Anifrolumab-fnia Injection, for Intravenous Use (Saphnelo™) HCPCS Code J3590: Billing Guidelines Effective Aug. 18, 2021, the Medicaid and NC Health Choice programs cover anifrolumab-fnia injection
Effective with date of service Aug. 18, 2021, the Medicaid and NC Health Choice programs cover anifrolumab-fnia injection, for intravenous use (Saphnelo™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.
Saphnelo™ is available as a 300 mg/2 mL (150 mg/mL) in a single-dose vial. It is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
Limitations of Use: The efficacy of Saphnelo™ has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of Saphnelo™ is not recommended in these situations.
Recommended Dose: 300 mg as an intravenous infusion over a 30-minute period every four weeks. See full prescribing information for further details.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis codes required for billing are:
- M32.0 - Drug-induced systemic lupus erythematosus
- M32.10 - Systemic lupus erythematosus, organ or system involvement unspecified;
- M32.11 - Endocarditis in systemic lupus erythematosus;
- M32.12 - Pericarditis in systemic lupus erythematosus;
- M32.13 - Lung involvement in systemic lupus erythematosus;
- M32.14 - Glomerular disease in systemic lupus erythematosus;
- M32.15 - Tubulo-interstitial nephropathy in systemic lupus erythematosus;
- M32.19 - Other organ or system involvement in systemic lupus erythematosus;
- M32.8 - Other forms of systemic lupus erythematosus;
- M32.9 - Systemic lupus erythematosus, unspecified;
- Providers must bill with HCPCS code: J3590 - Unclassified biologics
- One Medicaid and NC Health Choice unit of coverage is: 1 mg
- The maximum reimbursement rate per unit is: $16.56
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is: 00310-3040-00
- The NDC units should be reported as “UN1”
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and 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 NC Medicaid's PADP webpage.
NCTracks Call Center: 800-688-6696