Summary & Overview
HCPCS J7211: Factor VIII (Kovaltry) Injection, Recombinant, per 1 I.U.
HCPCS Level II code J7211 denotes the injectable recombinant factor VIII product Kovaltry, billed per 1 international unit. This code is central to billing for replacement therapy in hemophilia A and matters nationally due to the high cost, specialized supply chain, and frequent infusion-based care required for affected patients. Payers commonly involved in coverage and reimbursement for this code include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.
Readers will learn what J7211 represents clinically and operationally, where the service is typically delivered, and key considerations for billing and payment. The publication provides benchmarks and context for reimbursement, notes common modifiers and payer practices, and summarizes clinical use of recombinant factor VIII products. It also highlights policy-relevant issues such as site-of-care implications and the role of specialty pharmacy and infusion services in managing high-cost biologic therapies.
Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes is noted where applicable elsewhere in the full publication.
Billing Code Overview
HCPCS Level II code J7211 describes an injection of factor VIII (antihemophilic factor, recombinant), Kovaltry, billed per 1 international unit (I.U.). This code represents administration of a recombinant clotting factor product used to prevent or control bleeding in patients with hemophilia A.
Service type: Medication administration (injectable biologic)
Typical site of service: Hospital outpatient departments, infusion centers, specialty clinics, and physician offices
Clinical & Coding Specifications
Clinical Context
A 28-year-old male with severe hemophilia A (congenital factor VIII deficiency) presents to an outpatient infusion center for scheduled replacement therapy with recombinant factor VIII (Kovaltry) following joint pain and early signs of hemarthrosis in the right knee. The patient has a history of recurrent spontaneous bleeds and receives weight-based dosing individualized in international units (I.U.). The clinical workflow includes verification of prescription and prior authorization, medication preparation by pharmacy (reconstitution and dose calculation in I.U.), patient identity and allergy check, venous access assessment (peripheral IV or existing port), administration of the intravenous infusion by an RN, monitoring for infusion reactions for at least 30 minutes post-administration, documentation of lot number and I.U. administered, and coordination of follow-up hematology care.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier applicable (placeholder) | Rarely used; not typically appended when a specific modifier is required. |
11 | Primary procedure or service | When this infusion is the primary reason for the encounter. |