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    v1.0.30
    OpenPayerBilling CodesDrugs Administered Other than Oral MethodHCPCS hcpcs-j3397-vestronidase-alfa-injection
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    HCPCS Level II J3397: Injection, vestronidase alfa‑vjbk, 1 mg

    HCPCS Level II code J3397 describes the injectable enzyme replacement medication vestronidase alfa‑vjbk, 1 mg, intended for intravenous infusion treatment of eligible patients; the service type is therapeutic drug administration (intravenous infusion) and the typical site of service is an outpatient infusion center or hospital outpatient department where specialty biologic infusions are delivered.

    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 pediatric or adult patient with confirmed mucopolysaccharidosis VII (Sly syndrome) presents for enzyme replacement therapy using vestronidase alfa-vjbk (J3397, 1 mg). The patient arrives to an infusion center or hospital outpatient infusion suite accompanied by a caregiver for baseline vitals and assessment. Prior to infusion, nursing documents weight, reviews recent labs (including liver function tests and renal function), confirms no recent febrile illness, and reviews pre-medication orders for hypersensitivity risk (e.g., antihistamine, corticosteroid, antipyretic) per the prescribing clinician.

    The infusion is administered intravenously over the recommended infusion time with continuous nursing assessment for infusion-related reactions. Vital signs are recorded at baseline, periodically during the infusion, and after completion. If an infusion reaction occurs, the nurse follows the facility protocol which may include temporary infusion interruption, administration of rescue medications, and documentation of modifier(s) if applicable. Post-infusion, the patient is observed for a specified monitoring period and discharged with follow-up appointments for ongoing dosing cycles typically every two weeks as defined by the treatment plan.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    96365Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hourCommonly reported for the initial hour of therapeutic IV infusion when billing per infusion time
    96366Each additional hour (List separately in addition to code for primary infusion)Used when infusion duration exceeds the first hour and additional hourly billing is supported
    96372Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscularUsed if a premedication is given as an injection separate from IV infusion
    36415Collection of venous blood by venipuncturePerformed for baseline and monitoring laboratory draws associated with treatment
    99214Established patient office visit, moderate complexityMay be used for pre-infusion or follow-up outpatient evaluation by the ordering clinician

    Related Modifiers

    5 rows

    ModifierDescriptionWhen to Use
    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…
    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…
    97Modifier 97 is an informational modifier used with therapy CPT codes to indicate services are rehabilitative — intended to restore skills or function lost due to illness, injury, or disability. It is…- Use modifier 97 when reporting therapy services that are rehabilitative in nature — i.e., provided to restore skills or function lost or impaired because of illness, injury, or disability (for…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    208000000X
    363L00000X
    3336C0002X
    364SW0102X
    364SP0811X
    207ZP0007X
    2084B0040X
    3336C0003X

    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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