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HCPCS J3398 · Level II · Part B drug

J3398: voretigene neparvovec-rzyl (Luxturna), HCPCS Level II J code

Compiled from CMS files by the QuickIntell RCM Editorial Team · Data effective · Method: reference methodology · Report a data correction

Data currency: OPPS Addendum B: October 2026 (effective October 1, 2026); OPPS NDC-HCPCS crosswalk: October 2026 (effective October 1, 2026); NCCI MUE tables: 2026 Q4 (effective October 1, 2026); NCCI PTP edits: v323r0 (2026 Q4) (effective October 1, 2026); ASC Addendum BB (covered ancillary services): October 2026 (effective October 1, 2026). Next CMS release: January 1, 2027 (quarterly update).

Key facts for J3398

Billing unit
1 billion vector genomes
Inj luxturna 1 billion vec g
OPPS payment rate
$3,158.142
no ASP limit; SI K, October 2026
Practitioner MUE
150
MAI 2
OPPS status
SI K
APC 9070
NCCI exposure
no PTP pairs
Coverage articles
1
4 states

TL;DR

HCPCS J3398 is the Level II code for Injection, voretigene neparvovec-rzyl, 1 billion vector genomes, billed per 1 billion vector genomes. CMS publishes no ASP payment limit for it; hospital outpatient departments are paid separately under OPPS (status indicator K, $3,158.142 per billing unit in October 2026). The practitioner MUE allows up to 150 units per date of service (MAI 2). J3398 is billed in units of 1 billion vector genomes; 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 OPPS crosswalk maps 1 NDC to it, sold as Luxturna by Spark Therapeutics, Inc. 1 Medicare coverage article lists the code across 4 states, including A56419.

Medicare payment: OPPS rate (no ASP limit)

J3398 does not appear in the October 2026 Part B ASP payment limit file. CMS pays it separately to hospital outpatient departments under OPPS with status indicator K in APC 9070, at a national unadjusted rate of $3,158.142 per 1 billion vector genomes. Status K is a separately paid, non-pass-through drug or biological, including therapeutic radiopharmaceuticals. In a physician office the Medicare contractor prices the drug, often from invoice; commercial and Medicaid payers set their own rates.

NDC to HCPCS billing-unit conversion

The October 2026 OPPS crosswalk maps 1 NDC from 1 labeler to J3398. Report the NDC in the claim's drug segment and bill the number of J3398 units that equals the quantity administered divided by 1 billion vector genomes; the last column gives units per full package.

NDCs that crosswalk to J3398
NDCDrug nameLabelerPackage sizeBilling units / package
71394-0415-01LuxturnaSpark Therapeutics, Inc.0.5 × 1150

Medically Unlikely Edits (MUE)

CMS publishes 2 MUE values for J3398. For practitioners the limit is 150 units per date of service with adjudication indicator 2, a date-of-service policy edit: the limit reflects CMS policy and units above it deny even if split across lines; appeals rarely succeed.

MUE values for J3398 by setting
SettingMUE (units/DOS)MAICMS rationale
Practitioner services1502 Date of Service Edit: PolicyCMS Policy
Facility outpatient hospital1502 Date of Service Edit: PolicyCMS Policy

MUE for J3398 in every setting opens the lookup with this code filled in, next to any other code on the same claim.

NCCI edits and add-on relationships

No active practitioner PTP pair lists J3398 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.

The counts above are exposure, not answers for a specific claim. Check J3398 against another code to see whether a given pair bundles, which code is paid and whether a modifier can separate them.

J3398 is neither an add-on code nor a designated primary code in the 2026 Q4 NCCI add-on edit file.

Medicare coverage articles

1 current Medicare Administrative Contractor article lists J3398 in their HCPCS tables, covering 4 states. Each article carries the covered and non-covered ICD-10 codes that medical-necessity denials (CARC 50) are adjudicated against.

Billing and Coding Articles listing J3398
ArticleTitleContractor(s)StatesRelated LCD
A56419Billing and Coding: Voretigene Neparvovec-rzyl (Luxturna®)Palmetto GBANC SC VA WVL37863

Local coverage policies that list J3398

1 active Local Coverage Determination lists J3398 in the policy or in its billing and coding article. Each applies only in its contractor's jurisdiction; check the one for the state where the drug is administered.

  • L37863 Voretigene Neparvovec-rzyl (Luxturna®) · Palmetto GBA

Hospital outpatient (OPPS) status

In the October 2026 OPPS Addendum B, J3398 carries status indicator K and is assigned to APC 9070, with a published national unadjusted payment of $3,158.142. Status K means the drug is paid separately under OPPS rather than packaged into the procedure.

Ambulatory surgical center (ASC) payment

In the October 2026 ASC Addendum BB (covered ancillary services), J3398 carries payment indicator K2, which CMS defines as "Drugs, biologicals, and radiopharmaceuticals paid separately when provided integral to a surgical procedure on ASC list; payment based on OPPS rate". The national ASC payment is $3,158.14 per 1 billion vector genomes, paid only when the drug is furnished integral to a covered surgical procedure.

Common denials for J3398 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 J3398 before the claim leaves

QuickCode validates the NDC-to-unit conversion against the current OPPS NDC-HCPCS 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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In QuickIntell research

Frequently asked questions — HCPCS J3398

What does HCPCS code J3398 describe?

J3398 is defined by CMS as "Injection, voretigene neparvovec-rzyl, 1 billion vector genomes". Each billing unit represents 1 billion vector genomes, so the units reported on the claim must equal the dose administered divided by that unit.

Is J3398 a CPT code?

No. J3398 is a HCPCS Level II code, the letter-plus-four-digit set CMS maintains for drugs such as voretigene neparvovec-rzyl (Luxturna); CPT codes are five-character codes maintained by the AMA. On a Part B claim J3398 reports the drug itself in 1 billion vector genomes units, and the administration is billed on its own line.

What does Medicare pay for J3398 in a hospital outpatient department?

J3398 has no Part B ASP limit; the October 2026 OPPS Addendum B pays it separately under status K, APC 9070, at $3,158.142 per 1 billion vector genomes, and ASC Addendum BB gives it payment indicator K2 at $3,158.14.

How many units of J3398 can be billed per day?

The practitioner Medically Unlikely Edit is 150 units per date of service with adjudication indicator 2 (Date of Service Edit: Policy). MAI 2 edits are policy limits and are rarely overturned on appeal. CMS cites "CMS Policy" as the rationale.

Which NDCs map to J3398?

The October 2026 OPPS crosswalk lists 1 NDC from 1 labeler: Luxturna (Spark Therapeutics, Inc.). For example NDC 71394-0415-01 (package size 0.5) equals 150 billing units of J3398.

Does J3398 have NCCI bundling edits?

No active practitioner PTP pairs list J3398 as a column-1 or column-2 code in the v323r0 release.

Which Medicare coverage articles mention J3398?

1 current Billing and Coding Article in the Medicare Coverage Database lists J3398, covering 4 states: A56419 (Billing and Coding: Voretigene Neparvovec-rzyl (Luxturna®)).

Sources

Every figure on this page is taken from the CMS publications below, as released by the Centers for Medicare & Medicaid Services. Projection built 2026-10-10. Verify against the primary file before billing or contracting decisions. The reference methodology explains how each figure is computed from these files.

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, ASC Addendum BB and the Medicare Coverage Database. Payment limits and rates 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.

Found a figure that does not match the CMS file? Report a data correction with the CMS file and the value you expected; the request reaches the editorial team through the contact form.