J3398 HCPCS code: Injection, voretigene neparvovec-rzyl, 1 billion vector genomes
J3398 is the HCPCS Level II code for injection, voretigene neparvovec-rzyl, 1 billion vector genomes. Its Medicare coverage code is C (Carrier judgment): Coverage is decided by the Medicare contractor (MAC) case by case. The NCCI unit limit is 150 per day on outpatient hospital claims.
Code details
| Field | Value |
|---|---|
| Section | J codes — Drugs administered other than oral method |
| Coverage code | C — Carrier judgment |
| Pricing indicator | 51 — Drug or biological (priced per ASP/average sales price rules) |
| BETOS category | O1E — Other drugs |
| Added | 2019-01-01 |
| Last action effective | 2019-01-01 |
NCCI unit limits (MUE)
| Claim type | Max units per day | Rationale |
|---|---|---|
| outpatient hospital claims | 150 | CMS Policy |
| practitioner claims | 150 | CMS Policy |
Medicare policy articles for this code
- A56419: Billing and Coding: Voretigene Neparvovec-rzyl (Luxturna®) (Palmetto GBA (MAC - Part A, MAC - Part B))
Covered diagnoses (2 ICD-10-CM codes)
The diagnoses most often listed as covered in the policy articles above:
| ICD-10-CM | Diagnosis | Articles listing it |
|---|---|---|
| H35.50 | Unspecified hereditary retinal dystrophy | 1 |
| H35.52 | Pigmentary retinal dystrophy | 1 |
What changed for J3398
- 2019-01-01: J3398 added to HCPCS Level II
- Next scheduled CMS quarterly update (HCPCS and DMEPOS fee schedule): 2027-01-01
Frequently asked questions
What is HCPCS code J3398?
J3398 is the HCPCS Level II code for injection, voretigene neparvovec-rzyl, 1 billion vector genomes. Short descriptor: "Inj luxturna 1 billion vec g".
Does Medicare cover J3398?
Coverage code C — Carrier judgment. Coverage is decided by the Medicare contractor (MAC) case by case.
Which diagnoses support coverage for J3398?
Medicare policy articles that cite J3398 list 2 covered ICD-10-CM diagnosis codes across 1 article. The most cited include H35.50 (Unspecified hereditary retinal dystrophy), H35.52 (Pigmentary retinal dystrophy). A listed diagnosis is necessary but not sufficient; the policy's other criteria still apply.
How many units of J3398 can be billed per day?
150 on outpatient hospital claims; 150 on practitioner claims (NCCI medically unlikely edits).
Related J33 codes
- J3300 — Injection, triamcinolone acetonide (triesence), preservative free, 1 mg
- J3301 — Injection, triamcinolone acetonide, not otherwise specified, 10 mg
- J3302 — Injection, triamcinolone diacetate, per 5 mg
- J3303 — Injection, triamcinolone hexacetonide, per 5 mg
- J3304 — Injection, triamcinolone acetonide, preservative-free, extended-release, microsphere formulation, 1 mg
- J3305 — Injection, trimetrexate glucuronate, per 25 mg
- J3310 — Injection, perphenazine, up to 5 mg
- J3315 — Injection, triptorelin pamoate, 3.75 mg
- J3316 — Injection, triptorelin, extended-release, 3.75 mg
- J3320 — Injection, spectinomycin dihydrochloride, up to 2 gm
- J3350 — Injection, urea, up to 40 gm
- J3355 — Injection, urofollitropin, 75 iu
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Next steps
- Run a reimbursement report for a device billed under J3398
- Watch J3398 for fee, coverage and descriptor changes
- Build a full Medicare revenue model for J3398
Sources: CMS HCPCS Level II release October 2026; CMS DMEPOS fee schedule; CMS NCCI MUE tables; CMS Medicare utilization (physician and DME supplier files); CMS Medicare Coverage Database articles. Fees are Medicare allowables, not commercial rates. Not billing or legal advice.