J3401 HCPCS code: Beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml
J3401 is the HCPCS Level II code for beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml. Its Medicare coverage code is C (Carrier judgment): Coverage is decided by the Medicare contractor (MAC) case by case. The NCCI unit limit is 25 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 | 2024-01-01 |
| Last action effective | 2024-01-01 |
NCCI unit limits (MUE)
| Claim type | Max units per day | Rationale |
|---|---|---|
| outpatient hospital claims | 25 | CMS Policy |
| practitioner claims | 25 | CMS Policy |
What changed for J3401
- 2024-01-01: J3401 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 J3401?
J3401 is the HCPCS Level II code for beremagene geperpavec-svdt for topical administration, containing nominal 5 x 10^9 pfu/ml vector genomes, per 0.1 ml. Short descriptor: "Vyjuvek 5x10^9pfu/ml, 0.1 ml".
Does Medicare cover J3401?
Coverage code C — Carrier judgment. Coverage is decided by the Medicare contractor (MAC) case by case.
How many units of J3401 can be billed per day?
25 on outpatient hospital claims; 25 on practitioner claims (NCCI medically unlikely edits).
Related J34 codes
- J3400 — Injection, triflupromazine hcl, up to 20 mg
- J3402 — Injection, remestemcel-l-rknd, per therapeutic dose
- J3403 — Revakinagene taroretcel-lwey, per implant
- J3410 — Injection, hydroxyzine hcl, up to 25 mg
- J3411 — Injection, thiamine hcl, 100 mg
- J3415 — Injection, pyridoxine hcl, 100 mg
- J3420 — Injection, vitamin b-12 cyanocobalamin, up to 1000 mcg
- J3424 — Injection, hydroxocobalamin, intravenous, 25 mg
- J3425 — Injection, hydroxocobalamin, intramuscular, 10 mcg
- J3430 — Injection, phytonadione (vitamin k), per 1 mg
- J3465 — Injection, voriconazole, 10 mg
- J3470 — Injection, hyaluronidase, up to 150 units
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Next steps
- Run a reimbursement report for a device billed under J3401
- Watch J3401 for fee, coverage and descriptor changes
- Build a full Medicare revenue model for J3401
Sources: CMS HCPCS Level II release October 2025; 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.