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HCPCS J0278 · Level II · Part B drug

HCPCS J0278: Injection, amikacin sulfate, 100 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 J0278

Billing unit
100 MG
Amikacin sulfate injection
ASP payment limit
$0.612
October 2026; -0.3% vs July 2026
Practitioner MUE
15
MAI 3
OPPS status
SI N
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J0278 is the Level II code for Injection, amikacin sulfate, 100 mg, billed per 100 MG. The Medicare Part B ASP payment limit for October 2026 is $0.612 per billing unit, down 0.3% from July 2026. The practitioner MUE allows up to 15 units per date of service (MAI 3). Under OPPS it carries status indicator N. J0278 is billed in units of 100 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 12 NDCs to it, sold as Amikacin Sulfate by Hikma Pharmaceuticals USA Inc., Heritage Pharmaceuticals Inc., Sagent Pharmaceuticals. No current Billing and Coding Article lists J0278, 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 J0278 at $0.612 per 100 MG for October 2026, derived from manufacturer average sales price plus 6%, compared with $0.614 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J0278
QuarterPayment limitPerCoinsurance
October 2026$0.612100 MG20%
July 2026$0.614100 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 12 NDCs from 5 labelers to J0278. Report the NDC in the claim's drug segment and bill the number of J0278 units that equals the quantity administered divided by 100 MG; the last column gives units per full package.

NDCs that crosswalk to J0278
NDCDrug nameLabelerPackage sizeBilling units / package
00641-6166-10Amikacin SulfateHikma Pharmaceuticals USA Inc.4 × 10100
00641-6167-10Amikacin SulfateHikma Pharmaceuticals USA Inc.2 × 1050
23155-0290-41Amikacin SulfateHeritage Pharmaceuticals Inc.2 × 1050
23155-0290-42Amikacin SulfateHeritage Pharmaceuticals Inc.4 × 10100
23155-0785-41Amikacin SulfateHeritage Pharmaceuticals Inc.2 × 1050
23155-0786-41Amikacin SulfateHeritage Pharmaceuticals Inc.4 × 10100
25021-0173-02Amikacin SulfateSagent Pharmaceuticals2 × 1050
25021-0173-04Amikacin SulfateSagent Pharmaceuticals4 × 10100
63323-0815-02Amikacin SulfateFreseniUS Kabi USA, LLC2 × 1050
63323-0815-04Amikacin SulfateFreseniUS Kabi USA, LLC4 × 10100
83301-0022-02Amikacin SulfateMullan Pharmaceutical Inc.2 × 1050
83301-0023-02Amikacin SulfateMullan Pharmaceutical Inc.4 × 10100

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J0278. For practitioners the limit is 15 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 J0278 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services153 Date of Service Edit: ClinicalPrescribing Information
Facility outpatient hospital153 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 J0278 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.

J0278 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 J0278 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, J0278 carries status indicator N. Status N means payment is packaged into the associated procedure and no separate OPPS payment is made.

Common denials for J0278 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 J0278 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.

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Frequently asked questions — HCPCS J0278

What does HCPCS code J0278 describe?

J0278 is defined by CMS as "Injection, amikacin sulfate, 100 mg". Each billing unit represents 100 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J0278 in October 2026?

The ASP-based payment limit is $0.612 per 100 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $0.614.

How many units of J0278 can be billed per day?

The practitioner Medically Unlikely Edit is 15 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 J0278?

The October 2026 ASP crosswalk lists 12 NDCs from 5 labelers: Amikacin Sulfate (Hikma Pharmaceuticals USA Inc.); Amikacin Sulfate (Heritage Pharmaceuticals Inc.); Amikacin Sulfate (Sagent Pharmaceuticals); Amikacin Sulfate (FreseniUS Kabi USA, LLC). For example NDC 00641-6166-10 is a 4 package equal to 100 billing units. The crosswalk's billing-units-per-package figure converts each package into J0278 units.

Does J0278 have NCCI bundling edits?

No active practitioner PTP pairs list J0278 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.