Summary & Overview
HCPCS J9349: Injection, tafasitamab-cxix, 2 mg
HCPCS Level II code J9349 denotes the injectable oncology biologic tafasitamab-cxix, billed in 2 mg units. This code is used for administration of the drug in outpatient infusion settings and hospital outpatient departments and is relevant to oncology treatment pathways where tafasitamab-cxix is indicated. Nationally, accurate coding of high-cost injectable therapies like tafasitamab-cxix matters for billing consistency, payer coverage determinations, and program integrity.
Key payers included in this analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of payer coverage considerations, common billing modifiers and service-line context, and clinical administration setting implications. The publication provides benchmarks where available, summarizes relevant policy updates affecting coverage and billing for injectable oncology agents, and outlines coding nuances for hospital outpatient and ambulatory infusion settings.
The content is intended for billing managers, revenue cycle staff, oncology clinical administrators, and policy analysts seeking a concise reference on how HCPCS Level II code J9349 is used, where it is typically billed, and which payers are most commonly involved in reimbursement and coverage decisions. Data not available in the input for specific payer rates, ICD-10 pairings, and associated taxonomies.
Billing Code Overview
HCPCS Level II code J9349 represents the medication tafasitamab-cxix, billed per 2 mg unit for injection. This HCPCS entry corresponds to the drug product used in oncology care as an injectable biologic therapy.
Service Type: Injection (parenteral drug administration)
Typical Site of Service: Outpatient infusion center or hospital outpatient department, where intravenous or subcutaneous biologic oncology therapies are administered.
Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or other eligible B‑cell malignancy receiving intravenous tafasitamab-cxix therapy. The patient presents to an outpatient oncology infusion center for administration of J9349 (taf asitamab-cxix, 2 mg). Prior to infusion, the oncology nurse verifies identity, allergies, recent labs (CBC, metabolic panel), and the most recent imaging and hematology/oncology clinic notes confirming indication and dosing. The pharmacy compounds tafasitamab-cxix per weight-based protocol and performs medication reconciliation and independent double-check. The infusion nurse obtains baseline vital signs and an IV access, programs the infusion pump, and monitors the patient for infusion-related reactions during and for a period after administration. The oncology provider documents indication, dose, lot number, route (intravenous), start and stop times, premedications (for example acetaminophen and antihistamine if indicated), and any adverse events. Billing uses J9349 with appropriate modifier(s) for billing circumstance (for example, facility vs professional billing, partial administration, wastage reporting). Typical sites of service are outpatient hospital outpatient departments, physician office infusion centers, and ambulatory infusion suites. Typical clinical workflow steps include: order verification by pharmacy, sterile compounding, bedside administration, monitoring for infusion-related toxicity, and documentation in the electronic medical record for both clinical and billing purposes.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Use when no specific modifier applies and standard billing applies. |
11 | Professional component | Use when billing only the professional component distinct from facility services (rare for drug J‑codes). |
22 | Increased procedural services | Use when unusually high level of service is documented (e.g., extensive management of severe infusion reaction). |
23 | Unusual anesthesia | Not routinely used for J9349; apply only if unusual anesthesia services are required for administration. |
52 | Reduced services | Use if a reduced dose or shortened infusion was medically necessary and documented. |
53 | Discontinued procedure | Use if the infusion was started but discontinued (for example due to severe reaction) and documented. |
62 | Two surgeons | Not typically used for infusion drug billing; include only if documentation supports two surgeons/clinicians sharing responsibility. |
78 | Unplanned return to OR | Not applicable to routine infusion; use only if an urgent surgical intervention related to the infusion was required. |
80 | Assistant at surgery | Not applicable to infusion administration; include only when an assistant is legitimately billed. |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services | Use when services are furnished by an advanced practice clinician under applicable supervision rules. |
JW | Drug discarded/amount discarded | Use when reporting discarded portion of single‑use vial per payor requirement to document wastage. |
JZ | No drug administered | Use if no drug was administered (e.g., patient did not receive dose) and billing rules permit reporting this status. |
QX | CRNA service with medical direction by physician | Use only when a certified registered nurse anesthetist provides service under medical direction tied to the encounter. |
X2 | Modifier to indicate assistant at surgery not a qualified resident | Rare for infusion; use only if applicable and documented. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RH0000X | Hematology & Oncology | Physicians who order and manage tafasitamab-cxix therapy. |
364A00000X | Oncology Nursing | Registered nurses specializing in oncology infusion administration and monitoring. |
3336S0301X | Pharmacy | Infusion/chemotherapy pharmacists responsible for compounding and verification. |
363L00000X | Physician Assistant | Advanced practice clinicians who may manage follow-up, orders, and on‑site administration. |
363A00000X | Nurse Practitioner | Nurse practitioners working in oncology clinics and infusion centers. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C83.3 | Diffuse large B-cell lymphoma, unspecified | Primary indication for tafasitamab-cxix in relapsed/refractory DLBCL. |
C85.1 | Peripheral T-cell lymphoma, unspecified | Included when evaluating differential or mixed lymphoma management; tafasitamab is B‑cell directed so relevance is limited but may appear in workup. |
C83.7 | Primary cutaneous follicle center lymphoma | B‑cell lymphoma subtype that may require targeted monoclonal antibody therapy in some clinical contexts. |
C84.0 | Mycosis fungoides | A cutaneous T‑cell lymphoma; listed to document differential diagnoses in lymphoma care pathways. |
D47.1 | Chronic lymphocytic leukemia/small lymphocytic lymphoma | B‑cell malignancy where monoclonal antibody therapies are commonly used; tafasitamab may be considered in related B‑cell malignancy management discussions. |
C91.1 | Chronic lymphocytic leukemia of B-cell type | Related B‑cell disorder monitored in hematology/oncology clinics where monoclonal antibodies are used. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
96413 | Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to primary code) | Used when tafasitamab-cxix infusion extends beyond the usual initial hour and additional infusion time units must be billed alongside primary infusion codes. |
96415 | Oncology administration service supervision (for prolonged services); implementation varies by payor | Applies when prolonged supervision or management related to infusion is provided; check payor rules. |
96401 | Chemotherapy administration, intravenous, push technique, single drug | May apply if a rapid IV push administration technique were clinically appropriate and supported by documentation (less common for monoclonal antibodies). |
96365 | Intravenous infusion, therapeutic, prophylactic, or diagnostic; initial, up to 1 hour | Commonly used as the primary HCPCS/CPT-based infusion procedure code in physician office settings accompanying drug billing for monoclonal antibody infusions. |
96366 | Each additional hour (list separately in addition to code for primary infusion) | Billed when infusion time for tafasitamab-cxix requires additional hourly units beyond the initial hour. |