Antihemophilic Factor (recombinant), Fc-VWF-XTEN Fusion Protein-ehtl, Lyophilized Powder for Solution, for Intravenous Use (Altuviiio™) HCPCS Code J7199 - Hemophilia Clotting Factor, Not Otherwise Classified: Billing Guidelines

Effective with date of service March 27, 2023, Medicaid and NC Health Choice cover Altuviiio.

Effective with date of service March 27, 2023, the Medicaid and NC Health Choice programs cover antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl, lyophilized powder for solution, for intravenous use (Altuviiio) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J7199 - Hemophilia clotting factor, not otherwise classified.

Strength/Package Sizes: For injection: nominally 250, 500, 750, 1000, 2000, 3000, or 4000 IU, lyophilized powder in single-dose vials for reconstitution.

Indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for:

  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • On-demand treatment & control of bleeding episodes
  • Perioperative management of bleeding

Limitation of Use:

Altuviiio is not indicated for the treatment of von Willebrand disease.

Recommended Dose:

  • For routine prophylaxis: The recommended dosing for routine prophylaxis for adults and children is 50 IU/kg administered once weekly.
  • For on-demand treatment and control of bleeding episodes and perioperative management: single dose of 50 IU/kg
    • For minor and moderate bleeding episodes occurring within 2 to 3 days after a prophylactic dose, a lower dose of 30 IU/kg dose may be used. Additional doses of 30 or 50 IU/kg every 2 to 3 days may be considered.
    • For major bleeding episodes: Additional doses of 30 or 50 IU/kg every 2 to 3 days can be considered.
  • Estimated Increment of Factor VIII (IU/dL or % of normal) = 50 IU/kg × 2 (IU/dL per IU/kg.)
    • To achieve a specific target Factor VIII activity level, use the following formula: Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % normal) × 0.5 (IU/kg per IU/dL).

See full prescribing information for further detail.

For Medicaid and Health Choice Billing

  • The ICD-10-CM diagnosis code required for billing is: D66 - Hereditary Factor VIII deficiency
  • Providers must bill with HCPCS code: J7199 - Hemophilia clotting factor, not otherwise
  • One Medicaid and Health Choice unit of coverage is: 1 IU
  • The maximum reimbursement rate per unit can be obtained by contacting the North Carolina Pharmacy Help Desk at 800-591-1183 or NCPharmacy@mslc.com and submit their invoice to establish a reimbursement rate.
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 71104-0978-01, 71104-0979-01, 71104-0981-01, 71104-0982-01, 71104-0983-01, 71104-0984-01, 71104-0985-08, 71104-0986-08, 71104-0988-08, 71104-0989-08, 71104-0990-08, 71104-0991-08
  • The NDC units should be reported as "UN1."
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and 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 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 PADP is available on the NC Medicaid Fee Schedule & Covered Code portal.

Contact

NCTracks Call Center: 800-688-6696 

Related Topics: