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    v1.0.30
    OpenPayerBilling CodesDrugs Administered Other than Oral MethodHCPCS hcpcs-j3398-voretigene-neparvovec-rzyl-1b-vector-genomes
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    HCPCS J3398: Voretigene Neparvovec-rzyl Injection, 1 Billion Vector Genomes

    HCPCS Level II code J3398 describes injection of voretigene neparvovec-rzyl at a dose of 1 billion vector genomes, a gene therapy administered as an ocular intravitreal or subretinal injection for inherited retinal disease; the service is a medication administration for a biologic gene therapy typically delivered in an ambulatory surgical center or hospital outpatient setting.

    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 a pediatric or young adult with confirmed biallelic RPE65 mutation-associated retinal dystrophy presenting with severe visual impairment progressing to legal blindness. The clinical workflow begins with genetic testing confirming two pathogenic variants in the RPE65 gene and baseline ophthalmic assessment including best-corrected visual acuity, visual field testing (Goldmann or automated perimetry adapted for low vision), optical coherence tomography (OCT), fundus photography, and full ophthalmic examination under anesthesia if needed. Pre-procedural counseling includes discussion of risks, benefits, alternatives, and informed consent from the patient or guardian. The procedural setting is an ambulatory surgical center or hospital operating room with ophthalmic microsurgery capability.

    On the day of service, the patient undergoes general anesthesia. A vitreoretinal surgeon performs a standard 25- or 23-gauge pars plana vitrectomy followed by a subretinal injection of J3398 (voretigene neparvovec-rzyl), dosed per manufacturer instructions (one vial per treated eye as appropriate). Typical adjunct intraoperative steps include creation of a localized retinal detachment (bleb) and careful air-fluid exchanges; intraoperative imaging or indirect ophthalmoscopy confirms subretinal placement. Postoperative care includes topical antibiotics and steroids, positioning instructions as indicated, and scheduled follow-up visits to monitor visual function, intraocular pressure, and potential immune or inflammatory responses. Billing captures the drug with J3398 and may include concomitant surgical CPT codes for vitrectomy and subretinal injection, anesthesia charges, and facility services. Patient scenarios often involve modifier use for bilateral procedures, unusual procedural services, or professional/facility distinctions according to payer rules.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    67036Vitrectomy, mechanical, pars plana approach; with removal of vitreous — limited, usually complete pars plana vitrectomyCommon primary surgical code for pars plana vitrectomy performed immediately before subretinal injection of J3398
    67299Unlisted procedure, posterior segmentMay be used when reporting a novel or highly customized subretinal injection technique not adequately described by existing codes (payer-specific adjudication required)
    67210Destruction of localized lesion of retina (e.g., photocoagulation)Occasionally performed adjunctively for retinal pathology identified during screening or follow-up; not typical for the gene-therapy injection itself
    66821Injection of vitreous substitute or perfluorocarbon liquidsRelated intraoperative maneuvers such as fluid/air exchange or tamponade that may accompany complex subretinal delivery
    99100Anesthesia for patient of extreme age, under 1 year or over 70 years; may be considered for anesthesia complexity reportingUsed by anesthesia providers for age/extreme-risk reporting when anesthesia risk is higher during the gene therapy procedure

    Related Modifiers

    9 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…
    23Modifier -23 (Unusual Anesthesia) is used on anesthesia service CPT codes when a procedure that normally requires no anesthesia or only local anesthesia must be performed under general anesthesia…- Use modifier -23 only on anesthesia CPT codes (00100–01999) when a procedure that normally requires no anesthesia or only local anesthesia must be performed under general anesthesia because of…
    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…
    54Modifier ‑54 (“Surgical care only”) is appended to a CPT surgical procedure when the reporting surgeon performs the intraoperative (surgical) component but does not furnish the preoperative and/or…- Use modifier -54 when the reporting surgeon provided only the intraoperative (surgical) component of a procedure and preoperative and/or postoperative management has been or will be provided by…
    55Modifier –55 indicates the billing provider furnished only postoperative management for a procedure that has a global surgical period. According to AAPC, this modifier is appended to the same CPT…- Use modifier -55 when billing the same CPT surgical code that has a 10- or 90-day global period and you, as a provider other than the original surgeon, furnished ONLY postoperative management (no…
    56Modifier ‑56 indicates the reporting provider furnished only the preoperative management for a surgical procedure and did not perform the intraoperative or postoperative care. It is used in…- Use Modifier -56 when a provider performs only the preoperative management in a split‑care situation (one physician manages preop care while a different physician performs the intraoperative…
    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…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207ZP0102X
    2080P0208X
    363L00000X
    363LP0808X
    246ZN0300X
    281P00000X
    3416L0300X
    261QS1200X

    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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