Aetna modified CPB 0925 for benralizumab (Fasenra), effective January 5, 2026. Here's what billing teams need to know before submitting claims under this updated coverage policy.
Aetna, a CVS Health company, updated Clinical Policy Bulletin CPB 0925 Aetna system to revise medical necessity criteria for benralizumab (Fasenra) — the anti-IL-5 receptor alpha biologic billed under HCPCS J0517. The changes affect initial approval criteria for asthma and eosinophilic granulomatosis with polyangiitis (EGPA), with new step-therapy language that will directly drive claim denial rates if your documentation doesn't match. If your practice treats severe asthma or EGPA and bills J0517 to Aetna commercial plans, this policy affects your reimbursement workflow starting now.
Quick-Reference Table
| Field | Detail |
|---|---|
| Payer | Aetna, a CVS Health company |
| Policy | Benralizumab (Fasenra) — CPB 0925 |
| Policy Code | CPB 0925 |
| Change Type | Modified |
| Effective Date | January 5, 2026 |
| Impact Level | High |
| Specialties Affected | Allergist/Immunologist, Pulmonologist |
| Key Action | Audit prior authorization documentation for J0517 against new step-therapy and eosinophil count criteria before submitting claims |
Aetna Benralizumab Coverage Criteria and Medical Necessity Requirements 2026
The Aetna benralizumab coverage policy under CPB 0925 requires precertification for all participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277 to initiate prior authorization. Statement of Medical Necessity forms are available through Aetna's Specialty Pharmacy Precertification portal.
Aetna also applies a Site of Care Utilization Management policy to benralizumab. That means where you administer this drug matters for reimbursement. Review Aetna's drug infusion site-of-care policy before scheduling administration.
Prescribing Specialty Requirement
Benralizumab must be prescribed by — or in documented consultation with — an allergist/immunologist or pulmonologist for the asthma indication. This is a hard requirement. A prescription from a primary care provider without a specialist consultation on record is a clean path to denial.
Asthma: Initial Approval Criteria
This is where the updated coverage policy adds the most complexity. Aetna considers benralizumab medically necessary for asthma under two separate tracks.
Track 1 — Prior Biologic Use:
Members age six or older who received a biologic indicated for asthma (such as Dupixent or Nucala, billed under J2182 for mepolizumab or J2357 for omalizumab) within the past year qualify under this track. This is Aetna's step-therapy shortcut. If your patient already failed or is currently on another asthma biologic, document that clearly in your prior authorization request.
Track 2 — Severe Asthma, No Prior Biologic:
All five of the following must be met:
| # | Covered Indication |
|---|---|
| 1 | Member is age six or older |
| 2 | Baseline blood eosinophil count of at least 150 cells per microliter (CPT 85004 or 85048), or documented systemic corticosteroid dependence |
| 3 | Uncontrolled asthma with at least one of the following in the past year: two or more exacerbations requiring oral or injectable corticosteroids; one or more exacerbation resulting in hospitalization or ER visit; or poor symptom control (frequent symptoms, reliever use, activity limitation, or night waking) |
| 4 | Inadequate control despite high-dose inhaled corticosteroid and an additional controller (long-acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline) |
| 5 | Member will continue maintenance therapy alongside benralizumab |
The real issue here is the eosinophil count threshold. Make sure blood count labs — billed under CPT 85004 (automated differential WBC) or CPT 85048 (automated leukocyte count) — are documented in the record and reflected in the prior auth submission. Missing lab data is one of the top drivers of prior authorization denials for biologics.
EGPA: Initial Approval Criteria
For eosinophilic granulomatosis with polyangiitis, Aetna again uses a two-track approach.
Track 1 — Prior Biologic Use:
Members age 18 or older who received a biologic indicated for EGPA (such as Nucala/mepolizumab, J2182) in the past year.
Track 2 — De Novo EGPA Treatment:
All four of these must be met:
| # | Covered Indication |
|---|---|
| 1 | Member is age 18 or older |
| 2 | Blood eosinophil count above 1,000 cells per microliter or eosinophil level above 10% |
| 3 | Currently taking oral corticosteroids (unless contraindicated or not tolerated) |
| 4 | At least two of the following disease characteristics: biopsy showing eosinophilic vasculitis or granulomatous inflammation; mono or polyneuropathy with motor deficit or abnormal nerve conduction; non-fixed pulmonary infiltrates; sino-nasal abnormality; or cardiomyopathy of eosinophilic origin |
The eosinophil threshold for EGPA (greater than 1,000 cells/µL) is notably higher than for asthma (at least 150 cells/µL). Don't mix these up in your documentation. A prior auth submission with the wrong eosinophil threshold cited for the wrong indication will come back denied.
Aetna Benralizumab Exclusions and Non-Covered Indications
The policy data does not enumerate a separate exclusions list, but the structure of CPB 0925 makes the exclusions clear by implication. Benralizumab is not covered for:
| # | Excluded Procedure |
|---|---|
| 1 | Members under age six for asthma |
| 2 | Members under age 18 for EGPA |
| 3 | Asthma patients who do not meet both the eosinophil or corticosteroid-dependence threshold and the documented treatment failure criteria |
| 4 | Any indication where the prescribing provider is not an allergist/immunologist or pulmonologist, and no documented specialist consultation exists |
| 5 | Administration at a site of care that does not meet Aetna's utilization management criteria for specialty drug infusions |
If your patient doesn't clearly fit one of the two tracks for each indication, assume the claim will be denied on medical necessity grounds.
Coverage Indications at a Glance
| Indication | Status | Age Requirement | Key Criteria | Notes |
|---|---|---|---|---|
| Severe asthma (new to biologics) | Covered | ≥6 years | Eosinophils ≥150/µL or steroid-dependent; uncontrolled despite high-dose ICS + controller; will continue maintenance | Prior auth required; specialist Rx required |
| Asthma (prior biologic) | Covered | ≥6 years | Received asthma biologic (e.g., Dupixent, Nucala) in past year | Simpler pathway; still requires prior auth |
| EGPA (new to biologics) | Covered | ≥18 years | Eosinophils >1,000/µL or >10%; on oral corticosteroids; ≥2 disease characteristics | Prior auth required |
| EGPA (prior biologic) | Covered | ≥18 years | Received EGPA biologic (e.g., Nucala) in past year | Simpler pathway; still requires prior auth |
| Asthma — inadequate documentation | Not Covered | — | Missing eosinophil labs, no specialist consult, no documented treatment failure | Claim denial likely |
| Any indication — wrong site of care | Not Covered | — | Administration site doesn't meet Aetna's utilization management criteria | Site of care review required before scheduling |
Aetna Benralizumab Billing Guidelines and Action Items 2026
These are specific steps for billing teams and revenue cycle staff handling J0517 claims on Aetna commercial plans after January 5, 2026.
| # | Action Item |
|---|---|
| 1 | Confirm prior authorization is in place before every claim. Precertification is required for all Aetna commercial members. No prior auth means no reimbursement — this is not a plan-design variable. Call (866) 752-7021 or fax SMN forms to (888) 267-3277. |
| 2 | Pull and attach eosinophil lab results with every prior auth submission. For asthma, you need CPT 85004 or CPT 85048 results showing a baseline of at least 150 cells/µL. For EGPA, you need results showing greater than 1,000 cells/µL or greater than 10% eosinophils. No labs in the record is the fastest way to a denial. |
| 3 | Document the prescribing specialist for all asthma claims. Aetna requires the medication be prescribed by or in consultation with an allergist/immunologist or pulmonologist. If the ordering provider is not a specialist, include a specialist consultation note in the prior auth package. |
| 4 | Verify site of care before scheduling administration. Aetna's Site of Care Utilization Management policy applies to benralizumab. Check that your administration setting meets their criteria. If you're billing CPT 96372 for the subcutaneous injection, confirm the site is approved before the date of service — not after. |
| 5 | Use the correct step-therapy track in your prior auth documentation. If your patient had a prior asthma biologic (Dupixent, Nucala, tezepelumab billed under J2356, omalizumab under J2357, reslizumab under J2786), cite that prior use explicitly. This qualifies the patient for the simpler Track 1 pathway. Don't bury it in the clinical notes — put it in the primary justification. |
| 6 | Audit existing Fasenra patients for continued eligibility under the updated billing guidelines. The January 5, 2026 effective date means renewal requests submitted after that date must meet the revised criteria. Review your active benralizumab patients now. If a patient is coming up for reauthorization and their records don't clearly satisfy the updated criteria, get documentation updated before you submit. |
| 7 | Consult your compliance officer if you're billing for EGPA. EGPA is a rare indication with specific diagnostic documentation requirements — biopsy results, neuropathy assessments, pulmonary infiltrate imaging. If your documentation practice for EGPA hasn't been audited recently, do that review before the next renewal cycle. If you're not sure how your patient mix aligns with the new criteria, loop in your compliance officer before the effective date passes. |
| 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 Benralizumab Under CPB 0925
Primary Covered HCPCS Code
| Code | Type | Description |
|---|---|---|
| J0517 | HCPCS | Injection, benralizumab, 1 mg |
Supporting CPT Codes (Related to Criteria and Administration)
| Code | Type | Description |
|---|---|---|
| 85004 | CPT | Blood count; automated differential WBC count |
| 85048 | CPT | Blood count; leukocyte (WBC), automated |
| 94010–94799 | CPT | Pulmonary diagnostic testing and therapies |
| 96372 | CPT | Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular |
| 99406 | CPT | Smoking and tobacco use cessation counseling; intermediate (>3 min, up to 10 min) |
| 99407 | CPT | Smoking and tobacco use cessation counseling; intensive (>10 min) |
Corticosteroid and Comparator Biologic HCPCS Codes Referenced in CPB 0925
These codes appear in the policy as comparator or concomitant medications. They're relevant for documenting prior biologic use and corticosteroid dependence in your prior authorization submissions.
| Code | Type | Description |
|---|---|---|
| J2182 | HCPCS | Injection, mepolizumab (Nucala), 1 mg |
| J2356 | HCPCS | Injection, tezepelumab-ekko, 1 mg |
| J2357 | HCPCS | Injection, omalizumab, 5 mg |
| J2786 | HCPCS | Injection, reslizumab, 1 mg |
| J0702 | HCPCS | Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg |
| J1020 | HCPCS | Injection, methylprednisolone acetate, 20 mg |
| J1030 | HCPCS | Injection, methylprednisolone acetate, 40 mg |
| J1040 | HCPCS | Injection, methylprednisolone acetate, 80 mg |
| J1094 | HCPCS | Injection, dexamethasone acetate, 1 mg |
| J1100 | HCPCS | Injection, dexamethasone sodium phosphate, 1 mg |
| J1700 | HCPCS | Injection, hydrocortisone acetate, up to 25 mg |
| J1710 | HCPCS | Injection, hydrocortisone sodium phosphate, up to 50 mg |
| J1720 | HCPCS | Injection, hydrocortisone sodium succinate, up to 100 mg |
| J2650 | HCPCS | Injection, prednisolone acetate, up to 1 ml |
| J2920 | HCPCS | Injection, methylprednisolone sodium succinate, up to 40 mg |
| J2930 | HCPCS | Injection, methylprednisolone sodium succinate, up to 125 mg |
| J3300 | HCPCS | Injection, triamcinolone acetonide, preservative free, 1 mg |
| J3301 | HCPCS | Injection, triamcinolone acetonide, not otherwise specified, 10 mg |
| J3302 | HCPCS | Injection, triamcinolone diacetate, per 5 mg |
| J3303 | HCPCS | Injection, triamcinolone hexacetonide, per 5 mg |
| J7509 | HCPCS | Methylprednisolone oral, per 4 mg |
| J7510 | HCPCS | Prednisolone oral, per 5 mg |
| J7512 | HCPCS | Prednisone, immediate or delayed release, oral, 1 mg |
| J7622 | HCPCS | Beclomethasone, inhalation solution, compounded product, DME, unit dose |
| J7624 | HCPCS | Betamethasone, inhalation solution, compounded product, DME, unit dose |
| J7637 | HCPCS | Dexamethasone, inhalation solution, compounded product, DME, concentrated form |
| J7638 | HCPCS | Dexamethasone, inhalation solution, compounded product, DME, unit dose |
| J7677 | HCPCS | Revefenacin inhalation solution, FDA-approved, non-compounded, DME |
| J7683 | HCPCS | Triamcinolone, inhalation solution, compounded product, DME, concentrated form |
| J7684 | HCPCS | Triamcinolone, inhalation solution, compounded product, DME, unit dose |
| J8540 | HCPCS | Dexamethasone, oral, 0.25 mg |
Key ICD-10-CM Diagnosis Codes
| Code | Description |
|---|---|
| J45.40 | Moderate persistent asthma, uncomplicated |
| J45.41 | Moderate persistent asthma with (acute) exacerbation |
| J45.42 | Moderate persistent asthma with status asthmaticus |
| J45.50 | Severe persistent asthma, uncomplicated |
| J45.51 | Severe persistent asthma with (acute) exacerbation |
| J45.52 | Severe persistent asthma with status asthmaticus |
| J45.22 | Mild intermittent asthma with status asthmaticus |
| J45.32 | Mild persistent asthma with status asthmaticus |
| J45.902 | Unspecified asthma with status asthmaticus |
| J45.990 | Exercise induced bronchospasm |
| M30.1 | Polyarteritis with lung involvement (Churg-Strauss/EGPA) |
| J82.81 | Chronic eosinophilic pneumonia |
| J82.82 | Acute eosinophilic pneumonia |
| J44.0–J44.9 | Other chronic obstructive pulmonary disease (multiple codes) |
| J20.0–J20.9 | Acute bronchitis (multiple codes) |
| J21.9 | Acute bronchiolitis, unspecified |
| J98.01 | Acute bronchospasm |
| D14.1 | Benign neoplasm of larynx (laryngeal papillomatosis) |
| L53.1 | Erythema annulare centrifugum |
| N30.80 | Other cystitis, without hematuria |
| N30.81 | Other cystitis, with hematuria |
For asthma claims, J45.50–J45.52 are your primary diagnosis codes. For EGPA, M30.1 (Churg-Strauss) is the correct ICD-10 code. The J44.x COPD codes appear in the policy reference data but benralizumab is not approved for COPD under this bulletin — don't use them as the primary diagnosis for a Fasenra claim.
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