ZERBAXA®

(ceftolozane and tazobactam) for injection (1.5 g), for intravenous use

Announcements

Announcements

  • ZERBAXA Is Indicated for the Treatment of Pediatric Patients (Birth to Less Than 18 Years Old) with cUTI or cIAI. See Prescribing Information for details.

Ordering

Ordering ZERBAXA

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Wholesaler information

Product: ZERBAXA®

Packaging: Carton contains 10 single-dose vials

National Drug Code (NDC): 67919-030-01

Distributor order codes

Distributor Order code for ZERBAXA
AMERISOURCEBERGEN DRUG CORP. 10237721
BESSE MEDICAL 10240631
CARDINAL HEALTH 5045810
DMS PHARMACEUTICAL GROUP INC 583420
FFF ENTERPRISES ZER003001
MCKESSON CORPORATION 3971686
MORRIS & DICKSON CO 031179
SMITH DRUG COMPANY 737924

Merck does not recommend the use of one authorized distributor over another. Merck does not make any warranty as to the services offered by any particular distributor.

Package size and dimensions

Photo of one box of Zerbaxa 13.2 ounce vials and a sample vial.

Not actual size.

Sales package size (carton):

10 single-dose (20mL) vials

Carton dimensions:

6 5/16 x 2 11/16 x 2 9/16 inches

Coding and billing information

This resource contains a list of possible codes that may be relevant when billing for ZERBAXA® (ceftolozane and tazobactam). Please consult with the applicable payer or, where applicable, the Medicare Administrative Contractor, to understand the payer’s specific billing requirements.

You are solely responsible for determining the appropriate codes and for any action you take in billing. Information about HCPCS codes is based on guidance issued by the Centers for Medicare & Medicaid Services (CMS) applicable to Medicare and may not apply to other public or private payers. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness for a particular code and for information on additional codes.

The information available here is compiled from sources believed to be accurate, but Merck makes no representation that it is accurate. This information is subject to change. Payer coding requirements may vary or change over time, so it is important to regularly check with each payer as to payer-specific requirements. The information available here is not intended to be conclusive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Merck and its agents make no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use given the frequent changes in public and private payer billing. The use of this information does not guarantee payment or that any payment received will cover your costs.

HCPCS codes for ZERBAXA1

HCPCS code Description Billing units
J0695 Injection, ceftolozane 50 mg and tazobactam 25 mg Each billing unit of ZERBAXA equals 50 mg of ceftolozane and 25 mg of tazobactam
S9502 Home infusion therapy, antibiotic, antiviral, or antifungal therapy; once every 8 hours, administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem N/A

HCPCS, Healthcare Common Procedure Coding System; APC, ambulatory payment classifications.
Note: Paid under Outpatient Prospective Payment System (OPPS) as a separate APC payment.2
Use form CMS-1500 for in-office injection; in the hospital outpatient department setting, submit claims using form UB-04 (also known as CMS 1450).

For questions on billing if a portion of the package is wasted, consult the applicable payer’s policy regarding wastage. Please note that effective January 1, 2017, providers are required to use the JW modifier for Medicare claims with unused drugs or biologicals from single-use vials or single-use packages that are appropriately discarded.3

Drug administration current procedural terminology (CPT®) code4

CPT code 96365
Description Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

CPT copyright © 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Possible revenue codes for use in the hospital inpatient and hospital outpatient settings5

Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes.

Revenue code Description
0636 Drugs requiring detailed coding
0250 General pharmacy

You are solely responsible for determining the appropriate codes and for any action you take in billing. Merck and its agents make no warranties, express or implied, concerning the accuracy or appropriateness of this information for your particular use. The use of this information does not guarantee payment or that any payment received will cover your costs.

References

1. Centers for Medicare & Medicaid Services. HCPCS Quarterly Update, July 2022. Accessed July 7, 2022. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update

2. Centers for Medicare & Medicaid Services. Medicare Fee-For-Service Provider Utilization & Payment Data Outpatient Hospital Public Use File: A Methodological Overview. November 2020. Accessed July 7, 2022. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Downloads/Outpatient_Methodology.pdf

3. Centers for Medicare & Medicaid Services. MLN Matters 9603. Accessed July 7, 2022. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9603.pdf

4. American Medical Association. CPT Code/Relative Value Search – 96365. Accessed July 7, 2022. https://apps.ama-assn.org/CPTSearch/user/search/cptSearcghSubmit.do?locality=1keyword=96365

5. Noridian Healthcare solutions. Revenue codes. Last updated June 28, 2022. Accessed July 7, 2022. https://med.noridianmedicare.com/web/jea/topics/claim-submission/revenue-codes

Indications and Usage

ZERBAXA is indicated for the treatment of adult patients (18 years and older) with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens.

ZERBAXA is indicated for the treatment of adult and pediatric patients (birth to less than 18 years old) with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa.

ZERBAXA used in combination with metronidazole is indicated for the treatment of adult and pediatric patients (birth to less than 18 years old) with complicated intra-abdominal infections (cIAI) caused by the following susceptible Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZERBAXA and other antibacterial drugs, ZERBAXA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Important Safety Information

  • Patients with renal impairment: Decreased efficacy of ZERBAXA has been observed in patients with baseline CrCl of 30 to ≤50 mL/min. In a clinical trial of adult patients, patients with cIAIs with CrCl >50 mL/min had a clinical cure rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9% when treated with meropenem. In the same trial, patients with CrCl 30 to ≤50 mL/min had a clinical cure rate of 47.8% when treated with ZERBAXA plus metronidazole vs 69.2% when treated with meropenem. A similar trend was also seen in the cUTI trial. Dose adjustment is required for adult patients with CrCl 50 mL/min or less. All doses of ZERBAXA are administered over 1 hour. Monitor CrCl at least daily in patients with changing renal function and adjust the dose of ZERBAXA accordingly.
  • Hypersensitivity: ZERBAXA is contraindicated in patients with known serious hypersensitivity to the components of ZERBAXA (ceftolozane/ tazobactam), piperacillin/tazobactam, or other members of the beta-lactam class. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials. Before initiating therapy with ZERBAXA, make careful inquiry about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If an anaphylactic reaction to ZERBAXA occurs, discontinue use and institute appropriate therapy.
  • Clostridioides difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including ZERBAXA. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is confirmed, antibacterial use not directed against C. difficile should be discontinued, if possible.
  • Development of drug-resistant bacteria: Prescribing ZERBAXA in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
  • Adverse reactions in adult patients with HABP/VABP: The most common adverse reactions occurring in ≥5% of adult patients receiving ZERBAXA in the HABP/VABP trial were hepatic transaminase increased (11.9%), renal impairment/renal failure (8.9%), and diarrhea (6.4%).
  • Adverse reactions in adult patients with cIAI or cUTI: The most common adverse reactions occurring in ≥5% of adult patients receiving ZERBAXA in the cUTI and cIAI trials were headache (5.8%) in the cUTI trial, and nausea (7.9%), diarrhea (6.2%), and pyrexia (5.6%) in the cIAI trial.
  • Adverse reactions in pediatric patients with cIAI or cUTI: The most common adverse reactions occurring in ≥7% of pediatric patients receiving ZERBAXA in the cIAI trial were diarrhea (17%), thrombocytosis (16%), pyrexia (13%), abdominal pain (11%), vomiting (10%), increased aspartate aminotransferase (7%), and anemia (7%). The most common adverse reactions occurring in ≥7% of pediatric patients receiving ZERBAXA in the cUTI trial were thrombocytosis (9%), leukopenia (8%), diarrhea (7%), and pyrexia (7%).
  • Pediatric Use: There is insufficient information to recommend dosage adjustment for pediatric patients younger than 18 years of age with cIAI and cUTI with eGFR 50 mL/min/1.73m2 or less. ZERBAXA is not recommended in pediatric patients who have an eGFR 50 mL/min/1.73m2 or less. Pediatric patients born at term or pre-term may not have an eGFR of 50 mL/min/1.73m2 or greater at birth or within the first few months of life.

Before prescribing ZERBAXA, please read the accompanying Prescribing Information.

US-ZER-0146708/22