YERVOY. (ipilimumab) REIMBURSEMENT AND CODING. YERVOY (ipilimumab) A REFERENCE GUIDE TO INDICATIONS WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

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1 A REFERENCE GUIDE TO REIMBURSEMENT AND CODING YERVOY (ipilimumab) INDICATIONS YERVOY (ipilimumab) is indicated for the treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older). YERVOY (ipilimumab) is indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY (ipilimumab) can result in severe and fatal immune-mediated adverse reactions. These immunemediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immunemediated reactions. Please see additional Important Safety Information, including Boxed WARNING regarding immune-mediated

2 Bristol-Myers Squibb Is Committed to Helping Support Access This brochure is designed to help appropriate patients get access to our medications by providing helpful reimbursement information for healthcare offices. Healthcare benefits vary significantly; therefore, it is important that oncology offices verify each patient s insurance coverage prior to initiating therapy. Table of Contents ICD-10-CM Codes... HCPCS Codes... CPT Codes... NDC Information Codes... Coding and Billing Units... Dosing and Administration... Ordering... Distribution... General Reimbursement Information... Co-Pay Assistance Program... Patient Affordability... Important Safety Information Healthcare providers should code healthcare claims based upon the service that is rendered, the patient s medical record, the coding requirements of each health insurer, and best coding practices. The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 2

3 METASTATIC MELANOMA: ICD-10-CM Codes for YERVOY ICD-10-CM codes are used to identify a patient s diagnosis. On October 1, 2015, the newest version of these codes, ICD-10-CM, was implemented throughout the United States. This version replaces the previous version, ICD-9-CM. The ICD-10-CM diagnosis codes contain categories, subcategories, and codes. Characters for categories, subcategories, and codes may be letters or numerals All categories are 3 characters Subcategories are either 4 or 5 characters Codes may be 3, 4, 5, 6, or 7 characters The ICD-10-CM codes for the labeled indications for YERVOY are provided below by Bristol-Myers Squibb and should be verified with the payer. Some health plan and Medicare insurers may specify which codes are covered under their policies. Please code to the level of specificity documented in the medical record. For additional coding questions, call BMS Access Support at or visit ICD-10-CM Codes for YERVOY 1 C43 Malignant melanoma of skin C43.0 Malignant melanoma of lip C43.1 Malignant melanoma of eyelid, including canthus* C43.10 Malignant melanoma of unspecified eyelid, including canthus C43.11 Malignant melanoma of right eyelid, including canthus C43.12 Malignant melanoma of left eyelid, including canthus C43.2 Malignant melanoma of ear and external auricular canal* C43.20 Malignant melanoma of unspecified ear and external auricular canal C43.21 Malignant melanoma of right ear and external auricular canal C43.22 Malignant melanoma of left ear and external auricular canal * This is a category code and is invalid for stand-alone use. Please select one of the expanded codes listed below. (more C43 codes on the next page) Note: If infusion for antineoplastic immunotherapy is the only reason for the patient encounter, physicians and hospitals may report the code below as the primary diagnosis 1 : Z51.12 Encounter for antineoplastic immunotherapy The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 3

4 METASTATIC MELANOMA: ICD-10-CM Codes for YERVOY (cont d) ICD-10-CM Codes for YERVOY 1 C43.3 Malignant melanoma of other and unspecified parts of face* C43.30 Malignant melanoma of unspecified part of face C43.31 Malignant melanoma of nose C43.39 Malignant melanoma of other parts of face C43.4 Malignant melanoma of scalp and neck C43.5 Malignant melanoma of trunk* C43.51 Malignant melanoma of anal skin C43.52 Malignant melanoma of skin of breast C43.59 Malignant melanoma of other part of trunk C43.6 Malignant melanoma of upper limb, including shoulder* C43.60 Malignant melanoma of unspecified upper limb, including shoulder C43.61 Malignant melanoma of right upper limb, including shoulder C43.62 Malignant melanoma of left upper limb, including shoulder * This is a category code and is invalid for stand-alone use. Please select one of the expanded codes listed below. (more C43 codes on the next page) Note: If infusion for antineoplastic immunotherapy is the only reason for the patient encounter, physicians and hospitals may report the code below as the primary diagnosis 1 : Z51.12 Encounter for antineoplastic immunotherapy The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 4

5 METASTATIC MELANOMA: ICD-10-CM Codes for YERVOY (cont d) ICD-10-CM Codes for YERVOY 1 C43.7 Malignant melanoma of lower limb, including hip* C43.70 Malignant melanoma of unspecified lower limb, including hip C43.71 Malignant melanoma of right lower limb, including hip C43.72 Malignant melanoma of left lower limb, including hip C43.8 Malignant melanoma of overlapping sites of skin C43.9 Malignant melanoma of skin, unspecified *This is a category code and is invalid for stand-alone use. Please select one of the expanded codes listed below. The code C43 has an Excludes 2 note under it. Per ICD-10-CM official guidelines, an Excludes 2 note under a code represents Not included here. An Excludes 2 note indicates that the condition excluded is not part of the condition represented by the code, but a patient may have both conditions at the same time. When an Excludes 2 note appears under a code, it is acceptable to use both the code and the excluded code together, when appropriate. 1 Under code C43, the Excludes 2 note lists the following 1 : Malignant melanoma of skin of genital organs (C51, C52, C60, C63) Merkel cell carcinoma (C4A) Sites other than skin code to malignant neoplasm of the site Note: If infusion for antineoplastic immunotherapy is the only reason for the patient encounter, physicians and hospitals may report the code below as the primary diagnosis 1 : Z51.12 Encounter for antineoplastic immunotherapy The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 5

6 METASTATIC MELANOMA: ICD-10-CM Codes for YERVOY (cont d) For sites other than category C43, code to the malignant neoplasm of the site. 1 Some sites where melanoma is commonly seen are shown below and on the next page. ICD-10-CM Codes for YERVOY 1 C21 Malignant neoplasm of anus and anal canal C21.0 Malignant neoplasm of anus, unspecified C21.1 Malignant neoplasm of anal canal C51 Malignant neoplasm of vulva C51.0 Malignant neoplasm of labium majus C51.1 Malignant neoplasm of labium minus C51.2 Malignant neoplasm of clitoris C51.9 Malignant neoplasm of vulva, unspecified C52 Malignant neoplasm of vagina C57 Malignant neoplasm of other and unspecified female genital organs C57.7 Malignant neoplasm of other specified female genital organs C57.8 Malignant neoplasm of overlapping sites of female genital organs C57.9 Malignant neoplasm of female genital organ, unspecified Note: If infusion for antineoplastic immunotherapy is the only reason for the patient encounter, physicians and hospitals may report the code below as the primary diagnosis 1 : Z51.12 Encounter for antineoplastic immunotherapy The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 6

7 METASTATIC MELANOMA: ICD-10-CM Codes for YERVOY (cont d) ICD-10-CM Codes for YERVOY 1 C60 Malignant neoplasm of penis C60.0 Malignant neoplasm of prepuce C60.1 Malignant neoplasm of glans penis C60.8 Malignant neoplasm of overlapping sites of penis C60.9 Malignant neoplasm of penis, unspecified C63 Malignant neoplasm of other and unspecified male genital organs C63.0 Malignant neoplasm of epididymis* C63.00 Malignant neoplasm of unspecified epididymis C63.01 Malignant neoplasm of right epididymis C63.02 Malignant neoplasm of left epididymis C63.1 Malignant neoplasm of spermatic cord* C63.10 Malignant neoplasm of unspecified spermatic cord C63.11 Malignant neoplasm of right spermatic cord C63.12 Malignant neoplasm of left spermatic cord C63.2 Malignant neoplasm of scrotum C63.7 Malignant neoplasm of other specified male genital organs C63.8 Malignant neoplasm of overlapping sites of male genital organs C63.9 Malignant neoplasm of male genital organ, unspecified *This is a category code and is invalid for stand-alone use. Please select one of the expanded codes listed below. Note: If infusion for antineoplastic immunotherapy is the only reason for the patient encounter, physicians and hospitals may report the code below as the primary diagnosis 1 : Z51.12 Encounter for antineoplastic immunotherapy The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 7

8 HCPCS (Healthcare Common Procedure Coding System) and Revenue Codes for YERVOY Recommended HCPCS Code for YERVOY 2 HCPCS Code Description Billing Units J9228 Injection, ipilimumab, 1 mg 1 mg = 1 billing unit Use the following claim formats when YERVOY is administered to patients on an outpatient basis and billed to health plans: Physician office: CMS-1500 (paper format) or ASC 837P (electronic format) Hospital outpatient: UB-04 (CMS-1450) [paper format] or ASC 837I (electronic format) JW modifier Effective January 1, 2017, providers and suppliers are required to report the JW modifier on Part B drug claims for discarded drugs and biologicals. Also, providers and suppliers must document the amount of discarded drugs or biologicals in Medicare beneficiaries' medical records. 3 All the coding information presented is applicable to outpatient procedures only. Please see pages for more information. Revenue Codes 4 (for Use in the Hospital Outpatient Setting) Revenue Code Description 0636 Drugs requiring detailed coding 0335 Chemotherapy administration, IV 0260 IV solutions The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 8

9 CPT Codes for YERVOY The Current Procedural Terminology (CPT)* codes that may be appropriate when administering YERVOY appear in the table below Recommended CPT Codes for YERVOY 5 CPT Code Description APC Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Chemotherapy administration, IV infusion; each additional hour List separately in addition to code for primary procedures Use in conjunction with Report for infusion intervals of greater than 30 minutes beyond 1-hour increments Please contact the payer or BMS Access Support for additional coding information regarding YERVOY. * CPT codes and descriptions only are 2016 by American Medical Association (AMA). All rights reserved. The AMA assumes no liability for data contained or not contained herein. CPT is a registered trademark of the American Medical Association. APC=ambulatory payment classification; 5695=Level V Drug Administration, 5692=Level II Drug Administration. 6,7 The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 9

10 NDC Information for YERVOY The National Drug Codes (NDCs) for YERVOY, listed below, are often necessary in addition to the appropriate J-code when filing a claim for reimbursement. NDC Codes for YERVOY 8 One 200-mg (5-mg/ ml), single-use vial 200-mg vial = 200 billable units One 50-mg (5-mg/ ml), single-use vial 50-mg vial = 50 billable units The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 10

11 5010 Electronic Transaction Coding for YERVOY For electronic transactions, including 837P and 837I, the NDC is to be preceded by the qualifier N4 and followed immediately by the 11-digit NDC code for payers that require it 9 This is typically followed by the quantity qualifier, such as: UN (units), F2 (international units), GR (gram), or ML (milliliter), and the quantity administered Transaction Coding for YERVOY 9 How Supplied NDC NDC Qualifier NDC Basis of Measurement Sample NDC 5010 Format 50-mg/10-mL (5 mg/ml) single-use vial N4 ML N ML mg/40-mL (5 mg/ml) single-use vial N4 ML N ML40 The example given in the far right column above demonstrates NDC quantity reporting for 1 vial of YERVOY. The actual amount of drug used can vary based on factors such as indication or patient weight. Currently, reporting NDC quantity varies from payer to payer, so the provider should consult each specific payer to determine the required format. The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 11

12 YERVOY (ipilimumab) Coding and Billing Units for YERVOY Please contact the payer or BMS Access Support for additional information on coding and billing units CMS-1500 Form Physician Office A Item 19: Many payers require detailed information about the drug in Box 19.9 Typically, payers require the drug name, total dosage and strength, method of administration, 11-digit NDC, and basis of measurement B Item 21: Enter the site-specific ICD-10-CM codes in priority order 9 C Item 24A: NDC information is required in the shaded area above the line on which a drug is reported in 24D.9 The 11-digit NDC is preceded by the qualifier N4 and followed by the quantity qualifier (ML) and the quantity administered.9 For example, enter N ML10 for the 50-mg/10-mL vial or N ML40 for the 200-mg/40-mL vial8 D Item 24D: Enter HCPCS code J9228, CPT code 96413, and CPT code (if needed) for time of treatment infusion.2,5,9 In addition, it is required that you enter J9228-JW on next line to record waste3 E Item 24E: Enter the diagnosis code reference letter or number from Box 21 that relates to the date of service and the services or procedures performed that are entered on that same line under 24D9 F Item 24G: Billing units are reported here.9 1 mg = 1 billing unit A D B E F C This sample form is for informational purposes only. The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. 12

13 Coding and Billing Units for YERVOY (cont d) 1 2 3a PAT. 4 TYPE CNTL # OF BILL b. MED. REC. # 6 STATEMENT COVERS PERIOD 7 5 FED. TAX NO. FROM THROUGH 8 PATIENT NAME a 9 PATIENT ADDRESS a b b c d e 10 BIRTHDATE 11 SEX ADMISSION CONDITION CODES 12 DATE 13 HR 14 TYPE 15 SRC 16 DHR 29 ACDT STAT STATE 31 OCCURRENCE 32 OCCURRENCE 33 OCCURRENCE 34 OCCURRENCE 35 OCCURRENCE SPAN 36 OCCURRENCE SPAN 37 CODE DATE CODE DATE CODE DATE CODE DATE CODE FROM THROUGH CODE FROM THROUGH a b VALUE CODES 40 VALUE CODES 41 VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT a b A B C D c d 42 REV. CD. 43 DESCRIPTION 44 HCPCS / RATE / HIPPS CODE 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES PAGE OF CREATION DATE TOTALS 52 REL. 53 ASG. 50 PAYER NAME 51 HEALTH PLAN ID 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI INFO BEN. A 57 B OTHER C PRV ID 58 INSURED S NAME 59 P.REL 60 INSURED S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO. A B C 63 TREATMENT AUTHORIZATION CODES 64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME A B UB-04 Form C DX 67 A B C D E F G H I J K L M N O P Q 69 ADMIT 70 PATIENT 71 PPS DX REASON DX a b c CODE ECI a b c 74 PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE 75 CODE DATE CODE DATE CODE DATE 76 ATTENDING NPI QUAL LAST FIRST F c. OTHER PROCEDURE d. OTHER PROCEDURE e. OTHER PROCEDURE CODE DATE CODE DATE 77 OPERATING NPI QUAL CODE DATE LAST FIRST 81CC 80 REMARKS a 78 OTHER NPI QUAL b LAST FIRST c 79 OTHER NPI QUAL d LAST FIRST UB-04 CMS-1450 APPROVED OMB NO THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF. This sample form is for informational purposes only. E The accurate completion of reimbursement- or coverage-related documentation is the responsibility of the healthcare provider and patient. Bristol-Myers Squibb and its agents make no guarantee regarding reimbursement for any service or item. a b A B C A B C A B C A B C D E F Outpatient Hospital Form Locator (FL) 42: Enter a 4-digit revenue code that best describes the service provided, in accordance with hospital billing policy. 10 For chemotherapy administration, revenue codes 0260 (IV therapy) or 0335 (radiology therapeutic: chemotherapy-iv) could be used. 4 CMS recommends using revenue code 0636 (drugs requiring detailed coding) 7 FL 43: Enter the qualifier N4 followed by the 11-digit NDC in positions Additionally, report the quantity qualifier (ML) followed by the quantity administered (50 mg/10 ml or 200 mg/40 ml) beginning in position 14. 8,10 For example, use N ML10 for the 50-mg/ 10-mL vial or N ML40 for the 200-mg/40-mL vial 8 FL 44: Enter HCPCS code J9228, CPT code 96413, and CPT code (if needed) for time of treatment infusion. 2,5,10 In addition, it is required that you enter J9228-JW on next line to record waste 3 FL 46: Billing units are called service units and are placed here mg = 1 billing unit FLs 67A-67Q: Enter the site-specific ICD-10-CM diagnosis codes for the malignancy being treated 10 FL 80: Some payers require detailed information about the drug in FL 80. 9,10 Typically, payers require the drug name, total dosage and strength, method of administration, 11-digit NDC, and basis of measurement For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 13

14 Dosing and Administration of YERVOY Recommended dosing 8 Metastatic melanoma The recommended dose of YERVOY is 3 mg/kg administered intravenously over 90 minutes every 3 weeks for a maximum of 4 doses. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose Adjuvant Treatment of Fully Resected Stage III Melanoma (lymph node >1 mm) The recommended dose of YERVOY is 10 mg/kg administered intravenously over 90 minutes every 3 weeks for 4 doses followed by 10 mg/kg every 12 weeks for up to 3 years. In the event of toxicity, doses are omitted, not delayed Recommended dose modifications Endocrine: Withhold YERVOY for symptomatic endocrinopathy. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for symptomatic reactions lasting 6 weeks or longer or an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day. Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment. All Other Organ Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for Grade 2 reactions lasting 6 weeks or longer, an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day, and Grade 3 or 4 adverse reactions. 14

15 Determining Your Order for YERVOY Dosing for YERVOY is weight-based; therefore, the dosage of YERVOY will vary not only by indication, but by patient weight as well 8 Example Orders Patient Weight Examples YERVOY Total Dosage Needed Suggested Vials Metastatic Melanoma 50 kg (110 lbs) 3 mg/kg 150 mg 3 x = 150 mg 83 kg (183 lbs) 3 mg/kg 249 mg 1 x x 50 = 250 mg Adjuvant Treatment of Fully Resected Stage III Melanoma (lymph node >1 mm) 50 kg (110 lbs) 10 mg/kg 500 mg 2 x x = 500 mg 83 kg (183 lbs) 10 mg/kg 830 mg 4 x x 50 = 850 mg How to store YERVOY 8 YERVOY must be stored under refrigeration between 2 C and 8 C (36 F to 46 F) Protect vials from light Do not freeze For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 15

16 How YERVOY Is Distributed Physician Offices Specialty Distributor Phone Orders Website Cardinal Health Specialty Pharmaceutical Distribution Monday-Friday, 7 AM-6 PM CST (24-hour emergency on call) cardinalhealth.com CuraScript Specialty Distribution Monday-Friday, 8 AM-7 PM EST McKesson Specialty Health Monday-Friday, 7 AM-7 PM CST Oncology Supply Monday-Thursday, 8 AM-7:30 PM CST Friday, 8 AM-7 PM CST Note: If preferred, physician offices may also purchase YERVOY through a specialty pharmacy. Above information is accurate as of 04/17. The YERVOY distribution program includes extended payment terms to Bristol-Myers Squibb authorized YERVOY distributors. Healthcare providers and institutions should contact their YERVOY distributor to understand specific payment terms that may be available to them from their distributor. 16

17 How YERVOY Is Distributed (cont d) Hospitals, Infusion Centers, and Specialty Pharmacies Specialty Distributor Phone Orders Fax Orders and Website ASD Healthcare Cardinal Health Specialty Pharmaceutical Distribution Monday-Thursday, 7 AM-6:30 PM CST Friday, 7 AM-6 PM CST (24-hour emergency on call) Monday-Friday, 7 AM-6 PM CST (24-hour emergency on call) cardinalhealth.com DMS Pharmaceutical Group, Inc Monday-Friday, 8:30 AM-5:30 PM CST Smith Medical Partners Monday-Thursday, 8 AM-5 PM CST Friday, 8 AM-4:30 PM CST McKesson Plasma and Biologics Monday-Friday, 8 AM-6:30 PM CST Above information is accurate as of 04/17. The YERVOY distribution program includes extended payment terms to Bristol-Myers Squibb authorized YERVOY distributors. Healthcare providers and institutions should contact their YERVOY distributor to understand specific payment terms that may be available to them from their distributor. For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 17

18 Medicare Drug Reimbursement for YERVOY What is the Medicare reimbursement allowable for YERVOY? Physicians* The payment limit is 106% of average sales price (ASP), not including sequestration, and represents one billing unit of YERVOY, which is billed for each 1 mg 11 The amount paid to physicians for HCPCS code J9228 is published at the beginning of each calendar quarter in Payment Allowance Limits for Medicare Part B Drugs, 12 which can be downloaded at Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2017ASPFiles.html Medicare Part B will pay physicians 80% of the allowed price for J9228; the patient is responsible for 20% co-insurance, which may be covered by secondary insurance (private supplemental coverage, Medicaid, etc.) 13 Hospital outpatient clinics* Drugs paid separately under the hospital outpatient fee schedule are based on 106% of average sales price (ASP), not including sequestration, for one billing unit for the corresponding HCPCS code. This is 1 mg for J The Payment Allowance Limits 12 are published each quarter at Part-B-Drugs/McrPartBDrugAvgSalesPrice/2017ASPFiles.html Hospital inpatient settings Reimbursement in the inpatient setting is bundled into the Medicare Diagnosis Related Groups called MS-DRGs 14,15 This prospective rate changes on October 1 each year and does not allow for drugs to be paid separately 16 * While the statutory amount that Medicare will reimburse for a Part B Drug in a physician office will remain at ASP +6%, sequestration has resulted in a reduction to the Medicare portion of the payment to Medicare providers. Essentially, all payments from Medicare carriers to the providers (including physician offices, hospitals, etc.) will be reduced by 2%. 17 See The Centers for Medicare & Medicaid Services' (CMS) Internet Only Manual (IOM) Publication , Chapter

19 Commercial Insurance Reimbursement for YERVOY Physicians Drug reimbursement, like service reimbursement, is usually based on a fee schedule 18 The fee schedules are based on the ASP or AWP, as published by a credible source, 19,20 or an average costing methodology as determined by the payer, such as usual, customary, and reasonable (UC&R) 21 Hospital outpatient clinics In this setting, reimbursement is most commonly based on percentage of charges 20 Alternatively, some hospitals use the same ASP or AWP methodologies typically used by physician offices 20 Other methodologies include capitated model, cost minus submitted charges, or discount off submitted charges 20 Hospital inpatient settings Inpatient rates are prospective, meaning they are predetermined per discharge 14 There are private payers that pay on a version of the DRGs 15 There are also payers that pay on a negotiated and fixed rate per day called a per diem. 15 There are capitated rates for inpatients as well 14 New drugs may be carved out of per diems or capitated rates, if the hospital negotiates to do so 22 For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 19

20 The BMS Oncology Co-Pay Assistance Program Offers Financial Assistance to Eligible, Commercially- Insured Patients Bristol-Myers Squibb supports access to certain Bristol-Myers Squibb oncology products through the BMS Oncology Co-Pay Assistance Program. The program provides financial assistance with the out-of-pocket deductibles, co-pay, or co-insurance costs for eligible patients who have been prescribed certain Bristol-Myers Squibb oncology products. How the program works: Enrolled Patients only pay $25 per product for 2 Bristol-Myers Squibb or $25 Each product receives a $25,000 benefit products infused the same day Bristol-Myers Squibb will cover the remaining amount up to a maximum of $25,000 per year, per patient, per product Other restrictions apply. Final determination of Program eligibility is based on review of completed application. Please see page 22 for full Eligibility and Terms and Conditions. Please note: The Program will cover the out-of-pocket expenses of a Bristol-Myers Squibb medication only. It does not cover the costs of any other healthcare provider charges, or any other treatment costs. Patients may be responsible for non drug-related out-of-pocket costs, depending on their specific healthcare benefits. 20

21 How the Patient Enrolls Into the Co-Pay Assistance Program 1 Obtain an enrollment form in one of the following ways: Call BMS Access Support at , 8 AM to 8 PM ET, Monday-Friday Visit or Log on to 2 You and your patient complete the enrollment form. The patient s name, address, insurance carrier, and member identification number are required. Please fax the completed enrollment form to BMS Access Support determines patient eligibility, including verifying commercial insurance. BMS Access Support then notifies the provider and patient of enrollment determination and the appropriate next steps. Visit to download an application form. Fax the completed form to For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 21

22 Co-Pay Assistance Program Terms and Conditions Patient Eligibility: You have commercial (private) insurance that covers your prescribed Bristol-Myers Squibb (BMS) medication, but your insurance does not cover the full cost; that is, you have a co-pay obligation (out-of-pocket cost) for your prescribed medication. You are not participating in any state or federal healthcare program including Medicaid, Medicare, Medigap, CHAMPUS, TriCare, Veterans Affairs (VA), or Department of Defense (DoD), or any state, patient, or pharmaceutical assistance program. Patients who move from commercial (private) insurance to a state or federal healthcare program will no longer be eligible. If you purchased your prescription insurance through a Health Exchange (also known as a Health Insurance Marketplace or Small Business Options Program [SHOP] Marketplace), you are currently eligible. You live in the United States or Puerto Rico. Program Benefits: You must pay the first $25 of the co-pay for each dose of a BMS medication covered by this Program. If the patient is administered two BMS medications covered by this Program on the same day, the combination of those two medications will be treated as one dose, requiring the patient pay only $25 of the medications co-pay for that day. This Program will cover the remainder of the co-pay, up to a maximum of $25,000 per BMS medication during a calendar year. (For clarification, if a patient is prescribed two BMS medications in combination, the maximum is $50,000.) Patients are responsible for any costs that exceed the Program s per medication $25,000 maximum. In order to receive the Program benefits, the patient or provider must submit an Explanation of Benefits (EOB) form, or a Remittance Advice (RA). The submitted form must include the name of the insurer, plan information, and show that the BMS medication supported by this Program was the medication that was given. The form must be submitted within 180 days of receiving each dose. The Program may apply to retroactive out-of-pocket expenses that occurred within 120 days prior to the date of the enrollment. These benefits are subject to the $25 patient co-pay requirement and the 12-month Program maximum of $25,000 per medication. The Program benefits are limited to the co-pay costs for BMS medications covered by this Program that the patient receives as an outpatient. The Program will not cover, and shall not be applied toward, the cost of any dosing procedure, any other healthcare provider service or supply charges or other treatment costs, or any costs associated with a hospital stay. Program Timing: The enrollment period is 1 calendar year. Patients must enroll by December 31, Additional Terms and Conditions of Program: Patients, pharmacists, and healthcare providers must not seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this Program. Patients must not seek reimbursement from any health savings, flexible spending, or other healthcare reimbursement accounts for the amount of assistance received from the Program. Acceptance of this offer confirms that this offer is consistent with patient s insurance. Patients, pharmacists, and healthcare providers must report the receipt of co-pay assistance benefits as may be required by patient s insurance provider. This offer is not valid with any other program, discount, or incentive involving a BMS medication eligible for this Program. Only valid in the United States and Puerto Rico; this offer is void where prohibited by law, taxed, or restricted. The Program benefits are nontransferable. No membership fees. This offer is not conditioned on any past, present, or future purchase, including additional doses. The Program is Not Insurance. Bristol-Myers Squibb reserves the right to rescind, revoke, or amend this offer at any time without notice. 22

23 YERVOY Adjuvant Patient Program for Melanoma The Adjuvant Patient Program (APP) for Melanoma is designed to assist all eligible patients who have been prescribed YERVOY at the 10 mg/kg dose for the adjuvant treatment of fully resected stage III melanoma (lymph node >1 mm). Program features Available for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy Will provide free YERVOY to eligible patients for up to 3 years, where the physician determines that such treatment is medically necessary Open to eligible patients who are uninsured, commercially insured, or insured through a state or federal healthcare program Patients must be residents of, and receiving outpatient infusions in, the United States or Puerto Rico All free product provided must be used only for designated patients enrolled in the Program Enrolled patients must reapply annually to verify that they continue to meet eligibility requirements Other program rules apply Applying to the program BMS Access Support will confirm patient eligibility. If the patient meets the eligibility criteria and is accepted into the Adjuvant Patient Program, BMS Access Support will call the prescriber s office to arrange delivery. 1. The prescriber and the patient complete and sign the BMS Access Support enrollment form. Check the box for the Adjuvant Patient Program (APP) for Melanoma 2. After an initial screening, the office will receive an application to the Adjuvant Patient Program for Melanoma from BMS Access Support. Prescribers must complete and sign this application Fax completed application to Receiving YERVOY After each infusion is administered: The prescriber must confirm administration (for example, infusion flow sheet) The prescriber must confirm continued need for treatment The prescriber must notify BMS if any free product received is not used, arrange for BMS to pick up any unopened vials, and is financially responsible for any unopened vials not returned WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit 23

24 Other Information About Financial Support For patients with commercial (private) insurance Bristol-Myers Squibb product co-pay assistance programs may be available For patients with coverage through federal healthcare programs They are not eligible for co-pay assistance programs sponsored by Bristol-Myers Squibb However, BMS Access Support can help refer patients to an independent foundation that offers support for their individual needs For patients without prescription drug coverage Access Support can refer you to independent charitable foundations that may be able to provide financial support, including the Bristol-Myers Squibb Patient Assistance Foundation (BMSPAF), a charitable organization that provides medicine, free of charge, to eligible, uninsured patients who have an established financial hardship. The BMSPAF accepts the Access Support application. For more information, you can visit It is important to note that charitable foundations are independent from Bristol-Myers Squibb Company. Each foundation, including BMSPAF, has its own eligibility criteria and evaluation process. Bristol-Myers Squibb cannot guarantee that a patient will receive assistance 24

25 Important Safety Information for YERVOY WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS YERVOY can result in severe and fatal immune-mediated adverse reactions. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY. Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs), adrenocorticotropic hormone (ACTH) level, and thyroid function tests, at baseline and before each dose. Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immunemediated reactions. Recommended Dose Modifications Endocrine: Withhold YERVOY for systemic endocrinopathy. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for symptomatic reactions lasting 6 weeks or longer or an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day. Ophthalmologic: Permanently discontinue YERVOY for Grade 2-4 reactions not improving to Grade 1 within 2 weeks while receiving topical therapy or requiring systemic treatment. All Other Organ Systems: Withhold YERVOY for Grade 2 adverse reactions. Resume YERVOY in patients with complete or partial resolution of adverse reactions (Grade 0-1) and who are receiving <7.5 mg prednisone or equivalent per day. Permanently discontinue YERVOY for Grade 2 reactions lasting 6 weeks or longer, an inability to reduce corticosteroid dose to 7.5 mg prednisone or equivalent per day, and Grade 3 or 4 adverse reactions. Immune-mediated Enterocolitis Immune-mediated enterocolitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of enterocolitis (such as diarrhea, abdominal pain, mucus or blood in stool, with or without fever) and of bowel perforation (such as peritoneal signs and ileus). In symptomatic patients, rule out infectious etiologies and consider endoscopic evaluation for persistent or severe symptoms. Withhold YERVOY for moderate enterocolitis; administer anti-diarrheal treatment and, if persistent for >1 week, initiate systemic corticosteroids (0.5 mg/kg/day prednisone or equivalent). Permanently discontinue YERVOY in patients with severe enterocolitis and initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). Upon improvement to Grade 1, initiate corticosteroid taper and continue over at least 1 month. In clinical trials, rapid corticosteroid tapering resulted in recurrence or worsening symptoms of enterocolitis in some patients. Consider adding anti-tnf or other immunosuppressant agents for management of immunemediated enterocolitis unresponsive to systemic corticosteroids within 3-5 days or recurring after symptom improvement. In patients receiving YERVOY 3 mg/kg in Trial 1, severe, life-threatening, or fatal (diarrhea of 7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit Continued on next page Please see accompanying U.S. Full Prescribing Information, including Boxed Warning regarding immunemediated adverse reactions, at the end of this document. 25

26 Important Safety Information for YERVOY(cont d) 34 YERVOY-treated patients (7%) and moderate (diarrhea with up to 6 stools above baseline, abdominal pain, mucus or blood in stool; Grade 2) enterocolitis occurred in 28 YERVOY-treated patients (5%). Across all YERVOYtreated patients (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis. Infliximab was administered to 5 (8%) of the 62 patients with moderate, severe, or life-threatening immune-mediated enterocolitis following inadequate response to corticosteroids. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-5 immune-mediated enterocolitis occurred in 76 patients (16%) and Grade 2 enterocolitis occurred in 68 patients (14%). Seven (1.5%) developed intestinal perforation and 3 patients (0.6%) died as a result of complications. Immune-mediated Hepatitis Immune-mediated hepatitis, including fatal cases, can occur with YERVOY. Monitor LFTs (hepatic transaminase and bilirubin levels) and assess patients for signs and symptoms of hepatotoxicity before each dose of YERVOY. In patients with hepatotoxicity, rule out infectious or malignant causes and increase frequency of LFT monitoring until resolution. Withhold YERVOY in patients with Grade 2 hepatotoxicity. Permanently discontinue YERVOY in patients with Grade 3-4 hepatotoxicity and administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When LFTs show sustained improvement or return to baseline, initiate corticosteroid tapering and continue over 1 month. Across the clinical development program for YERVOY, mycophenolate treatment has been administered in patients with persistent severe hepatitis despite high-dose corticosteroids. In patients receiving YERVOY 3 mg/kg in Trial 1, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5 the ULN or total bilirubin elevations >3 the ULN; Grade 3-5) occurred in 8 YERVOY-treated patients (2%), with fatal hepatic failure in 0.2% and hospitalization in 0.4%. An additional 13 patients (2.5%) experienced moderate hepatotoxicity manifested by LFT abnormalities (AST or ALT elevations >2.5 but 5 the ULN or total bilirubin elevation >1.5 but 3 the ULN; Grade 2). In a dose-finding trial, Grade 3 increases in transaminases with or without concomitant increases in total bilirubin occurred in 6 of 10 patients who received concurrent YERVOY (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID). In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated hepatitis occurred in 51 patients (11%) and moderate Grade 2 immune-mediated hepatitis occurred in 22 patients (5%). Liver biopsy performed in 6 patients with Grade 3-4 hepatitis showed evidence of toxic or autoimmune hepatitis. Immune-mediated Dermatitis Immune-mediated dermatitis, including fatal cases, can occur with YERVOY. Monitor patients for signs and symptoms of dermatitis such as rash and pruritus. Unless an alternate etiology has been identified, signs or symptoms of dermatitis should be considered immune-mediated. Treat mild to moderate dermatitis (e.g., localized rash and pruritus) symptomatically; administer topical or systemic corticosteroids if there is no improvement within 1 week. Withhold YERVOY in patients with moderate to severe signs and symptoms. Permanently discontinue YERVOY in patients with severe, life-threatening, or fatal immune-mediated dermatitis (Grade 3-5). Administer systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent). When dermatitis is controlled, corticosteroid tapering should occur over a period of at least 1 month. In patients receiving YERVOY 3 mg/kg in Trial 1, severe, life-threatening, or fatal immune-mediated dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 YERVOY-treated patients (2.5%); 1 patient (0.2%) died as a result of toxic epidermal necrolysis and 1 additional patient required hospitalization for severe dermatitis. There were 63 patients (12%) with moderate (Grade 2) dermatitis. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated dermatitis occurred in 19 patients (4%). There were 99 patients (21%) with moderate Grade 2 dermatitis. Continued on next page Please see accompanying U.S. Full Prescribing Information, including Boxed Warning regarding immunemediated adverse reactions, at the end of this document. 26

27 Important Safety Information for YERVOY(cont d) Immune-mediated Neuropathies Immune-mediated neuropathies, including fatal cases, can occur with YERVOY. Monitor for symptoms of motor or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, or paresthesia. Withhold YERVOY in patients with moderate neuropathy (not interfering with daily activities). Permanently discontinue YERVOY in patients with severe neuropathy (interfering with daily activities), such as Guillain-Barré-like syndromes. Institute medical intervention as appropriate for management for severe neuropathy. Consider initiation of systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) for severe neuropathies. In patients receiving YERVOY 3 mg/kg in Trial 1, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported. Across the clinical development program of YERVOY, myasthenia gravis and additional cases of Guillain-Barré syndrome have been reported. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-5 immune-mediated neuropathy occurred in 8 patients (2%); the sole fatality was due to complications of Guillain-Barré syndrome. Moderate Grade 2 immune-mediated neuropathy occurred in 1 patient (0.2%). Immune-mediated Endocrinopathies Immune-mediated endocrinopathies, including life-threatening cases, can occur with YERVOY. Monitor patients for clinical signs and symptoms of hypophysitis, adrenal insufficiency (including adrenal crisis), and hyper- or hypothyroidism. Patients may present with fatigue, headache, mental status changes, abdominal pain, unusual bowel habits, and hypotension, or nonspecific symptoms which may resemble other causes such as brain metastasis or underlying disease. Unless an alternate etiology has been identified, signs or symptoms should be considered immune-mediated. Monitor clinical chemistries, adrenocorticotropic hormone (ACTH) level, and thyroid function tests at the start of treatment, before each dose, and as clinically indicated based on symptoms. In a limited number of patients, hypophysitis was diagnosed by imaging studies through enlargement of the pituitary gland. Withhold YERVOY in symptomatic patients and consider referral to an endocrinologist. Initiate systemic corticosteroids (1-2 mg/kg/day of prednisone or equivalent) and initiate appropriate hormone replacement therapy. In patients receiving YERVOY 3 mg/kg in Trial 1, severe to life-threatening immunemediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 YERVOY-treated patients (1.8%). All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies. Moderate endocrinopathy (requiring hormone replacement or medical intervention; Grade 2) occurred in 12 patients (2.3%) and consisted of hypothyroidism, adrenal insufficiency, hypopituitarism, and 1 case each of hyperthyroidism and Cushing s syndrome. The median time to onset of moderate to severe immune-mediated endocrinopathy was 2.5 months and ranged up to 4.4 months after the initiation of YERVOY. In patients receiving YERVOY 10 mg/kg in Trial 2, Grade 3-4 immune-mediated endocrinopathies occurred in 39 patients (8%) and Grade 2 immunemediated endocrinopathies occurred in 93 patients (20%). Of the 39 patients with Grade 3-4 immune-mediated endocrinopathies, 35 patients had hypopituitarism (associated with 1 or more secondary endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary hypothyroidism. The median time to onset of Grade 3-4 immune-mediated endocrinopathy was 2.2 months (range: 2 days-8 months). Twenty-seven (69.2%) of the 39 patients had hypopituitarism (associated with 1 or more secondary endocrinopathies, e.g., adrenal insufficiency, hypogonadism, and hypothyroidism), 3 patients had hyperthyroidism, and 1 had primary hypothyroidism. The median time to onset of Grade 3-4 immune-mediated endocrinopathy was 2.2 months (range: 2 days-8 months). Twenty-seven (69.2%) of Please see accompanying U.S. Full Prescribing Information, including Boxed Warning regarding immunemediated adverse reactions, at the end of this document. For reimbursement assistance, call BMS Access Support at , 8 AM to 8 PM ET, Monday Friday, or visit Continued on next page 27