Naxitamab-gqgk Injection, for Intravenous Use (Danyelza®) HCPCS Code J9999: Billing Guidelines

Tuesday, May 4, 2021

Effective with date of service Feb. 11, 2021 the North Carolina Medicaid and NC Health Choice programs cover naxitamab-gqgk injection, for intravenous use (Danyelza) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs.

Danyelza is available as an injection: 40 mg/10 mL (4 mg/mL) in a single-dose vial. It is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response or stable disease to prior therapy.

Recommended Dose: 3 mg/kg/day (up to 150 mg/day), administered as an intravenous infusion after dilution on Days one, three, and five of each treatment cycle. Treatment cycles are repeated every four weeks until complete response or partial response, followed by five additional cycles every four weeks. Subsequent cycles may be repeated every eight weeks. 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:  
    • C74.00 - Malignant neoplasm of cortex of unspecified adrenal gland;
    • C74.01 - Malignant neoplasm of cortex of right adrenal gland;
    • C74.02 - Malignant neoplasm of cortex of left adrenal gland;
    • C74.10 - Malignant neoplasm of medulla of unspecified adrenal gland;
    • C74.11 - Malignant neoplasm of medulla of right adrenal gland;
    • C74.12 - Malignant neoplasm of medulla of left adrenal gland;
    • C74.90 - Malignant neoplasm of unspecified part of unspecified adrenal gland;
    • C74.91 - Malignant neoplasm of unspecified part of right adrenal gland;
    • C74.92 - Malignant neoplasm of unspecified part of left adrenal gland.
  • Providers must bill with HCPCS code: J9999 - Not otherwise classified, antineoplastic drugs
  • One Medicaid and Health Choice unit of coverage is: 1 mg 
  • The maximum reimbursement rate per unit is: $549.94
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is: 73042-0201-01 
  • 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