Summary & Overview
HCPCS C9478: Injection, sebelipase alfa, 1 mg
HCPCS Level II code C9478 designates the 1 mg unit of sebelipase alfa, an intravenous enzyme replacement therapy for lysosomal acid lipase deficiency. Nationally, biologic infusions billed with this code are significant for specialty pharmacy, infusion center operations, and payer coverage policies given the high cost and clinical monitoring requirements of enzyme replacement therapies. This publication considers coverage and reimbursement practices across major national payers and Medicare.
Key payers covered include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of what the code represents, typical sites of service, and the clinical setting for administration. The analysis outlines benchmark themes relevant to payers, provider billing and service-line implications, and notable policy considerations affecting access and prior authorization practices.
The report provides operational context for health system billing teams, revenue cycle professionals, and payer policy analysts. It highlights where clinicians and administrators should focus when scheduling, documenting, and submitting claims for biologic infusion services billed with HCPCS Level II code C9478. Data not available in the input are clearly indicated where applicable.
Billing Code Overview
HCPCS Level II code C9478 represents Injection, sebelipase alfa, 1 mg. This code describes administration of sebelipase alfa, a recombinant enzyme replacement therapy used to treat lysosomal acid lipase deficiency.
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Service type: Intravenous infusion of a biologic agent
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Typical site of service: Hospital outpatient infusion center or ambulatory infusion clinic
Data not available in the input for modifiers, associated taxonomies, ICD-10 diagnoses, related codes, and service line.
Clinical & Coding Specifications
Clinical Context
A 6-year-old child with confirmed lysosomal acid lipase deficiency (Wolman disease or cholesteryl ester storage disease) presents to an outpatient infusion center for enzyme replacement therapy. The patient arrives with a current weight and vitals documented, an order for C9478 (injection, sebelipase alfa, 1 mg) signed by a pediatric metabolic specialist, and pre-infusion labs (basic metabolic panel, liver function tests) reviewed within protocol timeframes. A registered nurse prepares the dose based on weight and the product concentration, verifies patient identity and allergy history, obtains IV access, and performs pre-medication per institutional protocol if prior infusion reactions occurred. The infusion is administered per manufacturer and protocol-specific rate escalation with continuous monitoring for hypersensitivity or infusion-related reactions. Post-infusion observation is completed per protocol, the dose and lot/expiration of C9478 are documented in the medical record, and an itemized claim is generated referencing the HCPCS level II code C9478 for the drug administered in milligrams. Billing includes the drug units equivalent to milligrams administered; supportive services (IV placement, infusion nursing) are billed separately when applicable under relevant CPT codes and facility billing rules.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
25 |