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HCPCS J0491 · Level II · Part B drug

HCPCS J0491: Injection, anifrolumab-fnia, 1 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 J0491

Billing unit
1 MG
Inj anifrolumab-fnia 1mg
ASP payment limit
$18.461
October 2026; -0.3% vs July 2026
Practitioner MUE
300
MAI 3
OPPS status
SI K
APC 9434
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J0491 is the Level II code for Injection, anifrolumab-fnia, 1 mg, billed per 1 MG. The Medicare Part B ASP payment limit for October 2026 is $18.461 per billing unit, down 0.3% from July 2026. The practitioner MUE allows up to 300 units per date of service (MAI 3). Under OPPS it carries status indicator K in APC 9434. With a 1 mg billing unit, a single administration can be hundreds of units; the unit count on the claim must equal the milligrams given, and rounding rules for partial units follow the contractor's guidance. The ASP crosswalk maps 1 NDC to it, sold as Saphnelo by AstraZeneca Pharmaceuticals LP. No current Billing and Coding Article lists J0491, 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 J0491 at $18.461 per 1 MG for October 2026, derived from manufacturer average sales price plus 6%, compared with $18.508 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J0491
QuarterPayment limitPerCoinsurance
October 2026$18.4611 MG20%
July 2026$18.5081 MG—
Source: CMS Medicare Part B Drug Payment Limit File. Commercial and Medicaid payers set their own rates.

NDC to HCPCS billing-unit conversion

The October 2026 ASP crosswalk maps 1 NDC from 1 labeler to J0491. Report the NDC in the claim's drug segment and bill the number of J0491 units that equals the quantity administered divided by 1 MG; the last column gives units per full package.

NDCs that crosswalk to J0491
NDCDrug nameLabelerPackage sizeBilling units / package
00310-3040-00SaphneloAstraZeneca Pharmaceuticals LP2 × 1300

Medically Unlikely Edits (MUE)

CMS publishes 2 MUE values for J0491. For practitioners the limit is 300 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 J0491 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services3003 Date of Service Edit: ClinicalPrescribing Information
Facility outpatient hospital3003 Date of Service Edit: ClinicalPrescribing Information

NCCI edits and add-on relationships

No active practitioner PTP pair lists J0491 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.

J0491 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 J0491 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, J0491 carries status indicator K and is assigned to APC 9434, with a published national unadjusted payment of $18.51. Status K means the drug is paid separately under OPPS at the ASP-based rate rather than packaged into the procedure.

Common denials for J0491 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 J0491 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 J0491

What does HCPCS code J0491 describe?

J0491 is defined by CMS as "Injection, anifrolumab-fnia, 1 mg". Each billing unit represents 1 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J0491 in October 2026?

The ASP-based payment limit is $18.461 per 1 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $18.508.

How many units of J0491 can be billed per day?

The practitioner Medically Unlikely Edit is 300 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 J0491?

The October 2026 ASP crosswalk lists 1 NDC from 1 labeler: Saphnelo (AstraZeneca Pharmaceuticals LP). For example NDC 00310-3040-00 is a 2 package equal to 300 billing units. The crosswalk's billing-units-per-package figure converts each package into J0491 units.

Does J0491 have NCCI bundling edits?

No active practitioner PTP pairs list J0491 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.