(crizanlizumab-tmca) billing & coding guide · 3 please see page 18 for important safety...

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ADAKVEO® (crizanlizumab-tmca)

Billing & coding guide

Please see page 18 for Important Safety Information. Please click here for full Prescribing Information.

Phone: Cell: Email:

Name [First Last]:Title line 1:Title line 2:

Novartis Pharmaceuticals CorporationOne Health Plaza East Hanover, NJ 07936-1080

Coverage and coding: physician office

Coverage and coding: hospital outpatient departm

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This billing guide is intended to provide an overview of coding and coverage information related to ADAKVEO® (crizanlizumab-tmca). Health care providers can use this guide, in addition to other sources of information, to determine for themselves the appropriate claims to file for ADAKVEO-related services. Novartis does not guarantee payment or coverage for any product or service.

The health care billing environment is constantly evolving to keep pace with scientific advances and financial constraints. Information specific to billing and coding is subject to change without notice and should be verified by the provider for each patient prior to treatment. A provider should contact patients’ payers directly for any revised or additional requirements, information, or guidance.

It is always the provider’s responsibility to determine the appropriate health care setting, and to submit true and correct claims for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.



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Billing and coding requirements for ADAKVEO® (crizanlizumab-tmca) will vary based on many factors, including the site of service where the drug is administered, the type of insurance the patient has, and the benefit under which ADAKVEO is covered.

Site of serviceADAKVEO may be administered in physicians’ offices, or in hospital outpatient departments. For most payers, the site of service will affect the billing and coding requirements. This guide concentrates on coverage, coding, and billing for ADAKVEO when administered in physicians’ offices and hospital outpatient settings.

Payer typeCoverage, as defined by each payer type and benefit package, may vary depending on the site of service and the patient’s status and medical history.

Ê Medicaid Medicaid may be the most common payer for patients needing ADAKVEO, either as a primary or secondary source of coverage.1 Medicaid coverage and payment for ADAKVEO can vary by state or by the specific managed Medicaid plan. Providers should check with the state program or plan for specific coverage information

Ê Medicare Adults with sickle cell disease (SCD) may qualify for Medicare. Medicare typically covers and separately reimburses drugs provided in the physician office as well as drugs provided in the hospital outpatient department that are not self-administered and are provided incidental to a physician’s service

Ê Private payers Private payers may cover ADAKVEO and the medical services associated with its administration. However, there may be restrictions on coverage, such as special requirements for distribution and precertification. Private payers may vary also in the payment methods they use to reimburse the sites of service where ADAKVEO is administered

Benefit categoryMost payers cover physician-administered products such as ADAKVEO under a medical benefit rather than a pharmacy benefit. In the case of Medicare, ADAKVEO will typically be covered under Part B. However, private payers and Medicaid, including managed Medicaid, may require that physicians obtain ADAKVEO through a specialty pharmacy. Specialty pharmacies may bill the payer under the medical or pharmacy benefit, depending on what that payer requires.

Basic coverage information

References: 1. IQVIA LAAD, US Market Access Strategy Consulting Analysis. Sickle Cell Channel Payer Mix Data on File. IQVIA. Updated January 22, 2019. Accessed October 24, 2019.



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Coverage and coding:

physician officeADAKVEO® (crizanlizumab-tmca) received US Food and Drug Administration (FDA) approval on November 15, 2019, and is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.1

CoverageFor patients enrolled in Medicaid, a Medicare Advantage plan, or a commercial health plan, coverage of ADAKVEO will vary by payer. Some payers may also apply utilization restrictions for ADAKVEO. For Medicare patients, ADAKVEO will be covered under Medicare Part B when used for an FDA-approved indication and when medically reasonable and necessary. There are no precertification requirements for ADAKVEO under traditional fee-for-service Medicare.

Important Information It is always the provider’s responsibility to determine the appropriate health care setting and to submit true and correct claims for actual products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.

CodingBelow is a table of common diagnosis codes for sickle cell disease.*

International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis codes

ICD-10-CM2 diagnosis code* Description

D57.0 Hb-SS disease with crisis

D57.00Hb-SS disease with crisis unspecified

D57.01Hb-SS disease with acute chest syndrome

D57.02Hb-SS disease with splenic sequestration

D57.1 Sickle cell disease without crisis

D57.2 Sickle cell/Hb-C disease

D57.20Sickle cell/Hb-C disease without crisis

D57.21 Sickle cell/Hb-C disease with crisis

D57.211Sickle cell/Hb-C disease with acute chest syndrome

D57.212Sickle cell/Hb-C disease with splenic sequestration

D57.219Sickle cell/Hb-C disease with crisis, unspecified

D57.4 Sickle cell thalassemia


D57.40 Sickle cell thalassemia without crisis

D57.41 Sickle cell thalassemia with crisis

D57.411Sickle cell thalassemia with acute chest syndrome

D57.412Sickle cell thalassemia with splenic sequestration

D57.419Sickle cell thalassemia with crisis, unspecified

D57.8 Other sickle cell disorders

D57.80Other sickle cell disorders without crisis

D57.81 Other sickle cell disorders with crisis

D57.811Other sickle cell disorders with acute chest syndrome

D57.812Other sickle cell disorders with splenic sequestration

D57.819Other sickle cell disorders with crisis unspecified



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The table below provides common procedure and drug codes related to infusion of ADAKVEO® (crizanlizumab-tmca).

Current Procedural Terminology (CPT) code

CPT† code

963653 Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

Healthcare Common Procedure Coding System (HCPCS) level II codes

HCPCS code Descriptor Site of care Additional information

J34904 Unclassified drugs All sites of careInclude the N4 qualifier, NDC

number, unit of measure qualifier, and amount administered to the

patient in the shaded area of Box 24A above the date of service. Example:

N400000000000ME300J35905 Unclassified biologics All sites of care

National Drug Code (NDC)The National Drug Code is a unique 10-digit, three-segment number. It is a universal product identifier for drugs in the United States present on all over-the-counter and prescription medication packages and inserts.

Many NDC numbers listed on drug packaging are in a 10 digit format. The NDC number is essential for proper claim processing when submitting claims for drugs used; however, to be recognized by payers, it must be formatted into an 11 digit 5-4-2 sequence. This requires a zero to be placed in a specific position to meet the 5-4-2 format requirement. As not all NDC numbers are set up the same, the table below demonstrates how to achieve the 11 digit NDC code for ADAKVEO.

Please note, because many practice management systems automatically remove the hyphens, be sure they are excluded from submission on the claim.

10 digit format Tradename Package strength NDC number New format NDC number for payer

4-4-2 ADAKVEO 100 mg/10 mL (10 mg/mL) 0078-0883-61 5-4-2 00078-0883-61

* It is always the provider’s responsibility to determine the appropriate health care setting and to submit true and correct claims for actual products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.

† CPT © 2019 American Medical Association. All rights reserved.

References: 1. Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019. 2. Centers for Medicare and Medicaid Services. 2019 ICD-10-CM. https://www.cms.gov/medicare/coding/icd10/2019-icd-10-cm.html. Accessed June 26, 2019. 3. Find-A-Code. 96365 - CPT® Code in category: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=CPT&c=96365. Updated 2018. Accessed July 12, 2019. 4. Find-A-Code. J3490 - Unclassified drugs. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3490. Updated 2018. Accessed July 12, 2019. 5. Find-A-Code. J3590 - Unclassified biologics. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3590. Updated 2018. Accessed July 12, 2019.



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https://www.findacode.com/code.php?set=CPT&c=96365

https://www.findacode.com/code.php?set=HCPCS&c=J3490


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Physician office: sample CMS-1500 claim form1

ADAKVEO® (crizanlizumab-tmca) and the associated services provided in a physician office are billed on the CMS-1500 claim form1 or its electronic equivalent. A sample CMS-1500 claim form for billing ADAKVEO is provided below.

The sample claim form provided below is only an example. It is always the provider’s responsibility to determine the appropriate health care setting and to submit true and correct claims for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.

PLEASE PRINT OR TYPE APPROVED OMB-0938-1197 FORM 1500 (02-12)

ADAKVEO (crizanlizumab-tmca) infusion 300mg

D57.1

11 15 19 11 15 19 11 96365 A $$ 1

11 15 19 11 15 19 11 A $$ 1N400078088361ME300

J3490 or J3590

Sample CMS-1500 claim form1 for ADAKVEO® (crizanlizumab-tmca) - Physician office administrationAlthough this sheet provides information that should facilitate the claims process, all coding information is for reference purposes only. Novartis does not guarantee payment.

The health care billing environment is constantly evolving to keep pace with scientific advances and financial constraints. Information specific to billing and coding is subject to change and should be verified for each patient prior to treatment. A provider should contact patients’ payers directly for any revised or additional requirements, information, or guidance.

19

21

24D24A 24F 24G

This area may be used to list the drug name, the route of administration, and the amount administered.

Enter the appropriate ICD-10-CM diagnosis code (eg, D57.1 for sickle-cell disease without crisis). Code to the highest level of specificity.

In the nonshaded area, list the date of service.In the shaded area, provide a detailed drug description. The N4 indicator is listed first, the 11-digit National Drug Code number is listed second, the unit of measurement qualifier is listed third (eg, ME for milligrams), and the unit quantity is listed at the end.Example: N400078088361ME300 (Note: Some payers may request the NDC number be listed in box 19).

Enter the appropriate, not-otherwise-classified HCPCS code for ADAKVEO use as required by the payer. J3490, Unclassified drug;2 or J3590, Unclassified biologics;3 may be appropriate. Include the appropriate CPT code to report the administration procedure (eg, 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour).4

Enter the charge for each listed service andthe product.

Report the appropriate number of units for the procedure and the appropriate number of units for ADAKVEO. Please note that the appropriate number of units for an unclassified drug may vary by payer. For Medicaid, the units may vary by state also. For many payers, the appropriate number of units to enter for ADAKVEO is 1 unit. The payer will identify the specific number of mgs for ADAKVEO administered, from Box 19.

Enter required National Provider Identifier of the facility where the services were rendered.

Enter the billing provider’s National Provider Identifier.

Please note: Some payers may require a taxonomy code to be reported. The taxonomy code characterizes type, classification, and/or specialization based on the primary services rendered.

Box 19:

Box 21:

Box 24A:

Box 24D:

Box 24F:

Box 24G:

Box 32A:

Box 33A:

Box 33B:

33A 33B32A

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Miscellaneous coding and billing reference sheet

Physician office setting

References: 1. Centers for Medicare & Medicaid Services. CMS Manual System. Details for title: CMS 1500. https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms-Items/CMS1188854. Accessed November 14, 2019. 2. Find-A-Code. J3490 - Unclassified drugs. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3490. Updated 2018. Accessed July 12, 2019. 3. Find-A-Code. J3590 - Unclassified biologics. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3590. Updated 2018. Accessed July 12, 2019. 4. Find-A-Code. 96365 - CPT® Code in category: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=CPT&c=96365. Updated 2018. Accessed July 12, 2019.


IMPORTANT INFORMATION: The coding, coverage, and payment information contained herein is gathered from various resources, general in nature, and subject to change without notice. Third-party payment for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine the appropriate health care setting, and to submit true and correct claims for those products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies. Information and materials are provided to assist health care providers, but the responsibility to determine coverage, reimbursement, and appropriate coding for a particular patient and/or procedure remains at all times with the provider.

ADAKVEO Support at PANO | Phone: 1-800-282-7630 Monday-Friday, 9 AM to 8 PM ET | www.hcp.novartis.com/access/

References: 1. Centers for Medicare & Medicaid Services. CMS Manual System. Details for title: CMS 1500. https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/CMS1500805.pdf. Accessed November 14, 2019. 2. Find-A-Code. J3490 - Unclassified drugs. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3490. Updated 2018. Accessed July 12, 2019. 3. Find-A-Code. J3590 - Unclassified biologics. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3590. Updated 2018. Accessed July 12, 2019. 4. Find-A-Code. 96365 - CPT® Code in category: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=CPT&c=96365. Updated 2018. Accessed July 12, 2019.

IMPORTANT INFORMATION: The coding, coverage, and payment information contained herein is gathered from various resources, general in nature, and subject to change without notice. Third-party payment for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine the appropriate health care setting and to submit true and correct claims for those products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies. Information and materials are provided to assist health care providers, but the responsibility to determine coverage, reimbursement, and appropriate coding for a particular patient and/or procedure remains at all times with the provider.



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Coverage and coding:

hospital outpatient departmentADAKVEO® (crizanlizumab-tmca) received US Food and Drug Administration (FDA) approval on November 15, 2019, and is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.1

CoverageFor patients enrolled in Medicaid, a Medicare Advantage plan, or a commercial health plan, coverage of ADAKVEO will vary by payer. Some payers may also apply utilization restrictions for ADAKVEO. For Medicare patients, ADAKVEO will be covered under Medicare Part B when used for an FDA-approved indication and when medically reasonable and necessary. There are no precertification requirements for ADAKVEO under traditional fee-for-service Medicare.

Important Information It is always the provider’s responsibility to determine the appropriate health care setting and to submit true and correct claims for actual products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.

CodingBelow is a table of common diagnosis codes for sickle cell disease.*

International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis codes


D57.0 Hb-SS disease with crisis

D57.00Hb-SS disease with crisis unspecified

D57.01Hb-SS disease with acute chest syndrome

D57.02Hb-SS disease with splenic sequestration

D57.1 Sickle cell disease without crisis

D57.2 Sickle cell/Hb-C disease

D57.20Sickle cell/Hb-C disease without crisis

D57.21 Sickle cell/Hb-C disease with crisis

D57.211Sickle cell/Hb-C disease with acute chest syndrome

D57.212Sickle cell/Hb-C disease with splenic sequestration

D57.219Sickle cell/Hb-C disease with crisis, unspecified

D57.4 Sickle cell thalassemia


D57.40 Sickle cell thalassemia without crisis

D57.41 Sickle cell thalassemia with crisis

D57.411Sickle cell thalassemia with acute chest syndrome

D57.412Sickle cell thalassemia with splenic sequestration

D57.419Sickle cell thalassemia with crisis, unspecified

D57.8 Other sickle cell disorders

D57.80Other sickle cell disorders without crisis

D57.81 Other sickle cell disorders with crisis

D57.811Other sickle cell disorders with acute chest syndrome

D57.812Other sickle cell disorders with splenic sequestration

D57.819Other sickle cell disorders with crisis unspecified



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The table below provides common procedure and drug codes related to infusion of ADAKVEO® (crizanlizumab-tmca).

Current Procedural Terminology (CPT) code

CPT† code

963653 Intravenous infusion for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour

Healthcare Common Procedure Coding System (HCPCS) level II codes

HCPCS code Descriptor Site of care Additional information

J34904 Unclassified drugs All sites of care Include the N4 qualifier, NDC number, unit of measure qualifier, and amount administered to the patient in the shaded area of Box 24A above the date of service.

Example: N400000000000ME300

J35905 Unclassified biologics All sites of care

C93996 Unclassified drugs or biologics Hospital outpatient (Medicare only)

Revenue codesRevenue code Description0250 General Pharmacy

0260 IV therapy

0510 Clinic, general

0636 Pharmacy, drugs requiring detailed coding

National Drug Code (NDC)The National Drug Code is a unique 10-digit, three-segment number. It is a universal product identifier for drugs in the United States present on all over-the-counter and prescription medication packages and inserts.

Many NDC numbers listed on drug packaging are in a 10 digit format. The NDC number is essential for proper claim processing when submitting claims for drugs used; however, to be recognized by payers, it must be formatted into an 11 digit 5-4-2 sequence. This requires a zero to be placed in a specific position to meet the 5-4-2 format requirement. As not all NDC numbers are set up the same, the table below demonstrates how to achieve the 11 digit NDC code for ADAKVEO.

Please note, because many practice management systems automatically remove the hyphens, be sure they are excluded from submission on the claim.

10 digit format Tradename Package strength NDC number New format NDC number for payer

4-4-2 ADAKVEO 100 mg/10 mL (10 mg/mL) 0078-0883-61 5-4-2 00078-0883-61

* It is always the provider’s responsibility to determine the appropriate health care setting and to submit true and correct claims for actual products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.

† CPT © 2019 American Medical Association. All rights reserved.

References: 1. Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019. 2. Centers for Medicare and Medicaid Services. 2019 ICD-10-CM. https://www.cms.gov/medicare/coding/icd10/2019-icd-10-cm.html. Accessed June 26, 2019. 3. Find-A-Code. 96365 - CPT® Code in category: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=CPT&c=96365. Updated 2018. Accessed July 12, 2019. 4. Find-A-Code. J3490 - Unclassified drugs. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3490. Updated 2018. Accessed July 12, 2019. 5. Find-A-Code. J3590 - Unclassified biologics. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3590. Updated 2018. Accessed July 12, 2019. 6. Find-A-Code. C9399 - Unclassified drugs or biologicals. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=C9399. Updated 2018. Accessed July 12, 2019.



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Hospital outpatient: sample UB-04 form1

ADAKVEO® (crizanlizumab-tmca) and the associated services provided in a hospital outpatient setting are billed on the UB-04 claim form1 or its electronic equivalent. A sample UB-04 claim form for billing ADAKVEO is provided below.

The sample claim form provided below is only an example. It is always the provider’s responsibility to determine the appropriate health care setting and to submit true and correct claims for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies.

Miscellaneous coding and billing reference sheet

Hospital outpatient setting

References: 1. Centers for Medicare & Medicaid Services. CMS Manual System. Details for title: CMS 1450 (UB-04). https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing-Items/CMS-1450.html. Accessed July 12, 2019. 2. Find-A-Code. J3490 - Unclassified drugs. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3490. Updated 2018. Accessed July 12, 2019. 3. Find-A-Code. J3590 - Unclassified biologics. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3590. Updated 2018. Accessed July 12, 2019. 4. Find-A-Code. C9399 - Unclassified drugs or biologicals. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=C9399. Updated 2018. Accessed July 12, 2019. 5. Find-A-Code. 96365 - CPT® Code in category: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=CPT&c=96365. Updated 2018. Accessed July 12, 2019.

Sample UB-04 CMS-1450 claim form1 for ADAKVEO® (crizanlizumab-tmca)– Hospital outpatient administrationAlthough this sheet provides information that should facilitate the claims process, all coding information is for reference purposes only. Novartis does not guarantee payment.

The health care billing environment is constantly evolving to keep pace with scientific advances and financial constraints. Information specific to billing and coding is subject to change and should be verified for each patient prior to treatment. A provider should contact patients’ payers directly for any revised or additional requirements, information, or guidance.

IMPORTANT INFORMATION: The coding, coverage, and payment information contained herein is gathered from various resources, general in nature, and subject to change without notice. Third-party payment for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine the appropriate health care setting, and to submit true and correct claims for those products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies. Information and materials are provided to assist health care providers, but the responsibility to determine coverage, reimbursement, and appropriate coding for a particular patient and/or procedure remains at all times with the provider.

ADAKVEO Support at PANO | Phone: 1-800-282-7630 Monday-Friday, 9 AM to 8 PM ET | www.hcp.novartis.com/access/


__ __ __

1 2 4 TYPEOF BILL

FROM THROUGH5 FED. TAX NO.

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b

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ECI

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

a b c a b c

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ADMISSION CONDITION CODESDATE

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VALUE CODES VALUE CODES VALUE CODESCODE AMOUNT CODE AMOUNT CODE AMOUNT

TOTALS

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

FIRST

c. d. e. OTHER PROCEDURENPICODE DATE DATE

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c NPI

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UB-04 CMS-1450

7

10 BIRTHDATE 11 SEX12 13 HR 14 TYPE 15 SRC

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16 DHR 18 19 20

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

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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 7576 ATTENDING

80 REMARKS

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a

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78 OTHER

79 OTHER

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CREATION DATE

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24

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44 HCPCS / RATE / HIPPS CODE

PAGE OF

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a8 PATIENT NAME

50 PAYER NAME

63 TREATMENT AUTHORIZATION CODES

6 STATEMENT COVERS PERIOD

9 PATIENT ADDRESS

17 STATSTATE

DX REASON DX71 PPS

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LAST

LAST

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0510 Clinic

DX D57.1

ADAKVEO (crizanlizumab-tmca) infusion 300mg

96365 11152019 1 $$0636 N400078088361ME300 J3490,J3590 or C9399 11152019 1 $$

Enter the appropriate revenue code corresponding with the HCPCS code in box 44, which is required for billing the unclassified HCPCS code, and 0510 for clinic services (eg, 0636 revenue code for pharmacy drugs that require detailed coding).

Enter a detailed drug description for the payer. The N4 indicator is listed first, the 11-digit National Drug Code number is listed second, a code describing the unit of measurement qualifier is listed third (eg, ME for milligrams), and the unit quantity is listed at the end.Example: N400078088361ME300

Enter the appropriate, not-otherwise-classified HCPCS code for ADAKVEO use as required by the payer. J3490, Unclassified drug;2 or J3590, Unclassified biologics;3 may be appropriate. C93994 may be appropriate for patients with Medicare Part B as the primary payer. To report the administration procedure, enter an appropriate CPT code (eg, 96365 Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour).5

Enter the total number of units of service. For ADAKVEO, payers may request that the miscellaneous code be billed at 1 unit. Please note that the appropriate number of units for an unclassified drug may vary by payer. For Medicaid, the units may vary by state also. Some payers may refer to the actual quantity administered via Box 43 and Box 80.

Enter the total amount the facility actually charged for the product.

Enter the appropriate ICD-10-CM diagnosis code (eg, D57.1 for Sickle cell disease without crisis). Code to the highest level of specificity.

Enter the drug name, the route of administration, and the amount administered. This can be required by payers when billing a miscellaneous HCPCS code.

Box 42:

Box 43:

Box 44:

Box 46:

Box 47:

Box 67A-67Q:

Box 80:

42 43 44 46 47

67A-Q

80

1

References: 1. Centers for Medicare & Medicaid Services. CMS Manual System. Details for title: CMS 1450 (UB-04). https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1104CP.pdf. Accessed July 12, 2019. 2. Find-A-Code. J3490 - Unclassified drugs. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3490. Updated 2018. Accessed July 12, 2019. 3. Find-A-Code. J3590 - Unclassified biologics. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=J3590. Updated 2018. Accessed July 12, 2019. 4. Find-A-Code. C9399 - Unclassified drugs or biologicals. InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=HCPCS&c=C9399. Updated 2018. Accessed July 12, 2019. 5. Find-A-Code. 96365 - CPT® Code in category: Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug). InnoviHealth Systems, Inc. https://www.findacode.com/code.php?set=CPT&c=96365. Updated 2018. Accessed July 12, 2019.

IMPORTANT INFORMATION: The coding, coverage, and payment information contained herein is gathered from various resources, general in nature, and subject to change without notice. Third-party payment for medical products and services is affected by numerous factors. It is always the provider’s responsibility to determine the appropriate health care setting and to submit true and correct claims for those products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, and payment policies. Information and materials are provided to assist health care providers, but the responsibility to determine coverage, reimbursement, and appropriate coding for a particular patient and/or procedure remains at all times with the provider.



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17Please see Important Safety Information throughout and on page 21 and accompanying full Prescribing Information.16 ADAKVEO.com

ADAKVEO is the first and only FDA-approved once-monthly treatment to reduce the frequency of VOCs in SCD1,3

ADAKVEO® (crizanlizumab-tmca) 5 mg/kg is administered by IV infusion over 30 minutes at Weeks 0 and 2, then every 4 weeks1

Each dose is the same: 5 mg/kg.

ADAKVEO gives you the confidence of knowing your patients are receiving their once-monthly treatment with each infusion

Week Week Week Week

0 2 6 10

Continuously, Every 4 WeeksInitial Dose

Loading Dose

IMPORTANT SAFETY INFORMATION (continued)

Most Common Adverse Reactions.The most frequently reported adverse reactions (≥ 10%) in patients treated with ADAKVEO 5 mg/kg were back pain (14%), nausea (14%), pyrexia (14%), and arthralgia (13%). The majority of adverse reactions were mild to moderate (Grade 1 or 2). Severe (Grade 3) events were observed for arthralgia and pyrexia 0.9% [1 case] each.

Do not mix or coadminister with other drugs through the same IV line.

Please refer to full Prescribing Information for additional dosage and administration instructions.

Guidance for missed doses of ADAKVEO1

� If a dose is missed, administer ADAKVEO as soon as possible

� If ADAKVEO is administered within 2 weeks after the missed dose, continue dosing according to the patient’s original schedule

� If ADAKVEO is administered more than 2 weeks after the missed dose, continue dosing every 4 weeks thereafter

ADAKVEO dose and volume calculation1

� The following equation should be used to determine the total dose (mg) and required volume (mL) of ADAKVEO based on the patient’s actual body weight (kg)

Volume (mL)

Number of Vials

Patient’s body weight (kg) x 5 mg/kg

10 mg/mL of ADAKVEO

Volume (mL)

10 mL/vial

Example: An adult weighing 75 kg (165 lb) requires a volume of 37.5 mL or 3.75 vials of ADAKVEO (requires 4 vials)

=

=

100 mg/10 mL vial

DO

SING

The following specialty distributors are authorized to ship ADAKVEO® (crizanlizumab-tmca).

NDC number Supplied

00078-0883-61ADAKVEO injection is a sterile, clear to opalescent, colorless to slightly brownish-yellow solution for intravenous infusion supplied in a carton containing one 100 mg/10 mL (10 mg/mL) single-dose vial.

Authorized distributors

Authorized specialty distributors Phone number NDC number

ASD Specialty Healthcare 1-800-746-6273

0078-0883-61

Cardinal Health 1-866-677-4844

McKesson Plasma and Biologics 1-877-625-2566

McKesson Specialty HealthOncology: 1-800-482-6700 Other specialties: 1-855-477-9800

ADAKVEO is also available through specialty pharmacies if preferred or required by your patient’s health plan.

ADAKVEO is available by prescription only. Prescribing information may be accessed via https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/adakveo.pdf.

Novartis does not recommend the use of any particular distributor.

Additional product information may be requested from the Novartis Customer Interaction Center by calling 1-877-ADAKVE-0 (1-877-232-5830).




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Benefits verification and precertification checklistWhen calling a payer to verify benefits and inquire about precertification, the following key questions should be considered:

Is precertification required? – What is the precertification process? – What is the telephone or fax number for the precertification department? – What information is required? – How long will it take? – Does the precertification number need to be included on the claim form?

What is the patient’s deductible? – Has it been met? If not, what amount has been applied to date?

What is the patient’s co-payment or coinsurance for ADAKVEO® (crizanlizumab-tmca)? Does the patient have an out-of-pocket maximum?

– Has it been met? If not, what amount has been applied to date?

Does the patient have an annual or lifetime benefit maximum? – Has it been met? If not, what amount has been applied to date?

Does the patient have other insurance benefits that will need to be coordinated? What are the coding and claims submission requirements for ADAKVEO?

– HCPCS code to report ADAKVEO – Number of units – Claims telephone number and address – Claims completion instructions – Required documentation (eg, prescribing information and statement of medical necessity)



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Claims filing checklistThe following tips may assist you with filing claims successfully for an infusion therapy:

Verify patient eligibility and benefits with the payer before providing ADAKVEO® (crizanlizumab-tmca).

Document your verification of patient’s eligibility and benefits. Obtain precertification if required. Use appropriate codes to report the patient’s condition, the drugs the patient is on, and the

services you have provided. – HCPCS code – CPT code – ICD-10-CM code

Include additional information requested by the payer in box 19 of the CMS-1500 form or in box 80 of the CMS-1450 (UB-04).

– ADAKVEO – Dosage – National Drug Code number – Route of administration – Unit description (as required by the specific payer for a code that is not otherwise classified)

Attach additional information to the claim if necessary. – Letter of medical necessity – Prescribing information – Food and Drug Administration approval letter – Patient notes

Review claim for accuracy, including patient identification numbers, coding, and number of units.

File claim as soon as possible and within payer filing time limits. Reconcile claim reports promptly and thoroughly to ensure claims have been appropriately

processed and paid. Verify that payment amounts correspond with your public payer allowables and your private

payer contracts.



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Letter of medical necessity information

This section provides information and examples that can help ensure your communications with health plans regarding medical necessity are as complete as possible. These samples are intended to provide examples of the type of information that will usually be required. You can refer to the checklist on the first page of each section as you develop and complete your own letters.

Below is a checklist of items that may be needed to support the development of your letter of medical necessity:

Patient information Patient name Patient date of birth Insurance ID Insurance group number Case ID (if applicable)

Clinical rationale Patient diagnosis Number of vaso-occlusive crises in past 12 months Comprehensive list of previous treatment therapies used Confirmation that the patient has not received adequate results from previous treatments Rationale for selecting ADAKVEO® (crizanlizumab-tmca) Test results and chart notes Hospital admission and/or emergency room notes

Additional supporting documentation may vary between health plans, but may include: Prescribing information FDA approval letter Relevant peer-reviewed articles



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The following is an example of what payers may require in a letter of medical necessity. Be sure to understand the specific payer requirements for your patient.

[Date][Payer name][Payer street address][Payer city, state, ZIP code]

Patient name: [Patient full name]Date of birth: [Patient birth date]Member ID: [Patient member ID number]Policy or group number: [Patient policy or group number]Case ID number: [Case ID number (if applicable)]

To Whom It May Concern,

Patient’s clinical/medical history:

• Patient age • Patient’s diagnosis (ICD-10-CM code) • Date of diagnosis • Patient’s first visit, date of referral • Number of vaso-occlusive crises in past 12 months • Previous treatments including drug names, duration of treatment(s), responses to those treatments • Acute and chronic complications associated with the patient’s sickle cell disease

Treatment plan:

On November 15, 2019, the FDA approved ADAKVEO® (crizanlizumab-tmca) which is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.1

• Include plan of treatment (eg, dosage, frequency of injection, length of treatment) • Clinical rationale for the ADAKVEO prescription

Enclosures:

• FDA approval letter • Prescribing information • Clinical notes/medical records • Test results • Relevant peer-reviewed articles

Sincerely,_______________________[Physician name and signature][Physician address][Physician phone number]



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Letter of appeal informationThis section provides information and examples that can help ensure your communications with health plans regarding a precertification or appeal are as complete as possible. These samples are intended to provide examples of the type of information that will usually be required. You can refer to the checklist on the first page of each section as you develop and complete your own letters. Incorrect or incomplete submissions may delay the review process or result in an automatic denial of the request.

Below is a checklist of items that may be needed to support the development of your letter of appeal:

Patient information Patient name Patient date of birth Insurance ID Insurance group number Case ID (if applicable)

Clinical rationale Patient diagnosis Number of vaso-occlusive crises in past 12 months Comprehensive list of previous treatment therapies used Confirmation that the patient has not received adequate results from previous treatments Rationale for selecting ADAKVEO® (crizanlizumab-tmca) Test results and chart notes Hospital admission and/or emergency room notes

Additional supporting documentation may vary between health plans, but may include: Prescribing information FDA approval letter Relevant peer-reviewed articles For 2nd-and-3rd level appeals, include a copy of the previous denial letter(s)



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The following is an example of what payers may require in a letter of medical necessity. Be sure to understand the specific payer requirements for your patient.

[Date]

[Payer name][Payer street address][Payer city, state, ZIP code]

Patient name: [Patient full name]Date of birth: [Patient birth date]Member ID: [Patient member ID number]Policy or group number: [Patient policy or group number]Case ID number: [Case ID number (if applicable)]

To Whom It May Concern,

Patient’s clinical/medical history:

• Patient’s age • Patient’s diagnosis (ICD-10-CM code) • Date of diagnosis • Patient’s first visit, date of referral • Number of vaso-occlusive crises in past 12 months • Previous treatments including drug names, duration of treatment(s), responses to those treatments • Acute and chronic complications associated with the patient’s sickle cell disease

Treatment plan:

On November 15, 2019, the FDA approved ADAKVEO® (crizanlizumab-tmca) which is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.1

• Include plan of treatment (eg, dosage, frequency of injection, length of treatment) • Clinical rationale that supports ADAKVEO treatment for [patient name]

Enclosures:

• FDA approval letter • Prescribing information • Clinical notes/medical records • Test results • Relevant peer-reviewed articles • Copy of previous denial notifications if applicable

Sincerely,__________________________[Physician name and signature][Physician address][Physician phone number]



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In this section, you will find prescribing information details that can help ensure your communications with health plans regarding medical necessity and appeals are complete and supported by the FDA-approved label.

Indication, usage, dosage, and administration1

Item Details

Indications and usageADAKVEO is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.1

Dosage and administrationADAKVEO 5 mg/kg is administered by IV infusion over 30 minutes at Weeks 0 and 2, then every 4 weeks

Clinical trials experience1

Item Details

SUSTAIN trial duration 52 weeks

SUSTAIN trial primary end point outcome45.3% (1.63 vs 2.98, P=.010) reduction

in median annual rate of VOCs vs placebo

SUSTAIN safety data1

Ê Serious adverse reactions were reported in 2 patients (3%) treated with ADAKVEO 5mg/kg; both reactions were pyrexia

Ê Most common adverse reactions (incidence ≥10%) are nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%)

Demographics and baseline characteristics in SUSTAIN study (intent to treat population)1

ADAKVEO 5 mg/kg (n = 67)

Placebo (n = 65)

Age (years)Median

Range

29 26

16, 63 16, 56

Gender, n (%)Male

Female

32 (48%) 27 (42%)

35 (52%) 38 (59%)

Ethnicity, n (%)

Hispanic or Latino

Not Hispanic or Latino

Unknown

20 (30%) 11 (17%)

45 (67%) 53 (82%)

2 (3%) 1 (2%)

Race

Black or African American

White

Other

60 (90%) 60 (92%)

4 (6%) 3 (5%)

3 (4.5%) 2 (3%)

Sickle cell disease genotype, n (%)

HbSS

HbSC

HbSb0 - thalassemia

HbSb+ - thalassemia

Other

47 (70%) 47 (72%)

9 (13%) 8 (12%)

3 (5%) 7 (11%)

7 (10%) 1 (2%)

1 (2%) 2 (3%)

Item1 DetailsNumber of VOCs in previous 12 months: n (%)

Total n = 67

2 to 4 VOCs: 42 (63%)

5 to 10 VOCs: 25 (37%)

Hydroxyurea use: n (%)Yes: 42 (63%)

No: 25 (37%)


Clinical considerations for ADAKVEO® (crizanlizumab-tmca)

Reference: 1. Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019.



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INDICATIONADAKVEO® (crizanlizumab-tmca) is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients, aged 16 years and older, with sickle cell disease.1

Important Safety Information1

Infusion-Related Reactions

In the SUSTAIN clinical trial, infusion-related reactions (defined as occurring within 24 hours of infusion) were observed in 2 (3%) patients treated with ADAKVEO 5 mg/kg. Monitor patients for signs and symptoms of infusion-related reactions, which may include fever, chills, nausea, vomiting, fatigue, dizziness, pruritus, urticaria, sweating, or shortness of breath or wheezing. Discontinue ADAKVEO infusion for severe reactions and institute appropriate medical care.

Laboratory Test Interference: Platelet Counts

Interference with automated platelet counts (platelet clumping) has been observed following administration of ADAKVEO, in particular, when blood samples were collected in tubes containing EDTA.

Run blood samples within 4 hours of blood collection or collect blood samples in tubes containing citrate. When needed, estimate platelet count via peripheral blood smear.

Pregnancy

Based on animal data ADAKVEO has the potential to cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. ADAKVEO should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the fetus.

Most Common Adverse Reactions

The most frequently reported adverse reactions (≥10%) in patients treated with ADAKVEO were nausea (18%), arthralgia (18%), back pain (15%), and pyrexia (11%).

Other Clinically Important Adverse Reactions

Clinically relevant adverse reactions (all grades) that were reported in <10% of patients treated with ADAKVEO included: oropharyngeal pain, abdominal pain (abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort, and abdominal tenderness), diarrhea, vomiting, pruritus (pruritus and vulvovaginal pruritus), musculoskeletal chest pain, myalgia, infusion-site reaction (infusion-site extravasation, infusion-site pain, and infusion-site swelling), and infusion-related reaction.

Please see full Prescribing Information here.

Important Safety Information

Please see page 18 for Important Safety Information. Please click here for full Prescribing Information. Reference: 1. Adakveo [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019.



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Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936-1080 © 2019 Novartis Printed in USA 11/19 CZB-1217511


(crizanlizumab-tmca) billing & coding guide · 3 please see page 18 for important safety...

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