J1411 (HCPCS) Reimbursement & Policy Benchmarks | OpenPayer

Summary & Overview

HCPCS J1411: Injection of etranacogene dezaparvovec-drlb, therapeutic dose

HCPCS Level II code J1411 designates the injection of etranacogene dezaparvovec-drlb per therapeutic dose, a gene therapy product administered by infusion/injection. This code matters nationally because it captures billing for a novel, high-cost biologic therapy used in specialized outpatient and hospital settings, with implications for coverage policies, prior authorization, and site-of-service payment distinctions.

Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will learn how J1411 is used in claims to identify the therapeutic administration of etranacogene dezaparvovec-drlb, the clinical and billing context for its use, and the policy considerations payers typically address for gene therapies, such as benefit design, prior authorization, and cost management. The publication summarizes common billing considerations, outlines where this service is typically delivered, and highlights benchmark topics and policy updates relevant to national payers. Specific payer coverage policies, coding guidance, and typical site-of-service patterns are presented to inform provider billing and payer adjudication practices.

Data not available in the input for payer-specific rates, associated taxonomies, and ICD-10 diagnosis pairings.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicareJ1411HCPCS Level IIgene therapyinfusionoupatient infusionbillingdrug codetherapeutic doseetranacogene dezaparvovec

Billing Code Overview

HCPCS Level II code J1411 represents Injection, etranacogene dezaparvovec-drlb, per therapeutic dose. This code describes a single therapeutic-dose administration of a gene therapy product delivered by injection. The service type is a therapeutic gene therapy infusion/injection intended to provide a one-time or limited number of therapeutic doses, and the typical site of service is an outpatient infusion clinic or hospital outpatient department where gene therapies are administered.

Data not available in the input.

Clinical & Coding Specifications

Clinical Context

A typical patient receiving J1411 (injection, etranacogene dezaparvovec-drlb, per therapeutic dose) is an adult with severe to moderately severe hemophilia B (factor IX deficiency) who has been evaluated by a hematology team for gene therapy. The clinical workflow includes pre-treatment assessment (baseline factor IX activity, inhibitor testing, liver function tests, viral serologies, and discussion of risks/benefits), authorization and scheduling of a single intravenous infusion of the gene therapy in an outpatient infusion center or hospital outpatient clinic, peri-infusion monitoring for infusion reactions and liver enzyme elevations, and structured post-infusion follow-up with serial laboratory monitoring and hemophilia clinic visits to assess factor IX activity, bleeding phenotype, and adverse events. Typical site of service is an outpatient infusion center or hospital outpatient department; the service type is a single-dose systemic gene therapy infusion. The typical patient scenario: a 30–50-year-old male with congenital hemophilia B and frequent bleeding episodes despite prophylactic factor IX replacement is approved for etranacogene dezaparvovec-drlb, receives the infusion under hematology supervision with premedication as indicated, is observed for immediate reactions, and enters a long-term follow-up program for safety and efficacy monitoring.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier

HCPCS J7345: Aminolevulinic Acid HCl 10% Topical Gel, 10 mg

HCPCS-J1921-LABETALOL-HYDROCHLORIDE-5MG-INJECTION-HIKMA

HCPCS J1921: Labetalol Hydrochloride (Hikma) Injection, 5 mg

HCPCS-J7297-LEVONORGESTREL-IUD-LILETTA-52MG

HCPCS J7297: Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 mg

HCPCS-J1370-ESOMEPRAZOLE-INJECTION-1MG

HCPCS J1370: Injection of Esomeprazole Sodium, 1 mg

HCPCS-J7527-EVEROLIMUS-ORAL-025-MG

HCPCS J7527: Everolimus, Oral, 0.25 mg

HCPCS-J0874-DAPTOMYCIN-INJECTION-BAXTER-1MG

HCPCS J0874: Daptomycin (Baxter) Injection, 1 mg

HCPCS-J7649-ISOETHARINE-INHALATION-SOLUTION-DME-UNIT-DOSE

HCPCS J7649: Isoetharine HCl Inhalation Solution, Unit-Dose via DME

HCPCS-J0681-CEFTOBIPROLE-INJECTION-3MG

HCPCS J0681: Injection, Ceftobiprole Medocaril Sodium, 3 mg

HCPCS-J1073-TESTOSTERONE-PELLET-IMPLANT-75MG

HCPCS Level II J1073: Testosterone Pellet Implant, 75 mg

HCPCS-J1944-ARIPIPRAZOLE-LAUROXIL-INJECTION-1MG

HCPCS Level II J1944: Injection, aripiprazole lauroxil (Aristada), 1 mg

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Taxonomy Code	Specialty	Notes
`207RH0000X`	Hematology & Oncology	Primary specialty managing gene therapy for hemophilia B.
`363A00000X`	Clinical Laboratory	Labs for pre- and post-infusion monitoring (factor assays, LFTs).
`261QM0800X`	Hospitalist	Inpatient observation or hospital outpatient coordination if admitted for infusion.
`363L00000X`	Infusion Therapy	Infusion nurses and infusion center clinicians administering the dose.
`207K00000X`	Medical Genetics	Involved for gene therapy counseling and long-term follow-up.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`D66`	Hereditary factor VIII deficiency (Hemophilia A)	Not the indicated diagnosis for etranacogene dezaparvovec-drlb; included for differential consideration when evaluating bleeding disorders.
`D67`	Hereditary factor IX deficiency (Hemophilia B)	Primary indication for `J1411` gene therapy targeting factor IX deficiency.
`Z79.01`	Long-term (current) use of anticoagulants	Relevant to pre-treatment assessment and bleeding risk management.
`Z51.89`	Encounter for other specified aftercare	Used for long-term follow-up visits after gene therapy administration.
`D68.4`	von Willebrand disease	Differential diagnosis when assessing bleeding phenotype prior to gene therapy selection.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`96365`	Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour	Commonly used for billing the infusion administration time for a biologic or gene therapy when time-based reporting applies.
`96366`	Intravenous infusion, each additional hour (list separately in addition to code for primary procedure)	Used if infusion administration extends beyond the initial hour.
`96413`	Chemotherapy administration, intravenous infusion technique; each additional hour (for complex biologic infusions when chemotherapy series codes are used per payer guidance)	Used per payer rules when more complex infusion administration coding is required.
`96374`	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intra-arterial, single injection	Rarely applicable if alternative vascular access route is used; generally not typical for this systemic infusion.
`96372`	Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular	Not typically used for `J1411` but listed for associated supportive injections (e.g., premedication) when administered separately.

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