Lefamulin injection, for intravenous use (Xenleta™) HCPCS code J3490 - Unclassified drugs: Billing Guidelines

Tuesday, November 5, 2019

Effective with date of service Aug. 22, 2019, the North Carolina Medicaid and NC Health Choice programs cover lefamulin injection, for intravenous use (Xenleta) for use in the Physician Administered Drug Program when billed with HCPCS code J3490 - Unclassified drugs.

Xenleta is available as a single-dose injection that comes as a clear glass vial containing 150 mg of lefamulin in 15 mL of 0.9% sodium chloride for further dilution prior to intravenous infusion.

Xenleta is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: streptococcus pneumoniae, staphylococcus aureus (methicillin-susceptible isolates), haemophilus influenzae, legionella pneumophila, mycoplasma pneumoniae, and chlamydophila pneumoniae.

The recommended dose of Xenleta is 150 mg every 12 hours by intravenous infusion over 60 minutes for five to seven days with the option to switch to Xenleta 600 mg tablets every 12 hours to complete the treatment course. See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis codes required for billing are: A48.1 - legionnaires' disease; J13 - pneumonia due to streptococcus pneumoniae; J14 - pneumonia due to hemophilus influenzae; J15.211 - pneumonia due to methicillin susceptible staphylococcus aureus; J15.7 - pneumonia due to mycoplasma pneumoniae; J16.0 - chlamydial pneumonia
  • Providers must bill with HCPCS code: J3490 - Unclassified drugs
  • One Medicaid and NC Health Choice unit of coverage is: 1 mg
  • The maximum reimbursement rate per unit is: $0.74
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs are 72000-0120-01 and 72000-0120-06
  • 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 Physician Administered Drug Program (PADP), refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on DHB'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 NC Medicaid's PADP web page.

GDIT, (800) 688-6696