Skip to main content
HCPCS J2357 · Level II · Part B drug

HCPCS J2357: Injection, omalizumab, 5 mg

Reviewed by QuickIntell RCM Editorial Team · Last reviewed

Data effective
Data currency: ASP payment limits October 2026 (effective October 1, 2026); MUE and NCCI edits 2026 Q4 (effective October 1, 2026); OPPS Addendum B July 2026 (effective July 1, 2026). Next CMS release: January 1, 2027 (ASP, MUE, NCCI and OPPS quarterly updates).

Key facts for J2357

Billing unit
5 MG
Omalizumab injection
ASP payment limit
$45.687
October 2026; -1.9% vs July 2026
Practitioner MUE
120
MAI 3
OPPS status
SI K
APC 9300
NCCI exposure
no PTP pairs
Coverage articles
1
5 states

TL;DR

HCPCS J2357 is the Level II code for Injection, omalizumab, 5 mg, billed per 5 MG. The Medicare Part B ASP payment limit for October 2026 is $45.687 per billing unit, down 1.9% from July 2026. The practitioner MUE allows up to 120 units per date of service (MAI 3). Under OPPS it carries status indicator K in APC 9300. J2357 is billed in units of 5 MG; the quantity administered, the NDC package and the units on the claim must reconcile, which is the check that prevents CARC 16 and 151 returns on this line. The ASP crosswalk maps 9 NDCs to it, sold as Xolair by Genentech, Inc.. 1 Medicare coverage article lists the code across 5 states, including .

Medicare Part B payment limit (ASP)

CMS sets the Part B payment limit for J2357 at $45.687 per 5 MG for October 2026, derived from manufacturer average sales price plus 6%, compared with $46.588 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J2357
QuarterPayment limitPerCoinsurance
October 2026$45.6875 MG20%
July 2026$46.5885 MG—
CMS note: "lesser of" methodology applied

NDC to HCPCS billing-unit conversion

The October 2026 ASP crosswalk maps 9 NDCs from 1 labeler to J2357. Report the NDC in the claim's drug segment and bill the number of J2357 units that equals the quantity administered divided by 5 MG; the last column gives units per full package.

NDCs that crosswalk to J2357
NDCDrug nameLabelerPackage sizeBilling units / package
50242-0040-62XolairGenentech, Inc.1 × 130
50242-0214-01XolairGenentech, Inc.0.5 × 115
50242-0214-03XolairGenentech, Inc.0.5 × 115
50242-0214-55XolairGenentech, Inc.0.5 × 115
50242-0215-01XolairGenentech, Inc.1 × 130
50242-0215-03XolairGenentech, Inc.1 × 130
50242-0215-55XolairGenentech, Inc.1 × 130
50242-0227-01XolairGenentech, Inc.2 × 160
50242-0227-55XolairGenentech, Inc.2 × 160

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J2357. For practitioners the limit is 120 units per date of service with adjudication indicator 3, a date-of-service clinical edit: units above the limit deny but can be paid on appeal with documentation that the quantity was medically reasonable.

MUE values for J2357 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services1203 Date of Service Edit: ClinicalPrescribing Information
Facility outpatient hospital1203 Date of Service Edit: ClinicalPrescribing Information
DME supplier03 Date of Service Edit: ClinicalCMS Policy

NCCI edits and add-on relationships

No active practitioner PTP pair lists J2357 as a column-1 or column-2 code in v323r0. Drug supply codes are rarely bundled; the administration codes billed with them are where PTP edits usually apply.

J2357 is neither an add-on code nor a designated primary code in the 2026 Q4 NCCI add-on edit file.

Medicare coverage articles

1 current Medicare Administrative Contractor article lists J2357 in their HCPCS tables, covering 5 states. Each article carries the covered and non-covered ICD-10 codes that medical-necessity denials (CARC 50) are adjudicated against.

Billing and Coding Articles listing J2357
ArticleTitleContractor(s)StatesRelated LCD
Billing and Coding: Omalizumab and biosimilar, OMLYCLO® (omalizumab-igec)Wellpoint FederalCT IL MN NY WIL33394

Hospital outpatient (OPPS) status

In the July 2026 OPPS Addendum B, J2357 carries status indicator K and is assigned to APC 9300, with a published national unadjusted payment of $46.59. Status K means the drug is paid separately under OPPS at the ASP-based rate rather than packaged into the procedure.

Common denials for J2357 and how to prevent them

CARC 16 · M119

NDC missing, invalid or not matched to the HCPCS code

CARC 151 · N362

units billed exceed the MUE for the date of service

CARC 50 · N115

diagnosis not covered by the applicable coverage article or LCD

How QuickIntell checks J2357 before the claim leaves

QuickCode validates the NDC-to-unit conversion against the current ASP crosswalk, checks units against every published MUE setting and flags PTP and add-on conflicts on the same claim. QuickRCM routes CARC 16, 151 and 50 denials on drug lines with the matching coverage article attached so the appeal starts with evidence.

Explore QuickCodeExplore QuickRCMBook a demo

Frequently asked questions — HCPCS J2357

What does HCPCS code J2357 describe?

J2357 is defined by CMS as "Injection, omalizumab, 5 mg". Each billing unit represents 5 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J2357 in October 2026?

The ASP-based payment limit is $45.687 per 5 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $46.588.

How many units of J2357 can be billed per day?

The practitioner Medically Unlikely Edit is 120 units per date of service with adjudication indicator 3 (3 Date of Service Edit: Clinical). MAI 3 edits can be appealed with documentation that the units were medically reasonable. CMS cites "Prescribing Information" as the rationale.

Which NDCs map to J2357?

The October 2026 ASP crosswalk lists 9 NDCs from 1 labeler: Xolair (Genentech, Inc.). For example NDC 50242-0040-62 is a 1 package equal to 30 billing units. The crosswalk's billing-units-per-package figure converts each package into J2357 units.

Does J2357 have NCCI bundling edits?

No active practitioner PTP pairs list J2357 as a column-1 or column-2 code in the v323r0 release. Unit limits (MUE) and medical-necessity coverage rules still apply.

Which Medicare coverage articles mention J2357?

1 current Billing and Coding Article in the Medicare Coverage Database list J2357, covering 5 states: (Billing and Coding: Omalizumab and biosimilar, OMLYCLO® (omalizumab-igec)).

Sources

Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-01. Verify against the primary file before billing or contracting decisions.

Disclaimer

This page is an operational reference compiled from CMS publications: the Medicare Part B drug payment limit and NDC crosswalk files, NCCI MUE and add-on edit tables, aggregate PTP statistics, OPPS Addendum B and the Medicare Coverage Database. Payment limits are Medicare national amounts; commercial and Medicaid payers differ. CPT codes are shown as numbers only; CPT descriptors are copyright AMA. Nothing here is legal, clinical or billing advice.