Plazomicin Injection, for Intravenous Use (Zemdri™) HCPCS Code J3490: Billing Guidelines

Effective with date of service Aug. 17, 2018, the Medicaid and NC Health Choice programs cover plazomicin injection, for intravenous use (Zemdri) for use in the Physician's Drug Program when billed with HCPCS code J3490-Unclassified drugs. Zemdri is commercially available as a 500 mg/10 mL (50 mg/mL) as a single-dose vial.

Zembri is indicated for the treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI) including pyelonephritis.

• As only limited clinical safety and efficacy data are available, reserve Zemdri for use in patients who have limited or no alternative treatment options.
• To reduce the development of drug-resistant bacteria and maintain effectiveness of Zemdri and other antibacterial drugs, Zemdri should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms.

Recommended Dose

15 mg/kg every 24 hours by intravenous infusion over 30 minutes for 4 to 7 days to patients 18 years of age or older with creatinine clearance greater than or equal to 90 mL/min. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy. See package insert for dosage regimens for patients with renal impairment.

For Medicaid and NCHC Billing

The ICD-10-CM diagnosis codes required for billing are:

• Providers must bill with HCPCS code J3490-Unclassified drugs.
• One Medicaid and NCHC unit of coverage is 1 mg.
• The maximum reimbursement rate per unit is $0.68.
• Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs are 71045-0010-01, 71045-0010-02.
• 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 the NC Medicaid website.
• Providers shall bill their usual and customary charge for non-340B drugs.
• PDP 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 Physician's Drug Program is available on the NC Medicaid website’s PDP web page.