Summary & Overview
HCPCS J1413: Delandistrogene moxeparvovec-rokl Injection, Therapeutic Dose
HCPCS Level II code J1413 identifies a therapeutic-dose injection of delandistrogene moxeparvovec-rokl, a gene therapy delivered as a single therapeutic dose. This code matters nationally because it applies to a high-cost, specialized biologic therapy that typically requires facility resources, care coordination, and payer medical review. Its use affects hospital outpatient billing, coverage determinations, and specialty pharmacy or infusion workflows.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of what J1413 represents clinically and administratively, summaries of common coverage and billing considerations across major payers, and the types of benchmarks and policy updates that influence reimbursement and utilization management. The publication also provides clinical context for therapy administration, typical sites of service, and common modifiers used with high-cost therapeutic-dose injections. Where specific inputs were not provided, the summary notes that data are not available in the input.
Billing Code Overview
HCPCS Level II code J1413 represents an injection of delandistrogene moxeparvovec-rokl, billed per therapeutic dose. This code denotes administration of a gene therapy product packaged and delivered as a single therapeutic dose intended for intravenous or other clinically appropriate administration.
Service Type: Gene therapy injection, per therapeutic dose
Typical Site of Service: Hospital outpatient department or specialized infusion/infusion-capable clinic
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A typical patient is a pediatric or young adult with a confirmed genetic diagnosis of Duchenne muscular dystrophy (DMD) amenable to treatment with delandistrogene moxeparvovec-rokl. The patient presents to a specialized neuromuscular center for gene transfer therapy evaluation. Pre-procedure workup includes baseline neurology and cardiology assessments, laboratory testing (including liver function tests, complete blood count), and counseling on risks and benefits. On the day of service the patient receives a single intravenous administration of J1413 (delandistrogene moxeparvovec-rokl) per therapeutic dose in an inpatient or outpatient infusion suite staffed by providers experienced in gene therapy. Post-infusion monitoring includes vital sign observation, liver enzyme surveillance, and short-term inpatient observation when indicated for infusion reactions or elevated risk. Follow-up visits occur at scheduled intervals with multidisciplinary teams (neurology, cardiology, physical therapy) to assess efficacy and adverse events.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Standard billing when no modifier applies to the service |
22 |