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    v1.0.31
    OpenPayerBilling CodesDrugs Administered Other than Oral MethodHCPCS hcpcs-j1412-valoctocogene-roxaparvovec-gene-therapy-injection
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    HCPCS Level II J1412: Valoctocogene Roxaparvovec Injection per mL

    HCPCS Level II code J1412 represents an injectable gene therapy product, valoctocogene roxaparvovec-rvox, billed per mL with a nominal concentration of 2 x 10^13 vector genomes; the service is a high-complexity pharmaceutical infusion/administration typically provided in an outpatient infusion center or hospital outpatient department and billed as a drug administration line item separate from facility or procedural services.

    For related coverage guidance, see recent payer policy updates: Bendamustine Products Coverage Criteria, T-Cell Lymphoma Agents: Beleodaq, Istodax, Lymphir, Poteligeo, and Romidepsin, Brentuximab Vedotin (Adcetris®) Coverage Criteria.

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    Clinical & Coding Specifications

    Clinical Context

    A 32-year-old male with severe hemophilia A and inhibitors is evaluated in a tertiary care hematology clinic for gene therapy. After multidisciplinary assessment including baseline factor VIII activity, inhibitor titers, liver function tests, and vector suitability, the patient is scheduled for administration of valoctocogene roxaparvovec (J1412) delivered as a single intravenous infusion containing the specified vector genomes. Typical workflow: pre-infusion evaluation (consent, labs, immunologic screening), inpatient or outpatient infusion under monitored conditions (infusion suite or hospital outpatient infusion center), post-infusion observation (monitoring for infusion reactions, liver enzyme surveillance), and scheduled follow-up visits for efficacy and safety labs. The typical site of service is an outpatient infusion center or hospital outpatient department; complex cases may use inpatient admission for monitoring. Patient scenario includes prior documented severe congenital hemophilia A (factor VIII deficiency), prior factor replacement history, and counseling regarding potential risks such as transaminase elevations, immune responses, and need for long-term monitoring of factor VIII activity and inhibitor development.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    96365Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hourCommonly billed for the initial period of an IV infusion when documenting infusion time for administration of a complex biologic agent.
    96366Intravenous infusion, each additional hourBilled when the infusion or monitored administration extends beyond the initial hour.
    96372Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscularUsed if adjunctive injections (e.g., corticosteroid for reaction) are given during the course of care; not for the primary IV gene therapy product.
    36415Collection of venous blood by venipunctureBilled for blood draws required for baseline testing and post-infusion monitoring (liver enzymes, factor VIII activity, inhibitor titers).
    96374Therapeutic, prophylactic, or diagnostic IV push, each additional substance/drugUsed for IV push medications administered in the course of infusion-related management (e.g., antiemetics, rescue meds).

    Related Modifiers

    8 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…
    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
    2080P0207X
    208000000X
    363L00000X
    207P00000X
    3336C0003X
    1835C0206X
    242T00000X
    225XE0001X

    Related ICD-10-CM Codes

    25 rows

    ICD-10-CM CodeDescription
    D55.0Anemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency
    D57.1Sickle-cell disease without crisis
    D57.3Sickle-cell trait
    D61.9Aplastic anemia, unspecified
    D64.81Anemia due to antineoplastic chemotherapy
    D65Disseminated intravascular coagulation [defibrination syndrome]
    D66Hereditary factor VIII deficiency
    D67Hereditary factor IX deficiency
    D68.01Von Willebrand disease, type 1
    D68.1Hereditary factor XI deficiency

    Showing 1–10 of 25

    Related Payer Policy Updates

    Specialty: Hematology/Oncology1 / 3

    10 rows

    PolicyPayerEffective Date
    Bendamustine Products Coverage Criteriablue cross blue shield - tennessee2027-01-30
    T-Cell Lymphoma Agents: Beleodaq, Istodax, Lymphir, Poteligeo, and RomidepsinMass General Brigham Health Plan2027-01-04
    Brentuximab Vedotin (Adcetris®) Coverage Criteriablue cross blue shield - tennessee2026-12-31
    Pemetrexed Coverageblue cross blue shield - tennessee2026-12-31
    Tumor Treatment Fields - Medical PolicyHealth-New-England2026-12-01
    Extracorporeal PhotopheresisCigna2026-11-15
    VonvendiCigna2026-11-15
    Hematology - AphexdaCigna2026-11-15
    Extracorporeal PhotopheresisCigna2026-11-15
    Yartemlea (narsoplimab-wuug) Coverage for TA-TMANeighborhood Health Plan of Rhode Island2026-11-01

    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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