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HCPCS J1580 · Level II · Part B drug

HCPCS J1580: Injection, garamycin, gentamicin, up to 80 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 J1580

Billing unit
80 MG
Garamycin gentamicin inj
ASP payment limit
$1.849
October 2026; -4.0% vs July 2026
Practitioner MUE
9
MAI 3
OPPS status
SI N
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J1580 is the Level II code for Injection, garamycin, gentamicin, up to 80 mg, billed per 80 MG. The Medicare Part B ASP payment limit for October 2026 is $1.849 per billing unit, down 4.0% from July 2026. The practitioner MUE allows up to 9 units per date of service (MAI 3). Under OPPS it carries status indicator N. J1580 is billed in units of 80 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 21 NDCs to it, sold as Gentamicin Sulfate by Hikma Pharmaceuticals USA Inc., Baxter Healthcare Corporation, Henry Schein Inc.. No current Billing and Coding Article lists J1580, 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 J1580 at $1.849 per 80 MG for October 2026, derived from manufacturer average sales price plus 6%, compared with $1.925 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J1580
QuarterPayment limitPerCoinsurance
October 2026$1.84980 MG20%
July 2026$1.92580 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 21 NDCs from 7 labelers to J1580. Report the NDC in the claim's drug segment and bill the number of J1580 units that equals the quantity administered divided by 80 MG; the last column gives units per full package.

NDCs that crosswalk to J1580
NDCDrug nameLabelerPackage sizeBilling units / package
00143-9128-25Gentamicin SulfateHikma Pharmaceuticals USA Inc.2 × 2525
00338-0503-48Gentamicin SulfateBaxter Healthcare Corporation100 × 11
00338-0505-48Gentamicin SulfateBaxter Healthcare Corporation100 × 12
00338-0507-41Gentamicin SulfateBaxter Healthcare Corporation50 × 11
00338-0507-48Gentamicin SulfateBaxter Healthcare Corporation100 × 12
00338-0509-41Gentamicin SulfateBaxter Healthcare Corporation50 × 11
00338-0511-41Gentamicin SulfateBaxter Healthcare Corporation50 × 12
00404-9865-02Gentamicin SulfateHenry Schein Inc.2 × 11
00404-9866-20Gentamicin SulfateHenry Schein Inc.20 × 110
00409-1207-03Gentamicin SulfatePfizer Inc2 × 2525
51662-1508-03Gentamicin SulfateHF Acquisition Co. LLC, DBA HealthFirst20 × 25250
51662-1597-03Gentamicin SulfateHF Acquisition Co. LLC, DBA HealthFirst2 × 2525
55150-0401-25Gentamicin SulfateEugia US LLC2 × 2525
55150-0402-25Gentamicin SulfateEugia US LLC2 × 2525
55150-0403-25Gentamicin SulfateEugia US LLC20 × 25250
63323-0010-02Gentamicin SulfateFreseniUS Kabi USA, LLC2 × 2525
63323-0010-20Gentamicin SulfateFreseniUS Kabi USA, LLC20 × 25250
63323-0010-94Gentamicin SulfateFreseniUS Kabi USA, LLC2 × 2525
63323-0010-95Gentamicin SulfateFreseniUS Kabi USA, LLC20 × 25250
63323-0173-02Gentamicin SulfateFreseniUS Kabi USA, LLC2 × 2525
63323-0173-94Gentamicin SulfateFreseniUS Kabi USA, LLC2 × 2525

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J1580. For practitioners the limit is 9 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 J1580 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services93 Date of Service Edit: ClinicalPrescribing Information
Facility outpatient hospital93 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 J1580 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.

J1580 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 J1580 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, J1580 carries status indicator N. Status N means payment is packaged into the associated procedure and no separate OPPS payment is made.

Common denials for J1580 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 J1580 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 J1580

What does HCPCS code J1580 describe?

J1580 is defined by CMS as "Injection, garamycin, gentamicin, up to 80 mg". Each billing unit represents 80 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J1580 in October 2026?

The ASP-based payment limit is $1.849 per 80 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $1.925.

How many units of J1580 can be billed per day?

The practitioner Medically Unlikely Edit is 9 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 J1580?

The October 2026 ASP crosswalk lists 21 NDCs from 7 labelers: Gentamicin Sulfate (Hikma Pharmaceuticals USA Inc.); Gentamicin Sulfate (Baxter Healthcare Corporation); Gentamicin Sulfate (Henry Schein Inc.); Gentamicin Sulfate (Pfizer Inc). For example NDC 00143-9128-25 is a 2 package equal to 25 billing units. The crosswalk's billing-units-per-package figure converts each package into J1580 units.

Does J1580 have NCCI bundling edits?

No active practitioner PTP pairs list J1580 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.