Emapalumab-lzsg Injection, for Intravenous Use (Gamifant™) HCPCS code J9210: Billing Guidelines

Tuesday, June 16, 2020

Effective with date of service Dec. 28, 2019, the Medicaid and NC Health Choice programs cover emapalumab-lzsg injection, for intravenous use (Gamifant™) for use in the Physician Administered Drug Program (PADP) outpatient hospital setting (only) when billed with HCPCS code J9210 - Injection, emapalumab-lzsg, 1 mg.

Strength/Package Size(s): 

  • 10 mg/2 mL (5 mg/mL) solution in a single-dose vial for injection
  • 50 mg/10 mL (5 mg/mL) solution in a single-dose vial for injection

Indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

Recommended Dose (see full prescribing information for further details):  

  • Recommended starting dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week (every 3 or 4 days). 
  • Administer dexamethasone concomitantly with Gamifant™.
  • The Gamifant™ dose may be titrated up if disease response is unsatisfactory (see below). After the patient’s clinical condition is stabilized, decrease the dose to the previous level to maintain clinical response. 
    • Treatment day 1: Starting dose of 1 mg/kg
    • Treatment day 3: Increase to 3 mg/kg based on criteria for dose increase in package insert
    • From day 6 onwards: Increase to 6 mg/kg based on criteria for dose increase in package insert
    • From day 9 onwards: Increase to 10 mg/kg if based on an assessment by a healthcare provider based on initial signs of response, a further increase in Gamifant™ dose can be of benefit

For Medicaid and NC Health Choice Billing

 

  • The ICD-10-CM diagnosis code(s) required for billing is/are: D76.1 - Hemophagocytic lymphohistiocytosis
  • Providers must bill with HCPCS code: J9210 - Injection, emapalumab-lzsg, 1 mg
  • One Medicaid and NC Health Choice unit of coverage is: 1 mg 
  • The maximum reimbursement rate(s) per unit are:  
    • Gamifant™ 10 mg/2 mL vial: $721.42
    • Gamifant™ 50 mg/10 mL vial: $364.72
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are:72171-0501-01, 72171-0505-01
  • 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