HCPCS J7194: Factor IX Complex, Per International Unit - OpenPayer

Summary & Overview

HCPCS J7194: Factor IX Complex, Per International Unit

HCPCS Level II code J7194 designates Factor IX, complex, per i.u., an injectable biologic used for replacement therapy in patients with hemophilia B and other Factor IX deficiencies. This code matters nationally because access to and accurate billing for clotting factor products are critical for patient safety, continuity of care, and significant cost management across commercial and public payers.

Key payers addressed in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of billing and coding context for J7194, typical clinical settings for administration, and the payer landscape that shapes coverage policies and prior authorization practices. The publication summarizes common modifiers used with this code, outlines typical sites of service for infusion-based therapies, and highlights areas where policy updates or payer-specific guidelines often affect claim adjudication and patient access.

This executive summary provides clinicians, billing professionals, and policy analysts with a concise reference to the clinical intent of the code, expected service delivery settings, and which major payers commonly cover such therapies. Data not available in the input are noted where applicable in detailed sections.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicareJ7194HCPCS Level IIFactor IXhemophilia Binjectable biologicinfusion therapybillingpharmacy

Billing Code Overview

HCPCS Level II code J7194 describes Factor IX, complex, per international unit (i.u.), a clotting factor product used to treat or prevent bleeding in patients with hemophilia B or other Factor IX deficiencies. The service type is injectable biologic replacement therapy administered to replace or supplement deficient coagulation Factor IX.

Typical site of service is hospital outpatient infusion centers, ambulatory infusion suites, and specialized treatment centers where intravenous or subcutaneous clotting factor replacement is provided.

Clinical & Coding Specifications

Clinical Context

A 28-year-old male with severe hemophilia B (congenital factor IX deficiency) presents to an outpatient infusion center for scheduled replacement therapy with a factor IX concentrate. The patient reports acute joint pain and swelling of the right knee after minor trauma earlier in the day. The hematology team orders intravenous administration of factor IX concentrate dosed per international units to achieve hemostatic levels. Nursing reviews weight-based dosing, verifies the product lot and expiration, confirms venous access, and documents pre-infusion vital signs and inhibitor status. The infusion is administered under observation with post-infusion monitoring for allergic reaction, infusion-related complications, and hemostatic response. Product wastage is documented if any partial vial remains and is handled per payer and facility policy. Typical site of service is an outpatient infusion center, hospital outpatient department, or home infusion under a licensed provider arrangement when appropriate.

Coding Specifications

Modifier	Description	When to Use
`JW`	Drug or biological amount discarded/not administered to any patient	Use when a portion of a single-use vial of factor IX is discarded and must be reported for documentation of wastage per payer rules.
`QX`

HCPCS J7519: Injection, mycophenolate mofetil, 10 mg

HCPCS-J2400-CHLOROPROCAINE-INJECTION-30ML

HCPCS Level II J2400: Injection of Chloroprocaine Hydrochloride, 30 ml

HCPCS-J1435-ESTRONE-INJECTION-1MG

HCPCS J1435: Injection, Estrone, per 1 mg

HCPCS-J0360-HYDRALAZINE-INJECTION-20MG

HCPCS J0360: Injection, Hydralazine HCl up to 20 mg

HCPCS-J1745-INFLIXIMAB-INJECTION-10MG

HCPCS J1745: Injection, infliximab, 10 mg

HCPCS-J3055-TALQUETAMAB-INJECTION-0-25-MG

HCPCS Level II J3055: Injection, talquetamab-tgvs, 0.25 mg

HCPCS-J0350-ANISTREPLASE-INJECTION-30-UNITS

HCPCS J0350: Injection, Anistreplase, per 30 Units

HCPCS-J2543-PIPERACILLIN-TAZOBACTAM-1G-0-125G-INJECTION

HCPCS J2543: Injection of Piperacillin/Tazobactam, 1 g/0.125 g

HCPCS-J0171-EPINEPHRINE-INJECTION-0-1-MG

HCPCS J0171: Epinephrine (Adrenalin) Injection, 0.1 mg

HCPCS-J7622-BECLOMETHASONE-INHALATION-SOLUTION-UNIT-DOSE

HCPCS J7622: Beclomethasone Inhalation Solution, Compounded Unit Dose

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Taxonomy Code	Specialty	Notes
`207RH0000X`	Hematology & Oncology	Specialists who diagnose and manage hemophilia B and prescribe factor IX therapy.
`3336C0005X`	Infusion Therapy	Providers and services focused on outpatient infusion administration and monitoring.
`208D00000X`	Pediatrics (if pediatric patient)	Pediatric hematologists managing congenital bleeding disorders in children.
`363LF0000X`	Clinical Pharmacology	Specialty pharmacy providers involved in dispensing factor concentrates and patient education.
`282N00000X`	Nursing (General)	Infusion center nursing staff who perform dosing, administration, and monitoring.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`D66`	Hereditary factor VIII deficiency (Hemophilia A)	While this code specifies hemophilia A, hemophilia codes are relevant when documenting congenital bleeding disorders; ensure correct factor-specific code is used when applicable.
`D67`	Hereditary factor IX deficiency (Hemophilia B)	Primary indication for `J7194` factor IX concentrate; documents why factor IX replacement is needed.
`D68.4`	Acquired coagulation factor deficiency	Relevant when factor IX deficiency is acquired rather than congenital and replacement therapy is indicated.
`T81.0`	Hemorrhage and hematoma complicating a procedure, not elsewhere classified	Used when bleeding occurs as a complication of a procedure and factor IX is administered to manage hemorrhage.
`R58`	Hemorrhage, not elsewhere classified	Applied for acute bleeding episodes requiring factor IX replacement when no more specific code fits.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`96365`	Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour	Often used for billing the infusion administration time for factor IX when billed separately from the drug code.
`96413`	Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug	Sometimes used by infusion centers for complex biologic infusions when payer policy permits (check payer guidelines).
`96417`	Chemotherapy administration, each additional hour (List separately in addition to code for primary infusion)	Used to report extended infusion time beyond the initial hour when clinically indicated for complex administration.
`99070`	Supplies and materials (e.g., bandages, syringes) provided by the physician over and above those usually included with the office visit	Used to bill for additional supplies used during infusion if the payer allows separate supply charges.
`36415`	Collection of venous blood by venipuncture	Performed before infusion for baseline labs, inhibitor testing, or factor level measurements in the clinical workflow.

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