Pegunigalsidase Alfa-Iwxj Injection, for Intravenous Use (Elfabrio®) HCPCS Code J3590 - Unclassified Biologics: Billing Guidelines

Effective with date of service June 14, 2023, NC Medicaid covers pegunigalsidase alfa-iwxj injection, for intravenous use (Elfabrio).

Effective with date of service June 14, 2023, NC Medicaid Direct and NC Medicaid Managed Care cover pegunigalsidase alfa-iwxj injection, for intravenous use (Elfabrio) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.

Strength/Package Size: Injection: 20 mg/10 mL (2 mg/mL) solution in a single-dose vial.

Pegunigalsidase alfa-iwxj injection is indicated for the treatment of adults with confirmed Fabry disease.

Recommended Dose: 1 mg/kg every two weeks administered as an intravenous infusion.

See full prescribing information for further detail.

For Medicaid Billing:

  • The ICD-10-CM diagnosis codes required for billing is: E75.21 Fabry (-Anderson) disease
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid unit of coverage is: 1 mg
  • The maximum reimbursement rate per unit is: $223.29585
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 10122-0160-01, 10122-0160-02, 10122-0160-05, 10122-0160-10
  • 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 NC Medicaid's website.
  • Providers shall bill their usual and customary charge for non-340B drugs.
  • PADP reimburses for drugs billed for Medicaid 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 their actual 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 the NC Medicaid Fee Schedule & Covered Code portal.

ICD-10-CM Manual. American Medical Association, 2023 manual.

*Information current as of Aug. 10, 2023, and is not a substitute for professional judgment. For full prescribing information, please refer to current package insert or other appropriate sources prior to making clinical judgments.


NCTracks Call Center: 800-688-6696

Related Topics: