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HCPCS J9351 · Level II · Part B drug

HCPCS J9351: Injection, topotecan, 0.1 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 J9351

Billing unit
0.1 MG
Topotecan injection
ASP payment limit
$2.067
October 2026; -25.1% vs July 2026
Practitioner MUE
120
MAI 3
OPPS status
SI N
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J9351 is the Level II code for Injection, topotecan, 0.1 mg, billed per 0.1 MG. The Medicare Part B ASP payment limit for October 2026 is $2.067 per billing unit, down 25.1% from July 2026. The practitioner MUE allows up to 120 units per date of service (MAI 3). Under OPPS it carries status indicator N. 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 5 NDCs to it, sold as Topotecan by Pfizer Inc, Accord Healthcare Inc, Actavis Pharma, Inc.. No current Billing and Coding Article lists J9351, 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 J9351 at $2.067 per 0.1 MG for October 2026, derived from manufacturer average sales price plus 6%, compared with $2.759 in July 2026. Beneficiary coinsurance is 20%.

ASP payment limits for J9351
QuarterPayment limitPerCoinsurance
October 2026$2.0670.1 MG20%
July 2026$2.7590.1 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 5 NDCs from 4 labelers to J9351. Report the NDC in the claim's drug segment and bill the number of J9351 units that equals the quantity administered divided by 0.1 MG; the last column gives units per full package.

NDCs that crosswalk to J9351
NDCDrug nameLabelerPackage sizeBilling units / package
00409-0302-01TopotecanPfizer Inc1 × 140
16729-0151-31TopotecanAccord Healthcare Inc1 × 140
16729-0243-31TopotecanAccord Healthcare Inc4 × 140
45963-0615-56TopotecanActavis Pharma, Inc.1 × 140
63323-0762-10TopotecanFreseniUS Kabi USA, LLC1 × 140

Medically Unlikely Edits (MUE)

CMS publishes 3 MUE values for J9351. 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 J9351 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services1203 Date of Service Edit: ClinicalClinical: Society Comment
Facility outpatient hospital1203 Date of Service Edit: ClinicalClinical: Society Comment
DME supplier03 Date of Service Edit: ClinicalCMS Policy

NCCI edits and add-on relationships

No active practitioner PTP pair lists J9351 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.

J9351 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 J9351 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, J9351 carries status indicator N. Status N means payment is packaged into the associated procedure and no separate OPPS payment is made.

Common denials for J9351 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 J9351 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 J9351

What does HCPCS code J9351 describe?

J9351 is defined by CMS as "Injection, topotecan, 0.1 mg". Each billing unit represents 0.1 MG, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J9351 in October 2026?

The ASP-based payment limit is $2.067 per 0.1 MG, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules. The July 2026 limit was $2.759.

How many units of J9351 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 "Clinical: Society Comment" as the rationale.

Which NDCs map to J9351?

The October 2026 ASP crosswalk lists 5 NDCs from 4 labelers: Topotecan (Pfizer Inc); Topotecan (Accord Healthcare Inc); Topotecan (Actavis Pharma, Inc.); Topotecan (FreseniUS Kabi USA, LLC). For example NDC 00409-0302-01 is a 1 package equal to 40 billing units. The crosswalk's billing-units-per-package figure converts each package into J9351 units.

Does J9351 have NCCI bundling edits?

No active practitioner PTP pairs list J9351 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.