Ravulizumab-cwvz injection, for intravenous use (Ultomiris™) HCPCS code J3590: Billing Guidelines

<p>Effective with date of service Dec. 21, 2018, the North Carolina Medicaid and NC Health Choice programs cover ravulizumab-cwvz injection, for intravenous use (Ultomiris) for use in the Physician Administered Drug Program when billed with HCPCS code J3590 - Unclassified Biologics.</p>

Author: GDIT Call Center, (800) 688-6696

Effective with date of service Dec. 21, 2018, the North Carolina Medicaid and NC Health Choice programs cover ravulizumab-cwvz injection, for intravenous use (Ultomiris) for use in the Physician Administered Drug Program when billed with HCPCS code J3590 - Unclassified Biologics.

Ultomiris is available as 300 mg/30 mL (10 mg/mL) in a single-dose vial and is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

Recommended Dose: 

Starting two weeks after the loading dose, begin maintenance doses once every eight weeks.

For patients with a body weight of ≥ 40 kg to < 60 kg:
•    2,400 mg loading dose
•    3,000 mg maintenance dose

For patients with a body weight of ≥ 60 kg to < 100 kg:
•    2,700 mg loading dose
•    3,300 mg maintenance dose

For patients with a body weight ≥ 100 kg:
•    3,000 mg loading dose
•    3,600 mg maintenance dose

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code required for billing is:
    • D59.5 - Paroxysmal nocturnal hemoglobinuria
  • Providers must bill with HCPCS code: J3590 - Unclassified Biologics
  • One Medicaid and NC Health Choice unit of coverage is: one mg
  • The maximum reimbursement rate per unit is: $23.06
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDC is: 25682-0022-01
  • 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, Attachment A, H.7 on NC Medicaid's website.
  • Providers shall bill their usual and customary charge for non-340B drugs.
  • PADP reimburses for drugs billed for Medicaid and NC 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 Physician Administered Drug Program is available on NC Medicaid's PADP web page.

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