Ropeginterferon alfa-2b-njft Injection, for Subcutaneous Use (BESREMI®) HCPCS Code J3590: Billing Guidelines

Effective with date of service Dec. 30, 2021, Medicaid and NC Health Choice cover ropeginterferon alfa-2b-njft injection, for subcutaneous use (BESREMI®).

Effective with date of service Dec. 30, 2021, the Medicaid and NC Health Choice programs cover ropeginterferon alfa-2b-njft injection, for subcutaneous use (BESREMI®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics.

Strength/Package Size: Injection: 500 mcg/mL solution in a single-dose prefilled syringe

Indicated for the treatment of adults with polycythemia vera.

Recommended Dose: 

Patients Not Already on Hydroxyurea: 

  • Recommended starting dose: 100 mcg by subcutaneous injection every two weeks.
  • Increase the dose by 50 mcg every two weeks (up to a maximum of 500 mcg) until hematological parameters are stabilized.

Patients Transitioning from Hydroxyurea:

  • When transitioning to BESREMI® from hydroxyurea, start BESREMI® at 50 mcg by subcutaneous injection every two weeks in combination with hydroxyurea.
  • Gradually taper off the hydroxyurea by reducing the total biweekly dose by 20-40% every two weeks during weeks 3-12.
  • Increase the dose of BESREMI® by 50 mcg every two weeks (up to a maximum of 500 mcg), until the hematological parameters are stabilized (hematocrit less than 45%, platelets less than 400 x 109/L, and leukocytes less than 10 x 109/L).
  • Discontinue hydroxyurea by week 13. 

Maintain the two-week dosing interval of BESREMI® at which hematological stability is achieved for at least one year. After achievement of hematological stability for at least one year on a stable dose of BESREMI®, the dosing interval may be expanded to every four weeks. 

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis code required for billing is: D45 - Polycythemia vera
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid and NC Health Choice unit of coverage is: 1 mcg 
  • The maximum reimbursement rate per unit is: $15.09
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is:73536-0500-01
  • 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 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 Medicaid's PADP web page.

Contact

NCTracks Call Center: 800-688-6696

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