J2357Injection, omalizumab, 5 mg

Long descriptor

Injection, omalizumab, 5 mg

Short descriptor

Omalizumab injection

Code family

J — Drugs administered other than oral method; chemotherapy drugs

Status

Active

Added to HCPCS

Jan 1, 2005

Action effective date

Jan 1, 2005

Termination date

None

Medicare coverage code

C — Carrier judgment

Pricing indicator

51 — Drugs

NOC list

Not on the CMS NOC list

Maximum units per day (CMS Medically Unlikely Edits)

Quarterly history

Derived calculation “Derived $ / NDC” = billable units per NDC × the current payment limit. It is arithmetic for orientation, not a payment amount.

Drugs whose NDCs CMS crosswalks to J2357

• XolairomalizumabDerived calculationDerived: 3 of 6 NDC package(s) for this drug appear in the CMS NDC–HCPCS crosswalk for J2357.
• Xolair PFSomalizumabDerived calculationDerived: 6 of 10 NDC package(s) for this drug appear in the CMS NDC–HCPCS crosswalk for J2357.

Biosimilar and reference products (FDA Purple Book)

• Interchangeable biosimilarOmlycloomalizumab-igec

• Coverage documents for J2357 NCDs, LCDs, and Billing & Coding articles in the CMS Medicare Coverage Database that mention “J2357”. Covered diagnosis codes are listed in the articles.
• Self-administered drug (SAD) exclusion lists Drugs each MAC excludes from “incident to” Part B coverage because they are usually self-administered.
• Find your Medicare contractor (MAC) A/B and DME MAC jurisdictions by state — local coverage and prior-authorization rules come from your MAC.
• CMS discarded drug (JW/JZ) guidance When the JW and JZ modifiers are required for drugs from single-dose containers.
• NCCI Medically Unlikely Edits CMS MUE tables and quarterly changes for practitioner, outpatient hospital, and DME claims.

Verification neededCodeRx links to coverage documents instead of copying them: CMS distributes their code lists under AMA, ADA, and AHA license terms that limit reuse. Medicare Advantage, Medicaid, and commercial plans set their own coverage and prior-authorization rules.

All imported releases, checksums, and import reports are listed on the data sources page.

• A HCPCS code being valid does not mean Medicare or any other payer covers the item; coverage is determined by the payer and the MAC.
• CMS publishes NDC–HCPCS crosswalks to support ASP-based Part B payment; they are not a comprehensive list of NDCs that may be billed with this code.
• Payment limits are national Medicare Part B limits per billing unit, before deductible, coinsurance, and sequestration. They are not commercial payer rates.
• Hospital outpatient (OPPS) payment rates and status indicators are not included in this release.
• MUE values are the published CMS NCCI limits for Medicare fee-for-service claims; other payers may apply their own unit limits, and CMS keeps some MUE values confidential.