Caplacizumab-yhdp for injection, for intravenous or subcutaneous use (Cablivi®) HCPCS code J3590: Billing Guidelines

<p>Effective Feb. 25, 2019, the North Carolina Medicaid and NC Health Choice programs cover caplacizumab-yhdp for injection, for intravenous or subcutaneous use (Cablivi) for use in the Physician Administered Drug Program when billed with HCPCS code J3590 - Unclassified biologics.</p>

Author: GDIT, (800) 688-6696

Effective Feb. 25, 2019, the North Carolina Medicaid and NC Health Choice programs cover caplacizumab-yhdp for injection, for intravenous or subcutaneous use (Cablivi) for use in the Physician Administered Drug Program when billed with HCPCS code J3590 - Unclassified biologics.

Cablivi is available as 11 mg of lyophilized powder in a single-dose vial kit for injection.  It is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Cablivi should be administered upon the initiation of plasma exchange therapy. The recommended dose of Cablivi is as follows:

First day of treatment: 11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1.

Subsequent treatment during daily plasma exchange: 11 mg subcutaneous injection once daily following plasma exchange.

Treatment after the plasma exchange period: 11 mg subcutaneous injection once daily for 30 days beyond the last plasma exchange.

If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days.

Discontinue Cablivi if the patient experiences more than 2 recurrences of aTTP, while on Cablivi.

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code required for billing is:  M31.1 - Thrombotic microangiopathy
  • Providers must bill with HCPCS code:  J3590 - Unclassified biologics
  • One Medicaid and NC Health Choice unit of coverage is:  11 mg (1 kit)
  • The maximum reimbursement rate per unit is:  $7,884.00
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units.  The NDC is: 58468-0225-01
  • 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 9B, Attachment A, H.7 on the DHB 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 the DHB PADP web page.

Related Topics: