Author: GDIT (800) 688-6696
Effective with date of service Nov. 11, 2019, the NC Medicaid and NC Health Choice programs cover luspatercept-aamt for injection, for subcutaneous use (Reblozyl) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.
Strength/Package Size(s) for injection: 25 mg lyophilized powder in a single-dose vial for reconstitution and 75 mg lyophilized powder in a single-dose vial for reconstitution.
Indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.
Recommended Dose: The recommended starting dose is 1 mg/kg once every 3 weeks by subcutaneous injection. If a patient does not achieve a reduction in RBC transfusion burden after at least 2 consecutive doses (6 weeks) at the 1 mg/kg starting dose, increase the Reblozyl dose to 1.25 mg/kg. Do not increase the dose beyond the maximum dose of 1.25 mg/kg. See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis code(s) required for billing is/are:
- D56.1 - Beta thalassemia;
- D56.5 - Hemoglobin E-beta thalassemia
- Providers must bill with HCPCS code: J3590 - Unclassified biologics
- One Medicaid and NC Health Choice unit of coverage is: 1 mg
- The maximum reimbursement rate per unit is: $148.66
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 59572-0711-01 and 59572-0775-01.
- The NDC units should be reported as “UN1.”
- For additional information, refer to the January 2012 Medicaid 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 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 Medicaid's PADP web page.