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    v1.0.30
    OpenPayerBilling CodesDrugs Administered Other than Oral MethodHCPCS hcpcs-j3401-topical-gene-therapy-beremagene-geperpavec
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    HCPCS J3401: Topical Beremagene Geperpavec (0.1 ml)

    HCPCS Level II code J3401 describes beremagene geperpavec-svdt for topical administration (nominal 5 x 10^9 pfu/ml vector genomes per 0.1 ml); this code represents a topical gene therapy product supplied in 0.1 ml aliquots intended for topical dermatologic application and is billed as a drug/biologic product rather than a procedure, with the typical site of service being outpatient dermatology clinics or ambulatory infusion/office settings where topical biologic treatments are administered.

    For related coverage guidance, see recent payer policy updates: T-Cell Lymphoma Agents: Beleodaq, Istodax, Lymphir, Poteligeo, and Romidepsin, Tumor Treatment Fields - Medical Policy, Extracorporeal Photopheresis.

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    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.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    90471Immunization administration (single or first component)Use for single-agent topical biologic administration billing in some payer scenarios when an administration CPT is required alongside the drug HCPCS.
    99070Supplies and materials (except spectacles), provided by physician over and above those usually included with the office visit or procedureUse to report specialized supplies, dressings, or application materials related to topical gene therapy.
    99213Office or other outpatient visit for the evaluation and management of an established patient, typically 15 minutesUse for routine follow-up visits assessing response and adverse events after application.
    11042Debridement, subcutaneous tissue, first 20 sq cm or lessUse when surgical or sharp debridement is required before application of the topical vector.
    12001Simple repair of superficial wounds (minor)Use when minor surgical preparation or closure is performed in conjunction with application.
    99024Postoperative follow-up visit, included in global fee; unrelated visits may be reportedUse to document and bill postoperative follow-up when applicable.

    Related Modifiers

    7 rows

    ModifierDescriptionWhen to Use
    22Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    62Modifier 62 indicates that two surgeons function as co‑surgeons, each performing distinct parts of the same primary surgical procedure. It is appended to the primary procedure code (and any…- Use modifier -62 when two surgeons act as co‑surgeons (both primary surgeons) on a single definitive primary procedure, each performing distinct parts of the same surgical procedure (append -62 to…
    78CPT modifier -78 indicates an unplanned, related return to the operating or procedure room by the same provider during the global postoperative period. It is appended when treatment for a…- Use modifier -78 when an unplanned, related complication during the original procedure’s global postoperative period requires the patient to return to a formal operating or procedure room and the…
    80CPT® Modifier 80 (Assistant Surgeon) is appended to a surgical CPT code when a physician (MD or DO) provides full, continuous assistance throughout the operative procedure. It is intended only for…- Use CPT Modifier -80 when a physician (MD or DO) serves as an assistant surgeon and provides full, continuous assistance throughout the entire operative procedure; append -80 to the surgical CPT…
    82Modifier 82 is appended to a surgical CPT code to indicate that an attending physician acted as an assistant because a qualified resident surgeon was unavailable. In teaching hospitals it documents…- When to use: Append modifier 82 in teaching-hospital settings to indicate a physician served as an assistant surgeon because a qualified resident surgeon was unavailable (includes situations where…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207Q00000X
    207V00000X
    208000000X
    363LF0000X
    207L00000X
    261QS0132X
    261QH0700X
    172P00000X

    Related Payer Policy Updates

    Specialty: Hematology/Oncology1 / 3

    10 rows

    PolicyPayerEffective Date
    T-Cell Lymphoma Agents: Beleodaq, Istodax, Lymphir, Poteligeo, and RomidepsinMass General Brigham Health Plan2027-01-04
    Tumor Treatment Fields - Medical PolicyHealth-New-England2026-12-01
    Extracorporeal PhotopheresisCigna2026-11-15
    Electric Tumor Treatment Field Therapy (for Tennessee Only)Colorado Rocky Mountain Health Plans2026-11-01
    Tumor Treating Fields Therapypremerabluecrossofwashington2026-11-01
    Tumor Treating Fields Therapypremerabluecrossofwashington2026-11-01
    OmisirgeCigna2026-11-01
    Hematology - AdzynmaCigna2026-10-15
    Transcatheter Arterial Chemoembolization for Liver Tumorspremerabluecrossofwashington2026-10-01
    Cryoablation of Tumors Located in the Kidney, Lung, Breast, Pancreas, or Bonepremerabluecrossofwashington2026-10-01

    Related Codes

    HCPCS-J0013-ESKETAMINE-NASAL-SPRAY-1MG

    HCPCS Level II J0013: Esketamine Nasal Spray, 1 mg

    HCPCS-J0120-INJECTION-TETRACYCLINE-250MG

    HCPCS Level II J0120: Injection, Tetracycline, up to 250 mg

    HCPCS-J0121-OMADACYCLINE-INJECTION-1MG

    HCPCS Level II J0121: Omadacycline Injection, 1 mg

    HCPCS-J0122-ERAVACYCLINE-INJECTION-1MG

    HCPCS Level II J0122: Injection, eravacycline, 1 mg

    HCPCS-J0129-ABATACEPT-INJECTION-10MG-PHYSICIAN-SUPERVISED

    HCPCS Level II J0129: Abatacept Injection, 10 mg

    HCPCS-J0130-INJECTION-ABCIXIMAB-10MG

    HCPCS Level II J0130: Injection abciximab, 10 mg

    HCPCS-J0131-INJECTION-ACETAMINOPHEN-10MG-PARENTERAL-ANALGESIC

    HCPCS Level II J0131: Injection, Acetaminophen 10 mg

    HCPCS-J0132-INJECTION-ACETYLCYSTEINE-100MG-INJECTABLE-MEDICATION

    HCPCS Level II J0132: Injection, Acetylcysteine 100 mg

    HCPCS-J0133-ACYCLOVIR-INJECTION-5MG

    HCPCS Level II J0133: Injection, Acyclovir 5 mg

    HCPCS-J0134-ACETAMINOPHEN-INJECTION-FRESENIUS-KABI-10MG

    HCPCS Level II J0134: Injection, Acetaminophen (10 mg)

    Showing 1–10 of 991

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    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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