Summary & Overview
HCPCS J3358: Ustekinumab for Intravenous Injection, 1 mg
HCPCS Level II code J3358 denotes ustekinumab supplied for intravenous injection, billed per 1 mg. As a high-cost biologic used in autoimmune and inflammatory conditions, accurate coding for the drug itself is central to claim adjudication, reimbursement, and utilization tracking across outpatient infusion settings. Nationally, coding clarity for biologic agents like ustekinumab affects payer coverage determinations, prior authorization workflows, and provider billing practices.
Key payers included in this analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of how J3358 is used in clinical practice, typical sites of service for administration, and the common commercial and federal payers involved in coverage decisions. The publication summarizes available national benchmarks, common billing modifiers (listed separately), and relevant policy considerations that influence claim processing for intravenous biologics.
This resource is intended to help coding and billing staff, revenue cycle managers, and policy analysts understand the clinical and administrative context of J3358, including where to look for payer-specific policies and what aspects of documentation and coding typically drive coverage and payment outcomes.
Billing Code Overview
HCPCS Level II code J3358 represents ustekinumab for intravenous injection, billed per 1 mg. This code is used to report the medication component of intravenous administration of ustekinumab when the drug is provided in a clinical setting.
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Service type: Drug administration (intravenous biologic therapy)
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Typical site of service: Infusion center, hospital outpatient department, or other outpatient clinical settings where intravenous biologic therapies are administered.
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A 42-year-old patient with moderate-to-severe plaque psoriasis presents for biologic induction dosing of ustekinumab. The patient has completed pre-treatment screening including tuberculosis testing and baseline labs. The clinician prescribes intravenous ustekinumab for the initial weight-based load; subsequent maintenance doses are given subcutaneously. The infusion visit occurs in an outpatient infusion center or hospital outpatient department. Prior to infusion, nursing verifies consent, performs an allergy review, checks vitals, and establishes IV access. The drug is reconstituted and dosed per manufacturer weight-based guidelines (intravenous formulation billed per mg using J3358). The infusion is administered with monitoring for infusion reactions; post-infusion observation is provided per facility protocol. Documentation includes indication, weight, lot number, amount administered in mg, start and stop times, and any adverse events.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
JW | Drug amount discarded/never administered | When part of the vial/milligrams were discarded after preparation and documentation supports wasted amount |
JZ | No drug wastage | When entire amount prepared was administered to the patient |
JG | Professional administration of drug (physician billing) | When a physician provider bills for administering the drug under appropriate rules |
JA | Professional administration by other physician (distinct) | When another physician administers under specific payer rules (use per payer guidance) |
QX | Operating physician–assistant certification | When a physician assistant performs a component under Medicare rules and is eligible |
QY | Allied health professional billing under an opt-out or specific scenario | When applicable per payer policies for non-physician practitioners |
62 | Two surgeons | Rarely used; when two surgeons are involved in care and payer requires reporting |
78 | Unplanned return to OR by same physician following initial procedure | Uncommon for infusion but used if an infusion-related procedure required immediate return to OR |
80 | Assistant surgeon | When an assistant surgeon provides billed services during a related procedural episode |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services in place of a physician | When such a practitioner furnishes the service and payer allows modifier AS |
22 | Increased procedural services | When services required substantially greater work than typical (document justification) |
52 | Reduced services | When a service is partially reduced or not completed |
59 | Data not available in the input. | Data not available in the input. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RA0400X | Dermatology | Dermatologists frequently prescribe and manage ustekinumab for psoriasis |
207RC0000X | Allergy & Immunology | Specialists manage complex immune-mediated indications and biologic therapy |
208000000X | Family Medicine | Primary care providers may initiate or co-manage biologic therapy and referrals |
163W00000X | Internal Medicine (Rheumatology overlap) | Rheumatologists manage psoriatic arthritis and systemic biologic therapy |
282N00000X | Hematology/Oncology | Infusion centers under these taxonomies may administer intravenous biologics |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
L40.0 | Psoriasis vulgaris | Primary dermatologic indication for ustekinumab therapy |
L40.5 | Arthropathic psoriasis | Psoriatic arthritis patients may receive ustekinumab for joint and skin disease |
K50.00 | Crohn's disease, unspecified, without complications | Ustekinumab is indicated for moderate-to-severe Crohn's disease requiring biologic therapy |
K51.90 | Ulcerative colitis, unspecified, without complications | Ustekinumab is used for moderate-to-severe ulcerative colitis in certain patients |
M07.0 | Distal interphalangeal psoriatic arthropathy | Specific psoriatic arthritis manifestation treated with systemic biologics |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
96365 | Intravenous infusion, therapeutic, prophylactic, or diagnostic; initial, up to 1 hour | Often used to bill the infusion administration time for the initial ustekinumab IV dose |
96366 | Intravenous infusion; each additional hour (list separately in addition to code for primary infusion) | Used when infusion extends beyond the first hour and additional time is billed |
96413 | Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug | Sometimes used in infusion suites for biologic drug administration when payer requires chemotherapy administration codes |
94002 | Data not available in the input. | Data not available in the input. |