Summary & Overview
HCPCS J7195: Factor IX (recombinant) Injection, per IU
HCPCS Level II code J7195 denotes the per-IU billing unit for recombinant Factor IX (antihemophilic factor) injections used in replacement therapy, most commonly for Hemophilia B. This code matters nationally because recombinant clotting factors are high-cost specialty biologics with significant implications for clinical management, payer coverage policy, and per-unit reimbursement across outpatient infusion settings.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical role of recombinant Factor IX, typical sites of service where the product is administered, and the billing context for per-IU drug reporting. The publication provides benchmarks for utilization and unit-based billing, summarizes common modifier usage and billing practice considerations where available, and outlines relevant policy updates affecting specialty biologic reimbursement and coverage determinations nationally.
Data not available in the input for specific associated taxonomies, ICD-10 diagnosis pairings, and related codes.
Billing Code Overview
HCPCS Level II code J7195 represents an injection of Factor IX (antihemophilic factor, recombinant) measured per international unit (IU) and classified as not otherwise specified. This code describes the billed drug product when recombinant Factor IX is administered for replacement therapy in patients with Hemophilia B or other conditions requiring Factor IX replacement.
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Service type: Pharmaceutical therapeutic injection (recombinant clotting factor replacement)
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Typical site of service: Hospital outpatient department, ambulatory infusion center, physician office, or other infusion settings where parenteral biologic drug administration is performed.
Clinical & Coding Specifications
Clinical Context
A typical patient is a male with hemophilia B (congenital factor IX deficiency) presenting for outpatient intravenous replacement therapy with recombinant factor IX. The visit may be a scheduled prophylactic infusion to prevent spontaneous bleeding, an on-demand infusion for joint or muscle bleeding, or perioperative coverage prior to or after a minor surgical or dental procedure. The clinical workflow includes informed consent, review of weight and factor IX activity, calculation of required international units (IU) based on weight and target factor level, preparation of the recombinant factor IX product, verification of venous access (peripheral IV or central venous access device), administration by an infusion nurse or trained caregiver, monitoring for infusion reactions or thrombosis during and after infusion, documentation of lot number and IU administered, and billing the product units using J7195 per IU with appropriate modifier(s) to reflect circumstance of service.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier (default) |