Included in CMS/JCAHO Core Measures for CAP*

(1)

Forest Laboratories, Inc.

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

TEFLARO

®

Billing and Coding Guide

Included in CMS/JCAHO Core Measures for CAP*

* 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.

All Claims:

Verify that the patient’s identification number and all other information are entered correctly. Ensure that the patient’s name and address match the insurer’s records.

Verify that the provider’s National Provider Identifier Number(s) is included on the claim.

Use the most appropriate ICD-9-CM diagnosis codes associated with each individual patient’s diagnosis and care. Ensure the medical record contains appropriate documentation to support the diagnosis and procedure codes submitted on the claim.

When billing for drugs, ensure the following information is provided on the claim form if required by the payor: — Name of the drug, HCPCS code, and 11-digit NDC number

— Frequency of administration — Route of administration — Number of units administered

Use the correct CPT and/or HCPCS codes and modifiers where and when appropriate that best describe the treatment provided.

Indicate the setting where the service was provided (eg, physician office, hospital outpatient, or home). File the claim in a timely fashion.

Provide complete and accurate information upon request.

(2)

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:

Information current as of January 2012.

TEFLARO

®

(ceftaroline fosamil)

Indications and Usage Dosage and Administration Storage Information

Important Safety Information Full Prescribing Information

Checklist for Claim Submission

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 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

2 3

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.

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

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.

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

(3)

Indications and Usage

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

Community-Acquired Bacterial Pneumonia: TEFLARO is indicated for the treatment of

community-acquired 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.

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

methicillin-susceptible 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.

TEFLARO

®

Please see Important Safety Information on the following pages and enclosed

full Prescribing Information.

Dosage and Administration

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.

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

Storage

TEFLARO vials should be stored refrigerated at 2°C to 8°C (36°F to 46°F). Unrefrigerated, unreconstituted TEFLARO can be stored at temperatures not exceeding 25ºC (77ºF) for no more than 7 days.

Studies have shown that the constituted solution in the infusion bag should be used within 6 hours when stored at room temperature or within 24 hours when stored under refrigeration at 2°C to 8°C (36°F to 46°F).

Recommended Duration

Infusion Time of Total Antimicrobial

Infection Dosage Frequency (hours) Treatment

Acute Bacterial Skin and 600 mg Every 12 hours 1 5-14 days Skin Structure Infection

(ABSSSI)

Community-Acquired 600 mg Every 12 hours 1 5-7 days Bacterial Pneumonia (CABP)

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 hours}c

a_{Creatinine clearance (CrCl) estimated using the Cockcroft-Gault formula.} b_{End-stage renal disease is defined as CrCl <15 mL/min.}

c_{TEFLARO is hemodialyzable; thus TEFLARO should be administered after hemodialysis on hemodialysis days.}

(4)

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.

6

Important Safety Information

Contraindications

TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.

Warnings and Precautions Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported with beta-lactam antibacterials. Before therapy with TEFLARO is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. If this product is to be given to a penicillin- or other beta-lactam-allergic patient, caution should be exercised because cross sensitivity among beta-lactam antibacterial agents has been clearly established.

If an allergic reaction to TEFLARO occurs, the drug should be discontinued. Serious acute hypersensitivity (anaphylactic) reactions require emergency treatment with epinephrine and other emergency measures that may include airway management, oxygen, intravenous fluids, antihistamines, corticosteroids, and vasopressors as clinically indicated.

Clostridium difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including TEFLARO, and may range in severity from mild diarrhea to fatal colitis. 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 suspected or confirmed, antibacterials not directed against C. difficile

should be discontinued, if possible.

Direct Coombs’ Test Seroconversion

Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of patients receiving TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled Phase 3 trials. No adverse reactions representing hemolytic anemia were reported in any treatment group. If anemia develops during or after treatment with TEFLARO, drug-induced hemolytic anemia should be considered. If drug-induced hemolytic anemia is suspected, discontinuation of TEFLARO should be considered and supportive care should be administered to the patient if clinically indicated.

TEFLARO

7

Development of Drug-Resistant Bacteria

Prescribing TEFLARO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

In the four pooled Phase 3 clinical trials, serious adverse events occurred in 98/1300 (7.5%) of patients receiving TEFLARO and 100/1297 (7.7%) of patients receiving comparator drugs. Treatment discontinuation due to adverse events occurred in 35/1300 (2.7%) of patients receiving TEFLARO and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse events leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the TEFLARO group and 0.5% in the comparator group.

No adverse reactions occurred in greater than 5% of patients receiving TEFLARO. The most common adverse reactions occurring in >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 drug- drug 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 <15 mL/min).

The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established.

(5)

TEFLARO Reimbursement

Coding

ICD-9-CM Diagnosis Codes Providers should use current ICD-9-CM codes to report a patient’s diagnosis on claim submissions. Correct coding is the responsibility of the provider submitting a claim for the item or service. Please check with the payor to verify coding or special billing requirements. Below is a list of possible ICD-9-CM diagnosis codes that may be reasonably related to a diagnosis within the product’s approved label:

We recommend verifying a health plan’s coding policies prior to contacting the Forest Reimbursement Hotline. Note: Information in parentheses added for clarification.

ICD-9-CM Diagnosis Code1 _Description

481-482.XX Diseases of the respiratory system—bacterial pneumonia-designated pathogens only

680.XX-686.XX Infections of skin and subcutaneous tissue (designated pathogens limited to ABSSSI)

041.09 Other Streptococcus (use for Streptococcus pyogenes and

Streptococcus agalactiae only)

041.11 Methicillin-susceptible Staphylococcus aureus (MSSA)

041.12 Staphylococcus aureus (methicillin-resistant Staphylococcus aureus [MRSA]) 041.30 Klebsiella pneumoniae (skin infection)

041.4 Escherichia coli (skin infection)

041.89 Other Gram-negative organisms (use for Klebsiella oxytoca only) 998.5X Postoperative infection

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.

ICD-9-CM Procedure Codes Providers should use current ICD-9-CM procedure codes to report a major procedure when it is performed in the hospital inpatient setting. At least one ICD-9-CM procedure code is required on hospital inpatient claims along with the appropriate diagnosis codes. Correct coding is the responsibility of the provider submitting a claim for the item or service. Please check with the payor to verify coding or special billing requirements. Below is an example of a possible ICD-9-CM procedure code related to a procedure performed within the product’s approved label:

National Drug Codes (NDCs) NDCs help physicians and payors identify specific product package sizes. TEFLARO is supplied in single-use, clear glass vials containing either 600 mg or 400 mg of sterile ceftaroline fosamil powder. The NDC numbers for TEFLARO are listed below:

Some payors require physicians to use 11-digit NDCs when submitting a drug on a claim form. Converting the 10-digit NDC for TEFLARO to an 11-digit NDC requires the use of a leading zero in the product code section of the NDC (ie, the middle section):

TEFLARO Package Size NDC

600 mg individual vial 0456-0600-01 Carton containing 10 vials 0456-0600-10

TEFLARO TEFLARO 11-Digit NDC

10-Digit NDC With Leading Zero

0456-0600-01 0456-00600-01

TEFLARO Package Size NDC

400 mg individual vial 0456-0400-01 Carton containing 10 vials 0456-0400-10

ICD-9-CM Procedure Code1 _Description

99.21 Injection of antibiotic

1_{Centers for Medicare and Medicaid Services. ICD-9 Provider Diagnostic and Procedure Codes. Downloads:}

Version 29 Full and Abbreviated Code Titles – Effective October 1, 2011. V29 LONG_SHORT_DX070710 file. Information available on http://www.cms.gov/ICD9ProviderDiagnosticCodes/06_codes.asp. Accessed December 16, 2011.

10-Digit 11-Digit NDC Example

NDC Example With Leading Zero

(6)

10

TEFLARO Reimbursement

Healthcare Common Procedure Coding System (HCPCS) Level II Code HCPCS codes are 5-digit

alphanumeric codes that are assigned to drugs by the Centers for Medicare*_{and Medicaid Services (CMS).}

When billing for a drug, payors require physicians to indicate, on the claim, the quantity of product administered to the patient, expressed in the number of units described by the HCPCS code.

CMS has assigned TEFLARO a new, unique J-Code: J0712. This code is effective January 1, 2012 and should

be used for reimbursement of services provided in hospital outpatient settings, physician office settings, and freestanding IV infusion centers. Note that CMS discontinued and deleted HCPCS Code C9282 for TEFLARO and replaced it with the permanent HCPCS Code J0712.

Billing for Multiple Doses in a Single Day In the outpatient settings in which TEFLARO is covered under Medicare Part B (ie, hospital outpatient, physician offices, and freestanding IV infusion centers), the two administered doses should be billed at the same time. The medical necessity for the two doses needs to be documented on the billing form (ie, the patient has one of the indicated conditions and dosing regimen is called for by the label). Clinics should refer to the TEFLARO label for appropriate dosing.

2012 TEFLARO HCPCS Code Description Setting of Care

J0712 Injection, ceftaroline fosamil, 10 mg Outpatient (Medicare) C9282 No longer applicable as of

January 1, 2012 (Use J0712)

Information to Include With Use of HCPCS Codes

NDC Drug name Dose of product

Quantity administered Route of administration Packaging (eg, single-dose vial)

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.

* Commercial payors and state Medicaid programs may also require use of the permanent J-code and/or NDC. Please review the criteria for each specific plan to identify if a J-code is necessary for billing and coding.

__

__ __ __

1 2 4 TYPEOF BILL

FROM THROUGH

5 FED. TAX NO.

a b c d DX ECI 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 A B C A B C D E F G H I J K L M N O P Q a b c a b c d

ADMISSION CONDITION CODES

DATE

OCCURRENCE OCCURRENCE OCCURRENCE OCCURRENCE SPAN OCCURRENCESPAN

CODE DATE CODE CODE CODE DATE CODE THROUGH

VALUE CODES VALUECODES VALUE CODES

CODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE NPI

CODE DATE CODE DATE CODE DATE

FIRST

c.CODE DATEd. DATE e. OTHER PROCEDURE NPI FIRST NPI b LAST FIRST c NPI d LAST FIRST UB-04 CMS-1450 7

10 BIRTHDATE 11 SEX 12 13 HR 14 TYPE 15 SRC

DATE 16 DHR 181920 FROM 212223 25262728 CODE FROM DATE OTHER PRV ID

THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF. b . INFOBEN. CODE OTHER PROCEDURE THROUGH 29 ACDT 30 32 31 33 34 35 36 37 38 39 40 41

42 REV. CD.43 DESCRIPTION 45 SERV. DATE 46 SERV. UNITS 47 TOTALCHARGES 48NON-COVERED CHARGES49

52 REL

51 HEALTH PLAN ID 53 ASG. 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI

57

58 INSURED’S NAME 59 P.REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO.

64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME

6667 68 69 ADMIT 70 PATIENT 72 73 74 75 76 ATTENDING 80 REMARKS OTHER PROCEDURE a 77 OPERATING 78 OTHER 79 OTHER 81CC CREATIONDATE 3a PAT. CNTL # 24 b. MED. REC. #

44 HCPCS / RATE / HIPPS CODE

PAGE OF

APPROVED OMB NO.

e a

8 PATIENT NAME

50 PAYER NAME

63 TREATMENT AUTHORIZATION CODES

6 STATEMENT COVERS PERIOD 9 PATIENT ADDRESS 17 STAT STATE DX REASON DX 71 PPS CODE QUAL LAST LAST National Uniform Billing Committee NUBC™ OCCURRENCE QUAL QUAL QUAL LIC9213257 CODE DATE A B C A B C A B C A B C A B C __ __ __ __ 1 2 4 TYPE OF BILL FROM THROUGH 5 FED. TAX NO.

ADMISSION CONDITION CODES DATE

CODE DATE CODE CODE CODE DATE CODE THROUGH VALUE CODES VALUECODES VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE NPI CODE DATE CODE DATE CODE DATE

FIRST

c.CODE DATEd. DATE e. OTHER PROCEDURE NPI

FIRST NPI b LAST FIRST c NPI d LAST FIRST UB-04 CMS-1450 7 10 BIRTHDATE 11 SEX12 13 HR 14 TYPE 15 SRC

DATE 16 DHR 181920 FROM 212223 25262728 CODE FROM DATE OTHER PRV ID

THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF. b . INFO BEN. CODE OTHER PROCEDURE THROUGH 29 ACDT 30 32 31 33 34 35 36 37 38 39 40 41

42 REV. CD.43 DESCRIPTION 45 SERV. DATE 46 SERV. UNITS 47 TOTALCHARGES 48NON-COVERED CHARGES49

52 REL

51 HEALTH PLAN ID 53 ASG.54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI 57 58 INSURED’S NAME 59 P. REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO.

64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME 66 67 68 69 ADMIT 70 PATIENT 72 73 74 75 76 ATTENDING 80 REMARKS OTHER PROCEDURE a 77 OPERATING 78 OTHER 79 OTHER 81CC CREATIONDATE 3a PAT. CNTL # 24 b. MED. REC. #

44 HCPCS / RATE / HIPPS CODE

PAGE OF

APPROVED OMB NO.

e a

8 PATIENT NAME

50 PAYER NAME

6 STATEMENT COVERS PERIOD 9 PATIENT ADDRESS 17 STAT STATE DX REASON DX 71 PPS CODE QUAL LAST LAST National Uniform Billing Committee NUBC™ OCCURRENCE QUAL QUAL QUAL LIC9213257 CODE DATE A B C A B C A B C A B C A B C __ __ __ __ 1 2 4 TYPE OF BILL FROM THROUGH 5 FED. TAX NO.

a b c d DX ECI 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 A B C

A

B

C

D

E

F

G

H

I

J

K

L

M

N

O

P

Q

a

b

c

a b c d

ADMISSION CONDITION CODES

DATE

VALUE CODES VALUECODES VALUE CODES

CODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE _NPI

CODE DATE CODE DATE CODE DATE

FIRST

c. d. e. OTHER PROCEDURE _NPI

CODE DATE DATE

FIRST NPI b LAST FIRST c NPI d LAST FIRST UB-04 CMS-1450 7

10 BIRTHDATE _{11 SEX 12} _{13 HR 14 TYPE 15 SRC}

DATE 16DHR ₁₈ ₁₉ ₂₀ FROM 21 22 23 25 26 27 28 CODE FROM DATE OTHER PRV ID

42 REV. CD. 43 DESCRIPTION 45 SERV. DATE 46 SERV. UNITS 47 TOTALCHARGES 48NON-COVERED CHARGES 49

52 REL

51 HEALTH PLAN ID 53 ASG._{54 PRIOR PAYMENTS} _{55 EST. AMOUNT DUE} _{56 NPI}

57

66

67

68 69 ADMIT 70 PATIENT 72 73 74 75 _{76 ATTENDING} 80 REMARKS OTHER PROCEDURE a 77 OPERATING 78 OTHER 79 OTHER 81CC CREATIONDATE 3a PAT. CNTL # 24 b. MED. REC. #

44 HCPCS / RATE / HIPPS CODE

PAGE OF

APPROVED OMB NO.

e a

8 PATIENT NAME

50 PAYER NAME

6 STATEMENT COVERS PERIOD

9 PATIENT ADDRESS 17STAT _STATE DX REASON DX 71 PPS CODE QUAL LAST LAST National Uniform Billing Committee NUBC™ OCCURRENCE QUAL QUAL QUAL LIC9213257 CODE DATE A B C A B C A B C A B C A B C J0712 J0712 JW [no. of units] [no. of units] 11

Billing for Wastage Physicians and hospitals are expected to schedule patients in such a way that they can use drugs most efficiently, in a clinically appropriate manner. Drug wastage may be documented in the patient’s medical record with the date, time, amount wasted, and reason for wastage. Each payor may have different policies regarding drug wastage and may require physicians and hospitals to include the amount of product administered and the amount discarded when line-item billing for TEFLARO. It is recommended to verify the drug wastage requirements of the specific health plan. Finally, some payors request that physicians and hospitals identify any discarded product by appending the JW modifier to the claim.

— Example TEFLARO CMS-1450 HCPCS Billing for Wasted Product:

Enter appropriate number of service units:

Using J0712, report the number of units of TEFLARO used To report the number of units of TEFLARO wasted, append

(7)

1a. INSURED’S I.D. NUMBER (For Program in Item 1) 4. INSURED’S NAME (Last Name, First Name, Middle Initial) 7. INSURED’S ADDRESS (No., Street)

CITY STATE

ZIP CODE TELEPHONE (Include Area Code) 11. INSURED’S POLICY GROUP OR FECA NUMBER a. INSURED’S DATE OF BIRTH b. EMPLOYER’S NAME OR SCHOOL NAME

d. IS THERE ANOTHER HEALTH BENEFIT PLAN? 13. INSURED’S OR AUTHORIZED PERSON’S SIGNATURE I authorize

payment of medical benefits to the undersigned physician or supplier for services described below.

SEX

F HEALTH INSURANCE CLAIM FORM

OTHER 1. MEDICARE MEDICAID TRICARE CHAMPVA

READ BACK OF FORM BEFORE COMPLETING & SIGNING THIS FORM.

12. PATIENT’S OR AUTHORIZED PERSON’S SIGNATURE I authorize the release of any medical or other information necessary to process this claim. I also request payment of government benefits either to myself or to the party who accepts assignment below.

SIGNED DATE

ILLNESS (First symptom) OR INJURY (Accident) OR PREGNANCY(LMP)

MM DD YY 15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS. GIVE FIRST DATEMM DD YY 14. DATE OF CURRENT:

19. RESERVED FOR LOCAL USE

21. DIAGNOSIS OR NATURE OF ILLNESS OR INJURY (Relate Items 1, 2, 3 or 4 to Item 24E by Line)

From MM DD YY To MM DD YY 1 2 3 4 5 6

25. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 27. ACCEPT ASSIGNMENT? (For govt. claims, see back) 31. SIGNATURE OF PHYSICIAN OR SUPPLIER

INCLUDING DEGREES OR CREDENTIALS (I certify that the statements on the reverse apply to this bill and are made a part thereof.)

SIGNED DATE SIGNED MM DD YY FROM TO FROM TO MM DD YY MM DD YY MM DD YY MM DD YY

CODE ORIGINAL REF. NO.

$ CHARGES

28. TOTAL CHARGE 29. AMOUNT PAID30. BALANCE DUE $ $ $

PICA PICA

2. PATIENT’S NAME (Last Name, First Name, Middle Initial) 5. PATIENT’S ADDRESS (No., Street)

CITY STATE

ZIP CODE TELEPHONE (Include Area Code) 9. OTHER INSURED’S NAME (Last Name, First Name, Middle Initial) a. OTHER INSURED’S POLICY OR GROUP NUMBER b. OTHER INSURED’S DATE OF BIRTH c. EMPLOYER’S NAME OR SCHOOL NAME d. INSURANCE PLAN NAME OR PROGRAM NAME

YES NO ( )

If yes, return to and complete item 9 a-d. 16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION 18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES 20. OUTSIDE LAB? $ CHARGES 22. MEDICAID RESUBMISSION 23. PRIOR AUTHORIZATION NUMBER MM DD YY

CARRIER

PATIENT AND INSURED INFORMATION

PHYSICIAN OR SUPPLIER INFORMATION

M F YES NO YES NO 1. 3. 2. 4. DATE(S) OF SERVICE PLACE OF SERVICE

PROCEDURES, SERVICES, OR SUPPLIES (Explain Unusual Circumstances) CPT/HCPCS MODIFIER DIAGNOSIS POINTER F M SEX MM DD YY YES NO YES NO YES NO PLACE (State) GROUP HEALTH PLANFECA

BLK LUNG

Single Married Other 3. PATIENT’S BIRTH DATE 6. PATIENT RELATIONSHIP TO INSURED 8. PATIENT STATUS

10. IS PATIENT’S CONDITION RELATED TO: a. EMPLOYMENT? (Current or Previous) b. AUTO ACCIDENT? c. OTHER ACCIDENT? 10d. RESERVED FOR LOCAL USE

Employed Student Student Self Spouse Child Other (Medicare #) (Medicaid #) (Sponsor’s SSN) (Member ID#) (SSN or ID) (SSN) (ID)

( ) M SEX DAYSOR UNITS F. H.I. J. 24. A. B.C.D. E. PROVIDER ID. # 17. NAME OF REFERRING PROVIDER OR OTHER SOURCE 17a.

EMG RENDERING

32. SERVICE FACILITY LOCATION INFORMATION 33. BILLING PROVIDER INFO & PH #

NUCC Instruction Manual available at: www.nucc.org

c. INSURANCE PLAN NAME OR PROGRAM NAME Full-Time Part-Time 17b. NPI a. b. a. b. NPI NPI NPI NPI NPI NPI APPROVED BY NATIONAL UNIFORM CLAIM COMMITTEE 08/05

G. EPSDT Family PlanID. QUAL. NPI NPI CHAMPUS ( ) 1500

APPROVED OMB-0938-0999 FORM CMS-1500 (08-05)

CITY STATE

ZIP CODE TELEPHONE (Include Area Code) 11. INSURED’S POLICY GROUP OR FECA NUMBER a. INSURED’S DATE OF BIRTH b. EMPLOYER’S NAME OR SCHOOL NAME

SEX

F HEALTH INSURANCE CLAIM FORM

SIGNED DATE

MM DD YY 15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS. GIVE FIRST DATEMM DD YY 14. DATE OF CURRENT:

From MM DD YY To MM DD YY 1 2 3 4 5 6

25. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 27. ACCEPT ASSIGNMENT? (For govt. claims, see back) 31. SIGNATURE OF PHYSICIAN OR SUPPLIER

SIGNED DATE SIGNED MM DD YY FROM TO FROM TO MM DD YY MM DD YY MM DD YY MM DD YY

$ CHARGES

28. TOTAL CHARGE 29. AMOUNT PAID30. BALANCE DUE $ $ $

PICA PICA

CITY STATE

YES NO ( )

If yes, return to and complete item 9 a-d. 16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION 18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES 20. OUTSIDE LAB? $ CHARGES 22. MEDICAID RESUBMISSION 23. PRIOR AUTHORIZATION NUMBER MM DD YY

CARRIER

M F YES NO YES NO 1. 3. 2. 4. DATE(S) OF SERVICE PLACE OF SERVICE

PROCEDURES, SERVICES, OR SUPPLIES (Explain Unusual Circumstances) CPT/HCPCS MODIFIER DIAGNOSIS POINTER F M SEX MM DD YY YES NO YES NO YES NO PLACE (State) GROUP HEALTH PLANFECA

BLK LUNG

Employed Student Student Self Spouse Child Other (Medicare #) (Medicaid #) (Sponsor’s SSN) (Member ID#) (SSN or ID) (SSN) (ID)

( ) M SEX DAYSOR UNITS F. H.I. J. 24. A. B.C.D. E. PROVIDER ID. # 17. NAME OF REFERRING PROVIDER OR OTHER SOURCE 17a.

EMG RENDERING

G. EPSDT Family PlanID. QUAL. NPI NPI CHAMPUS ( ) 1500

APPROVED OMB-0938-0999 FORM CMS-1500 (08-05)

1a. INSURED’S I.D. NUMBER (For Program in Item 1)

4. INSURED’S NAME (Last Name, First Name, Middle Initial)

7. INSURED’S ADDRESS (No., Street)

CITY STATE

ZIP CODE TELEPHONE (Include Area Code)

11. INSURED’S POLICY GROUP OR FECA NUMBER

a. INSURED’S DATE OF BIRTH

b. EMPLOYER’S NAME OR SCHOOL NAME

d. IS THERE ANOTHER HEALTH BENEFIT PLAN?

13. INSURED’S OR AUTHORIZED PERSON’S SIGNATURE I authorize payment of medical benefits to the undersigned physician or supplier for services described below.

SEX

F

HEALTH INSURANCE CLAIM FORM

OTHER 1. MEDICARE MEDICAID TRICARE CHAMPVA

SIGNED DATE

MM DD YY 15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS.GIVE FIRST DATE MM DD YY 14. DATE OF CURRENT:

From MM DD YY MM DD YYTo 1 2 3 4 5 6

25. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 27. ACCEPT ASSIGNMENT?(For govt. claims, see back)

31. SIGNATURE OF PHYSICIAN OR SUPPLIER INCLUDING DEGREES OR CREDENTIALS (I certify that the statements on the reverse apply to this bill and are made a part thereof.)

SIGNED DATE SIGNED MM DD YY FROM TO FROM TO MM DD YY MM DD YY MM DD YY MM DD YY

$ CHARGES

28. TOTAL CHARGE 29. AMOUNT PAID 30. BALANCE DUE $ $ $

PICA PICA

2. PATIENT’S NAME (Last Name, First Name, Middle Initial)

5. PATIENT’S ADDRESS (No., Street)

CITY STATE

ZIP CODE TELEPHONE (Include Area Code)

9. OTHER INSURED’S NAME (Last Name, First Name, Middle Initial)

a. OTHER INSURED’S POLICY OR GROUP NUMBER

b. OTHER INSURED’S DATE OF BIRTH

c. EMPLOYER’S NAME OR SCHOOL NAME

d. INSURANCE PLAN NAME OR PROGRAM NAME

YES NO

( )

If yes, return to and complete item 9 a-d.

16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION

18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES

20. OUTSIDE LAB? $ CHARGES

22. MEDICAID RESUBMISSION

23. PRIOR AUTHORIZATION NUMBER MM DD YY

CARRIER

M F YES NO YES NO 1. 3. 2. 4. DATE(S) OF SERVICE PLACE OF SERVICE

PROCEDURES, SERVICES, OR SUPPLIES (Explain Unusual Circumstances) CPT/HCPCS MODIFIER DIAGNOSIS POINTER F M SEX MM DD YY YES NO YES NO YES NO PLACE (State) GROUP

HEALTH PLAN FECABLK LUNG

Single Married Other 3. PATIENT’S BIRTH DATE

6. PATIENT RELATIONSHIP TO INSURED

8. PATIENT STATUS

10. IS PATIENT’S CONDITION RELATED TO:

a. EMPLOYMENT? (Current or Previous)

b. AUTO ACCIDENT?

c. OTHER ACCIDENT?

10d. RESERVED FOR LOCAL USE Employed Student Student

Self Spouse Child Other (Medicare #) (Medicaid #) (Sponsor’s SSN) (Member ID#) (SSN or ID) (SSN) (ID)

( ) M SEX DAYS OR UNITS F. H. I. J. 24. A. B. C. D. E. PROVIDER ID. # 17. NAME OF REFERRING PROVIDER OR OTHER SOURCE 17a.

EMG RENDERING

G. EPSDT Family Plan ID. QUAL. NPI NPI CHAMPUS ( ) 1500

APPROVED OMB-0938-0999 FORM CMS-1500 (08-05)

— Example TEFLARO CMS-1500 Claim Form HCPCS Billing for Wasted Product:

— For more information on product wastage billing requirements, please contact the Forest Reimbursement Hotline at: 1-855-284-1818

TEFLARO Reimbursement

J0712

J0712 J W

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.

Current Procedural Terminology (CPT) Drug Administration Code CPT codes are 5-digit numeric codes established

by the American Medical Association (AMA) that describe professional medical procedures and services. TEFLARO is administered every 12 hours as an intravenous (IV) infusion over 1 hour. The following possible CPT codes may be appropriate to report TEFLARO administration services based on site of service:

Revenue Codes Revenue codes capture facility cost data by department, which the facility uses for cost-reporting purposes. Some payors request that providers report revenue codes on claim forms. Hospital outpatient departments

may report the following possible revenue codes for TEFLARO2_:

— Payors may require physicians to report a different drug administration code when billing for TEFLARO. It is recommended to verify a health plan’s coding policies. The Forest Reimbursement Hotline can provide healthcare professionals with answers to general questions about TEFLARO coverage and reimbursement at: 1-855-284-1818

CPT Code Description

96365 IV infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour 99601 Home infusion/specialty drug administration, per visit (up to 2 hours)

Revenue Code Description

0250 General pharmacy

0260 Intravenous therapy, general 0636 Drugs requiring detailed coding

2_{Hospital Outpatient PPS. Revenue codes. Revenue Code to Cost Center Crosswalk. Information available}

(8)

14

Payor Coverage

Medicare

— TEFLARO is likely to be eligible for coverage under Medicare Part A when it is used in the hospital inpatient setting of care, if the drug represents a cost to the hospital, and the drug is reasonable and necessary for the diagnosis or treatment of the illness or injury for which it is administered, according to accepted standards of medical practice

— TEFLARO may be covered by Medicare Part A when it is used in a Skilled Nursing Facility (SNF) if: the drug represents a cost to the SNF; is necessary for the diagnosis or treatment of the illness or injury for which it is administered, according to accepted standards of medical practice; and the patient meets the eligibility requirements. The SNF eligibility requirements include that a patient must have been an inpatient of a hospital for a medically necessary stay of at least three consecutive calendar days, and must have been transferred to a participating SNF within 30 days after hospital discharge. In order to be covered, the extended-care services received must be needed for a condition which was treated during the patient’s qualifying hospital stay, or for a condition which arose while in the SNF for treatment of a condition for which the beneficiary was previously treated in a hospital. If all of these requirements are met regarding treatment, TEFLARO is likely to be eligible for coverage under

Medicare Part A3

— Drugs administered by a physician, in either the physician’s office or a freestanding clinic, which represent a cost to the physician’s practice, are generally covered under Medicare Part B if (1) they are reasonable and necessary for the diagnosis or treatment of the illness or injury for which they are administered, according to accepted standards of medical practice; (2) they are not usually self-administered; and (3) they meet the requirements for coverage of items as incident to a physician’s service. The general requirements for coverage under the “incident to” provision are that the drug be of a form that is not usually self-administered, that the drug be furnished by a physician, and that the drug must be administered by a physician or by auxiliary personnel employed by the physician and

under the physician’s personal supervision.4_{Based on these criteria, drugs such as TEFLARO, when}

administered by physicians in either the physician’s office or freestanding clinic, are likely to be eligible for Medicare Part B coverage and payment

TEFLARO Reimbursement

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.

15

— TEFLARO may be covered by Medicare Part B when administered in a hospital outpatient department if the drug represents a cost to the hospital; is reasonable and necessary for the diagnosis or treatment of an illness or injury for which it is administered, according to accepted standards of medical practice; and is not usually self-administered

— Medicare has not issued a unique National Coverage Determination (NCD) for TEFLARO. Local Medicare administrative contractors (formerly Fiscal Intermediaries and Carriers) may make local coverage decisions (LCDs) for TEFLARO. Some local contractors may publish LCDs or other coverage instruction through articles and bulletins that relate to TEFLARO. However, the absence of a published coverage policy does not mean that

there is no coverage for TEFLARO5

— For more information on Medicare coverage of TEFLARO, contact the Forest Reimbursement Hotline at: 1-855-284-1818

Medicaid

— TEFLARO is eligible for coverage under most state Medicaid programs. However, coverage will vary from state to state as each Medicaid program establishes its own eligibility standards and determines the type, amount, duration, and scope of services. Some Medicaid programs may cover TEFLARO as a medical benefit, pharmacy benefit, or both. In addition, state Medicaid programs may apply coverage and utilization restrictions such as prior authorization

— For more information on Medicaid coverage of TEFLARO, contact the Forest Reimbursement Hotline at: 1-855-284-1818

Commercial Insurers

— Third-party payors, including HMO plans, managed care organizations, indemnity plans, and others may provide coverage for TEFLARO. However, specific coverage requirements and restrictions depend on a patient’s benefits and will vary based on plan type and provider site of service. Some payors establish formal published policies, but the lack of a published policy from a particular payor does not mean that TEFLARO is not covered by that payor. In addition, commercial payors may cover physician-administered drugs as a medical benefit, a pharmacy benefit, or both. Each benefit is administered separately and may have different deductible, co-payment, and/or coinsurance structures

— For more information on commercial coverage of TEFLARO, contact the Forest Reimbursement Hotline at: 1-855-284-1818

3_{Medicare Claims Processing Manual, Chapter 6, Section 10.}

4_{See the Medicare Benefits Policy Manual, Chapter 15, section 50 for further information.}

5_{Medicare Benefits Policy Manual, Chapter 15, Section 50. Information available on http://www.cms.}

gov/Manuals/IOM/itemdetail.asp?filterType=none&filterByDID=99&sortByDID=1&sortOrder= ascending&itemID=CMS012673&intNumPerPage=10. Accessed September 26, 2010.

(9)

Payor Reimbursement

Medicare Part A

— TEFLARO Hospital Inpatient Department Services paid under the Medicare Hospital Inpatient

Prospective Payment System (PPS) are assigned to a Medicare Severity Diagnosis Related Group (MS-DRG). Each MS-DRG is linked to a payment amount that represents the payment for all services provided during a patient’s stay in the hospital. The cost of treatment for TEFLARO is bundled into the

MS-DRG payment and is not eligible for separate reimbursement from Medicare in the inpatient setting6

— TEFLARO Skilled Nursing Facility SNF services are paid by Medicare under a prospective payment

system (PPS). The SNF PPS bundles all services into a per diem rate, which includes most administered drugs. Payment for TEFLARO would be bundled into the per diem rate and is not eligible for separate

reimbursement from Medicare in the Skilled Nursing Facility Setting7

— TEFLARO Administration Services: Hospital Inpatient Department Medicare Part A reimbursement

for TEFLARO drug administration services provided in the hospital inpatient setting is bundled into the MS-DRG PPS payment. The cost of treatment for TEFLARO is bundled into the MS-DRG payment and is not eligible for separate reimbursement from Medicare in the inpatient setting

— TEFLARO Administration Services: Skilled Nursing Facility Medicare Part A reimbursement for

TEFLARO drug administration services provided in the Skilled Nursing Facility setting is bundled into the SNF PPS payment. The cost of treatment for TEFLARO is bundled into the SNF PPS payment and is not eligible for separate reimbursement from Medicare in the Skilled Nursing Facility setting

TEFLARO Reimbursement

6_{Medicare Claims Processing Manual, Chapter 3, Section 20.} 7_{Medicare Claims Processing Manual, Chapter 6, Section 10.}

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.

Medicare Part B Payment for TEFLARO and related administration services will vary by setting of care. — TEFLARO Physician Clinic For most physician-administered products eligible for Medicare coverage,

Medicare sets an allowable payment amount, updated quarterly, at Average Sales Price (ASP) +6%.8,9

Medicare reimbursement is based on the lesser of this allowable amount or actual charges as follows: physician clinics are reimbursed for 80% of the allowable amount, and the patient or patient’s secondary

insurer is responsible for the remaining 20% coinsurance10

— TEFLARO: Hospital Outpatient Department Services paid under the Medicare Hospital Outpatient

Prospective Payment System (OPPS) are assigned to an Ambulatory Payment Classification (APC) code. Each APC code is linked to a payment amount. Multiple APCs may be billed per single patient encounter. Certain newly FDA-approved drugs and biologics may be granted transitional pass-through status and a unique C-code, with the drug being reimbursed at ASP +6%, if CMS deems these drugs new for Medicare purposes. In addition, separate payments are made for some drugs, biologicals, and devices. Most drugs that do not have pass-through status, and are separately reimbursed by Medicare under the APC system, are paid at ASP +4% in 2012 and adjusted quarterly. TEFLARO has been granted pass-through status for

Calendar Year (CY) 2012. As a result, in CY 2012 TEFLARO will be reimbursed at ASP +6%.11

8_{The ASP is calculated quarterly based on data sent to CMS from the manufacturers within 30 days of the close of the quarter. Since CMS releases}

ASP pricing information 30 days before the beginning of each calendar quarter, the ASP data from one quarter will not be able to factor into the very next quarter. Contractors may contact CMS for payment limits on new drugs not included in the quarterly ASP or Not Otherwise Classified (NOC) files available on the CMS website. If the payment limit is available, contractors will substitute the limit provided by

CMS for the pricing based on WAC or invoice pricing. For more information, refer to Medicare Claims Processing Manual, Chapter 17, Sections 20.1.2, 20.1.3, and 20.2 and visit http://www.cms. gov/McrPartBDrugAvgSalesPrice/01_overview.asp#TopOfPage. Accessed September 28, 2010.

9_{Medicare Claims Processing Manual, Chapter 17, Section 20.1.3.}

10 _{Medicare Part B (Medical Insurance). Information available on http://www.medicare.gov/navigation/}

medicare-basics/medicare-benefits/part-b.aspx. Accessed November 30, 2010.

11 _{Federal Register Vol 76, No 230, November 30, 2011. Hospital Outpatient Prospective Payment System}

(10)

18

— TEFLARO Administration Services: Physician Medicare reimbursement for TEFLARO drug

administration services provided in the physician setting is based on the national physician fee schedule that is adjusted for geographic variations and updated annually. Medicare reimbursement is based on the lesser of the adjusted fee schedule amount or actual charges as follows: physicians are reimbursed for 80% of the allowable amount, and the patient or patient’s secondary insurer is

responsible for the remaining 20% coinsurance12

— TEFLARO Administration Services: Hospital Outpatient Department Drug administration CPT codes

are assigned to APCs according to their clinical and resource requirements. Several drug administration codes may map to a single APC. APCs for drug administration services are updated yearly by CMS For more information on Medicare reimbursement for TEFLARO, contact the Forest Reimbursement Hotline at: 1-855-284-1818.

Medicaid Medicaid payment for TEFLARO and associated drug administration services typically varies by setting of care. Also, Medicaid is always the payor of last resort; therefore, it is secondary to Medicare or any third party that may be liable for medical payments or medical support on the beneficiary’s behalf.

— TEFLARO Physician Physician Reimbursement for TEFLARO provided in the physician office setting

varies by state Medicaid program. Some Medicaid programs may base reimbursement on ASP +4%. Others may base reimbursement on a percent mark-up or mark-down of ASP, AWP, or WAC. Drug reimbursement rates may be updated on a monthly, quarterly, or yearly basis. Until the ASP is established for TEFLARO, Medicaid programs may utilize a temporary reimbursement rate such as WAC, similar

to Medicare. Drug administration rates vary by state Medicaid program, with many states basing

reimbursement on a statewide fee schedule that may be updated on a quarterly or annual basis

— TEFLARO Facility such as Hospital Outpatient Department, Hospital Inpatient Department, or Skilled

Nursing Facility Reimbursement for TEFLARO provided in hospital outpatient, hospital inpatient, or SNF settings also varies by state Medicaid program. For instance, payment may be based on a percentage of

ASP, AWP, WAC, or facility-specific cost-to-charge ratios. Drug administration rates may be based on a

fee schedule, contracted rates, cost-to-charge ratios, or facility-specific per diem methodologies For more information on Medicaid reimbursement for TEFLARO, contact the Forest Reimbursement Hotline at: 1-855-284-1818.

TEFLARO Reimbursement

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.

19

12 _{Medicare Part B (Medical Insurance). Information available on http://www.medicare.gov/navigation/}

medicare-basics/medicare-benefits/part-b.aspx. Accessed November 30, 2010.

Commercial Payors Many plans restrict patients to a select network of providers and have contractual arrangements with these “in-network” providers.

— TEFLARO Physician Commercial payor reimbursement for TEFLARO may be based on a percent mark-up of

ASP similar to Medicare reimbursement methodologies. Payment may also be based on a percent mark-up or mark-down of AWP or WAC. Until the ASP is established for TEFLARO, commercial payors may utilize a temporary

reimbursement rate such as WAC, similar to Medicare. Drug administration rates may be based on a common fee

schedule similar to Medicare’s physician fee schedule or on contracted rates

— TEFLARO Facility such as Hospital Outpatient Department, Hospital Inpatient Department, or Skilled

Nursing Facility Reimbursement for TEFLARO may be based on a percent mark-up of ASP similar to Medicare

reimbursement methodologies. Payment may also be based on a percent mark-up or mark-down of AWP or WAC or facility-specific cost-to-charge ratios. Until the ASP is established for TEFLARO, commercial payors may

utilize a temporary reimbursement rate such as WAC, similar to Medicare. Drug administration rates may be

based on a common fee schedule similar to the Medicare physician fee schedule, facility-specific cost-to- charge ratios, per diem methodologies, or other contracted rates

For more information on commercial payor reimbursement for TEFLARO, contact the Forest Reimbursement Hotline at: 1-855-284-1818.

(11)

CITY STATE ZIP CODE TELEPHONE (Include Area Code) 11. INSURED’S POLICY GROUP OR FECA NUMBER a. INSURED’S DATE OF BIRTH b. EMPLOYER’S NAME OR SCHOOL NAME

SEX

F HEALTH INSURANCE CLAIM FORM

READ BACK OF FORM BEFORE COMPLETING & SIGNING THIS FORM. 12. PATIENT’S OR AUTHORIZED PERSON’S SIGNATURE I authorize the release of any medical or other information necessary

to process this claim. I also request payment of government benefits either to myself or to the party who accepts assignment below.

SIGNED DATE ILLNESS (First symptom) OR

INJURY (Accident) OR PREGNANCY(LMP)

MM DD YY 15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS.GIVE FIRST DATEMM DD YY 14. DATE OF CURRENT:

From MM DD YY MM DD YYTo 1 2 3 4 5 6

25. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 27. ACCEPT ASSIGNMENT?(For govt. claims, see back)

31. SIGNATURE OF PHYSICIAN OR SUPPLIER INCLUDING DEGREES OR CREDENTIALS (I certify that the statements on the reverse apply to this bill and are made a part thereof.)

SIGNED DATE SIGNED MM DD YY FROM TO FROM TO MM DD YY MM DD YY MM DD YY MM DD YY

$ CHARGES

28. TOTAL CHARGE 29. AMOUNT PAID 30. BALANCE DUE $ $ $

PICA PICA

CITY STATE

YES NO

( )

If yes, return to and complete item 9 a-d.

16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION 18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES 20. OUTSIDE LAB? $ CHARGES 22. MEDICAID RESUBMISSION 23. PRIOR AUTHORIZATION NUMBER MM DD YY

CARRIER

M F YES NO YES NO 1. 3. 2. 4. DATE(S) OF SERVICE PLACE OF SERVICE

PROCEDURES, SERVICES, OR SUPPLIES (Explain Unusual Circumstances) CPT/HCPCS MODIFIER DIAGNOSIS POINTER F M SEX MM DD YY YES NO YES NO YES NO PLACE (State) GROUP

HEALTH PLAN FECABLK LUNG

Employed

Student Student Self Spouse Child Other (Medicare #) (Medicaid #) (Sponsor’s SSN) (Member ID#) (SSN or ID) (SSN) (ID)

( ) M SEX DAYS OR UNITS F. H. I. J. 24. A. B. C. D. E. PROVIDER ID. # 17. NAME OF REFERRING PROVIDER OR OTHER SOURCE 17a.

EMG RENDERING

G. EPSDT Family Plan ID. QUAL. NPI NPI CHAMPUS ( ) 1500

APPROVED OMB-0938-0999 FORM CMS-1500 (08-05)

PHYSICIAN OR SUPPLIER INFORMATION

NPI NPI NPI NPI 2 3 4 5 6

25. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 26. PATIENT’S ACCOUNT NO. 31. SIGNATURE OF PHYSICIAN OR SUPPLIER

SIGNED DATE

32. SERVICE FACILITY LOCATION INFORMATION

a. _NPI b.

CMS-1500 Claim Form—Physician

Note: For dual eligible claims (ie, claims for patients with both Medicare and Medicaid) and certain commercial claims, providers must include NDC information in positions 01-13 of box 24. See Medicare Claims Processing Manual, Chapter 26, available at http://www.cms.hhs.gov/manuals/downloads/clm104c26.pdf.

Medicare Administrative Contractors (MACs) may require additional information than what is indicated below. A best practice is to defer to a MAC’s billing and reimbursement guidelines to ensure timely and accurate payment.

SIGNED DATE ILLNESS (First symptom) OR

INJURY (Accident) OR PREGNANCY(LMP) MM DD YY

MM DD YY 15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS.GIVE FIRST DATE 14. DATE OF CURRENT:

21. DIAGNOSIS OR NATURE OF ILLNESS OR INJURY (Relate Items 1, 2, 3 or 4 to Item 24E by Line) 17. NAME OF REFERRING PROVIDER OR OTHER SOURCE 17a.

17b. NPIb. b. Box 21: Enter the appropriate ICD-9-CM diagnosis code.

11. INSURED’S POLICY GROUP OR FECA NUMBER

INSURED’S DATE OF BIRTH

EMPLOYER’S NAME OR SCHOOL NAME

IS THERE ANOTHER HEALTH BENEFIT PLAN? SEX DD

DD YY

PATIENT AND INSURED INFORMATION

M F

( )

c. INSURANCE PLAN NAME OR PROGRAM NAME

Box 24E: Document the appropriate diagnosis code (as reported in Box 21) for each line item.

13. INSURED’S OR AUTHORIZED PERSON’S SIGNATURE I authorize payment of medical benefits to the undersigned physician or supplier for services described below.

15. IF PATIENT HAS HAD SAME OR SIMILAR ILLNESS. SIGNED FROM TO FROM TO MM DD YY MM DD YY MM DD YYMM DD YY MM DD YY MM DD YY MM DD YYMM DD YY

If yes, return to and complete item 9 a-d.

16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION

18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES

20. OUTSIDE LAB? $ CHARGES

22. MEDICAID RESUBMISSION

23. PRIOR AUTHORIZATION NUMBER YES NO

YES NO

Box 24G: Enter the number of units of TEFLARO administered (eg, 60 units if 600 mg administered). Enter the appropriate number of units for the administration CPT code.

Box 24I-J: National Provider Identifier

Box 24D: Enter the appropriate HCPCS and CPT codes. Example: J0712 (Injection, ceftaroline fosamil, 10 mg) 96365 (IV infusion for therapy, prophylaxis, or diagnosis; initial, up to 1 hour)

Other administration codes may be appropriate.

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.

__ __ __ __ 1 2 4 TYPE OF BILL FROM THROUGH 5 FED. TAX NO.

ADMISSION CONDITION CODES

DATE

VALUE CODES VALUECODES VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE NPI

CODE DATE CODE DATE CODE DATE

FIRST

c. CODE DATE d. DATE e. OTHER PROCEDURE NPI

FIRST NPI b LAST FIRST c NPI d LAST FIRST UB-04 CMS-1450 7

10 BIRTHDATE 11 SEX 12 13 HR 14 TYPE 15 SRC

DATE 16DHR 18 19 20 FROM 21 22 23 25 26 27 28 CODE FROM DATE OTHER PRV ID

42 REV. CD. 43 DESCRIPTION 45 SERV. DATE 46 SERV. UNITS 47 TOTALCHARGES 48NON-COVERED CHARGES 49

52 REL

51 HEALTH PLAN ID 53 ASG.54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI 57

66 67 68 69 ADMIT 70 PATIENT 72 73 74 75 76 ATTENDING 80 REMARKS OTHER PROCEDURE a 77 OPERATING 78 OTHER 79 OTHER 81CC CREATIONDATE 3a PAT. CNTL # 24 b. MED. REC. #

44 HCPCS / RATE / HIPPS CODE

PAGE OF

APPROVED OMB NO.

e a

8 PATIENT NAME

50 PAYER NAME

6 STATEMENT COVERS PERIOD

9 PATIENT ADDRESS 17STAT STATE DX REASON DX 71 PPS CODE QUAL LAST LAST National Uniform Billing Committee NUBC™ OCCURRENCE QUAL QUAL QUAL LIC9213257 CODE DATE A B C A B C A B C A B C A B C 11 12 13 14 15 16 17 18 19 20 21 20 23 A B C 51 HEALTHLTHLPLAN ID

58 INSURED’S NAME 59 PP.P REL 60 INSURED

64 DOCUMENT

PA PA

P GE OF

50 PAPAP YERAYERA NAME

63 TREATMENTTREATMENTTREA AUTHORIZATIONUTHORIZATIONUTHORIZA CODES

A B C A B 1 2 3 49 4 1 2 a b c d a b ADMISSION CONDITION DATEATEA

OCCURRENCE OCCURRENCE OCCURRENCE OCCURRENCE CODE DATEATEA CODE CODE CODE DATEATEA CODE

VALUE VALUE V CODE AMOUNT 10 BIRTHDATEATEA 11 SEX 12 13 HR 14 TYPE 15 SRC

DATEATEA 16 DHR 18 19 20 FROM 21 22 23 DATEATEA b 32 31 33 34 35 38 39

42 REV CD. 43 DESCRIPTION 44 HCPCS / RATEATEA/ HIPPS CODE 45 SERV.V.V DATEATEA a

8 PAPAP TIENTATIENTA NAME 9 PAPAP TIENTATIENTA ADDRESS

17 STASTAST TATA

OCCURRENCE

CMS-1450 (also referred to as UB-04) Claim Form—

Hospital Outpatient Setting

Note: For certain payors, providers must also include the NDC number in box 43. Specific instructions for formatting this field are available in the Medicare Claims Processing Manual, Chapter 25, available at http://www.cms.hhs.gov/manuals/downloads/clm104c25.pdf.

Medicare Administrative Contractors (MACs) may require additional information than what is indicated below. A best practice is to defer to a MAC’s billing and reimbursement guidelines to ensure timely and accurate payment.

Box 43: Enter the name of the product and NDC code. Example: TEFLARO, 0456-0600-01

Box 44: Enter the appropriate HCPCS and CPT codes. Example: J0712 (Injection, ceftaroline fosamil, 10 mg)

96365 (IV infusion for therapy, prophylaxis, or diagnosis; initial, up to 1 hour)

Other administration codes may be appropriate.

Box 67A-67Q: Enter the primary diagnosis code on line A, the secondary diagnosis code on line B, tertiary on line C, etc.

Box 46: Enter the number of units administered (eg, 60 units if 600 mg administered).

Box 42: Enter the appropriate Revenue Code corresponding to the HCPCS code J0712 in box 44 (eg, 0636 for pharmacy, drugs that require detailed coding).

Non-Medicare payors may require revenue code 0250. Report the appropriate revenue code for the administration procedure on the same line item as the CPT code.

(12)

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:

Information current as of January 2012.

TEFLARO

®

(ceftaroline fosamil)

Indications and Usage Dosage and Administration Storage Information

Important Safety Information Full Prescribing Information