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HCPCS J3404 · Level II · Part B drug

HCPCS J3404: Injection, zopapogene imadenovec-drba suspension, per therapeutic dose

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 J3404

Billing unit
Per Therapeutic Dose
Inj zopapogene per ther dose
ASP payment limit
$119,675.512
October 2026
Practitioner MUE
none published
CMS publishes no MUE for this code
OPPS status
SI G
APC 0924
NCCI exposure
no PTP pairs
Coverage articles
0
none list this code

TL;DR

HCPCS J3404 is the Level II code for Injection, zopapogene imadenovec-drba suspension, per therapeutic dose, billed per Per Therapeutic Dose. The Medicare Part B ASP payment limit for October 2026 is $119,675.512 per billing unit. Under OPPS it carries status indicator G in APC 0924. J3404 is billed in units of Per Therapeutic Dose; 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 Papzimeos by Precigen, Inc.. No current Billing and Coding Article lists J3404, 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 J3404 at $119,675.512 per Per Therapeutic Dose for October 2026, derived from manufacturer average sales price plus 6%. Beneficiary coinsurance is 20%.

ASP payment limits for J3404
QuarterPayment limitPerCoinsurance
October 2026$119,675.512Per Therapeutic Dose20%
July 2026n/aPer Therapeutic Dose—
CMS note: Added October 2026

NDC to HCPCS billing-unit conversion

The October 2026 ASP crosswalk maps 1 NDC from 1 labeler to J3404. Report the NDC in the claim's drug segment and bill the number of J3404 units that equals the quantity administered divided by Per Therapeutic Dose; the last column gives units per full package.

NDCs that crosswalk to J3404
NDCDrug nameLabelerPackage sizeBilling units / package
84768-0511-01PapzimeosPrecigen, Inc.1 × 11

Medically Unlikely Edits (MUE)

CMS does not publish an MUE for J3404 in the 2026 Q4 tables. Some MUE values are confidential and applied without publication, so unit limits can still deny; document the dose and the units calculation on every claim.

NCCI edits and add-on relationships

No active practitioner PTP pair lists J3404 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.

J3404 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 J3404 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, J3404 carries status indicator G and is assigned to APC 0924, with a published national unadjusted payment of $121,900.00. Status G marks pass-through drug payment, which is time-limited.

Common denials for J3404 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 J3404 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 J3404

What does HCPCS code J3404 describe?

J3404 is defined by CMS as "Injection, zopapogene imadenovec-drba suspension, per therapeutic dose". Each billing unit represents Per Therapeutic Dose, so the units reported on the claim must equal the dose administered divided by that unit.

What is the Medicare reimbursement for J3404 in October 2026?

The ASP-based payment limit is $119,675.512 per Per Therapeutic Dose, with 20% beneficiary coinsurance. Medicare Administrative Contractors apply this limit; commercial payers use their own fee schedules.

Which NDCs map to J3404?

The October 2026 ASP crosswalk lists 1 NDC from 1 labeler: Papzimeos (Precigen, Inc.). For example NDC 84768-0511-01 is a 1 package equal to 1 billing unit. The crosswalk's billing-units-per-package figure converts each package into J3404 units.

Does J3404 have NCCI bundling edits?

No active practitioner PTP pairs list J3404 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 2026-10-02. 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.