guide for zinplava™ (bezlotoxumab) · before prescribing zinplava, please read the accompanying...

Before prescribing ZINPLAVA, please read the accompanying Prescribing Information. The Patient Information also is available.

GUIDE FOR

Information for Dosing, Administration, Billing, and Patient Access

https://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_pi.pdf

https://www.merck.com/product/usa/pi_circulars/z/zinplava/zinplava_ppi.pdf




2

Contents

Introduction 3

Indication and Usage, and Selected Safety Information 4

Dosing, Preparation, and Administration 5

Billing and Coding 7

Possible Relevant Diagnosis Codes 7

HCPCS Code 8

Revenue Code 8

CPT® Code 9

Billing Units 9

The Merck Access Program 10

Selected Safety Information 11

Appendices 12

Appendix A: Sample UB-04 Claim Form for Hospital Outpatient Department Billing 12

Appendix B: Sample CMS-1500 Claim Form For Office Billing 13

Appendix C: Prior Authorization Checklist 14

Appendix D: Appeal Checklist 15

Appendix E: Sample Prior Authorization Letter 16

Appendix F: Sample Appeal Letter 17






3

Introduction

Merck has developed this Product Guide as a tool to help you navigate the health care insurance environment for ZINPLAVA.

The billing and coding 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.

You are solely responsible for determining the appropriate codes and for any action you take in billing. Information about Healthcare Common Procedure Coding System (HCPCS) codes is based on guidance issued by the Centers for Medicare & Medicaid Services (CMS) applicable to Medicare Part B 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 of a particular code and for information on additional codes. Diagnosis codes should be selected only by a health care professional.






4

Indication and Usage

ZINPLAVA is indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at a high risk for CDI recurrence.

ZINPLAVA is not indicated for the treatment of CDI. ZINPLAVA is not an antibacterial drug. ZINPLAVA should only be used in conjunction with antibacterial drug treatment of CDI.

Selected Safety InformationIn patients with a history of congestive heart failure (CHF), ZINPLAVA should be used when the benefit outweighs the risk. Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. In patients with a history of CHF, 12.7% (n=15/118) of ZINPLAVA-treated patients and 4.8% (n=5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. During the same period, for patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients 19.5% (n=23/118) than in placebo-treated patients 12.5% (n=13/104). The causes of death varied and included cardiac failure, infections, and respiratory failure.

Complete safety information can be found on page 11.

18 years of age or older






5

Dosing, Preparation, and Administration

Dosing Recommendations in AdultsThe recommended dose of ZINPLAVA is a single dose of 10 mg/kg administered as an intravenous infusion over 60 minutes. The safety and efficacy of repeat administration of ZINPLAVA in patients with CDI have not been studied.

Important Administration InstructionsAdminister ZINPLAVA at any time during antibacterial drug treatment for CDI.

Preparation of Diluted Solution ZINPLAVA must be diluted prior to intravenous infusion.

Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution.

Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to moderately opalescent, colorless to pale yellow solution. Do not use the vial if the solution is discolored or contains visible particles.

Do not shake the vial.

Withdraw the required volume from the vial(s) based on the patient’s weight (in kg) and transfer into an intravenous bag containing either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 1 mg/mL to 10 mg/mL. Mix diluvted solution by gentle inversion. Do not shake.

Discard vial(s) and all unused contents.

60MINUTES






6

Storage of Diluted Solution The product does not contain preservative. The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2°C to 8°C (36°F to 46°F) for up to 24 hours. If refrigerated, allow the intravenous bag to come to room temperature prior to use.

These time limits include storage of the infusion solution in the intravenous bag through the duration of infusion.

Do not freeze the diluted solution.

Administration Administer the diluted solution as an intravenous infusion over 60 minutes using a sterile, nonpyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.

The diluted solution can be infused via a central line or peripheral catheter. Do not administer ZINPLAVA as an intravenous push or bolus.

Do not co-administer other drugs simultaneously through the same infusion line.

Dosing, Preparation, and Administration

36º46º

(continued)






7

Billing and Coding

ICD-10 = International Statistical Classification of Diseases and Related Health Problems –10th Revision. Copyright © 2017 American Medical Association. All Rights Reserved. ICD-10 is a registered trademark of American Medical Association.

ICD-10-CM DIAGNOSIS CODE DESCRIPTOR

A04.71Enterocolitis due to C. difficile, recurrent

A04.72Enterocolitis due to C. difficile,

not specified as recurrent

The following codes may be relevant for ZINPLAVA and its administration. This information is current as of January 2018. The information provided here is compiled from sources believed to be accurate, but Merck makes no representation that it is accurate. Information about Healthcare Common Procedure Coding System (HCPCS) codes is based on guidance issued by the Centers for Medicare & Medicaid Services (CMS) applicable to Medicare Part B and may not apply to other public or private payers. Note that coverage and billing requirements often differ depending on the setting in which care is provided. 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. Merck cautions that payer coding requirements vary and can frequently change, so it is important to regularly check with each payer or, where applicable, the Medicare Administrative Contractor, as to payer-specific requirements.

You are solely responsible for determining the appropriate codes and for any action you take in billing. The information provided here is not intended to be definitive 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.

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. Diagnosis codes should be selected only by a health care professional.

Possible Relevant Diagnosis Codes1






8

HCPCS Code2

Always verify the payer’s coding requirements before submitting a claim.

For dates of service prior to January 1, 2018, use the appropriate unspecified HCPCS code to bill for ZINPLAVA.

For questions on billing if a portion of the package is wasted, consult the applicable payer’s policy regarding wastage. Please note that starting on 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

Revenue Code for Use in the Hospital Inpatient and Hospital Outpatient Settings

Below is a list of possible codes that could be relevant for ZINPLAVA and its administration. Please consult with the applicable payer to understand the payer’s specific billing requirements.

HCPCS CODE DESCRIPTOR

J0565 (effective January 1, 2018)

Injection, bezlotoxumab, 10 mg

REVENUE CODE DESCRIPTOR

0636 Drugs requiring detailed coding

Billing and Coding (continued)

NDC=National Drug Code.

Please Note: The NDC above is the billable NDC that appears on the carton. The NDC on the vial should not be used for billing purposes.

NDC and Packaging InformationPlease consult with the payer to understand specific billing requirements.

PRODUCT PACKAGE NDC

ZINPLAVACarton containing one 1,000 mg/40

mL (25 mg/mL) single-dose 50 mL vial 0006-3025-00






9

Billing Units2

The HCPCS code for ZINPLAVA effective January 1, 2018 is J0565 described as: “Injection, bezlotoxumab, 10 mg.” When billing for ZINPLAVA using J Code J0565, each billing unit of J0565 equals 10 mg of ZINPLAVA.

The following chart includes examples of weight-based dosing and illustrates the correlation between vials, milligrams, and billing units.

NUMBER OF 1,000-MG VIALS NUMBER OF MGNUMBER OF BILLING UNITS BASED ON

J0565 (10 MG BEZLOTOXUMAB PER UNIT)2

1 400 mg 40

1 500 mg 50

1 600 mg 60

1 700 mg 70

1 800 mg 80

1 900 mg 90

1 1,000 mg 100

2 1,100 mg 110

2 1,200 mg 120

Billing and Coding (continued)

For questions on billing if a portion of the package is wasted, consult the applicable payer’s policy regarding wastage. As of 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.

CPT®a Code for Administration

aCPT=Current Procedural Terminology. Copyright © 2017 American Medical Association. All Rights Reserved. CPT is a registered trademark of American Medical Association.

CPT CODE DESCRIPTOR

Verify the appropriateCPT® code with your payer

Please refer to the AMA CPT 2017 Professional EditionManual for a complete description of various CPT codes






10

The Merck Access Program

THE MERCK ACCESS PROGRAM CAN HELP ANSWER YOUR QUESTIONS ABOUT

Insurance coverage for patients

Prior authorizations and appeals

Coding and billing

Potential financial assistance options for eligible patients

Merck Patient Assistance Program

Referral to the Merck Patient Assistance Program for eligibility determination (provided through the Merck Patient Assistance Program, Inc.)

The Merck Access Program is available:

OR

Call 877-709-4455, Monday through Friday, 8 am to 8 pm ET





11

Selected Safety Information

In patients with a history of congestive heart failure (CHF), ZINPLAVA should be used when the benefit outweighs the risk. Heart failure was reported more commonly in the two Phase 3 clinical trials in ZINPLAVA-treated patients compared to placebo-treated patients. In patients with a history of CHF, 12.7% (n=15/118) of ZINPLAVA-treated patients and 4.8% (n=5/104) of placebo-treated patients had the serious adverse reaction of heart failure during the 12-week study period. During the same period, for patients with a history of CHF, there were more deaths in ZINPLAVA-treated patients 19.5% (n=23/118) than in placebo-treated patients 12.5% (n=13/104). The causes of death varied and included cardiac failure, infections, and respiratory failure.

The most common adverse reactions occurring within 4 weeks of infusion with a frequency greater than placebo and reported in ≥ 4% of patients treated with ZINPLAVA and Standard of Care (SoC) antibacterial drug therapy vs placebo and SoC antibacterial drug therapy were nausea (7% vs 5%), pyrexia (5% vs 3%), and headache (4% vs 3%).

Serious adverse reactions occurring within 12 weeks following infusion were reported in 29% of ZINPLAVA-treated patients and 33% of placebo-treated patients. Heart failure was reported as a serious adverse reaction in 2.3% of the ZINPLAVA-treated patients and 1.0% of placebo-treated patients.

In ZINPLAVA-treated patients, 10% experienced one or more infusion specific adverse reactions compared to 8% of placebo-treated patients, on the day of or the day after, the infusion. Infusion specific adverse reactions reported in ≥0.5% of patients receiving ZINPLAVA and at a frequency greater than placebo were nausea (3%), fatigue (1%), pyrexia (1%), dizziness (1%), headache (2%), dyspnea (1%), and hypertension (1%). Of these patients, 78% experienced mild adverse reactions, and 20% experienced moderate adverse reactions. These reactions resolved within 24 hours following onset.

As with all therapeutic proteins, there is a potential for immunogenicity following administration of ZINPLAVA. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Comparison of the incidence of antibodies to bezlotoxumab in the two Phase 3 studies with the incidence of antibodies in other studies or to other products may be misleading. In those 2 Phase 3 studies, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.






Appendix A

Sample UB-04 (also known as CMS 1450) Claim Form for Hospital Outpatient Department Billing; ZINPLAVA™ (bezlotoxumab) for Injection 25 mg/mL

12

__ __ __

1 2 4 TYPEOF BILL

FROM THROUGH5 FED. TAX NO.

a

b

c

d

DX

ECI

1

2

3

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9

10

11

12

13

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A

B

C

A B C D E F G HI J K L M N O P Q

a b c a b c

a

b c d

ADMISSION CONDITION CODESDATE

OCCURRENCE OCCURRENCE OCCURRENCE OCCURRENCE SPAN OCCURRENCE SPANCODE DATE CODE CODE CODE DATE CODE THROUGH

VALUE CODES VALUE CODES VALUE CODESCODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

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

FIRST

c. d. e. OTHER PROCEDURE NPICODE 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

16 DHR 18 19 20

FROM

21 2522 26 2823 27

CODE FROM

DATE

OTHER

PRV ID

THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF.

b

.INFO

BEN.

CODEOTHER PROCEDURE

THROUGH

29 ACDT 30

3231 33 34 35 36 37

38 39 40 41

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

52 REL51 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

CREATION DATE

3a PAT.CNTL #

24

b. MED.REC. #

44 HCPCS / RATE / HIPPS CODE

PAGE OF

APPROVED OMB NO. 0938-0997

e

a8 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 UniformBilling CommitteeNUBC

™

OCCURRENCE

QUAL

QUAL

QUAL

CODE DATE

A

B

C

A

B

C

A

B

C

A

B

C

A

B

C

a

b

a

b

Locator 42 • Enter appropriate revenue code for each line

item • Drugs that are billed with HCPCS codes

usually require revenue code 0636—Drugs requiring detailed coding

Locator 43 • For each line item, enter the description of

the revenue code used • For the line item for ZINPLAVA (bezlotoxumab),

enter both the drug’s brand and generic names

Locator 44 • For claims with dates of service on or after

January 1, 2018, use code J0565 (Injection, bezlotoxumab, 10 mg)

Locator 46 • For code J0565, enter the

appropriate number of units, with each unit corresponding to 10 mg of ZINPLAVA (bezlotoxumab)

• On a separate line enter the appropriate number of units discarded (if applicable) and include in Locator 44 the JW modifier

Locator 67 • Enter appropriate ICD-10-CM

diagnosis code(s)

Sample UB-04 (also known as CMS 1450) Claim Form for Hospital Outpatient Department Billing: ZINPLAVA™ (bezlotoxumab) for Injection 25 mg/mL

AINF-1184147-0002 11/17

Note: For questions on billing if a portion of a package is wasted, consult the applicable payer’s policy regarding wastage. Record the amount of drug administered and the amount wasted in the patient’s medical record. Please note that CMS has announced that effective January 1, 2017, Medicare will require the use of the JW modifier on all claims that include wasted product.

For dates of service prior to January 1, 2018, use the appropriate unspecified HCPCS code to bill for ZINPLAVA. The suggestions contained on this form are compiled from sources believed to be accurate for the Medicare Part B program, but Merck makes no representation that the information is accurate or that it will comply with the requirements of any particular Medicare Administrative Contractor (MAC) or payer. You are solely responsible for determining the billing and coding requirements applicable to any payer or MAC. Diagnosis codes should be selected only by a health care professional. The information provided here is not intended to be conclusive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor or any instructions provided by a payer or MAC. Billing and coding requirements may vary or change over time, so it is important to regularly check these requirements with each payer or MAC. Merck makes no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use and cautions that changes in public and private payer billing requirements occur frequently. The use of this information does not guarantee payment or that any payment received will cover your costs.

www.nucc.org

APPROVED BY NATIONAL UNIFORM CLAIM

PICA PICA

1

2

3

4

5

6

NPI

NPI

( )

17a.

I.

17b. NPI

M

1a. INSURED’S I.D. NUMBER

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

14. DATE OF CURRENT ILLNESS, INJURY, or PREGNANCY (LMP)

12. PATIENT’S OR AUTHORIZED PERSON’S SIGNATURE to process this claim. I also request below.

18. HOSPITALIZATION DATES RELATED TO CURRENT SERVICES

16. DATES PATIENT UNABLE TO WORK IN CURRENT OCCUPATION15. OTHER DATE

SIGNEDSIGNED DATE

c. OTHER ACCIDENT?

YES NO

PLACE (State)b. RESERVED FOR NUCC USE

Self

M F

3. PATIENT’S BIRTH DATE MM DD YY

J.RENDERING

PROVIDER ID. #

YES NO If yes, complete items 9, 9a, and 9d.

YES NO

YES NO

1. MEDICARE MEDICAID

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

5. PATIENT’S ADDRESS (No., Street)

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

a. OTHER INSURED’S POLICY OR GROUP NUMBER

c. RESERVED FOR NUCC USE

6. PATIENT RELATIONSHIP TO INSURED

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

7. INSURED’S ADDRESS (No., Street)

ETATS YTIC

11. INSURED’S POLICY GROUP OR FECA NUMBER

a. INSURED’S DATE OF BIRTH

( )

b. OTHER CLAIM ID (Designated by NUCC)

c. INSURANCE PLAN NAME OR PROGRAM NAME

d. IS THERE ANOTHER HEALTH BENEFIT PLAN?

READ BACK OF FORM BEFORE COMPLETING & SIGNING THIS FORM.

22. RESUBMISSION

23. PRIOR AUTHORIZATION NUMBER

F.

$ CHARGES

G.

17. NAME OF REFERRING PROVIDER OR OTHER SOURCE

19. ADDITIONAL CLAIM INFORMATION (Designated by NUCC)

21. DIAGNOSIS OR NATURE OF ILLNESS OR INJURY Relate A-L to service line below (24E)

24. A. B. C.

EMG

D. PROCEDURES, SERVICES, OR SUPPLIES (Explain Unusual Circumstances)

MODIFIERCPT/HCPCS

E.DIAGNOSISPOINTER

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.)

a. EMPLOYMENT? (Current or Previous)

( )

10. IS PATIENT’S CONDITION RELATED TO:

b. AUTO ACCIDENT?

A.

NUCC Instruction Manual available at: www.nucc.org PLEASE PRINT OR TYPE APPROVED OMB-0938-1197 FORM 1500 (02-12)

HEALTH INSURANCE CLAIM FORM

(Medicare#) (Medicaid#) (ID#/DoD#) (Member

TRICARE CHAMPVA GROUP

(ID#)ID#)

FECA OTHER

(ID#) (ID#)

Spouse Child Other

ZIP CODE TELEPHONE (Include Area Code)

MM YY DD

STATE 8. RESERVED FOR NUCC USE

(Include Area Code) ZIP CODE

CITY

TELEPHONE

d. INSURANCE PLAN NAME OR PROGRAM NAME

I authorize the release of any medical or other information necessarypayment of government benefits either to myself or to the party who accepts assignment

MM YY DD

10d. CLAIM CODES (Designated by NUCC)

DATE(S) OF SERVICEFrom

MM DDTo

YY MM DD YY

I authorize

MM YY DD MM YYDDFROM

MM YYDDTO

MM YYDDFROM

MM YYDDTO

$ CHARGES 20. OUTSIDE LAB?

CODE

YES NO

ORIGINAL REF. NO.

PLACE OFSERVICE

DAYS

UNITSOR

H.EPSDT

PlanFamily

QUAL.ID.

NPI

NPI

NPI

NPI

NPI

SIGNED DATE

25. FEDERAL TAX I.D. NUMBER SSN EIN 26. PATIENT’S ACCOUNT NO. 27. ACCEPT ASSIGNMENT?

YES NO

28. TOTAL CHARGE

$

29. AMOUNT PAID 30. Rsvd.for NUCC Use

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

a. b.

CA

RR

IER

P

AT

IEN

T A

ND

INS

UR

ED

INFO

RM

AT

ION

P

HY

SIC

IAN

OR

SU

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LIE

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MA

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COMMITTEE (NUCC) 02/12

(For Program in Item 1)

SEX

F

SEX

BLKHEALTH PLAN LUNG

( )

a. b.

QUAL.

E.

I.

QUAL.

B.

F.

J.

C.

G.

K.

D.

H.

L.

ICD Ind.

NPI

Layout by Fiachra Forms http://fiachraforms.com/quickstart_CMS1500_PDF.html

Save and Print Options

Sample CMS-1500 Claim Form for Office Billing: ZINPLAVA™ (bezlotoxumab) for Injection 25 mg/mL

*Some Medicare Administrative Contractors may want you to record the total number of vials used. Check with the relevant MAC for details.

For dates of service prior to January 1, 2018, use the appropriate unspecified HCPCS code to bill for ZINPLAVA.

The suggestions contained on this form are compiled from sources believed to be accurate for the Medicare Part B program, but Merck makes no representation that the information is accurate or that it will comply with the requirements of any particular Medicare Administrative Contractor (MAC) or payer. You are solely responsible for determining the billing and coding requirements applicable to any payer or MAC. Diagnosis codes should be selected only by a health care professional. The information provided here is not intended to be conclusive or exhaustive, and is not intended to replace the guidance of a qualified professional advisor. Billing and coding requirements may vary or change over time, so it is important to regularly check these requirements with each payer or MAC. Merck and its agents make no warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for your particular use and caution that changes in public and private payer billing requirements occur frequently. The use of this information does not guarantee payment or that any payment received will cover your costs.

AINF-1184146-0001 11/17

Note: For questions on billing if a portion of a package is wasted, consult the applicable payer’s policy regarding wastage. Record the amount of drug administered and the amount wasted in the patient’s medical record. Please note that CMS has announced that effective January 1, 2017, Medicare will require the use of the JW modifier on all claims that include wasted product.

BOX 24 D• For claims with dates of service on or after

January 1, 2018, use code J0565 (Injection, bezlotoxumab, 10 mg)

BOX 24 G*• For code J0565, enter the appropriate

number of units, with each unit corresponding to 10 mg of ZINPLAVA (bezlotoxumab)

• On a separate line, enter the appropriate number of units discarded (if applicable) using the JW modifier

BOX 19 • Some payers may require drug name, route of

administration, NDC, and/or dosage to be provided in Box 19. Check with your payer to verify requirements.

Box 21 • Enter appropriate ICD-10-CM diagnosis code(s)

Box 24 E • Record the relevant diagnosis pointer from Box 21

Appendix B

Sample CMS-1500 Claim Form For Office Billing; ZINPLAVATM (bezlotoxumab) for Injection 25 mg/mL

13

The items and information listed below may be necessary to obtain a prior authorization decisionfor a medication. It is important to review the insurer’s guidelines for obtaining a prior authorization,as these can differ depending on the insurer, the medication being prescribed, and other factors.

• Completed prior authorization request form (if required by patient’s insurer)— Note: Some payers may require specific forms to be completed for certain medications

or therapeutic areas—always verify that the correct form is completed

• Letter of medical necessity— Be sure to note the proposed treatment plan and include the provider ID number in the letter

• Documentation that supports the treatment decision, such as:— Prior treatment history and response to treatment— Patient history and clinical notes (eg, comorbidities, etc.)— Relevant laboratory results— Product package insert/physician label

• Additional relevant documentation (if available) regarding the treatment decision

THE ITEMS LISTED BELOW MAY BE NECESSARY TO OBTAIN A PRIOR AUTHORIZATION DECISIONFROM AN INSURER

• Patient information, including name, insurance policy number, and date of birth

• Physician information, including name and tax ID number

• Facility information, including name and tax ID number

• Date of service

• Patient diagnosis

• Relevant procedure and HCPCS codes for services/products to be performed/provided

• Product National Drug Code (NDC)

• Patient clinical notes detailing the relevant diagnosis and patient medical history

IT MIGHT BE NECESSARY TO PROVIDE THE FOLLOWING INFORMATION TO THE PATIENT’S INSURER WHEN MAKING A REQUEST FOR PRIOR AUTHORIZATION

As a provider, you are solely responsible for billing third-party payers correctly, and you should determine if any payer-specific guidelines apply. The information provided here is general in nature and is not intended to be conclusive or exhaustive, nor is it intended to replace the guidance of a qualified professional advisor. Merck and its agents make no guarantees regarding the timeliness or appropriateness of this information for your particular use, given the frequent changes in public and private payer billing.

Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved. AINF-1180298-0002 05/16

Prior Authorization Checklist

Appendix C

The Prior Authorization Checklist can help you to understand the documents and information that may be helpful when seeking a prior authorization. As always, you should check for payer-specific requirements.

14


Appeal Checklist

As a provider, you are solely responsible for billing third-party payers correctly, and you should determine if any payer-specific guidelines apply. The information provided here is general in nature and is not intended to be conclusive or exhaustive, nor is it intended to replace the guidance of a qualified professional advisor. Merck and its agents make no guarantees regarding the timeliness or appropriateness of this information for your particular use, given the frequent changes in public and private payer billing.

If a claim for a medication is denied, the items listed below may be helpful in the appeal process. It is important to review the denial and the insurer’s guidelines, as the required documentation and process for making an appeal will be different depending on the insurer and the patient.

As a first step, ensure that the claim was completed and submitted correctly.

• The product is covered by the patient’s insurer for the patient’s diagnosis

• A prior authorization or precertification was obtained, if required by the patient’s insurer

• Patient information was recorded correctly (eg, name, date of birth, insurance policy number, etc.)

• The dosing and duration of therapy are accurate

• The reason for denial, which may often be found in the explanation of benefits (EOB)

• Instructions for initiating the appeal process

• The necessary forms for appeal completion according to the insurer

• Insurer appeal guidelines regarding what documentation to include

• Filing deadlines and payer review timelines

• Letter of medical necessity — Be sure to note the proposed treatment plan and include the Provider ID number in the letter

• Formal letter appealing the denial

• Relevant documentation regarding treatment decisions, such as: — Prior treatment history and response to treatment — Patient history and clinical notes (eg, comorbidities, etc.) — Relevant laboratory results — Product package insert/physician label

• Additional relevant documentation (if available) regarding the treatment decision

ALWAYS VERIFY THAT

PRIOR TO INITIATING THE APPEAL PROCESS, IT IS IMPORTANT TO UNDERSTAND THE FOLLOWING

BELOW IS A LIST OF FORMS AND DOCUMENTS THAT MIGHT BE HELPFUL WHEN FILING AN APPEAL

Appendix D

The Appeal Checklist can help you to understand the documents and information that may be helpful when filing an appeal. As always, you should check for payer-specific requirements.

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<Date> ATTENTION: <Medical Director Name and/or Medical Review/Appeals> <Payer/Health Plan Name> <Payer Address>

REGARDING: Medical necessity for <Product Name> PATIENT NAME: <Patient Name> DATE OF BIRTH: <Patient Date of Birth> POLICY ID NUMBER: <Policy ID Number> PROVIDER ID NUMBER: <Provider ID Number>

Dear <Medical Director Name and/or Medical Review/Appeals>:

I am writing to request authorization for <Product Name> for my patient, <Patient Name>. I have prescribed <Product Name> because this patient has been diagnosed with <diagnosis>, and I believe that therapy with <Product Name> is appropriate for this patient. Attached to this request are clinical notes regarding this patient’s disease state, the FDA approval letter for <Product Name>, and the <Product Name> package insert.

<Product Name> is indicated for <Indication from Prescribing Information>.

<Rationale for treating the patient with <Product Name>. In this rationale, include a description of the patient’s disease state, treatment history, comorbid health issues, and any other factors that have influenced your treatment decision.>

Thank you for taking the time to read this letter. I look forward to your prompt review of this request.

Best regards,

<Physician Signature> <Physician Name>

ATTACHMENTS TO CONSIDER • <Product Name> FDA approval letter• <Product Name> package insert• Patient clinical notes and other relevant supporting documentation


<Date> ATTENTION: <Medical Director Name and/or Medical Review/Appeals> <Payer/Health Plan Name> <Payer Address>

REGARDING: Medical necessity for <Product Name> PATIENT NAME: <Patient Name> DATE OF BIRTH: <Patient Date of Birth> POLICY ID NUMBER: <Policy ID Number> PROVIDER ID NUMBER: <Provider ID Number>


I am writing to request authorization for <Product Name> for my patient, <Patient Name>. I have prescribed <Product Name> because this patient has been diagnosed with <diagnosis>, and I believe that therapy with <Product Name> is appropriate for this patient. Attached to this request are clinical notes regarding this patient’s disease state, the FDA approval letter for <Product Name>, and the <Product Name> package insert.



Thank you for taking the time to read this letter. I look forward to your prompt review of this request.

Best regards,

<Physician Signature> <Physician Name>

ATTACHMENTS TO CONSIDER • <Product Name> FDA approval letter • <Product Name> package insert • Patient clinical notes and other relevant supporting documentation


Appendix E

The Sample Prior Authorization Letter can help you to understand the documents and information that may be helpful when seeking a prior authorization. As always, you should check for payer-specific requirements.

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Appendix F

The Sample Appeal Letter can help you to understand the documents and information that may be helpful when filing an appeal. As always, you should check for payer-specific requirements.

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Copyright © 2016 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.All rights reserved. AINF-1180298-0000 05/16

<Date>ATTENTION: <Medical Director Name and/or Medical Review/Appeals><Payer/Health Plan Name><Payer Address>

REGARDING: Denied claim for <Product Name>PATIENT NAME: <Patient Name>DATE OF BIRTH: <Patient Date of Birth>POLICY ID NUMBER: <Policy ID Number>PROVIDER ID NUMBER: <Provider ID Number>


I am writing to appeal the denied claim for <Product Name> for my patient, <Patient Name>, who has been diagnosed with <diagnosis>. Attached to this request are clinical notes regarding this patient’s disease state, the FDA approval letter for <Product Name>, and the <Product Name> package insert.



Thank you for taking the time to read this letter. I believe that treatment with <Product Name> is appropriate for this patient. I look forward to your prompt review of this request.

Best regards,

<Physician Signature><Physician Name>

ATTACHMENTS TO CONSIDER• <Product Name> FDA approval letter• <Product Name> package insert• Patient clinical notes and other relevant supporting documentation


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Before prescribing ZINPLAVA™ (bezlotoxumab), please read the accompanying Prescribing Information. The Patient Information also is available.





guide for zinplava™ (bezlotoxumab) · before prescribing zinplava, please read the accompanying...

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