Lumasiran Injection, for Subcutaneous Use (Oxlumo™) HCPCS Code J3490: Billing Guidelines

Tuesday, February 9, 2021

Effective with date of service Dec. 22, 2020, the Medicaid and NC Health Choice programs cover lumasiran injection, for subcutaneous use (Oxlumo™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.

Strength/Package Size: Injection: 94.5 mg/0.5 mL in a single-dose vial.

Indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

Recommended Dose (see full prescribing information for further detail):
The recommended dose of Oxlumo™ by subcutaneous injection is based on body weight.

  • Body weight less than 10 kg:
    • Loading dose: 6 mg/kg once monthly for 3 doses
    • Maintenance dose: (begin 1 month after the last loading dose) 3 mg/kg once monthly
  • Body weight 10 kg to less than 20 kg:
    • Loading dose: 6 mg/kg once monthly for 3 doses
    • Maintenance dose: (begin 1 month after the last loading dose) 6 mg/kg once every 3 months (quarterly)
  • Body weight 20 kg and above:
    • Loading dose: 3 mg/kg once monthly for 3 doses
    • Maintenance dose: (begin 1 month after the last loading dose) 3 mg/kg once every 3 months (quarterly)

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code required for billing is: E72.53 - Primary hyperoxaluria
  • Providers must bill with HCPCS code: J3490 - Unclassified drugs
  • One Medicaid and Health Choice unit of coverage is: 1 mg
  • The maximum reimbursement rate per unit is: $628.57
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is:71336-1002-01
  • The NDC units should be reported as “UN1”
  • For additional information, refer to the January 2012 Special Bulletin National Drug Code Implementation Update
  • For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website
  • Providers shall bill their usual and customary charge for non-340B drugs
  • PADP reimburses for drugs billed for Medicaid and Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
  • The fee schedule for the PADP is available on Medicaid's PADP web page

Contact

NCTracks Call Center: 800-688-6696