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HCPCS J9361 · Level II · Part B drug

HCPCS J9361: Injection, efbemalenograstim alfa-vuxw, 0.5 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 J9361

Billing unit
0.5 MG
Inj, efbemalenograstim alfa-
ASP payment limit
$121.429
October 2026
Practitioner MUE
40
MAI 3
OPPS status
SI E2
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J9361 is the Level II code for Injection, efbemalenograstim alfa-vuxw, 0.5 mg, billed per 0.5 MG. The Medicare Part B ASP payment limit for October 2026 is $121.429 per billing unit. The practitioner MUE allows up to 40 units per date of service (MAI 3). Under OPPS it carries status indicator E2. J9361 is billed in units of 0.5 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 1 NDC to it, sold as Ryzneuta by Acrotech Biopharma LLC. No current Billing and Coding Article lists J9361, so coverage follows the FDA label, compendia and any applicable NCD.

Medicare Part B payment limit (ASP)

CMS sets the Part B payment limit for J9361 at $121.429 per 0.5 MG for October 2026, derived from manufacturer average sales price plus 6%. Beneficiary coinsurance is 20%.

ASP payment limits for J9361
QuarterPayment limitPerCoinsurance
October 2026$121.4290.5 MG20%
July 2026n/a0.5 MG—
CMS note: Added October 2026

NDC to HCPCS billing-unit conversion

The October 2026 ASP crosswalk maps 1 NDC from 1 labeler to J9361. Report the NDC in the claim's drug segment and bill the number of J9361 units that equals the quantity administered divided by 0.5 MG; the last column gives units per full package.

NDCs that crosswalk to J9361
NDCDrug nameLabelerPackage sizeBilling units / package
72893-0016-02RyzneutaAcrotech Biopharma LLC1 × 140

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J9361. For practitioners the limit is 40 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 J9361 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services403 Date of Service Edit: ClinicalPrescribing Information
Facility outpatient hospital403 Date of Service Edit: ClinicalPrescribing Information
DME supplier403 Date of Service Edit: ClinicalPrescribing Information

NCCI edits and add-on relationships

No active practitioner PTP pair lists J9361 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.

J9361 is neither an add-on code nor a designated primary code in the 2026 Q4 NCCI add-on edit file.

Medicare coverage articles

No current Billing and Coding Article lists J9361 in its HCPCS table. Coverage then follows the drug's FDA label, compendia and any National Coverage Determination; check the Medicare Coverage Database before administering off-label.

Hospital outpatient (OPPS) status

In the July 2026 OPPS Addendum B, J9361 carries status indicator E2. Status E indicates the item is not payable by Medicare under OPPS.

Common denials for J9361 and how to prevent them

NDC missing, invalid or not matched to the HCPCS code

units billed exceed the MUE for the date of service

diagnosis not covered by the applicable coverage article or LCD

How QuickIntell checks J9361 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.

Frequently asked questions — HCPCS J9361

What does HCPCS code J9361 describe?

J9361 is defined by CMS as "Injection, efbemalenograstim alfa-vuxw, 0.5 mg". Each billing unit represents 0.5 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J9361 in October 2026?

The ASP-based payment limit is $121.429 per 0.5 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules.

How many units of J9361 can be billed per day?

The practitioner Medically Unlikely Edit is 40 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 J9361?

The October 2026 ASP crosswalk lists 1 NDC from 1 labeler: Ryzneuta (Acrotech Biopharma LLC). For example NDC 72893-0016-02 is a 1 package equal to 40 billing units. The crosswalk's billing-units-per-package figure converts each package into J9361 units.

Does J9361 have NCCI bundling edits?

No active practitioner PTP pairs list J9361 as a column-1 or column-2 code in the v323r0 release. Unit limits (MUE) and medical-necessity coverage rules still apply.

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.