Included in CMS/JCAHO Core Measures for CAP*

Included in CMS/JCAHO Core Measures for CAP*

TEFLARO Billing and Coding Guide ®

Forest Laboratories, Inc.

* TEFLARO (ceftaroline fosamil) is one of the recommended b-lactam antibiotics for Community-Acquired Pneumonia in Immunocompetent Patients—Non-ICU Patients. PN-6, 6ab-6. Specifications Manual for National Hospital Inpatient Quality Measures, Version 4.0. Discharges 01-01-12 (1Q12) through 06-30-12 (2Q12). Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is now known as The Joint Commission. CMS=Centers for Medicare and Medicaid Services.

TEFLARO is a registered trademark used by Forest Laboratories, Inc.

Introduction This guide has been designed to provide healthcare professionals with information related to the insurance reimbursement environment for TEFLARO (ceftaroline fosamil). In this guide, you will find information on: ®

TEFLARO (ceftaroline fosamil) ®

The TEFLARO Reimbursement Hotline provides healthcare professionals with answers to general questions about TEFLARO insurance coverage and reimbursement. A reimbursement hotline associate will research coverage and verify benefits, provide coding and billing information, as well as investigate and provide access information. Coverage and payment depend on a patient’s individual insurance plan. Therefore, it is recommended that an individual’s insurance benefits for coverage of TEFLARO be verified.

Indications and Usage Dosage and Administration Storage Information Important Safety Information Full Prescribing Information

TEFLARO Reimbursement Hotline 855-284-1818 Available Monday-Friday 9:00 AM to 5:00 PM (Eastern Time) Fax: 855-829-0025 Visit www.TEFLARO.com

TEFLARO Reimbursement Coding — International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) Diagnosis Codes — International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) Procedure Codes — National Drug Codes (NDCs) — Healthcare Common Procedure Coding System (HCPCS) Codes – Not Otherwise Classified HCPCS Codes — Current Procedural Terminology (CPT) Drug Administration Codes Payor Coverage — Medicare — Medicaid — Commercial Insurers

Checklist for Claim Submission Information current as of January 2012.

Payor Reimbursement — Medicare — Medicaid — Commercial Insurers Sample CMS-1500 Claim Form — How physician offices may bill for a product not assigned a permanent HCPCS code Sample CMS-1450 (UB-04) Claim Form — How hospital facilities may bill for a product assigned a pass-through HCPCS code

The TEFLARO Reimbursement Hotline provides assistance with: Reimbursement Verification of benefit and coverage information Verification of third-party insurance coverage for patients prescribed or requiring TEFLARO Identification of insurance forms and/or documents that are required as well as phone/fax number or website to obtain forms Identification of prior authorization and step-edit requirements

Coding and Billing ICD-9-CM Diagnosis Codes ICD-9-CM Procedure Codes National Drug Codes (NDCs) Healthcare Common Procedure Coding System (HCPCS) – TEFLARO permanent J-Code: J0712 IV administration, infusion codes

Forest Laboratories, Inc. cannot guarantee payment of any claim. Coding, coverage, and reimbursement may vary significantly by the payor, plan, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payors following the receipt of claims. For additional information, customers should consult with their payors for all relevant coding, reimbursement, and coverage requirements. It is the sole responsibility of the provider to select the proper code and ensure the accuracy of all claims submitted for reimbursement. All services must be medically appropriate and properly supported in the patient medical record. 2

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TEFLARO

®

Indications and Usage

Dosage and Administration

TEFLARO is indicated for the treatment of patients with the following infections caused by susceptible isolates of the designated microorganisms.

The recommended dose of TEFLARO is 600 mg administered every 12 hours by intravenous (IV) infusion over 1 hour in patients ≥18 years of age. The duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress.

Community-Acquired Bacterial Pneumonia: TEFLARO is indicated for the treatment of communityacquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.

The recommended dosage and administration by infection is described in the table below.

Acute Bacterial Skin and Skin Structure Infections: TEFLARO is also indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillinsusceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca. To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEFLARO and other antibacterial drugs, TEFLARO should be used to treat only ABSSSI or CABP that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological examinations should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. 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.

Recommended Duration of Total Antimicrobial Treatment

Infection

Dosage

Frequency

Infusion Time (hours)

Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

600 mg

Every 12 hours

1

5-14 days

Community-Acquired Bacterial Pneumonia (CABP)

600 mg

Every 12 hours

1

5-7 days

The recommended dosage of TEFLARO in patients with renal impairment is described in the table below. Estimated CrCla (mL/min)

Recommended Dosage Regimen for TEFLARO

>50

No dosage adjustment necessary

>30 to ≤50

400 mg IV (over 1 hour) every 12 hours

≥15 to ≤30

300 mg IV (over 1 hour) every 12 hours

End-stage renal disease, including hemodialysisb

200 mg IV (over 1 hour) every 12 hoursc

Creatinine clearance (CrCl) estimated using the Cockcroft-Gault formula. End-stage renal disease is defined as CrCl 2% of patients receiving TEFLARO in the pooled Phase 3 clinical trials were diarrhea, nausea, and rash. Drug Interactions No clinical drug-drug interaction studies have been conducted with TEFLARO. There is minimal potential for drugdrug interactions between TEFLARO and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow. Use in Specific Populations TEFLARO has not been studied in pregnant women. Therefore, TEFLARO should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is not known whether ceftaroline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TEFLARO is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established. Because elderly patients, those ≥65 years of age, are more likely to have decreased renal function and ceftaroline is excreted primarily by the kidney, care should be taken in dose selection in this age group and it may be useful to monitor renal function. Dosage adjustment for elderly patients should therefore be based on renal function. Dosage adjustment is required in patients with moderate (CrCl >30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/min) renal impairment and in patients with end-stage renal disease (CrCl