BAVENCIO (avelumab) Coverage, Coding, and Payment Guide

Transcription

1 BAVENCIO (avelumab) Coverage, Coding, and Payment Guide Please see Important Safety Information on page 15 and full Prescribing Information for BAVENCIO starting on page 17. This document is for informational purposes only. It is always the provider s responsibility to determine the appropriate healthcare setting and to submit true and correct claims for products and services rendered. EMD Serono, Inc. and Pfizer Inc do not guarantee coverage and/or reimbursement for BAVENCIO. Coverage, coding, and reimbursement policies vary significantly by payer, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Patients and healthcare professionals should always verify coverage, coding, and reimbursement guidelines on a payer- and patientspecific basis. Please contact CoverOne at COVER1 ( ) for support with payer-specific BAVENCIO questions, or assistance verifying insurance benefits for a specific patient. 1

2 Table of Contents Commonly Used Billing Codes for BAVENCIO (avelumab)...4 National Drug Code (NDC) Healthcare Common Procedure Coding System (HCPCS) Current Procedural Terminology (CPT ) Code for Drug Administration Service Revenue Codes For Use in the Hospital Setting ONLY... 6 International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) Diagnosis Codes for Metastatic Merkel Cell Carcinoma INDICATIONS BAVENCIO (avelumab) is indicated for the treatment of: Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) Patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) Diagnosis Codes for Locally Advanced or Metastatic Urothelial Carcinoma... 8 Medicare...9 Medicaid...10 Commercial Payers...11 SELECTED SAFETY INFORMATION BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% (21/1738) of patients. BAVENCIO can cause immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis was reported in 0.9% (16/1738) of patients across clinical trials. Sample Claim Forms...12 CoverOne...14 Important Safety Information...15 References...16 Please see Important Safety Information on page 15 and full Prescribing Information for BAVENCIO starting on page

3 Coverage, coding, and payment for BAVENCIO (avelumab) Injection 20 mg/ml will vary by payer, plan, setting of care, and patient. The information in this guide provides a general coverage, coding, and payment framework for BAVENCIO across major payer segments. Healthcare professionals should always verify coverage, coding, and payment guidelines on a patient-specific basis. The CoverOne program provides patient access and reimbursement support services, and may be reached by calling COVER1 ( ). Commonly Used Billing Codes for BAVENCIO (avelumab) The codes discussed below may be appropriate when billing for BAVENCIO and its administration for the treatment of its FDA-approved indications. It is always the provider s responsibility to determine the appropriate healthcare setting and to submit true and correct claims for products and services rendered. EMD Serono, Inc. and Pfizer Inc do not guarantee coverage and/or reimbursement for BAVENCIO. Coverage, coding, and reimbursement policies vary significantly by payer, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Patients and healthcare professionals should always verify coverage, coding, and reimbursement guidelines on a payer- and patient-specific basis. Healthcare Common Procedure Coding System (HCPCS) HCPCS coding requirements will vary by payer, setting of care, and date of service. Please verify patientspecific insurance benefits to confirm specific coding and billing guidelines for BAVENCIO. HCPCS Description Payer and Setting of Care C9491 Injection, avelumab, 10 mg Medicare Hospital Outpatient Prospective Payment System (OPPS) Claims 1 C9491 is effective for Medicare OPPS claims with dates of service on or after October 1, Medicare OPPS claims for BAVENCIO with dates of service prior to October 1, 2017 should be billed using C9399 (unclassified drugs or biologicals) 1 unit of C9491 equals 10 mg of avelumab. As a result, 20 units of C9491 equals one 200 mg single-use vial of BAVENCIO. Actual units reported will vary by dosage required for each individual patient, and any specific billing instructions required by the local payer C9491 should not be used for Medicare Part B claims for the physician setting Private payers and select Medicaid programs have the discretion to accept C-codes for certain settings of care, but are not required to accept C-codes National Drug Code (NDC) HCPCS Description Payer and Setting of Care Most payers require providers to include the NDC in the additional information that typically is required J3490 Unclassified drugs when billing for a new drug using an unclassified HCPCS code (discussed in more detail in the next section). The 11-digit NDC for BAVENCIO is listed below. NDC Packaging J3590 J9999 Unclassified biologics Not otherwise classified, antineoplastic drugs Medicare physician office claims; commercial payer and Medicaid claims (hospital outpatient and physician office) BAVENCIO is supplied in a single-dose vial of 200 mg/10 ml (20 mg/ml), individually packed Claims with an unclassified HCPCS code must include additional information about the drug in the relevant section of the electronic or paper claim to identify the drug being administered. See below and refer to the sample claim forms on pages for more detail. For dates of service prior to October 1, 2017, Medicare hospital outpatient claims with C9399 must include 2 : the NDC, the quantity of the drug that was administered (expressed in the unit of measure applicable to the drug or biological) and the date the drug was furnished to the beneficiary. For other unclassified HCPCS codes including J3490, J3590, and J9999 the additional information may vary by payer and may include the name of the drug, NDC, quantity administered, route of administration, date of service, and/or other information that may be requested by a specific contractor or plan Providers should contact CoverOne or their local commercial payers, Medicare contractor, and Medicaid plans for specific information on reporting drugs using unclassified HCPCS codes. 4 Please see Important Safety Information on page 15 and full Prescribing Information for BAVENCIO starting on page 17. 5

4 The recommended dose of BAVENCIO (avelumab) Injection 20 mg/ml is administered as 10 mg/kg intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. In the event of a Grade 1 or 2 infusion-related reaction, the Dosage Modification section of the Prescribing Information directs providers to interrupt or slow the infusion rate. Please refer to the full Prescribing Information for complete Dosage and Administration guidelines. International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) Diagnosis Codes All hospital and physician office claims must include at least one ICD-10-CM diagnosis code to describe the patient s condition. Metastatic Merkel Cell Carcinoma Current Procedural Terminology (CPT )* Code for Drug Administration Service ICD-10-CM Description CPT Description C4A.0 Merkel cell carcinoma of lip Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug Chemotherapy administration, intravenous infusion technique; each additional hour (list separately in addition to code for primary procedure) * CPT Copyright 2016 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The appropriate CPT code for the administration of BAVENCIO will depend on the actual service performed. Providers should consult a current CPT manual and always select the code that accurately describes the administration service based off the specific patient encounter. Revenue Codes For Use in the Hospital Setting ONLY All hospital claim forms must include a revenue code for each charge line item. The following revenue codes are most relevant for physician-administered drugs. Code Code Description 0636 Pharmacy Drugs Requiring Detailed Coding 025X Pharmacy Revenue code 0636 is required on Medicare hospital outpatient claims. For payers other than Medicare, the revenue code may vary. Although some private payers and Medicaid plans accept revenue code 0636, others may require a different revenue code, such as Each CPT code must be reported with a revenue code, which may vary depending on the type of procedure and the cost center in which the procedure is performed. C4A.10 C4A.11 C4A.12 C4A.20 C4A.21 C4A.22 C4A.30 C4A.31 C4A.39 C4A.4 C4A.51 C4A.52 C4A.59 C4A.60 C4A.61 C4A.62 C4A.70 C4A.71 C4A.72 C4A.8 C4A.9 Merkel cell carcinoma of unspecified eyelid, including canthus Merkel cell carcinoma of right eyelid, including canthus Merkel cell carcinoma of left eyelid, including canthus Merkel cell carcinoma of unspecified ear and external auricular canal Merkel cell carcinoma of right ear and external auricular canal Merkel cell carcinoma of left ear and external auricular canal Merkel cell carcinoma of unspecified part of face Merkel cell carcinoma of nose Merkel cell carcinoma of other parts of face Merkel cell carcinoma of scalp and neck Merkel cell carcinoma of anal skin Merkel cell carcinoma of skin of breast Merkel cell carcinoma of other part of trunk Merkel cell carcinoma of unspecified upper limb, including shoulder Merkel cell carcinoma of right upper limb, including shoulder Merkel cell carcinoma of left upper limb, including shoulder Merkel cell carcinoma of unspecified lower limb, including hip Merkel cell carcinoma of right lower limb, including hip Merkel cell carcinoma of left lower limb, including hip Merkel cell carcinoma of overlapping sites Merkel cell carcinoma, unspecified! Revenue codes are not used in the physician office setting. The ICD-10-CM diagnosis codes listed above are provided only as examples of potentially relevant codes. Providers should consult a current ICD-10-CM manual and always select the most appropriate diagnosis code(s) with the highest level of specificity to describe a patient s actual condition. All diagnosis codes should be supported with adequate documentation in the patient s medical record. 6 Please see Important Safety Information on page 15 and full Prescribing Information for BAVENCIO starting on page 17. 7

5 ICD-10-CM Diagnosis Codes (continued) Locally Advanced or Metastatic Urothelial Carcinoma Code Code Description C67.0 Malignant neoplasm of trigone of bladder C67.1 Malignant neoplasm of dome of bladder C67.2 Malignant neoplasm of lateral wall of bladder C67.3 Malignant neoplasm of anterior wall of bladder C67.4 Malignant neoplasm of posterior wall of bladder C67.5 Malignant neoplasm of bladder neck C67.6 Malignant neoplasm of ureteric orifice C67.7 Malignant neoplasm of urachus C67.8 Malignant neoplasm of overlapping sites of bladder C67.9 Malignant neoplasm of bladder, unspecified C65.1 Malignant neoplasm of the right renal pelvis C65.2 Malignant neoplasm of the left renal pelvis Office HOPD Medicare BAVENCIO (avelumab) Injection 20 mg/ml is eligible for Medicare Part B fee-for-service coverage when used for the treatment of its FDA-approved indication when administered incident to a physician s service and when reasonable and necessary for an individual patient. 3 Medicare Administrative Contractors (MACs) have the discretion to issue Local Coverage Determinations (LCDs) or other written coverage and coding guidance for BAVENCIO. Please contact your local MAC or the CoverOne program to verify specific BAVENCIO coverage guidance for your geographic area. Medicare Advantage plans must provide at least the same coverage as fee-for-service Medicare 4 ; therefore, these plans should cover BAVENCIO for its FDA-approved indication when its use is reasonable and necessary for an individual patient. However, Medicare Advantage plans may require prior authorization for BAVENCIO. Contact CoverOne or the Medicare Advantage plan directly to confirm planspecific coverage requirements. Medicare coding for BAVENCIO varies depending on the setting of care. Until a product-specific J-code is issued, physician offices may bill for BAVENCIO using unclassified HCPCS code J3490, J3590, or J9999. Effective for claims with dates of service on or after October 1, 2017, BAVENCIO is an eligible transitional pass-through drug and has been assigned HCPCS code C9491 (Injection, avelumab, 10 mg) for use in the Medicare OPPS setting. Medicare OPPS claims with dates of service prior to October 1, 2017 should be billed with unclassified HCPCS code C9399. Beginning January 1, 2017, Medicare claims require the use of the JW modifier (drug amount discarded/ not administered to any patient) when applicable. 5 Other payers may have similar requirements. C65.9 Malignant neoplasm of the unspecified renal pelvis C66.1 Malignant neoplasm of the right ureter C66.2 Malignant neoplasm of the left ureter C66.9 Malignant neoplasm of the unspecified ureter C68.0 Malignant neoplasm of urethra Z85.51 Personal history of malignant neoplasm of bladder D09.0 Carcinoma in situ of bladder The ICD-10-CM diagnosis codes listed above are provided only as examples of potentially relevant codes. Providers should consult a current ICD-10-CM manual and always select the most appropriate diagnosis code(s) with the highest level of specificity to describe a patient s actual condition. All diagnosis codes should be supported with adequate documentation in the patient s medical record. Claims with an unclassified HCPCS code must include additional information about the drug (see page 5 for more details). Providers may contact CoverOne or their Medicare contractor for specific information on reporting drugs using unclassified HCPCS codes, including requirements related to JW modifier reporting. a HOPD, Hospital outpatient department. a Additional information on the JW modifier is available at: HospitalOutpatientPPS/Downloads/JW-Modifier-FAQs.pdf. Accessed August 8, Medicare payment for new physician-administered injectable drugs covered under Part B, such as BAVENCIO, will vary by clinical care setting. Generally, reimbursement is based on Wholesale Acquisition Cost (WAC) for a brief initial period, and later transitions to Average Sales Price (ASP), as required under federal law 6,b and CMS regulations. 2 Please contact your local MAC or the CoverOne program to verify specific BAVENCIO payment details for your geographic area and clinical care setting. The CoverOne program is available to assist patients and providers and may be reached by calling COVER1 ( ). IMPORTANT NOTE: Many Medicare enrollees receive coverage through a Medicare Advantage plan. Reimbursement policies under these plans may differ from those of traditional Medicare and may vary from plan to plan. b Medicare payments are subject to 2% sequestration reductions as required under the Budget Control Act of 2011 (P.L ). 8 Please see Important Safety Information on page 15 and full Prescribing Information for BAVENCIO starting on page 17. 9

6 Medicaid Medicaid coverage, coding, and payment policies will vary by state Medicaid program and should be verified for each particular state. In addition, some Medicaid plans may require prior authorization for BAVENCIO (avelumab) Injection 20 mg/ml. Until a product-specific J-code is issued, physician offices and HOPDs may bill Medicaid for BAVENCIO using unclassified HCPCS code J3490, J3590, or J9999. Some Medicaid programs may choose to accept claims with C9491, but are not required to do so. Providers are also required to report the 11-digit NDC on Medicaid claims for all provider-administered drugs. As with other payers, Medicaid plans require additional information on claims with an unclassified HCPCS code. Please see page 5 for more details. Medicaid programs use a variety of payment methodologies for drugs and biologicals in the physician office setting, including AWP c, ASP, state-specific fee schedules, or percentage Office of charges. Medicaid programs use a variety of payment methodologies for drugs and biologicals in the hospital outpatient setting, including AWP, ASP, ambulatory payment groups, state-specific fee schedules, HOPD preset per-diem/per-visit rates, or percentage of charges. There is significant variation in Medicaid payment amounts among states. Providers should verify payment rates for their state Medicaid program. The CoverOne program is available to assist patients and providers in verifying state Medicaid policies for BAVENCIO and may be reached by calling COVER1 ( ). Commercial Payers Coverage, coding, and payment guidelines vary significantly by private/commercial payer, plan, setting of care, and patient. Additionally, benefits may also depend on the specific contract terms that a provider negotiates with a given plan. Patients and providers should verify patient-specific benefits to determine if BAVENCIO is covered under each specific plan and if prior authorization is required. Until a product-specific J-code is issued, physician offices and HOPDs may bill for BAVENCIO using unclassified HCPCS code J3490, J3590, or J9999. Private payers have the Office HOPD discretion to accept C9491, but are not required to do so. As with other payers, commercial plans require additional information on claims with an unclassified HCPCS code. Many private payers also require the reporting of 11-digit NDC codes in addition to HCPCS codes. Please see page 5 for more details. Private insurers use a variety of payment methodologies for drugs and biologicals administered in the physician office and hospital outpatient settings, including AWP, ASP, invoice, or percentage of charges. The exact payment mechanism used by a specific payer usually depends on the provider s contractual agreement with that payer. The CoverOne program is available to assist patients and providers in verifying private insurance benefits and may be reached by calling COVER1 ( ). IMPORTANT NOTE: Many Medicaid enrollees receive coverage through Medicaid managed care plans. Coverage and payment policies under these plans may differ from those of traditional Medicaid and may vary from plan to plan COVER1 ( ) Monday-Friday 8:00am-8:00pm Eastern Time c AWP is set by certain third-party pricing services. EMD Serono and Pfizer do not set AWP. Please see Important Safety Information on page 15 and full Prescribing Information for BAVENCIO starting on page

7 SAMPLE CMS-1500 Claim Form for BAVENCIO (avelumab) Injection 20 mg/ml BOX 19 (Electronic claim form: Loop 2400) Claims submitted with an unclassified HCPCS code including J3490, J3590, and J9999 should include additional information about the drug. This additional information may vary by payer, but often includes the product name, 11-digit NDC, and quantity administered. Providers may contact their local payers, Medicare contractor, and Medicaid plans for specific information on reporting drugs using unclassified HCPCS codes. Example dosage shown. Actual dosage will vary by patient. PHYSICIAN OFFICE BOX 21 (Electronic claim form: Loop 2300, Segment HI) Enter the appropriate primary diagnosis code from the patient s medical record in Item 21A. For example, urothelial carcinoma is most commonly described by ICD-10-CM series C67, C66, C65, and C68.0. Merkel cell carcinoma is described by ICD-10-CM series C4A. Use Item 21B-L to report any applicable secondary diagnosis(es). Example ICD-10-CM code shown; report the ICD-10-CM code(s) that reflect the patient s actual condition. The reported ICD-10-CM code(s) should reflect the highest level of specificity. SAMPLE UB-04/CMS-1450 Claim Form for BAVENCIO (avelumab) Injection 20 mg/ml HOSPITAL OUTPATIENT DEPARTMENT a PAT. CNTL # 4 TYPE OF BILL b. MED. REC. # BOX 45 6 STATEMENT COVERS PERIOD 5 FED. TAX NO. FROM THROUGH 7 BOX 42 (837I electronic claim: Loop 2400, Segment type SV2) 8 PATIENT NAME a 9 PATIENT ADDRESS a Enter date of service. b b c d e List the appropriate revenue code for BAVENCIO. 10 BIRTHDATE 11 SEX ADMISSION CONDITION CODES 12 DATE 16 DHR 29 ACDT HR 14 TYPE 15 SRC 17 STAT STATE Revenue code 0636 is required by Medicare. For payers other BOX 46 (837I electronic claim: Loop 2400, than 31 Medicare, OCCURRENCE the revenue 32 OCCURRENCE code may vary; 33 although OCCURRENCE some 34 OCCURRENCE 35 OCCURRENCE SPAN 36 OCCURRENCE SPAN 37 CODE DATE CODE DATE CODE DATE CODE DATE CODE FROM Segment THROUGH type SV2, CODE Service FROM line SV205) THROUGH private payers and Medicaid plans accept revenue code 0636, others may require other revenue codes, such as Enter the number of service units for each line item. For C9491, each unit corresponds to 10 mg of BAVENCIO. One 200 mg single-dose vial VALUE CODES 40 VALUE CODES 41 VALUE CODES CODE would AMOUNT be reported with CODE 20 units. AMOUNT When billing CODE an unclassified AMOUNT HCPCS Enter an appropriate revenue code for the administration service a code, report a unit of 1.* based on the cost center in which the service is performed. b For Medicare claims (if applicable), on a separate line, enter the number c of units discarded and include the HCPCS code and JW modifier in Box 44. d 42 REV. CD. 43 DESCRIPTION 44 HCPCS / RATE / HIPPS CODE 45 SERV. DATE 46 SERV. UNITS 47 TOTAL CHARGES 48 NON-COVERED CHARGES C (837I electronic claim: Loop 2400, Segment type DTP) BAVENCIO (avelumab), 800 mg, C67.X J9999 BOX 24D (Electronic claim form: Loop 2400, Segment SV) Enter the appropriate HCPCS code for BAVENCIO. Until a productspecific HCPCS code is issued, BAVENCIO may be billed using an unclassified HCPCS code. For example: J9999 Not otherwise classified, antineoplastic drugs J3490 Unclassified drugs J3590 Unclassified biologics Note that claims with an unclassified HCPCS code should include additional information (see Box 19 above). BOX 24A-B (Electronic claim form: BOX 24a: Loop 2400, Segment DTP BOX 24b: Loop 2300/2400, Segment CLM/SV) A A 1 Enter the date of service and the appropriate place of service code. BOX 24E (Electronic claim form: Loop 2400, Segment SV) Specify the diagnosis from Box 21 that corresponds to the product or procedure listed in Box 24D. BOX 24F (Electronic claim form: Loop 2400, Segment SV102) Enter the total charge for each line item. Enter the appropriate CPT code for the administration service. For BOX 24G (Electronic claim form: Loop 2400, Segment SV) example, a 60-minute chemotherapy IV infusion would be reported with CPT code Chemotherapy administration, intravenous infusion Enter the number of service units for each line item. When billing an technique; up to 1 hour, single or initial substance/drug. unclassified HCPCS code, report a unit of 1.* PLEASE PRINT OR TYPE APPROVED OMB FORM 1500 (02-12) *Beginning January 1, 2017, Medicare claims require the use of the JW modifier (drug amount discarded/not administered to any patient) when applicable. (Source: Centers for Medicare and Medicaid Services. Transmittal R3538CP: JW Modifier Drug amount discarded/not administered to any patient.) Other payers may have similar requirements. *Effective January 1, 2017, Medicare requires providers to use the JW modifier (Drug amount discarded/not administered to any patient) for all claims with unused drugs or biologicals from single use vials that are appropriately discarded (or "wastage"), and to document the discarded drug or biological in the patient's medical record. (Source: Centers for Medicare and It is Medicaid always Services. the provider s Transmittal responsibility R3538CP: JW to Modifier--Drug determine the amount appropriate discarded/not healthcare administered setting to any and patient.) to submit Providers true should and correct contact claims their local for MAC products to determine and services its specific rendered. policy around EMD reporting Serono, wastage Inc. and for drugs Pfizer billed Inc with do not an unclassified guarantee HCPCS coverage code. and/or Wastage-reporting reimbursement requirements for BAVENCIO. for other payers Coverage, may vary, coding, and should and reimbursement be confirmed on a policies payer-and vary patient-specific significantly basis. by payer, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following receipt of claims. Patients and healthcare professionals should always verify coverage, coding, and reimbursement guidelines on a payer- and patient-specific basis. This document is for informational purposes only and is accurate as of <date>. It is always the provider's responsibility to determine the appropriate healthcare setting and to submit true and correct claims for products and services rendered. EMD Serono, Inc. and Pfizer Inc do not guarantee coverage and/or reimbursement for BAVENCIO. Coverage, coding, and reimbursement policies vary significantly by payer, patient, and setting Please of care. contact Actual coverage CoverOne and reimbursement at COVER1 decisions are made by individual ( ) payers following receipt for of support claims. Patients with and healthcare payer-specific professionals should BAVENCIO always verify questions, coverage, coding, or and assistance reimbursement guidelines verifying on a payer- insurance and patient-specific benefits basis. for a specific patient. Please contact CoverOneTM at COVER1 ( ) for payer-specific BAVENCIO questions or to verify insurance benefits for a specific patient. May 2017 US/AVE/1116/0129f Enter the total charge for each line item after October 1, 2017) October 1, 2017) should reflect the highest level of specificity PAGE OF CREATION DATE TOTALS 52 REL. 53 ASG. 50 PAYER NAME 51 HEALTH PLAN ID 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE INFO BEN. 56 NPI A 57 B OTHER BOX 80 C PRV ID 58 INSURED S NAME 59 P.REL 60 INSURED S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO. A B information about the drug. C 63 TREATMENT AUTHORIZATION CODES 64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME A B C DX C67.X BOX 44 (837I electronic claim: Loop 2400, Segment type SV2, Service line SV201) Enter the appropriate HCPCS code for BAVENCIO. For example: Medicare: C Injection, avelumab, 10 mg (effective for dates of service on or C Unclassified drugs or biologicals (for dates of service prior to If applicable, discarded product should be reported on a separate line with the HCPCS code and JW modifier. The corresponding number of units discarded should be reported in Box 46. Medicaid and commercial payers that do not accept C9491 or C9399: J Not otherwise classified, antineoplastic drugs J Unclassified drugs J Unclassified biologics Note that claims with an unclassified HCPCS code should include additional information (see Box 80 below). Enter the appropriate CPT code for the administration service. For example, a 60-minute chemotherapy IV infusion would be reported with CPT code Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug. 67 A B C D E F G H I J K L M N O P Q a b c 69 ADMIT 70 PATIENT 71 PPS DX REASON DX CODE ECI 74 PRINCIPAL PROCEDURE CODE DATE a. OTHER PROCEDURE CODE DATE b. OTHER PROCEDURE CODE DATE ATTENDING NPI QUAL c. OTHER PROCEDURE d. OTHER PROCEDURE CODE DATE CODE DATE e. OTHER PROCEDURE CODE DATE b LAST FIRST 12 Please contact CoverOne 13 at COVER1 ( ) for support with payer-specific BAVENCIO questions, or assistance verifying insurance benefits for a specific patient. October 2017 US/AVE/1116/0129g(1) BOX 43 Enter the corresponding description for the revenue code listed in Box REMARKS BAVENCIO (avelumab) mg Furnished MM/DD/YYYY 81CC a c BOX 47 (837I electronic claim: Loop 2300, Segment type CLM, Claim Information CLM02) BOX 67 (837I electronic claim: Loop 2300, Segment type HI, Diagnosis Information H101-2) Enter the primary diagnosis code. For example, urothelial carcinoma is most commonly described by ICD-10-CM series C67, C66, C65, and C68.0. Merkel cell carcinoma is described by ICD-10-CM series C4A. Use fields A-Q to report any applicable secondary diagnosis(es). Example ICD-10-CM code shown; report the ICD-10-CM code(s) that reflect the patient s actual condition. The reported ICD-10-CM code(s) (837I electronic claim: Loop 2300, Segment type NTE) Claims with an unclassified HCPCS code should include additional Medicare hospital outpatient claims with dates of service prior to October 1, 2017 submitted with C9399 must include the NDC, the quantity of the drug that was administered (expressed in the unit of measure applicable to the drug or biological), and the date the drug was furnished to the beneficiary. Note that for Medicare hospital outpatient claims with dates of service on or after October 1, 2017, BAVENCIO should be reported with C9491 (see Box 44 above). For other unclassified HCPCS codes including J3490, J3590, and LAST FIRST J9999 the additional information may vary by payer, but often includes 77 OPERATING NPI QUAL the product name, 11-digit NDC, and quantity administered. Providers LAST FIRST may contact their local commercial payers and Medicaid plans for 78 OTHER NPI QUAL specific information on reporting drugs using unclassified HCPCS codes. Example 79 dosage OTHER shown. NPI Actual dosage will QUAL vary by patient. 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. orm NUBC Billing Committee *Beginning January 1, 2017, Medicare claims require the use of the JW modifier (drug amount discarded/not administered to any patient) when applicable. (Source: Centers for Medicare and Medicaid Services. LIC * Transmittal R3538CP: JW Modifier Drug amount discarded/not administered to any patient.) Other payers may have similar requirements. confirmed on a payer- Centers and patient-specific for Medicare basis. and Medicaid Services (CMS), October 2017 Update of the Hospital Outpatient Prospective Payment System (OPPS), Transmittal 3853, August 25, Source: Centers for Medicare and Medicaid Services. Claims Processing Manual Chapter 17, Section This document is for informational purposes only and is accurate as of <date>. It is always the provider s responsibility to determine the appropriate healthcare setting and to submit true and correct claims for products and services rendered. EMD Serono, Inc. and Pfizer Inc. do not guarantee coverage and/or reimbursement for BAVENCIO. Coverage, coding, and reimbursement It is always policies the vary provider s significantly by responsibility payer, patient, and setting to determine of care. Actual coverage the appropriate and reimbursement healthcare decisions are made setting by individual and payers to submit following true the receipt and of claims. correct Patients claims and healthcare for products professionals and should services always verify coverage, rendered. coding, EMD and reimbursement Serono, guidelines Inc. and on a Pfizer payer- and Inc patient-specific do not guarantee basis. coverage and/or reimbursement for BAVENCIO. Coverage, coding, and reimbursement policies vary significantly by payer, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers Please contact CoverOne at COVER1 ( ) for payer-specific BAVENCIO questions, or to verify insurance benefits for a specific patient. following the receipt of claims. Patients and healthcare professionals should always verify coverage, coding, and reimbursement guidelines on a payer- and patient-specific basis A B C A B C A B C

8 CoverOne is a patient access and reimbursement program available to help patients gain appropriate access to BAVENCIO (avelumab) Injection 20 mg/ml in the United States. CoverOne offers the following services: Reimbursement Support Insurance Benefit Verification Prior Authorization Assistance Information on Relevant Billing Codes for BAVENCIO HCPCS, CPT, ICD-10-CM, NDC Patient Assistance Program Denied/Underpaid Claims Assistance Payer Research (non-patient specific) Medicare, Private Payers, State Medicaid Alternate Funding Research CoverOne includes a patient assistance program that provides BAVENCIO at no charge for patients who meet certain income, insurance (ie, uninsured), and residency eligibility criteria. To determine patient eligibility, providers should complete and fax a CoverOne Enrollment Form prior to treatment to Co-pay Assistance Program Patient assistance is not applied retroactively CoverOne provides co-pay assistance for privately insured BAVENCIO patients with co-pay/ co-insurance responsibilities who meet the program eligibility criteria. Privately insured patients may apply for assistance through the CoverOne Co-pay Program by faxing a completed CoverOne Enrollment Form to Government-insured patients, including Medicare and Medicaid beneficiaries, are not eligible for the CoverOne Co-pay Program Limits, terms, and conditions apply. Full terms and conditions for co-pay assistance can be found at CoverOne.com CoverOne will notify you of the eligibility determination as soon as possible Enrolled patients will be responsible for a $10 co-pay/co-insurance, and may be eligible for BAVENCIO co-pay assistance up to a maximum of $30,000 per year For enrolled patients, disbursement of co-pay assistance funds occurs after the patient has received treatment in the outpatient setting, and an Explanation of Benefits (EOB) showing a separately payable BAVENCIO claim eligible for co-pay assistance is sent to CoverOne CoverOne PO Box Phoenix, AZ IMPORTANT SAFETY INFORMATION BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% (21/1738) of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3. BAVENCIO can cause immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immunemediated hepatitis. Immune-mediated hepatitis was reported in 0.9% (16/1738) of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3. BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis and permanently discontinue for lifethreatening (Grade 4) or recurrent (Grade 3) colitis upon re-initiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% (26/1738) of patients, including seven (0.4%) with Grade 3. BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus. Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% (8/1738) of patients, including one (0.1%) with Grade 3. Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% (98/1738) of patients, including three (0.2%) with Grade 3. Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer anti-hyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% (2/1738) of patients, including two cases of Grade 3 hyperglycemia. BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% (1/1738) of patients. BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immunemediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO: myocarditis with fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain- Barré syndrome, and systemic inflammatory response. BAVENCIO can cause severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Patients should be premedicated with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent doses based upon clinical judgment and presence/ severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% (439/1738) of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3. BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants. The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusionrelated reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%). Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%). The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%). Selected laboratory abnormalities (Grades 3-4, 3%) in patients PHONE: 844-8COVER1 ( ) FAX: with locally advanced or metastatic UC were hyponatremia (16%), CoverOne.com Monday-Friday, 8:00am-8:00pm Eastern Time increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%). Please see full Prescribing Information for BAVENCIO in starting on page

9 CoverOne provides patient access and reimbursement support services to help patients gain appropriate access to BAVENCIO (avelumab) Injection 20 mg/ml in the United States. We recognize that each patient s situation is different, and are dedicated to helping patients one at a time COVER1 ( ) Monday-Friday 8:00am-8:00pm Eastern Time CoverOne.com References: 1. Centers for Medicare and Medicaid Services (CMS), October 2017 Update of the Hospital Outpatient Prospective Payment System (OPPS); Transmittal 3853, August 25, Centers for Medicare and Medicaid Services. Claims Processing Manual, Chapter Accessed August 21, Centers for Medicare and Medicaid Services. Medicare Benefit Policy Manual, Chapter Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf. Accessed August 21, Centers for Medicare and Medicaid Services. Medicare Managed Care Model Chapter 4. Downloads/mc86c04.pdf. Accessed August 21, CMS, JW Modifier: Drug amount discarded/not administered to any patient; Transmittal R Social Security Act, Section 1847A. Accessed August 28, EMD Serono, Inc. and Pfizer Inc do not guarantee coverage and/or reimbursement for BAVENCIO. Coverage, coding, and reimbursement policies vary significantly by payer, patient, and setting of care. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Patients and healthcare professionals should always verify coverage, coding, and reimbursement guidelines on a payer- and patient-specific basis. Please see Important Safety Information on page 15 and full Prescribing Information for BAVENCIO starting on page Copyright 2017 EMD Serono, Inc. All rights reserved. October 2017 US/AVE/1016/0116c(1)

10 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BAVENCIO safely and effectively. See full prescribing information for BAVENCIO. BAVENCIO (avelumab) injection, for intravenous use Initial U.S. Approval: RECENT MAJOR CHANGES Indication and Usage (1.2) 5/ INDICATIONS AND USAGE BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). (1.1) This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.1, 14.1) Patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy (1.2) Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (1.2) This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.2, 14.2) DOSAGE AND ADMINISTRATION Premedicate for the first 4 infusions and subsequently as needed. (2.1) Administer 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks. (2.2) WARNINGS AND PRECAUTIONS Immune-mediated pneumonitis: Withhold for moderate pneumonitis; permanently discontinue for severe, life-threatening, or recurrent moderate pneumonitis. (5.1) Immune-mediated hepatitis: Monitor for changes in liver function. Withhold for moderate hepatitis; permanently discontinue for severe or lifethreatening hepatitis. (5.2) Immune-mediated colitis: Withhold for moderate or severe colitis; permanently discontinue for life-threatening or recurrent severe colitis. (5.3) Immune-mediated endocrinopathies: Withhold for severe or life-threatening endocrinopathies (5.4) Immune-mediated nephritis and renal dysfunction: Withhold for moderate or severe nephritis and renal dysfunction; permanently discontinue for lifethreatening nephritis or renal dysfunction. (5.5) Infusion-related reactions: Interrupt or slow the rate of infusion for mild or moderate infusion-related reactions. Stop the infusion and permanently discontinue BAVENCIO for severe or life-threatening infusion-related reactions. (5.7) Embryo-fetal toxicity: BAVENCIO can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.8, 8.1, 8.3) ADVERSE REACTIONS Most common adverse reactions ( 20%) in patients with metastatic Merkel cell carcinoma were fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema. (6.1) Most common adverse reactions ( 20%) in patients with locally advanced or metastatic urothelial carcinoma were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at ext or FDA at FDA-1088 or USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. (8.2) DOSAGE FORMS AND STRENGTHS Injection: 200 mg/10 ml (20 mg/ml) solution in single-dose vial. (3) CONTRAINDICATIONS None. (4) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 6/2017 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Metastatic Merkel Cell Carcinoma 1.2 Locally Advanced or Metastatic Urothelial Carcinoma 2 DOSAGE AND ADMINISTRATION 2.1 Premedication 2.2 Recommended Dosage 2.3 Dose Modifications 2.4 Preparation and Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Immune-Mediated Pneumonitis 5.2 Immune-Mediated Hepatitis 5.3 Immune-Mediated Colitis 5.4 Immune-Mediated Endocrinopathies 5.5 Immune-Mediated Nephritis and Renal Dysfunction 5.6 Other Immune-Mediated Adverse Reactions 5.7 Infusion-Related Reactions 5.8 Embryo-Fetal Toxicity 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Metastatic Merkel Cell Carcinoma 14.2 Locally Advanced or Metastatic Urothelial Carcinoma 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full prescribing information are not listed Page 1 of 22