Remimazolam for Injection, for Intravenous Use (Byfavo™) HCPCS Code J3490: Billing Guidelines

Tuesday, March 30, 2021

Effective with date of service Jan. 28, 2021, the Medicaid and NC Health Choice programs cover remimazolam for injection, for intravenous use (Byfavo™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.

Each glass, single-patient-use vial contains 20 mg Byfavo™ (remimazolam) lyophilized powder for reconstitution, equivalent to 27.2 mg remimazolam besylate.

Byfavo™ is a benzodiazepine that binds to brain benzodiazepine sites (gamma amino butyric acid type A [GABAA] receptors), while its carboxylic acid metabolite (CNS7054) has a 300 times lower affinity for the receptor. Byfavo™ is indicated for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

Recommended Dose (See full prescribing information for further detail):  

  • Administer an initial dose intravenously as a 5 mg push injection over a one-minute time period.
  • If necessary, administer supplemental doses of 2.5 mg intravenously over a 15-second time period. At least two minutes must elapse prior to the administration of any supplemental dose.

ASA III-IV Patients (at the discretion of the physician):

  • Based on the general condition of the patient, administer 2.5 mg to 5 mg over a one-minute time period.
  • If necessary, administer supplemental doses of 1.25 mg to 2.5 mg intravenously over a 15-second time period. At least two minutes must elapse prior to the administration of any supplemental dose.

For Medicaid and NC Health Choice Billing

  • Many FDA indication-related ICD-10 codes may be applicable. The indications for the use of this drug must be documented in the patient's record as well as the appropriate ICD-10 code(s) that describe(s) the patient's condition.
  • Providers must bill with HCPCS code: J3490 - Unclassified drugs
  • One Medicaid and NC Health Choice unit of coverage is: 1 mg
  • The maximum reimbursement rate per unit is: $2.11
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are:71390-0011-00 and 71390-0011-11
  • 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 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 Medicaid's PADP web page

Contact

NCTracks Contact Center: 800-688-6696