ZERBAXA®

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

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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 10237721
CARDINAL HEALTH 5045810
DMS PHARMACEUTICAL GROUP INC 583420
FFF ENTERPRISES ZER003001
MCKESSON CORPORATION 3971686
METRO MEDICAL SUPPLY 661074
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 13.2 oz. 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 code for ZERBAXA1

HCPCS code J0695
Description Injection, ceftolozane 50 mg and tazobactam 25 mg
Billing units Each billing unit of ZERBAXA equals 50 mg of ceftolozane and 25 mg of tazobactam

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

Administration codes for new technology add-on payment (NTAP)

Beginning October 1, 2021, Medicare will provide an NTAP for ZERBAXA® (ceftolozane and tazobactam) of up to $1,836.98 per qualifying case to inpatient prospective payment system (IPPS)–participating acute care hospitals, in cases where ZERBAXA is used to treat HABP/VABP. This NTAP payment will be incremental to the MS-DRG reimbursement for qualifying Medicare inpatient cases.6

Hospitals report use of ZERBAXA by recording an ICD-10-PCS code on the claim for the traditional Medicare admission, indicating that ZERBAXA was administered during the admission. These codes are recorded in the same section of the claim as other ICD-10-PCS codes applicable to the admission.6

The ICD-10-PCS codes that describe the administration of ZERBAXA, available for use on October 1, 2021, are6,7:

ICD-10-PCS code Descriptor
XW03396 Introduction of ceftozolane and tazobactam into peripheral vein, percutaneous approach, new technology group 6
XW04396 Introduction of ceftozolane and tazobactam into central vein, percutaneous approach, new technology group 6

MS-DRG, Medicare severity diagnosis-related group; ICD-10-PCS, International Classification of Diseases, 10th Revision, Procedure Coding System.

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.

New technology add-on payment (NTAP)

Thumbnail of the cover of the NTAP resource

NTAP guide

Status granted by CMS for FY2022

Effective October 1, 2021

Download PDF

References

1. Centers for Medicare & Medicaid Services. IHCPCS Quarterly Update, July 2021. Accessed August 18, 2021. https://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/HCPCS-Quarterly-Update

2. Centers for Medicare & Medicaid Services. Hospital Outpatient Prospective Payment System. Accessed August 18, 2021. https://www.cms.gov/outreach-and-educationmedicare-learning-network-mlnmlnproductsmln-publications/mln6922507

3. Centers for Medicare & Medicaid Services. MLN Matters 9603. Accessed August 18, 2021. 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 August 18, 2021. https://apps.ama-assn.org/CPTSearch/user/search/cptSearcghSubmit.do?locality=1keyword=96365

5. Noridian Healthcare solutions. Revenue codes. Accessed August 18, 2021. https://med.noridianmedicare.com/web/jea/topics/claim-submission/revenue-codes

6. Centers for Medicare & Medicaid Services. IPPS final rule, 2021. Accessed August 18, 2021. https://public-inspection.federalregister.gov/2021-16519.pdf

7. Centers for Medicare & Medicaid Services. ICD-10-PCS, 2022. Accessed August 30, 2021. https://www.cms.gov/medicare/icd-10/2022-icd-10-pcs

Indications

ZERBAXA is indicated for the treatment of 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 patients 18 years and older 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 patients 18 years and older 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.

Selected 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, 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 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: The most common adverse reactions occurring in ≥5% of patients in the HABP/VABP trial were hepatic transaminase increased (11.9%), renal impairment/renal failure (8.9%), and diarrhea (6.4%).
  • The most common adverse reactions occurring in ≥5% of patients 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.

Before prescribing ZERBAXA, please read the accompanying Prescribing Information.

US-ZER-0141403/22