Notice to Providers Regarding the Special Billing of Zolgensma Claims

April 22, 2020

The Department of Health Care Services (DHCS) would like to notify providers of the special billing and claims processing methodology for Zolgensma (onasemnogene abeparvovec-xioi) Suspension for intravenous infusion, when billed under HCPCS code, J3590 (Unclassified biologics)

National standards and system limitations for J3590 do not allow for accurate claims adjudication when billing a single claim line. National Council for Prescription Drug Programs (NCPDP) standards and the UB-04 or other standard claim forms do not accommodate the large dollar amount of the claim.

When submitting claims for Zolgensma, providers are instructed to do the following:

  1. Submit and receive back an approved Treatment Authorization Request (TAR) or approved product specific Service Authorization Request (SAR).

  2. Bill using miscellaneous HCPCS code, J3590 (Unclassified biologics). For information about billing with J3590, please refer to General Medicine and Injections sections of the – Medi-Cal Billing and Policy manual.

  3. Completion of claim forms:
    • This billing methodology is restricted to hospital outpatient services. Note that pharmacies and clinics cannot bill using this methodology.

    • Outpatient claims may be billed electronically or by paper claim using 837P (Professional) or UB-04 Medi-Cal claim forms with the following conditions:

      • The TAR/SAR is not negotiated.

      • Provider must submit one service line for three units on the TAR/SAR request and will submit three claim lines.

      • Each claim line to represent one unit.

      • This process will ensure that the total reimbursement paid for the three claim lines is no more than provider submitted invoice paid price.
  1. Providers are advised to take the following steps in order to ensure that Zolgensma claims are identified and processed expeditiously:
    • Paper claims may be identified by notation of “Zolgensma” on the “Remarks” section of the UB-04 claim form (Field #80) and submitted to:

    • Attention: Claims Manager Medi-Cal Fiscal Intermediary/DXC P.O. Box 526006 Sacramento, CA 95852-6006

    • Electronic claims may be identified by notation of “Zolgensma” on the cover sheet, addressed to Attention: Claims Manager and submitted with the 837P claim form.
  2. Except for the first claim line, payment for any additional line will be delayed for 2-3 additional weeks due to systems constraints.

  3. Payment for Zolgensma shall be a once in a lifetime reimbursement under J3590 or any other code (HCPCS, CPT, or by NDC).

  4. For instructions regarding physician claim form completion, refer to the forms section of Medi-Cal website for completion of 837P form and UB-04

  5. Providers may continue to bill with J3590 until a specific procedural code becomes available for Zolgensma, at which time providers must submit claims using the specific code.