Quick answer
J2357Q5154
What Medicare pays for Omalizumab (Xolair) (2026 Q3)
Once a claim carries a covered diagnosis, Medicare Part B reimburses the drug at the ASP + 6% payment limit. Current allowed amounts per billing unit:
| HCPCS | Description | Per unit | Allowed (ASP + 6%) |
|---|---|---|---|
| J2357 | Omalizumab injection | 5 mg | $46.588 |
Source: CMS ASP Drug Pricing File, 2026 Q3. Payment = ASP + 6% per unit; multiply by units billed (watch JZ/JW wastage). Your patient's share is typically 20% after the deductible. Estimate the full cost & patient out-of-pocket →
Omalizumab (Xolair) is a physician-administered biologic billed under Medicare Part B (not the Part D pharmacy benefit). Under Part B, Medicare pays the practice for the drug (HCPCS J2357) plus its administration — but only when the claim's diagnosis (ICD-10) code supports medical necessity. Each MAC publishes the specific covered diagnoses in a Billing & Coding Article; a claim with a diagnosis outside that list is typically denied as not medically necessary (CO-50).
Covered ICD-10 diagnoses for Omalizumab (Xolair)
The 17 codes below are the diagnoses Wellpoint Federal accepts for J2357 under Article A52448, grouped exactly as CMS groups them and organized by condition category for scanning. Use the filter in each group to find a specific code or condition.
Group 1 — 17 covered diagnoses
Diseases of the respiratory system (7)
| ICD-10 | Covered diagnosis |
|---|---|
| J33.0 | Polyp of nasal cavity |
| 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 |
Diseases of the skin & subcutaneous tissue (4)
| ICD-10 | Covered diagnosis |
|---|---|
| L50.1 | Idiopathic urticaria |
| L50.6 | Contact urticaria |
| L50.8 | Other urticaria |
| L50.9 | Urticaria, unspecified |
Injury, poisoning & external causes (3)
| ICD-10 | Covered diagnosis |
|---|---|
| T78.40XA | Allergy, unspecified, initial encounter |
| T78.40XD | Allergy, unspecified, subsequent encounter |
| T78.40XS | Allergy, unspecified, sequela |
Factors influencing health status (3)
| ICD-10 | Covered diagnosis |
|---|---|
| Z91.010 | Allergy to peanuts |
| Z91.013 | Allergy to seafood |
| Z91.040 | Latex allergy status |
What commercial payers require for Omalizumab (Xolair)
Medicare Part B is only half the answer — most Omalizumab (Xolair) claims are adjudicated by a commercial plan with its own medical policy. Below is what 28 commercial payers publish for Omalizumab (Xolair), read from each payer's own policy document. 25 of 28 that state a position require prior authorization, and 13 run a site-of-care program that can push the infusion out of the hospital outpatient setting.
| Payer | Prior auth | Preferred product first | Site of care | Indications named | Policy date |
|---|---|---|---|---|---|
| Aetna policy ↗ | Required | — | Site of Care Utilization Management Policy applies for omalizumab products | 4 | 2026-06-05 |
| Anthem / Elevance policy ↗ | Required | — | — | 4 | 2025-05-16 |
| BCBS Federal Employee Program policy ↗ | Required | — | — | 4 | 2026-01-01 |
| BCBS Kansas policy ↗ | Not required | — | Site-of-care program applies | 4 | — |
| BCBS Louisiana policy ↗ | Required | — | — | 4 | 2026-05-01 |
| BCBS Massachusetts policy ↗ | Required | — | — | 4 | 2026-03-15 |
| BCBS Michigan policy ↗ | Required | — | Site-of-care program applies | 4 | 2025-10-01 |
| BCBS Minnesota policy ↗ | Required | — | provider-administered (buy-and-bill) Xolair vial requires self-administration step-through or justification | 4 | 2026-03-03 |
| BCBS Mississippi policy ↗ | Required | — | — | 3 | 2025-10-01 |
| BCBS Nebraska policy ↗ | Required | — | — | 4 | 2025-11-05 |
| BCBS South Carolina policy ↗ | Not required | — | Site-of-care program applies | 4 | — |
| BCBS Tennessee policy ↗ | Required | — | — | 4 | 2025-12-31 |
| Blue Shield of California policy ↗ | Required | — | preferred site of service (home, office, or independent infusion center not associated with a hospital) | 4 | 2026-05-01 |
| Capital BlueCross policy ↗ | Required | — | — | 4 | 2026-03-03 |
| CareFirst BCBS policy ↗ | Required | — | — | 2 | — |
| Centene / Ambetter policy ↗ | Required | — | — | 4 | — |
| Cigna policy ↗ | Required | — | Site-of-care program applies | 4 | 2026-06-01 |
| Excellus BCBS policy ↗ | Required | — | site of care may affect approval timeframe | 4 | 2026-06-01 |
| Florida Blue policy ↗ | Required | — | additional requirements may apply in hospital-affiliated outpatient setting; 09-J3000-46 | 4 | 2026-07-01 |
| HCSC (IL/TX/OK/NM/MT) policy ↗ | Not required | — | Site-of-care program applies | 4 | 2025-04-15 |
| Highmark BCBS policy ↗ | Required | — | — | 4 | 2026-04-01 |
| HMSA (BCBS Hawaii) policy ↗ | Required | — | — | 2 | 2025-12-19 |
| Horizon BCBS NJ policy ↗ | Required | — | requested drug will be administered in an office/outpatient setting by a healthcare professional | 2 | 2020-04-10 |
| Independence Blue Cross policy ↗ | Required | — | — | 4 | 2026-03-23 |
| Premera Blue Cross policy ↗ | Required | — | Site of service review applies to ages 13+ for medical benefit; SOS criteria does not apply to Alaska fully-insured members | 4 | 2026-05-01 |
| Regence BCBS policy ↗ | Required | — | site of care administration requirements per Site of Care Review policy dru408 for provider-administered medications | 4 | 2025-11-15 |
| UnitedHealthcare policy ↗ | Required | — | — | 4 | 2026-07-01 |
| Wellmark BCBS policy ↗ | Required | — | — | 4 | 2026-03-19 |
What Omalizumab (Xolair) payers put in writing
Quoted from the medical policies linked above — 24 distinct requirements across 28 payers. These are the sentences an appeal has to answer.
Clinical prerequisites — what must be true before they pay
Member has a pre-treatment IgE level greater than or equal to 30 IU/mL
— Aetna, BCBS Tennessee and 2 other payers policy ↗Member has inadequate asthma control despite current treatment with both of the following medications at optimized doses
— Aetna, BCBS Tennessee, Wellmark BCBS policy ↗A total endoscopic nasal polyp score (NPS) of at least 5 with a minimum score of 2 for each nostril
— Aetna, BCBS Tennessee, Wellmark BCBS policy ↗Member has experienced a spontaneous onset of wheals (hives), angioedema, or both, for at least 6 weeks
— Aetna, BCBS Tennessee, Wellmark BCBS policy ↗Member is 6 years of age or older
— Aetna, CareFirst BCBS, Florida Blue policy ↗Member is 18 years of age or older
— Aetna, Florida Blue, Wellmark BCBS policy ↗
Prior authorization
Prior authorization validity will be provided initially for 12 months (365 days).
— BCBS Minnesota, Capital BlueCross policy ↗Submission of the following information is necessary to initiate the prior authorization review
— BCBS Tennessee, Wellmark BCBS policy ↗Precertification of omalizumab products is required of all Aetna participating providers and members in applicable plan designs
— Aetna policy ↗Prior authorization is required to ensure the safe, clinically appropriate, and cost-effective use of Xolair
— BCBS Federal Employee Program policy ↗Initiation of omalizumab (Xolair, Omlyclo) meets the definition of medical necessity for members diagnosed with any of the following conditions when ALL associated criteria are met
— Florida Blue policy ↗All requests must meet the Prior Authorizations requirement.
— BCBS Massachusetts policy ↗
Quantity and frequency limits
Quantity Limits: Align with FDA recommended dosing
— BCBS Michigan policy ↗Omalizumab dose does not exceed 300 mg every 4 weeks; maximum 2 vials or 60 HCPCS units every 28 days
— BCBS Nebraska policy ↗75 to 375 mg given as a subcutaneous injection every 2 or 4 weeks
— Blue Shield of California policy ↗Not to exceed 600 mg given as a subcutaneous injection every 2 to 4 weeks
— Blue Shield of California policy ↗Not to exceed 300 mg given as a subcutaneous injection every 4 weeks
— Blue Shield of California policy ↗75 mg to 600 mg given as a subcutaneous injection every 2 or 4 weeks
— Blue Shield of California policy ↗
Dosing rules
Asthma The recommended dose is 75 mg to 375 mg by subcutaneous injection
— Aetna policy ↗Polyps (CRSwNP) The recommended dose is 75 mg to 600 mg by subcutaneous injection
— Aetna policy ↗IgE-mediated food allergy, may approve up to 600 mg every 2 weeks. Coding
— Anthem / Elevance policy ↗(or autoinjectors) OR eight 150 mg vials* xi. 600 mg every two weeks: four 300
— Florida Blue policy ↗Administer Xolair 150 to 375 mg by subcutaneous (SC) injection every 2 or 4 weeks.
— BCBS Kansas policy ↗Administer Xolair 150 or 300 mg by subcutaneous injection every 4 weeks.
— BCBS Kansas policy ↗
Read from each payer's published medical policy between 2026-08-03 and 2026-08-13. Every requirement above is quoted from the policy it links to. Commercial policy changes without notice — confirm before you bill.
How to bill Omalizumab (Xolair)
Put the patient's covered ICD-10 diagnosis on the claim line with J2357. Matching codes, units and JZ/JW wastage →
Which policy governs Omalizumab (Xolair)
The covered code lists live in Article A52448 (tied to LCD L33394) — CMS moved code lists out of LCDs and into Articles, which is why the diagnoses live in the Article. What an LCD, an Article and an NCD each govern →
If a claim for Omalizumab (Xolair) is denied
The usual cause is a diagnosis outside Article A52448's covered list, or a product code and unit count that do not match what was given. The five denial patterns and how to fix each →
Frequently asked questions
- Is Omalizumab (Xolair) covered by Medicare?
- Yes. Omalizumab (Xolair) (J2357) is covered under Medicare Part B as a physician-administered drug when billed for a medically necessary, covered diagnosis. Local coverage is defined by Wellpoint Federal in Billing & Coding Article A52448, tied to LCD L33394.
- What diagnoses are covered for Omalizumab (Xolair) (J2357)?
- Medicare lists 17 covered ICD-10 diagnosis codes for J2357 under Article A52448. The full list is on this page, grouped by condition category. Coverage can vary by Medicare Administrative Contractor (MAC); confirm against the article that applies in your state.
- Which Medicare policy covers Omalizumab (Xolair)?
- Billing & Coding Article A52448 (v24), tied to LCD L33394 (“Drugs and Biologicals, Coverage of, for Label and Off-Label Uses”), published by Wellpoint Federal and last updated 09/17/2025.
- Why was my Omalizumab (Xolair) claim denied as not medically necessary?
- The most common cause is an ICD-10 diagnosis on the claim that is not in the covered list for J2357. Confirm the patient's diagnosis is in the groups below, that documentation supports medical necessity, and that you are using the article for your MAC.
Related references
Covered is only half the answer.
You know the diagnosis is payable. Now quote the patient before the visit and catch underpayments: get Omalizumab (Xolair)'s exact Medicare allowed amount, your payer's rate vs. ASP+6%, and the patient's out-of-pocket — in about 30 seconds, free.
Estimate Omalizumab (Xolair) cost & patient owe →Source & verification
- Source
- CMS Medicare Coverage Database — Billing & Coding Article A52448 (v24), LCD L33394 “Drugs and Biologicals, Coverage of, for Label and Off-Label Uses” — Wellpoint Federal.
- Primary sources
- DailyMed — Omalizumab (Xolair) prescribing information · CMS Part B Drug ASP Pricing File — the quarterly payment limit quoted above · CMS Medicare Coverage Database — Article A52448
- CMS article last revised
- 09/17/2025
- Page last reviewed by CareCost
- Aug 23, 2026 (coverage data retrieved 2026-08-26; we re-verify against CMS quarterly).
- Code licensing
- ICD-10-CM codes are public domain (CMS/CDC). CPT® codes are AMA-copyrighted and are intentionally not listed here — see the administration-code reference for those.
- Not advice
- This is general billing reference, not legal or billing advice. Always verify against the LCD/Article that applies to your MAC and patient.
- How we build this
- Compiled programmatically from the CMS Coverage API under a founder-led methodology maintained by Erin Rose (Founder), and reviewed against the source article with a practitioner-correction loop. See our methodology and editorial policy.
- Spotted an error?
- Email editorial@carecostestimate.com.