Aetna modified CPB 1052 for exagamglogene autotemcel (Casgevy), effective January 5, 2026. Here's what billing teams need to know before submitting claims.
Aetna updated its Casgevy coverage policy under CPB 1052, covering the gene therapy used to treat sickle cell disease and transfusion-dependent beta-thalassemia. The primary billing code is HCPCS J3392 (injection, exagamglogene autotemcel, per treatment), supported by HLA typing CPT codes 81370–81383 and infusion administration codes 96365–96368 and 96413–96417. This is a high-exposure policy update — a single documentation gap will kill your claim.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna |
| Policy | Exagamglogene Autotemcel (Casgevy) |
| Policy Code | CPB 1052 |
| Change Type | Modified |
| Effective Date | January 5, 2026 |
| Impact Level | High |
| Specialties Affected | Hematology, Bone Marrow Transplant, Gene Therapy Programs |
| Key Action | Contact Aetna's National Medical Excellence (NME) team at 877-212-8811 for precertification before any Casgevy administration |
Aetna Casgevy Coverage Criteria and Medical Necessity Requirements 2026
Aetna covers one lifetime dose of Casgevy (HCPCS J3392) for two indications: sickle cell disease (ICD-10 D57.x) and transfusion-dependent beta-thalassemia (ICD-10 D56.1). The word "one dose total" is doing a lot of work here. Document everything from the start — there is no second bite at this apple.
Precertification is required. Call Aetna's National Medical Excellence team at 877-212-8811 before treatment. This is not a standard prior authorization through the usual channel — NME handles GCIT products separately. If your team routes this through normal prior auth workflows, expect a denial.
Casgevy is designated as an Aetna Gene-based, Cellular & Other Innovative Therapies (GCIT®) product. That designation means dedicated review by the Aetna GCIT team. It also means the treatment must happen at an Aetna Institutes® GCIT Designated Network facility unless the member's plan has opted out of that requirement. Verify network status before scheduling stem cell collection, not after.
The prescribing physician must be a hematologist or consult with one. Document that consultation in the medical record. If the prescriber is an oncologist or internist acting alone, you have a medical necessity problem before the claim is even built.
Sickle Cell Disease — Medical Necessity Criteria
All of the following must be met for Aetna to consider Casgevy medically necessary for sickle cell disease:
| # | Covered Indication |
|---|---|
| 1 | Member is 12 years of age or older |
| 2 | Diagnosis confirmed by molecular or genetic testing with one of these genotypes: βs/βs, βs/β0, or βs/β+ |
| 3 | Documented history of at least two severe vaso-occlusive episodes per year during the previous two years |
| 4 | Member is eligible for hematopoietic stem cell transplant (HSCT) but cannot find a matched (10/10) HLA-related donor — HLA typing via CPT codes 81370–81383 is part of this documentation chain |
| 5 | Member has not received a prior HSCT |
| 6 | Member has not received Casgevy or any other gene therapy previously |
| 7 | Member has experienced an inadequate response or intolerance to hydroxyurea (HCPCS S0176), or has a documented contraindication to hydroxyurea |
That hydroxyurea step-edit is critical. Aetna requires a documented trial failure or contraindication — not just a preference for gene therapy. Pull hydroxyurea prescription records and adverse event documentation before you submit.
Transfusion-Dependent Beta-Thalassemia — Medical Necessity Criteria
⚠ Verification Required: The source policy summary for beta-thalassemia criteria was truncated in the data available for this post. The criteria below reflect what was available in the source excerpt. Do not rely on this section as a complete or final criteria set. Verify all beta-thalassemia coverage requirements against the full published CPB 1052 policy at aetna.com before submitting any claims or precertification requests for this indication.
For transfusion-dependent beta-thalassemia, the coverage policy requires all of the following (based on available source data — see note above):
| # | Covered Indication |
|---|---|
| 1 | Member is 12 years of age or older |
| 2 | Diagnosis of transfusion-dependent beta-thalassemia confirmed by molecular or genetic testing (non-β0/β0 or β0/β0 genotype) |
| 3 | Member has received at least 100 mL/kg or 10 units of packed red blood cells (pRBCs) per year during the previous two years |
| 4 | Member is HSCT-eligible but cannot find a matched (10/10) HLA-related donor |
| 5 | Member has not received a prior HSCT |
| 6 | Member has not received Casgevy or any other gene therapy previously |
The two-year transfusion burden threshold is objective and verifiable — get the transfusion records in hand before you initiate the precertification request. Aetna will ask for them. Check the full policy for any additional criteria not captured here.
Aetna Casgevy Exclusions and Non-Covered Indications
Aetna will not approve Casgevy if the member has any of the following conditions. These are hard stops — not conditions that can be addressed with additional documentation.
Absolute contraindications under this coverage policy:
| # | Excluded Procedure |
|---|---|
| 1 | HIV-1 or HIV-2, hepatitis B (ICD-10 B16.x, B18.0, B18.1, B19.10, B19.11), or hepatitis C (ICD-10 B17.10, B17.11, B18.2, B19.20, B19.21) |
| 2 | Any prior or current malignancy (ICD-10 C00.0–C96.Z) |
| 3 | Clinically significant active infection (ICD-10 A00.0–B99.9) |
| 4 | Advanced liver disease — bridging fibrosis, cirrhosis, or active hepatitis |
| 5 | Uncorrected bleeding disorder (ICD-10 D65–D69.9) |
| 6 | Myeloproliferative disorder (ICD-10 D47.1, D47.2, D47.3, D47.4) or immunodeficiency disorder (ICD-10 D80.x, D81.x) |
| 7 | Severe cerebral vasculopathy |
| 8 | Clinically significant pulmonary hypertension |
| 9 | Inadequate pulmonary or cardiac function |
| 10 | Uncontrolled seizure disorder |
| 11 | Renal impairment — creatinine clearance below 60 mL/min/1.73 m² |
Any one of these disqualifies the member. Casgevy billing for a member with an active malignancy or HIV is not a gray area — it will result in a claim denial.
Coverage Indications at a Glance
| Indication | Status | Key Code(s) | Notes |
|---|---|---|---|
| Sickle cell disease (βs/βs, βs/β0, βs/β+), age ≥12, ≥2 VOEs/year, HSCT-eligible, no matched donor, hydroxyurea step-edit met, no exclusion criteria | Covered | J3392, D57.x | One lifetime dose; precertification via NME required |
| Transfusion-dependent beta-thalassemia, age ≥12, ≥100 mL/kg or 10 units pRBCs/year, HSCT-eligible, no matched donor, no exclusion criteria | Covered | J3392, D56.1 | One lifetime dose; precertification via NME required. Verify full criteria against published CPB 1052 — source data was truncated. |
| Any indication in member with HIV, HBV, or HCV | Not Covered | — | Hard exclusion; no exceptions |
| Any indication in member with prior or current malignancy | Not Covered | — | Hard exclusion |
| Any indication in member with prior HSCT or prior gene therapy | Not Covered | — | Hard exclusion |
| Any indication in member under age 12 | Not Covered | — | Age criteria not met |
| Any indication in member with advanced liver disease, renal impairment, or uncontrolled seizures | Not Covered | — | Hard exclusion |
| HLA typing to confirm matched donor absence | Covered (supporting) | 81370–81383 | Required for HSCT-eligibility documentation |
Aetna Casgevy Billing Guidelines and Action Items 2026
Exagamglogene autotemcel billing carries more documentation weight than almost any other therapy you bill. A single missing element — no hydroxyurea trial record, no HLA typing, wrong facility — will cost you a claim denial. Build your workflow around that reality.
| # | Action Item |
|---|---|
| 1 | Call NME at 877-212-8811 before you do anything else. Do not route Casgevy precertification through the standard prior authorization channel. Aetna handles GCIT products through NME only. Get the reference number and document it in the patient file immediately. |
| 2 | Verify GCIT network status for your treatment facility. Confirm the administering site is listed on Aetna's Institutes GCIT Designated Network before the patient is scheduled. Treatment at a non-designated site is a reimbursement risk even if every clinical criterion is met. |
| 3 | Assemble the full documentation package before submitting. You need: molecular or genetic testing confirming the qualifying genotype, two years of vaso-occlusive episode records (for SCD) or transfusion records showing the 100 mL/kg or 10-unit annual threshold (for beta-thal), HLA typing results (CPT 81370–81383) confirming no matched 10/10 donor, and hydroxyurea trial failure or contraindication documentation (HCPCS S0176 prescription history or adverse event notes). |
| 4 | Confirm the prescribing hematologist is documented. The policy requires prescription by or in consultation with a hematologist. If any other specialty initiated the order, get the hematology consultation note into the record before submitting. |
| 5 | Run a hard exclusion check before submitting. Pull labs for HIV-1, HIV-2, HBV, and HCV. Confirm no active malignancy in the problem list. Check creatinine clearance against the 60 mL/min/1.73 m² threshold. If any exclusion criteria apply, do not submit — and loop in your compliance officer before any further action on that case. |
| 6 | Bill J3392 for the Casgevy dose and the appropriate infusion administration codes. CPT codes 96413–96417 are listed as related codes under this policy for chemotherapy administration by intravenous infusion technique. CPT codes 96365–96368 are listed as related codes for intravenous infusion for therapy, prophylaxis, or diagnosis. Do not mix these up — they cover distinct administration scenarios within the treatment episode. |
| 7 | Document this as a one-time treatment at the time of billing. Casgevy is a one-dose therapy. If your system allows repeat authorizations, flag this account to prevent future precertification requests for the same patient. Prior approval for a second dose will be denied. |
| 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 Casgevy Under CPB 1052
Covered HCPCS Code (When Selection Criteria Are Met)
| Code | Type | Description |
|---|---|---|
| J3392 | HCPCS | Injection, exagamglogene autotemcel, per treatment |
Other Related HCPCS Code
| Code | Type | Description |
|---|---|---|
| S0176 | HCPCS | Hydroxyurea, oral, 500 mg |
Key ICD-10-CM Diagnosis Codes
| Code | Description | Coverage Status |
|---|---|---|
| D56.1 | Beta thalassemia | Qualifying indication |
| D57.0 | Sickle-cell anemia with crisis | Qualifying indication |
| D57.1 | Sickle-cell disease without crisis | Qualifying indication |
| D57.2 | Sickle-cell/Hb-C disease | Qualifying indication |
| D57.3 | Sickle-cell trait | Not a qualifying indication. Sickle-cell trait does not meet the genotype or clinical criteria for Casgevy coverage under CPB 1052. Do not use D57.3 as the primary diagnosis for Casgevy claims. |
| D57.4 | Sickle-thalassemia | Qualifying indication |
| D57.5 | Sickle-cell/Hb-E disease | Qualifying indication |
| D57.6 | Other sickle-cell disorders | Qualifying indication |
| D57.7 | Other sickle-cell disorders | Qualifying indication |
| D57.8 | Other sickle-cell disorders | Qualifying indication |
| D57.9 | Sickle-cell disease, unspecified | Qualifying indication |
| B16.0–B16.9 | Acute hepatitis B | Exclusion — hard stop |
| B17.10–B17.11 | Acute hepatitis C | Exclusion — hard stop |
| B18.0–B18.2 | Chronic viral hepatitis B/C | Exclusion — hard stop |
| B19.10–B19.21 | Unspecified viral hepatitis B/C | Exclusion — hard stop |
| B20 | HIV disease | Exclusion — hard stop |
| B97.35 | HIV-2 | Exclusion — hard stop |
| C00.0–C96.Z | Current malignancy | Exclusion — hard stop |
| D47.1 | Chronic myeloproliferative disease | Exclusion — hard stop |
| D47.2 | Monoclonal gammopathy | Exclusion — hard stop |
| D47.3 | Essential thrombocythemia | Exclusion — hard stop |
| D47.4 | Osteomyelofibrosis | Exclusion — hard stop |
| D65–D69.9 | Coagulation defects/bleeding disorders | Exclusion — hard stop |
| D80.0–D80.9 | Immunodeficiency with predominantly antibody defects | Exclusion — hard stop |
| D81.0–D81.4 | Combined immunodeficiencies | Exclusion — hard stop |
| A00.0–B99.9 | Certain infectious and parasitic diseases (active infection) | Exclusion — hard stop |
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