Currentvns_healthPolicy N/A

Omalizumab (Xolair) — medical-benefit coverage criteria for subcutaneous use

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This policy governs medical-benefit coverage and limitations for Xolair (omalizumab) when administered subcutaneously via buy-and-bill to affected VNS Health members; it applies to provider-administered drug billing and clinical indication requirements.

Policy Summary

Payervns_health

PolicyOmalizumab (Xolair) — medical-benefit coverage criteria for subcutaneous use

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFor chronic idiopathic urticaria, patient must remain symptomatic despite H1 antihistamine treatment prior to use of omalizumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2indications listed

J2357HCPCS code

>=6min age — asthma

>=12min age — urticaria

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Currentvns_healthPolicy N/A

Omalizumab (Xolair) — medical-benefit coverage criteria for subcutaneous use

Customize your policy alerts

Sign up for all vns_health policy alerts

Know when vns_health releases new policies or updates existing guidance.

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Policy Summary

Payervns_health

PolicyOmalizumab (Xolair) — medical-benefit coverage criteria for subcutaneous use

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFor chronic idiopathic urticaria, patient must remain symptomatic despite H1 antihistamine treatment prior to use of omalizumab.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2indications listed

J2357HCPCS code

>=6min age — asthma

>=12min age — urticaria

FDA-indicated uses

Covered when ALL of the following are met:

Asthma indication: Moderate to severe persistent asthma in patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids.age >= 6 years; positive perennial aeroallergen test; inadequate control on inhaled corticosteroids

FDA-indicated asthma population

Chronic idiopathic urticaria indication: Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.age >= 12 years; symptomatic despite H1 antihistamines

FDA-indicated urticaria population

This therapy is not indicated for other allergic conditions or for other forms of urticaria beyond the FDA‑listed indication for chronic idiopathic urticaria, and it is not indicated for management of acute bronchospasm or status asthmaticus.

Use of omalizumab for indications outside the FDA‑listed uses — including other allergic conditions or non‑idiopathic forms of urticaria — is not supported by this policy and may be considered not medically necessary.

Provider Actions, Billing Rules, and Denial Conditions

Billing Rule

Medical‑benefit coding and billing (buy‑and‑bill)

Coverage of omalizumab is provided under the member's medical benefit via the buy-and-bill process for provider-administered drugs; billing should reference HCPCS J2357 (Injection, omalizumab, 5 mg) and the appropriate CPT administration codes for the injection.

Drug is billed under the medical benefit via buy-and-bill.
Use HCPCS J2357 to report omalizumab (5 mg).
Include appropriate CPT administration codes when submitting the claim.

Step Therapy

Step requirement for chronic idiopathic urticaria

For the chronic idiopathic urticaria indication, the patient must remain symptomatic despite H1 antihistamine treatment before omalizumab is used.

Applies to adults and adolescents 12 years of age and older.

Documentation Required

Claim coding: J2357 and administration CPT codes

When submitting claims under the medical benefit via buy-and-bill, providers should report omalizumab with HCPCS code J2357 and include the appropriate CPT administration code(s) for the injection (e.g., 96372, 96401).

HCPCS: J2357 — Injection, omalizumab, 5 mg.
Possible CPT administration codes: 96372 and 96401 (as applicable to the administration).

Denial Risk

Not indicated — other allergic conditions and acute/emergent respiratory events

Use of omalizumab for other allergic conditions, other forms of urticaria, acute bronchospasm, or status asthmaticus is not indicated by this policy and may be denied.

Do not submit claims for indications outside the FDA‑listed uses; coverage is limited to the specified asthma and chronic idiopathic urticaria populations.

Definitions

Omalizumab (Xolair) — definition and brief descriptor

Generic nameOmalizumab

Brand nameXolair

Drug class / mechanismMonoclonal antibody targeting IgE; binds the high-affinity Fc receptor for IgE, preventing IgE binding and reducing free serum IgE and mediator release

Route of administrationSubcutaneous (provider-administered, buy-and-bill)

Primary FDA-indicated usesModerate-to-severe persistent allergic asthma (age ≥6 years) with positive perennial aeroallergen sensitivity and inadequate control on inhaled corticosteroids; chronic idiopathic urticaria (age ≥12 years) refractory to H1 antihistamines

Policy Summary

Payervns_health

PolicyOmalizumab (Xolair) — medical-benefit coverage criteria for subcutaneous use

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionFor chronic idiopathic urticaria, patient must remain symptomatic despite H1 antihistamine treatment prior to use of omalizumab.

SourceLink

On This Page

Omalizumab (Xolair) — medical-benefit coverage criteria for subcutaneous use

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Omalizumab (Xolair) — medical-benefit coverage criteria for subcutaneous use

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Coverage Criteria for Omalizumab (Xolair)

Coding and Billing References

Provider Actions, Billing Rules, and Denial Conditions

Background

Definitions

96372	Therapeutic, Prophylactic, and Diagnostic Injections and Infusions.
96401	Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic