HCPCS Code J1413: Injection, Delandistrogene Moxeparvovec-Rokl Per Therapeutic Dose

Learn more about HCPCS Code J1413 for delandistrogene moxeparvovec-rokl injection per therapeutic dose, billing, and documentation.

Use Code

## **What is HCPCS Code J1413?** HCPCS Code J1413 is designated for the injection of delandistrogene moxeparvovec-rokl, provided per therapeutic dose. This code is maintained by CMS and falls under the category of Drugs, Administered by Injection. Delandistrogene moxeparvovec rokl (marketed as Elevidys by Sarepta Therapeutics) is a specific injectable drug used for therapeutic purposes in patients with Duchenne muscular dystrophy (DMD gene, confirmed mutation, or exon deletion), and each billable unit corresponds to one therapeutic dose. This coding helps healthcare providers, clients, and insurers standardize billing and claims processing for this medication under Medicare and other health insurance programs. J1413 was established as part of the HCPCS Level II codes system, which identifies products and services not included in CPT codes, facilitating consistent payment processing. HCPCS code J1413 has been active since January 2024. Billing under this code requires adherence to CMS coding and payment policy instructions to ensure compliance and proper reimbursement for the injectable drug therapy. Delandistrogene moxeparvovec-rokl (Elevidys) itself received accelerated FDA approval in June 2023, followed by traditional approval for ambulatory patients in June 2024.

## **HCPCS code J1413 documentation requirements** HCPCS code J1413 documentation requirements include submitting medical records that support the use of the drug delandistrogene moxeparvovec rokl per therapeutic dose. Documentation should include detailed clinical information such as diagnosis codes, deletion or confirmed mutation in the DMD gene, medical history, lab results, physician notes, and treatment plans that justify the medical necessity of this injectable drug. Claims with code J1413 may trigger edits that require manual rate insertion by Medicare contractors, highlighting the importance of accurate documentation for claims processing. Providers, treatment teams, and ambulatory service settings must ensure coding complies with CMS guidelines and correct coding principles as specified in the Medicare Claims Processing Manual, particularly for outpatient hospital department billing. Supporting clinical documentation should also confirm drug administration, therapy monitoring, and appropriateness to meet CMS prior authorization criteria and payment requirements. This is crucial to avoid denial or delay of reimbursement by Medicare.

## **HCPCS Code J1413 billing requirements** HCPCS Code J1413 billing requirements include billing the injection delandistrogene moxeparvovec rokl per therapeutic dose in hospital outpatient settings. - Claims using J1413 will suspend on receipt to allow Medicare contractors to manually insert the payment rate, reflecting its status in the outpatient prospective payment system (OPPS). Providers must report the code consistent with correct coding principles and CMS guidelines, including submitting all related charges. - J1413 billing is restricted to hospital outpatient services; pharmacies and clinics cannot use this code for billing. Billing should be done using the appropriate institutional claim forms (e.g., 837I or UB-04) with units accurately reported (one unit per therapeutic dose). - Providers should include relevant modifiers as required and ensure clinical documentation supports medical necessity for claims processing. - Proper submission helps avoid claim denials and ensures timely reimbursement under Medicare's outpatient drug payment policies.

## **Other relevant codes** Other relevant codes related to HCPCS code J1413 (Injection, delandistrogene moxeparvovec-rokl) include: - **J1412 and J1414**: These are adjacent codes in the same series for injections of delandistrogene moxeparvovec-rokl, representing different dosages or therapeutic presentations. - **ICD-10-CM code G71.01**: This diagnosis code corresponds to Duchenne or Becker muscular dystrophy, the primary indication for the use of delandistrogene moxeparvovec-rokl.

Frequently asked questions

HCPCS code J1413 refers to the injection delandistrogene moxeparvovec rokl per therapeutic dose, administered in monitored hospital outpatient or ambulatory service settings, used primarily for Duchenne muscular dystrophy therapy.

The CPT code 96372 is used for the administration of semaglutide injection, covering therapeutic, prophylactic, or diagnostic subcutaneous or intramuscular injections.

The HCPCS code for Rhogam (Rho(D) immune globulin) is P9029 or P9030, depending on dose and formulation, used to prevent Rh immunization in pregnancy.

The J-code for dexmedetomidine injection is J1130, representing dexmedetomidine hydrochloride injection billed per 10 micrograms.