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    v1.0.31
    OpenPayerBilling CodesDrugs Administered Other than Oral MethodHCPCS hcpcs-j3389-topical-prademagene-zamikeracel-per-treatment
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    HCPCS Level II J3389: Topical Prademagene Zamikeracel Treatment

    HCPCS Level II code J3389 describes topical administration of prademagene zamikeracel per treatment, a biologic topical therapy delivered directly to the skin for local therapeutic effect; service type: topical biologic application; typical site of service: outpatient infusion/clinic or ambulatory procedure area where topical biologic treatments are administered.

    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 typical patient is an adult with a surface-accessible cutaneous or mucosal neoplasm enrolled in a clinical protocol or receiving an FDA-authorized topical gene-modulating therapy using prademagene zamikeracel. The patient presents to a dermatology, oncology, or surgical oncology clinic or an ambulatory infusion/oncology treatment center for topical application. Pre-treatment evaluation includes confirmation of diagnosis, review of prior therapies, informed consent, and documentation of lesion location, size, and number. On the day of service the patient is positioned, the treatment area is cleansed and prepared per product instructions, and J3389 is administered as a topical application to the targeted lesion(s) by a qualified clinician or trained nurse. Post-application observation is performed for local reactions; procedure details and lot numbers are documented in the medical record. Follow-up visits assess local response, adverse events, and need for repeat topical treatments per protocol or prescribing information.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    99213Office or other outpatient visit for the evaluation and management of an established patient, typically 15 minutesOften used for the pre-treatment evaluation or follow-up visit when a separate E/M is documented on the day of topical application of J3389.
    96423Chemotherapy administration into the skin by topical, percutaneous or mucosal route; single or initial substance/drugUsed for billing topical or mucosal administration techniques when payers require a procedure code for topical drug administration (note: confirm payer acceptance with J3389).
    11100Biopsy of single skin lesion; tangential, shave, or punchPerformed before topical therapy for diagnostic confirmation of a lesion targeted for J3389 application.
    11719Trimming of dystrophic nails, any number; each additional toe or finger (list separately in case of nail matrix-involved topical therapy)May be performed when lesion preparation involves nail dystrophy prior to topical application.
    99070Supplies and materials (except spectacles) provided by the physician over and above those usually included with the office visit or procedureUsed to report special supplies or disposables associated with topical application of an investigational product when payers permit ancillary supply billing.

    Related Modifiers

    5 rows

    ModifierDescriptionWhen to Use
    25CPT modifier 25 indicates that on the same day as another procedure or service, the same physician or other qualified health care professional provided a significant, separately identifiable…- When to apply: Use modifier 25 only on an E/M code to indicate the same provider delivered a significant, separately identifiable E/M service on the same day as another procedure or service — i.e.,…
    59Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
    51Modifier –51 (Multiple Procedures) is used when the same provider performs multiple procedures in the same session to identify secondary, non‑exempt procedures and indicate payment reduction logic…- Use modifier -51 when the same provider performs multiple distinct procedures during the same patient encounter: report the highest‑valued procedure first (no modifier) and append -51 to…
    76Modifier -76, Repeat Procedure or Service by Same Physician or Other Qualified Health Care Professional, is appended when the same provider performs an identical, medically necessary procedure or…- Use modifier -76 when the same physician or other qualified health care professional performs an identical procedure or service a second (or subsequent) time on the same date of service and the…
    77Modifier 77 indicates that a previously performed procedure or service was legitimately repeated by a different physician or other qualified health care professional. The AMA’s CPT definition…- Use modifier 77 when a basic procedure or service already performed is repeated by a different physician or other qualified health care professional (for example, a second provider independently…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    208000000X
    207RG0100X
    2086S0102X
    207L00000X
    364S00000X
    332BC3200X
    2083P0011X
    163WC2100X

    Related ICD-10-CM Codes

    13 rows

    ICD-10-CM CodeDescription
    C44.40Unspecified malignant neoplasm of skin of scalp and neck
    C44.41Basal cell carcinoma of skin of scalp and neck
    C44.42Squamous cell carcinoma of skin of scalp and neck
    C44.90Unspecified malignant neoplasm of skin, unspecified
    C44.91Basal cell carcinoma of skin, unspecified
    C44.92Squamous cell carcinoma of skin, unspecified
    D04.10Carcinoma in situ of skin of unspecified eyelid, including canthus
    D04.9Carcinoma in situ of skin, unspecified
    L21.9Seborrheic dermatitis, unspecified
    L30.9Dermatitis, unspecified

    Showing 1–10 of 13

    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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