Daratumumab and Hyaluronidase-fihj Injection, for Subcutaneous Use (Darzalex Faspro™) HCPCS Code J9999: Billing Guidelines

Tuesday, July 21, 2020

Effective with date of service May 6, 2020, the Medicaid and NC Health Choice programs cover daratumumab and hyaluronidase-fihj injection, for subcutaneous use (Darzalex Faspro™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs.

Strength/Package Size(s): Injection: 1,800 mg daratumumab and 30,000 units hyaluronidase per 15 mL (120 mg and 2,000 units/mL), solution in a single-dose vial

Indicated for the treatment of adult patients with multiple myeloma:

  • in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
  • in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
  • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
  • as monotherapy in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

Recommended Dose: 1,800 mg/30,000 units (1,800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to recommended schedule:

Monotherapy and In Combination with Lenalidomide and Dexamethasone (D-Rd)

  • Weeks 1 to 8: weekly (total of 8 doses)
  • Weeks 9 to 24: every two weeks (total of 8 doses); first dose of the every-2-week dosing schedule is given at Week 9
  • Week 25 onwards until disease progression: every four weeks; first dose of the every-4-week dosing schedule is given at week 25

In Combination with Bortezomib, Melphalan and Prednisone (D-VMP)

  • Weeks 1 to 6: weekly (total of 6 doses)
  • Weeks 7 to 54: every three weeks (total of 16 doses); first dose of the every-3-week dosing schedule is given at week 7
  • Week 55 onwards until disease progression: every four weeks; first dose of the every-4-week dosing schedule is given at week 55

In Combination with Bortezomib and Dexamethasone (D-Vd)

  • Weeks 1 to 9: weekly (total of 9 doses)
  • Weeks 10 to 24: every three weeks (total of 5 doses); first dose of the every-3-week dosing schedule is given at week 10
  • Week 25 onwards until disease progression: every four weeks; first dose of the every-4-week dosing schedule is given at week 25

See full prescribing information for further details.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing is/are: C90.00 - Multiple myeloma not having achieved remission; C90.01 - Multiple myeloma in remission; C90.02 - Multiple myeloma in relapse
  • Providers must bill with HCPCS code: J9999 - Not otherwise classified, antineoplastic drugs
  • One Medicaid and NC Health Choice unit of coverage is: 10 mg 
  • The maximum reimbursement rate per unit is: $45.44
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDC is: 57894-0503-01
  • 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 Contact Center: 800-688-6696