Aetna's Specialty Pharmacy Precertification page. Submit all 11 criteria elements for Zolgensma. For Itvisma, confirm the documentation checklist directly with Aetna before submission — the policy is new to this product and criteria details must be verified against the complete published policy.
Site-of-Care Requirement
Both products must be administered at an Aetna Institutes® GCIT (Gene Based, Cellular and Other Innovative Therapy) Network facility — unless the member's specific health plan has opted out of this requirement. Verify network status before scheduling infusion. A claim denial based on site of care is preventable if you check this upfront.
Aetna Zolgensma Exclusions and Non-Covered Indications
Aetna considers Zolgensma experimental, investigational, or unproven for all indications outside the 11 criteria listed above. There are no partial approvals here — if any single criterion is unmet, the claim falls into the experimental category.
CAR-T therapy codes — CPT 38225 (harvesting of T lymphocytes), 38226 (preparation for transportation), 38227 (receipt and preparation of CAR-T cells), and 38228 (autologous CAR-T cell administration) — are explicitly not covered for the indications listed in CPB 0953. These codes are not part of Zolgensma or Itvisma administration. If your billing team accidentally links these codes to an SMA claim, expect a denial. Keep them off the claim.
Coverage Indications at a Glance
| Indication | Status | Relevant Codes | Notes |
|---|---|---|---|
| SMA with bi-allelic SMN1 mutations, onset <6 months, age <2 years, no advanced disease | Covered | J3399, CPT 81329/81336/81337 | All 11 criteria must be met; prior auth required |
| SMA treated with Itvisma | Covered | No specific HCPCS code yet | Full criteria must be obtained from complete CPB 0953; confirm billing code with Aetna during precertification |
| SMA — member on nusinersen (Spinraza) or risdiplam (Evrysdi) without discontinuation | Not Covered | J2326 (nusinersen) | Concurrent therapy must stop before administration |
| SMA — member with anti-AAV9 titer >1:50 | Not Covered | CPT 87301 | ELISA test result required at baseline |
| SMA — member with advanced disease (complete paralysis, tracheostomy, or ventilator ≥16 hrs/day) | Not Covered | E0465, E0466 | Ventilator use codes used as exclusion indicators |
| SMA — member with prior gene therapy | Not Covered | J3399 | One-time treatment; no re-treatment covered |
| SMA — any other indication not meeting criteria | Experimental/Investigational | — | Applies to Zolgensma; obtain complete Itvisma criteria from Aetna |
| CAR-T therapy for SMA indications | Not Covered | CPT 38225, 38226, 38227, 38228 | Explicitly excluded from CPB 0953 indications |
Aetna Zolgensma Billing Guidelines and Action Items 2025
The effective date of September 26, 2025 is close. These are the steps your billing and revenue cycle team should take now.
| # | Action Item |
|---|---|
| 1 | Update your precertification checklist for Zolgensma before September 26, 2025. The policy now requires documentation for all 11 criteria. Build a checklist your clinical team can complete before submission. Missing any single element — vaccination status, baseline labs, AAV9 titer, concurrent therapy discontinuation — is a denial waiting to happen. |
| 2 | Flag Itvisma claims immediately. Itvisma has no specific HCPCS code as of this policy update. Do not bill J3399 for Itvisma — that code belongs to Zolgensma only. Call Aetna during precertification to confirm the correct billing code. Document that conversation and the code you receive in writing. |
| 3 | Verify GCIT network status for every Zolgensma and Itvisma case. Check Aetna's GCIT Designated Networks list before scheduling infusion. If the member's plan has opted out of the network requirement, document that opt-out. A claim denial for site of care is one of the most avoidable denials in gene therapy billing. |
| 4 | Order and document all required baseline labs before administration. Aetna requires hepatic function panel (CPT 80076), platelet count (CPT 85025, 85027, 85032, or 85049), troponin I (CPT 84484), and creatinine (CPT 82565) at baseline. These labs must be on file. Bill them on separate claims where appropriate and make sure the results appear in your authorization documentation. |
| 5 | Confirm SMN1 genetic testing is in the record. CPT 81329, 81336, or 81337 must support the SMA diagnosis with bi-allelic mutation documentation. If the genetic test was done at another facility, get the report in the chart before submitting the prior auth. Aetna will not approve without it. |
| 6 | Remove CPT 38225, 38226, 38227, and 38228 from any SMA charge capture templates. These CAR-T codes are explicitly not covered under CPB 0953. If your charge capture was built for gene therapy broadly, audit it now to make sure these codes don't appear on SMA claims. |
| 7 | Talk to your compliance officer if you have Itvisma cases pending. The policy criteria for Itvisma are new, the billing code is unresolved, and the full documentation requirements must be confirmed against the complete published CPB 0953. This is not a situation where you want to guess. Get guidance before the claim goes out. |
| 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 Zolgensma and Itvisma Under CPB 0953
Not Covered CPT Codes Under CPB 0953
| Code | Type | Description | Reason |
|---|---|---|---|
| 38225 | CPT | CAR-T therapy; harvesting of blood-derived T lymphocytes for development | Not covered for CPB 0953 indications |
| 38226 | CPT | Preparation of blood-derived T lymphocytes for transportation (e.g., cryopreservation, storage) | Not covered for CPB 0953 indications |
| 38227 | CPT | Receipt and preparation of CAR-T cells for administration | Not covered for CPB 0953 indications |
| 38228 | CPT | CAR-T cell administration, autologous | Not covered for CPB 0953 indications |
HCPCS Codes Under CPB 0953
| Code | Type | Description | Notes |
|---|---|---|---|
| J3399 | HCPCS | Injection, onasemnogene abeparvovec-xioi, per treatment, up to 5×10¹⁴ vg [Zolgensma] — description truncated in source data | Zolgensma only — do not use for Itvisma |
| E0465 | HCPCS | Home ventilator, any type, with invasive interface (e.g., tracheostomy tube) | Used as exclusion indicator — invasive ventilation disqualifies coverage |
| E0466 | HCPCS | Home ventilator, any type, with non-invasive interface (e.g., mask, chest shell) | Used as exclusion indicator — ≥16 hrs/day for ≥14 days disqualifies coverage |
| J2326 | HCPCS | Injection, nusinersen, 0.1 mg [Spinraza] | Must be discontinued before Zolgensma/Itvisma; concurrent use disqualifies |
ICD-10-CM Diagnosis Codes Under CPB 0953
The full set of 229 ICD-10-CM codes referenced in CPB 0953 is available in the complete policy document. The majority of these codes document infectious conditions and comorbidities that serve as exclusion criteria. Consult the full CPB 0953 code list or your coding team to identify the correct SMA diagnosis code for your claims.
A representative sample of the exclusionary infection and comorbidity codes from the policy data is below.
| Code | Description |
|---|---|
| A08.0–A08.8 | Viral and other specified intestinal infections (exclusion: active infectious process) |
| A49.1–A49.9 | Bacterial infection of unspecified site (exclusion: active infectious process) |
| A80–A89 | Viral and prion infections of the central nervous system (exclusion criteria) |
| A90–A98 | Arthropod-borne viral fevers and viral hemorrhagic fevers (exclusion criteria) |
| B10.10–B10.12 | Other human herpesviruses (exclusion criteria) |
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