Summary & Overview

HCPCS C9484: Injection, eteplirsen, 10 mg

HCPCS Level II code C9484 denotes the injectable therapy eteplirsen, billed per 10 mg. Eteplirsen is an exon-skipping antisense oligonucleotide indicated for a subset of patients with Duchenne muscular dystrophy and is administered via outpatient infusion or clinic injection. Nationally, accurate coding for high-cost specialty drugs like eteplirsen matters for claims processing, coverage determination, and trend tracking across public and commercial payers.

Key payers covered in this overview include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the code's clinical context, typical site of service, and what to expect when this code appears on service lines. The publication also outlines which payers are commonly involved in coverage decisions for specialty injectable therapies and directs readers to sections on benchmarks, policy updates, and payer-specific coverage patterns where available.

The content serves providers, billing staff, and policy analysts seeking clarity on code definition, clinical setting, and payer landscape for eteplirsen administration. Data not provided in the input (such as common modifiers, associated taxonomies, ICD-10 pairings, and detailed payer policy language) are noted as unavailable and should be obtained from payer manuals and clinical guidelines for claims submission and authorization planning.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicareC9484HCPCS Level IIeteplirseninjectable therapyspecialty druginfusion clinicDuchenne muscular dystrophymedical billingdrug administration

Billing Code Overview

HCPCS Level II code C9484 represents Injection, eteplirsen, 10 mg. This billing code describes the supply and administration unit for the antisense oligonucleotide therapy eteplirsen, dosed per 10 mg increment. The service type is an injectable specialty drug administration, and the typical site of service is outpatient infusion or clinic-based injectable administration.

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Clinical & Coding Specifications

Clinical Context

A typical patient scenario involves a pediatric or young adult male with genetically confirmed Duchenne muscular dystrophy (DMD) who is eligible for exon-skipping therapy. The patient presents to an outpatient infusion center for administration of C9484 — injection, eteplirsen, 10 mg — as part of a scheduled, recurring intravenous treatment plan. Prior to infusion, clinic staff confirm diagnosis, current weight, prior infusion tolerance, baseline pulmonary and cardiac status, and recent laboratory results. A registered nurse obtains venous access, prepares the dose calculated from the patient’s weight, and administers the infusion per manufacturer and institutional protocols. Vital signs and infusion tolerance are monitored during and for a period after the infusion. Documentation includes medication administration record with dosage (mg and total volume), lot and NDC when applicable, start and stop times, site and method of IV access, any premedications given, and any adverse reactions. Scheduling typically occurs every week (or per prescribing protocol) with authorization and benefit verification completed in advance. Billing uses C9484 for the drug supply; facility charges and any infusion-related services are billed separately under appropriate CPT/HCPCS and institutional revenue codes.

Coding Specifications

Modifier	Description	When to Use
`JW`	Drug amount discarded/not administered	Use when partial vial contents are discarded after administering the billed amount of `C9484`.
`HC`	Product of human cell or tissue source (CMS legacy)	Use if payer requires distinction for biologic origin when applicable.
`SQ`	Sequence code (payer-specific)	Use per payer instructions when sequencing multiple services or doses (payer-specific use).
`76`	Repeat procedure or service by same physician	Use when an infusion is repeated during the same encounter by the same provider.
`77`	Repeat procedure by another physician	Use when another physician repeats the infusion procedure during same encounter.
`59`	Distinct procedural service	Use when infusion is billed on same day as another distinct non-overlapping service that requires separation.
`25`	Significant, separately identifiable E/M service	Use when a qualifying Evaluation and Management visit is performed on the same day as the infusion.
`24`	Unrelated E/M service by same physician during postoperative period	Use when E/M is unrelated to recent procedure during global period, if applicable.
`KX`	Requirements specified in the medical policy have been met	Use when payer requires attestation that coverage criteria for eteplirsen have been met.
`GA`	Waiver of liability statement on file (ABN)	Use when patient has signed an advance beneficiary notice for non-covered services.

Taxonomy Code	Specialty	Notes
`207Q00000X`	Neurology	Neurologists diagnose DMD and manage disease-modifying therapy decisions.
`2084P0800X`	Pediatric Neurology	Pediatric neurologists manage pediatric DMD patients and prescribe eteplirsen.
`363L00000X`	Infusion Nurse	Specialized nursing providing IV administration and monitoring.
`207L00000X`	Physical Medicine & Rehabilitation	PM&R coordinates multidisciplinary care and monitors functional outcomes.
`164W00000X`	Pediatric Critical Care (or Pediatrics)	Pediatricians often coordinate outpatient therapy and growth/weight monitoring.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`G71.01`	Duchenne muscular dystrophy	Primary indication for eteplirsen; exon-skipping therapy targets DMD caused by specific dystrophin gene mutations.
`R09.2`	Respiratory insufficiency, unspecified	Monitors respiratory compromise commonly seen in progressive DMD; relevant to infusion risk assessment.
`I50.9`	Heart failure, unspecified	Cardiomyopathy and heart failure are complications of DMD and influence treatment monitoring.
`Z79.899`	Other long term (current) drug therapy	Captures ongoing chronic medication therapy status for care coordination.
`Z51.89`	Encounter for other specified aftercare	Used for ongoing infusion therapy encounters and long-term management visits.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`96365`	Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour	Used to bill the initial infusion administration time for an IV drug like eteplirsen in an outpatient setting.
`96366`	Intravenous infusion, each additional hour (list separately in addition to code for primary infusion)	Used when infusion duration exceeds the first hour and additional time is billed.
`96368`	Intravenous infusion, each additional sequential infusion of a new drug, up to 1 hour	Used if another therapeutic IV agent is administered sequentially during the same visit.
`36415`	Collection of venous blood by venipuncture	Used for pre-infusion or monitoring laboratory blood draws related to therapy.
`99213`	Office or other outpatient visit for established patient, low to moderate complexity	Used when an E/M visit occurs on the same day as infusion and is separately reportable (with modifier `25` if appropriate).