Billing Guidelines: Coagulation Factor IX (Recombinant), GlycoPEGylated, lyophilized powder for solution for intravenous injection (Rebinyn) HCPCS code J7199

<p>Effective with date of service Jan. 30, 2018, the North Carolina Medicaid and NC Health Choice (NCHC) programs cover Coagulation Factor IX (Recombinant), GlycoPEGylated, lyophilized powder for solution for intravenous injection (Rebinyn) for use in the Physician&rsquo;s Drug Program (PDP) when billed with HCPCS code J7199 - Hemophilia clotting factor, not otherwise classified.</p>

Author: CSRA

Effective with date of service Jan. 30, 2018, the North Carolina Medicaid and NC Health Choice (NCHC) programs cover Coagulation Factor IX (Recombinant), GlycoPEGylated, lyophilized powder for solution for intravenous injection (Rebinyn) for use in the Physician’s Drug Program (PDP) when billed with HCPCS code J7199 - Hemophilia clotting factor, not otherwise classified.

Rebinyn is available as 500, 1000 and 2000 IU single-use vials of lyophilized powder. Rebinyn is approved by the U.S. Food and Drug Administration (FDA) for use in adults and children with hemophilia B for on-demand treatment and control of bleeding episodes and perioperative management of bleeding. Rebinyn is not indicated for routine prophylaxis in the treatment of patients with hemophilia B or for immune tolerance induction in patients with hemophilia B.

Recommended Dose

  • On-demand treatment and control of bleeding episodes: 40 IU/kg body weight for minor and moderate bleeds, and 80 IU/kg body weight for major bleeds. Additional doses of 40 IU/kg can be given.
  • Perioperative management of bleeding: Pre-operative dose of 40 IU/kg body weight for minor surgery, and 80 IU/kg body weight for major surgery. As clinically needed, repeated doses of 40 IU/kg (in one- to three-day intervals) within the first week after major surgery may be administered. Frequency may be extended to once weekly after the first week until bleeding stops and healing is achieved.

See full prescribing information for further detail.

For Medicaid and NCHC Billing

  • The ICD-10-CM diagnosis code required for billing is D67 - Hereditary factor IX deficiency.
  • Providers must bill with HCPCS code J7199 - Hemophilia clotting factor, not otherwise classified.
  • One Medicaid unit of coverage is 1 IU. NCHC bills according to Medicaid units.
  • Providers may contact the North Carolina Pharmacy Help Desk at 1-800-591-1183 or NCPharmacy@mslc.com and submit their invoice to establish a reimbursement rate.
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs are 00169-7901-01, 00169-7902-01 and 00169-7905-01.
  • 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 PDP, refer to the PDP Clinical Coverage Policy No. 1B, Attachment A, H.7 on North Carolina Medicaid’s website.
  • Providers shall bill their usual and customary charge for non-340-B drugs.
  • PDP reimburses for drugs billed for Medicaid and NCHC beneficiaries by 340-B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340-B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340-B purchasing agreement by appending the “UD” modifier on the drug detail.
  • The fee schedule for the PDP is available on Medicaid’s PDP web page.

CSRA 1-800-688-6696

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