Summary & Overview
HCPCS Level II J3401: Beremagene Geperpavec Topical Gene Therapy
HCPCS Level II code J3401 denotes beremagene geperpavec-svdt for topical administration (nominal 5 x 10^9 pfu/ml per 0.1 ml), a topical gene therapy product used in dermatologic or mucosal surface indications. As a designated HCPCS Level II code, J3401 is the billing identifier for the drug formulation and unit of supply described, which matters nationally as novel gene therapies enter outpatient and ambulatory care settings and require payer coverage and coding clarity.
Key payers in the analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical context, service settings, and coding specifics tied to the HCPCS Level II designation. The publication covers national benchmarks for coding and billing adoption, typical payer coverage patterns, and relevant policy developments affecting access and reimbursement for topical gene therapy agents. Where input data is not provided, the text notes that those items are not available.
This resource is intended for revenue cycle leaders, billing staff, clinical administrators, and policy analysts seeking a clear, national-level summary of HCPCS Level II code J3401, its clinical use case, and implications for outpatient coding and payer interactions.
Billing Code Overview
HCPCS Level II code J3401 represents beremagene geperpavec-svdt for topical administration, provided as a preparation containing nominal 5 x 10^9 pfu/ml vector genomes per 0.1 ml. The service is a topical gene therapy product intended for application to affected skin or mucosal surfaces.
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Service type: Topical gene therapy medication
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Typical site of service: Outpatient clinic, physician office, or ambulatory procedure area where topical dermatologic treatments are administered
Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.
Clinical & Coding Specifications
Clinical Context
A typical patient is an adolescent or adult with a confirmed pathogenic variant in the dystrophin gene causing dystrophic skin changes or a clinically indicated genetic dermatologic condition for which topical gene therapy with beremagene geperpavec-svdt is authorized. The patient presents to an outpatient dermatology or specialized gene-therapy clinic for evaluation. The clinical workflow includes pre-treatment assessment (medical history, medication review, informed consent, baseline photographs of the treatment area, and documentation of lesion size and location), preparation of the treatment area (cleansing and removal of dressings), measurement and calculation of required dose volumes based on lesion surface area, and topical application of J3401 by a trained clinician or registered nurse in a procedure room. Post-application instructions and wound care are provided; the patient is observed briefly for local or systemic reactions before discharge. Follow-up visits occur at defined intervals to assess efficacy, adverse events, and the need for repeat applications. Clinic supplies, cold-chain handling, and accurate lot and vial documentation are included in the medication administration record and claim submission.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier present | Use when no other modifier is applicable to the service. |