Efgartigimod Alfa and Hyaluronidase-Qvfc Injection, for Subcutaneous Use (Vyvgart® Hytrulo) HCPCS code J3590 - Unclassified Biologicals: Billing Guidelines

Effective with date of service July 11, 2023, NC Medicaid covers efgartigimod alfa and hyaluronidase-qvfc injection

Effective with date of service July 11, 2023, NC Medicaid Direct and NC Medicaid Managed Care cover efgartigimod alfa and hyaluronidase-qvfc injection, for subcutaneous use (Vyvgart Hytrulo) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologicals.

Strength/Package Size: Injection: 1,008 mg efgartigimod alfa and 11,200 units hyaluronidase per 5.6 mL (180 mg/2,000 units per mL) in a single-dose vial.

Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.  

Recommended Dose: The recommended dose of Vyvgart Hytrulo is 1,008 mg /11,200 units (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase) administered subcutaneously over approximately 30 to 90 seconds in cycles of once weekly injections for four weeks. See full prescribing information for further detail. 

For Medicaid Billing

  • The ICD-10-CM Diagnosis Codes Required for Billing are:
    • G70.00 - Myasthenia gravis without (acute) exacerbation;
    • G70.01 - Myasthenia gravis with (acute) exacerbation
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid unit of coverage is: 1 vial (1,008 mg efgartigimod alfa and 11,200 units hyaluronidase)  
  • The maximum reimbursement rate per unit is: $17,034.83999
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is: 73475-3102-03 
  • 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 Sept. 26, 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.

Contact

NCTracks Call Center: 800-688-6696 

Related Topics: