Isatuximab-irfc Injection, for Intravenous Use (Sarclisa®) HCPCS Code J9999: Billing Guidelines

Tuesday, May 19, 2020

Effective with date of service March 19, 2020, the Medicaid and NC Health Choice programs cover isatuximab-irfc injection for intravenous use (Sarclisa®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs.

Strength/Package Sizes:  

  • 100 mg/5 mL (20 mg/mL) solution in single-dose vial for injection
  • 500 mg/25 mL (20 mg/mL) solution in single-dose vial for injection

Indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

Recommended Dose: 10 mg/kg as an intravenous infusion with pomalidomide and dexamethasone according to the following schedule: 

Cycle 1 - Days 1, 8, 15 and 22 (weekly) 
Cycle 2 and beyond - Days 1 and 15 (every 2 weeks)

Each treatment cycle consists of a 28-day period.

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code(s) required for billing 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: 1 mg 
  • The maximum reimbursement rate per unit is: $7.02
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 00024-0654-01 and 00024-0656-01
  • 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