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    v1.0.31
    OpenPayerBilling CodesDrugs Administered Other than Oral MethodHCPCS hcpcs-j3385-velaglucerase-alfa-injection-100-unit
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    HCPCS J3385: Injection, velaglucerase alfa, 100 units

    HCPCS Level II code J3385 describes an injectable biologic, velaglucerase alfa, supplied in 100-unit increments for enzyme replacement therapy; the service is an infusion/injection medication administration typically provided in hospital outpatient infusion centers, specialty infusion clinics, or physician office settings for treatment of conditions requiring glucocerebrosidase replacement.

    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 34-year-old adult with Gaucher disease type 1 presents to an outpatient infusion center for enzyme replacement therapy. The patient has a documented prescription for velaglucerase alfa dosed in units and arrives for a scheduled intravenous infusion every two weeks. Pre-infusion nursing assessment includes vital signs, review of prior infusion reactions, current weight for dose verification, and confirmation of any premedication orders (e.g., antihistamine, acetaminophen) if prior infusion reactions occurred. Pharmacy verifies the J3385 vial count required to meet the ordered dose and performs aseptic reconstitution and dilution per manufacturer guidelines. During infusion, nursing documents infusion start and stop times, any adverse reactions, and any modifier-applicable circumstances (for example, use of separate billing for drug wastage with modifier JW if wasted drug is discarded). Post-infusion the patient is observed for an appropriate period, discharged with appointment for the next infusion, and clinical documentation includes drug name velaglucerase alfa, total units administered, lot number, expiration date, route (intravenous), and site of service (typically outpatient infusion center or hospital outpatient department).

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    96413Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drugUsed for billing the infusion administration time when velaglucerase alfa infusion duration fits the time-based chemotherapy/biologic infusion coding rules.
    96415Each additional hour (chemotherapy administration)Used when infusion of velaglucerase alfa extends beyond the initial hour and additional time-based units are billed.
    90791Psychiatric diagnostic evaluation (placeholder for non-related behavioral health)Data not typically related; included only when behavioral health evaluation coincides with infusion visit (not standard for this therapy).
    96365Intravenous infusion, therapeutic, prophylactic, or diagnostic; initial, up to 1 hourAlternative infusion administration code sometimes used in non-oncology infusion centers for biologic drug administration when payer allows.
    96376Injection, therapeutic, prophylactic or diagnostic, intravenous push, single or initial substance/drugUsed if a portion of therapy requires IV push medication during the infusion visit (e.g., premedication), documented separately.

    Related Modifiers

    5 rows

    ModifierDescriptionWhen to Use
    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…
    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…
    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…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    2080P0206X
    207RH0000X
    363L00000X
    207K00000X
    261QS1200X
    251X00000X
    2086H0002X
    261QX0203X

    Related ICD-10-CM Codes

    26 rows

    ICD-10-CM CodeDescription
    C90.00Multiple myeloma not having achieved remission
    C92.00Acute myeloblastic leukemia, not having achieved remission
    D56.9Thalassemia, unspecified
    D57.1Sickle-cell disease without crisis
    D64.9Anemia, unspecified
    D69.6Thrombocytopenia, unspecified
    E75.21Fabry (-Anderson) disease
    E75.22Gaucher disease
    E75.23Krabbe disease
    E75.29Other sphingolipidosis

    Showing 1–10 of 26

    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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