Billing and Coding Guide: PEPAXTO® (Melphalan Flufenamide)

Billing and Coding Guide: PEPAXTO® (melphalan flufenamide)

A Comprehensive Billing, Coding, and Administration Resource NOW APPROVED N OW A PPR OVED

In combination with dexamethasone, for adult patients with In combination with dexamethasone, for adult patients with MULTIPLE MYELOMA whose disease is refractory to at least one proteasome inhibitor, MULTIPLE MYEPleaseLOMA whose see Important disease is Safetyrefractory Information to at least one on pageproteasome 15. inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody1 one immunomodulatory agent, and one anti-CD38 monoclonal antibody1

INDICATION IMPORTANT SAFETY INFORMATION INDICATION IMPORTANT SAFETY INFORMATION PRODUCT X is a peptide drug conjugate indicated, in Felis eget velit aliquet sagittis id consectetur purus ut. PRODUCT X is a peptide drug conjugate indicated, in Felis eget velit aliquet sagittis id consectetur purus ut. combination with dexamethasone, for the treatment of Ornare arcu dui vivamus arcu felis bibendum ut tristique. combination with dexamethasone, for the treatment of Ornare arcu dui vivamus arcu felis bibendum ut tristique. adult patients with multiple myeloma whose disease Mi tempus imperdiet nulla malesuada pellentesque elit adult patients with multiple myeloma whose disease Mi tempus imperdiet nulla malesuada pellentesque elit is refractory to at least one proteasome inhibitor, eget gravida. Habitasse platea dictumst quisque sagittis. is refractory to at least one proteasome inhibitor, eget gravida. Habitasse platea dictumst quisque sagittis. one immunomodulatory agent, and one anti-CD38 Neque convallis a cras semper. Sit amet risus nullam one immunomodulatory agent, and one anti-CD38 Neque convallis a cras semper. Sit amet risus nullam monoclonal antibody. eget. in arcu cursus. Pretium quam vulputate dignissim monoclonal antibody. eget. in arcu cursus. Pretium quam vulputate dignissim suspendisse in est ante in. Felis eget velit aliquet sagittis suspendisse in est ante in. Felis eget velit aliquet sagittis This indication is approved under accelerated approval id consectetur purus ut. Ornare arcu dui vivamus arcu This indication is approved under accelerated approval id consectetur purus ut. Ornare arcu dui vivamus arcu based on response rate. Continued approval for this felis bibendum ut tristique. Mi tempus imperdiet nulla based on response rate. Continued approval for this felis bibendum ut tristique. Mi tempus imperdiet nulla indication may be contingent upon verification and malesuada pellentesque elit eget gravida. Habitasse indication may be contingent upon verification and malesuada pellentesque elit eget gravida. Habitasse description of clinical benefit in a confirmatory trial. platea dictumst quisque sagittis. Neque convallis a cras description of clinical benefit in a confirmatory trial. platea dictumst quisque sagittis. Neque convallis a cras semper. Sit amet risus semper. Sit amet risus nullam eget. nullam eget.

Please see additional Important Safety Information throughout. Please see additional Important Safety Information throughout. Please see accompanying full Prescribing Information. Please see accompanying full Prescribing Information.

1 1 ® 2

Oncopeptides is a global pharmaceutical company focused on the development of therapies for difficult-to-treat hematological diseases. More information is available on www.oncopeptides.com.1 Oncopeptides is pleased to provide you with a comprehensive billing and coding guide to assist you in obtaining reimbursement for PEPAXTO (melphalan flufenamide). This document is presented for informational purposes only and is not intended to provide reimbursement or legal advice. • Laws, regulations, and policies concerning reimbursement are complex and updated frequently. • While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. • All codes are supplied for informational purposes only, and this information does not represent any statement, promise, or guarantee by Oncopeptides about coverage, levels of reimbursement, payment, or charge. Please consult with payor organization(s) for local or actual coverage and reimbursement policies and with your internal reimbursement specialist for any reimbursement or billing questions.

INDICATION2 PEPAXTO is an alkylating drug indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use2 PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials. IMPORTANT SAFETY INFORMATION PEPAXTO is contraindicated in patients with a history of serious allergic reaction to melphalan flufenamide or melphalan.

For additional reimbursement assistance, please contact ON COURSE at 844-300-ONCO (6626), Monday through Friday 8AM-8PM ET, or visit www.oncoursesupport.com.

Note: The information provided herein is suggestive only. Oncopeptides does not make any warranties as to its accuracy and has no obligation to update the information. Oncopeptides has not verified the accuracy of this information with any authority responsible for coverage, coding or payment. Individual payors may differ as to their coverage, coding, and payment rules. The healthcare provider is responsible for verifying the applicable coverage, coding, and payment rules with each applicable payor. This includes choosing the correct diagnostic and procedure codes based on the diagnosis and treatment of each individual patient. Even if a claim is properly completed, Oncopeptides makes no warranty regarding whether there will be payment on such claim. Please see Important Safety Information on page 15.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 3

Table of Contents PEPAXTO Ordering ...... 4 PEPAXTO Dosage and Administration ...... 5 Billing and Coding Summary ...... 6 Common Billing Codes ...... 7 • PEPAXTO NDC ...... 7 • ICD-10 codes ...... 8 • HCPCS codes ...... 9 • CPT codes ...... 10 Coding Considerations ...... 11 • Concomitant therapies and lab monitoring ...... 11 • Revenue center codes ...... 11 • Modifiers ...... 11 Sample Claim Forms ...... 12 • Physician office sample claims form (CMS-1500) ...... 12 • Hospital outpatient sample claims form (UB-04/CMS-1450) ...... 13 General Resources ...... 14 • PEPAXTO website ...... 14 • ON COURSE website ...... 14 • ON COURSE contact information ...... 14 Important Safety Information ...... 15 References ...... 16

CPT, Current Procedural Terminology®; HCPCS, Healthcare Common Procedure Coding System; ICD-10, International Classification of Diseases; NDC, National Drug Code. Please see Important Safety Information on page 15.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 4

PEPAXTO Ordering PEPAXTO is a white to off-white lyophilized powder for reconstitution (after reconstitution the solution is clear and colorless to light yellow) supplied in a 50 mL single dose vial containing 20 mg melphalan flufenamide. Each 20 mg vial is packaged in a single carton (NDC 73657-020-01).2 Store PEPAXTO refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light. Retain in original carton until use.2 PEPAXTO is a hazardous drug. Follow special handling and disposal procedures. All materials that have been utilized for dilution and administration, including any reconstituted solution made over 30 minutes prior, should be disposed of according to standard procedures for hazardous drugs.2

PEPAXTO is available to institutions and community oncology practices from the following authorized distributors:

McKesson Plasma & ASD Healthcare Cardinal Health SPD Biologics McKesson Specialty Oncology Supply

Call: 1-800-746-6273 Call: 1-877-453-3972 Call: 1-877-625-2566 Call: 1-800-482-6700 Call: 1-800-633-7555

Fax: 1-800-547-9413 Fax: 1-800-294-5399 Fax: 1-888-752-7626 Fax: 1-888-752-7626 Fax: 1-800-248-8205

www.asdhealthcare.com www.cardinalhealth.com mms.mckesson.com mms.mckesson.com www.oncologysupply.com

Oncopeptides does not endorse the use of any of the listed distributors in particular.

Please contact your distributor for returns of expired product or product damaged in shipment.

For additional assistance, please contact ON COURSE at 844-300-ONCO (6626), Monday through Friday 8AM-8PM ET, or visit www.oncoursesupport.com. Please see Important Safety Information on page 15.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 5

PEPAXTO Dosage and Administration The recommended dosage of PEPAXTO is 40 mg administered osing sele END OF CCE intravenously over 30 minutes on Day 1 of each 28-day treatment EE 1 DA 1 EE DA EE DA 1 EE DA cycle. Treatment may continue until disease progression or until DA unacceptable toxicity occurs.2

Repeat cycle Dexamethasone dosage is 40 mg administered orally or until disease intravenously on Days 1, 8, 15, and 22 of each 28-day treatment progression or unacceptable cycle. For patients 75 years of age or older, dexamethasone dose toicity should be reduced to 20 mg. Refer to the prescribing information for dexamethasone for additional dosing information.2 PEPAXTO mg by central 2 Dexamethasone mg orally Treatment with PEPAXTO requires several considerations : line infusion or intravenously ( mg for (recommended starting dose2 2 • Monitoring of complete blood count (CBC), particularly for patients ≥ years neutrophil, red blood cell, and platelet counts. Monitor CBC and standard blood chemistry at baseline and during treatment as clinically indicated. Monitor more frequently during the first 2 months of treatment. • Consider providing premedication and concomitant medications such as serotonin-3 (5-HT3) receptor antagonist or other antiemetics prior to and during the treatment with PEPAXTO. • Reference the full prescribing information for dosage modifications, which may be necessary to address adverse reactions.

Administration of PEPAXTO requires reconstitution and dilution prior to infusion2: • PEPAXTO is light sensitive. Retain in original carton until use. • Additional agents required for preparation are: – 5% Dextrose Injection, USP (room temperature) – 250 mL bag of cold (2°C to 8°C [36°F to 46°F]) 0.9% Sodium Chloride Injection, USP (refrigerate for at least 4 hours) • PEPAXTO degrades in solution, especially at room temperature, and the storage timelines for diluted solution should not exceed 60 minutes at room temperature or 6 hours refrigerated at 2°C to 8°C (36°F to 46°F) when placed in refrigerator within 30 minutes after initial reconstitution. • Administer PEPAXTO as a 30-minute infusion via a central venous access device — for example: mediport, PICC, or tunneled central venous catheter. For additional assistance, please contact ON COURSE at 844-300-ONCO (6626), Monday through Friday 8AM-8PM ET, or visit www.oncoursesupport.com. Please see Important Safety Information on page 15.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 6

Billing and Coding Summary

National Drug Code (NDC)2 10-digit: 73657-020-01 11-digit: 73657-0020-01 0260: IV therapy Revenue Center (Hospital use only)3 0335: Chemotherapy administration, IV 0636: Drugs requiring detailed coding

International Classification C90.00: Multiple myeloma not having achieved remission 4 of Diseases (ICD)-10-CM C90.02: Multiple myeloma in relapse J3490: Unclassified drugs Healthcare Common Procedure J9999: Not otherwise classified, antineoplastic drugs Coding System (HCPCS)5,* C9399: Unclassified drugs or biologicals† 96413: Injection and intravenous infusion chemotherapy and other highly complex drug or highly Current Procedural Terminology (CPT)6 complex biologic agent administration; up to 1 hour, single or initial substance/drug (for 30-minute IV infusion)

*Please refer to page 9 for site of service considerations for temporary and permanent J and C codes. †Medicare only hospital outpatient department.

As of February 2021, sequestration decisions have not been finalized. Sequestration deductions may or may not be taken by CMS for Medicare patients.

Please note: PEPAXTO was approved to be administered with dexamethasone. Reference other sections throughout this document for additional coding considerations.

For additional reimbursement assistance, please contact ON COURSE at 844-300-ONCO (6626), Monday through Friday 8AM-8PM ET, or visit www.oncoursesupport.com. Please see Important Safety Information on page 15.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 7

Common Billing Codes: NDC National Drug Code (NDC) is a universally accepted standard to identify a unique formulation of a specific product. Unless otherwise stated in a payor policy, commercial, Medicare, and Medicaid payors require the NDC code to be included on the claims paperwork for most sites of service. • NDC: The NDC number may be available as 10 or 11 digits. Electronic Data Interchange (EDI) generally requires the use of an 11-digit NDC. Please reference the individual payor’s requirements to ensure that you provide the correct code. For your convenience, both the 10- and the 11-digit codes for PEPAXTO are listed below. • Electronic billing (ANSI 5010): If using EDI claims to manage electronic payments, such as for Medicaid, you will need to submit either an 837p (electronic version of form CMS-1500) or an 837i (electronic version of form UB-04) form. Both of these will also require the NDC qualifier, which precedes the NDC in the claims forms.

PEPAXTO NDC2

Qualifier*,7 10-digit 11-digit National Drug Code (NDC) N4 73657-020-01 73657-0020-01

Tradename: PEPAXTO Product Description Established name: melphalan flufenamide Package/strength: 20 mg/50 ml single-dose vial

Wholesale Acquisition 8 Cost (WAC) $9,500

*For electronic billing

Please reference the “Coding Considerations” section for additional information.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 8

Common Billing Codes: ICD-10-CM The International Classification of Diseases (ICD) is a globally used diagnostic tool for epidemiology, health management, and clinical purposes. ICD Clinical Modification (CM) codes are required by all payors to identify a patient’s diagnosis on claims paperwork. The most current iteration of standard ICD codes is known as ICD-10-CM. ICD-11-CM codes are in development, expected to go into effect on January 1, 2022.

ICD-10-CM Codes4

C90: Multiple myeloma and malignant plasma cell neoplasms*

C90.0: Multiple myeloma

C90.00: Multiple myeloma not having achieved remission

C90.02: Multiple myeloma in relapse

*Always use the most expanded code possible.

Please reference the “Coding Considerations” section for additional information.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 9

Common Billing Codes: HCPCS Healthcare Common Procedure Coding System (HCPCS) is a collection of procedural codes for their identification in claims paperwork. Initially created by the Centers for Medicare and Medicaid Services, HCPCS codes have become a standard in both Medicare and commercial claims. It can take several months following approval of a new therapeutic to receive permanent J and C codes. Oncopeptides is expecting permanent codes to become available in 2021. In the meantime, temporary, or pass-through, codes listed below are acceptable. When unclassified codes are used, some payors may require additional documentation such as the drug purchase invoice, prescribing information, documentation of medical necessity, or other to support the claim. Because requirements may vary by payor, it is advisable to check local requirements before submitting claims using unclassified codes. Unclassified codes are not drug specific and thus are always reported as 1 unit.

HCPCS Codes5 Permanent Site of Service Payor Claims following FDA approval up to the assignment of a permanent HCPCS code National Code Medicare Physician Office J3490: Unclassified drugs Non-Medicare J9999: Not otherwise classified, antineoplastic drugs

Site of Service Payor Claims immediately following FDA approval Claims beginning 3-6 months after To be FDA approval determined Hospital Medicare C9399: Unclassified drugs or biologicals Temporary drug-specific C code Outpatient J3490: Unclassified drugs Department Non-Medicare J9999: Not otherwise classified, antineoplastic drugs As of February 2021, sequestration decisions have not been finalized. Sequestration deductions may or may not be taken by CMS for Medicare patients.

Please reference the “Coding Considerations” section for additional information.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 10

Common Billing Codes: CPT Current Procedural Terminology (CPT) codes provide a uniform coding system consisting of descriptive terms and identifying codes that are used primarily to identify medical services and procedures furnished by healthcare providers. CPT Copyright 2020 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

CPT Code6

96413: Injection and intravenous infusion chemotherapy and other highly complex drug or highly complex biologic agent administration; up to 1 hour, single or initial substance/drug (for 30 min IV infusion)

Additional CPT codes should be used to capture administration of concomitant therapies, 5-HT3 antagonists, and/or other anti-emetic agents. Note: PEPAXTO is indicated to be used in combination with dexamethasone, which may also require separate billing.

Please reference the “Coding Considerations” section for additional information.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 11

Coding Considerations Concomitant Therapies Note: Patients treated with PEPAXTO may require additional therapeutics and services. Please reference the list below, respective products’ prescribing information inserts, and individual payors’ requirements to assess how to include additional CPT codes in the claims reimbursement paperwork.

PEPAXTO was studied in combination with dexamethasone.2 Dexamethasone is available from multiple manufacturers. Please Dexamethasone reference appropriate prescribing information and the appropriate codes your practice uses to ensure accurate billing. PEPAXTO is recommended to be used with prophylactic concomitant treatment with 5-HT3 antagonists and/or other anti-emetic Anti-emetics agents.2 These are available from multiple manufacturers. Please reference appropriate prescribing information and the appropriate codes your practice uses to ensure accurate billing. Treatment with PEPAXTO requires monitoring of complete blood count (CBC), particularly for neutrophil, red blood cell, and platelet counts. Monitor CBC and standard blood chemistry at baseline and during treatment as clinically indicated. Monitor more Lab/blood work frequently during the first 2 months of treatment.2 Please reference appropriate codes your practice uses to capture lab/blood work and any necessary follow up.

Revenue Center Codes Revenue Center Codes are typically used by outpatient hospital facilities.3

0260: IV therapy 0335: Chemotherapy administration, IV 0636: Drugs requiring detailed coding

Modifiers Modifiers are used to provide additional information about a service or procedure. These could include designations of site of service, interrupted procedures, wastage, follow-up physician visits, and others. Please reference your institution's or practice's best practices for capturing additional services. Appropriately used, modifiers improve coding and reimbursement accuracy.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 12

Sample Claim Forms Physician office sample claims form (CMS-1500)7 For informational purposes only MEDICARE EXAMPLE Box 24D: Enter the appropriate, not- otherwise-classified HCPCS code for PEPAXTO, as required by the payor. J3490 Note: If using Electronic Data Interchange (EDI) (unclassified drug), J3590 (unclassified claims to manage electronic payments, such as biologic), or J9999 (NOC, antineoplastic for Medicaid, you will need to submit an 837p drug) may be appropriate. Include the (electronic version of form CMS-1500). 123456 appropriate CPT code to report the

Smith, John, X 01 01 50 Smith, John, X administration procedure (e.g., 96413). Box 19: This area may be used to list 123 Cherry Lane 123 Cherry Lane the drug name, strength, total amount Any Town XY Any Town XY Enter the charge for each listed administered, the route of administration, 12345 123 555-0123 12345 123 555-0123 Box 24F: service and product. and NDC. Payor requirements may vary N/A 9999999

and can include requests for additional N/A 01 01 50 documentation (e.g., prescribing information) to accompany the claim. Box 24G: Report the appropriate Medicare number of units for PEPAXTO. Format for N/A the appropriate number of units for an Box 21: Enter the appropriate ICD-10-CM unclassified drug may vary by payor and/ diagnosis code. Code to the highest level or by state, in case of Medicaid. For many of specificity. payors, the appropriate number of units to Dr Jones 123-456-7890 enter for PEPAXTO is 1. The payor will identify

PEPAXTO (melphalan flufenamide) 40MG IV, 73657-0020-01 the specific number of mgs administered of PEPAXTO from Box 19. Box 24A: In the non-shaded area, list the C90.00

date of service. 123456789XYZ Box 33A: Enter the billing provider’s For commercial claims: in the shaded area, 00 enter the N4 qualifier, followed by the 03 01 21 96413 XXXX0.00.XX 1 123-456-7890 National Provider Identifier. 11-digit NDC, the unit of measure qualifier 03 01 21 J9999 XXXX0.00.XX 1 123-456-7890 (e.g., UN for unit), and the unit quantity. NOC, not otherwise classified. Some payors may request the NDC to be listed in Box 19. The healthcare provider is responsible for verifying the applicable coverage, coding, and payment rules � 123-55-5321 XXXX0.00.XX with each applicable payor. This includes choosing 230 555-66-55 Dr J Jones the correct diagnostic and procedure codes based Box 32A: Enter required National Provider 555 Any Street on the diagnosis and treatment of each individual Dr Jones [signature] Any Town, XY USA 12345 03-01-2021 Identifier of the facility where the services 123-456-7890 patient. Even if a claim is properly completed, were rendered. Oncopeptides makes no warranty regarding Clear Form whether there will be payment on such claim.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 13

Sample Claim Forms Hospital outpatient sample claims form (UB-04/CMS-1450)9 For informational purposes only Note: If using Electronic Data Interchange (EDI) MEDICARE EXAMPLE claims to manage electronic payments, such ______1 2 3a PAT. 4 TYPE as for Medicaid, you will need to submit an 837i CNTL # OF BILL b. MED. REC. # FL 46: Report the appropriate number of 6 STATEMENT COVERS PERIOD 7 5 FED. TAX NO. (electronic version of form UB-04). FROM THROUGH units for PEPAXTO. Format for the appropriate 8 PATIENT NAME a John X. 9 PATIENT ADDRESS a 123 Cherry Lane b Smith b Any Town c XY d 12345 e number of units for an unclassified drug ADMISSION CONDITION CODES 30 Enter the 10 BIRTHDATE 11 SEX 16 DHR 17 STAT 29 ACDT Form location (FL) 42: 12 DATE 13 HR 14 TYPE 15 SRC 18 19 20 21 22 23 24 25 26 27 28 STATE may vary by payor and/or by state, in case of 01.01.50 M appropriate revenue code corresponding with 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 Medicaid. For many payors, the appropriate the HCPCS code in FL 44, which is required for a a b b number of units to enter for PEPAXTO is 1. billing the unclassified HCPCS code. Please 38 39 VALUE CODES 40 VALUE CODES 41 VALUE CODES CODE AMOUNT CODE AMOUNT CODE AMOUNT determine the appropriate revenue code; a Some payors may refer to the actual quantity b examples include 0260 for IV therapy, 0335 for c administered as per FL 43 and FL 80. chemotherapy administration, IV, and 0636 for d 42 REV. CD. 43 DESCRIPTION 44 HCPCS / R ATE / HIPPS CODE 45 SERV. DATE 46 SERV. UNITS 47 TO TAL CHARGES 48 NON-COVERED CHARGES 49 pharmacy drugs that require detailed coding. 1 0260 IV Therapy 96413 03-01-21 1 XXX XX 1 2 2 3 0636 Drugs requiring detailed coding C9399 03-01-21 1 XXX XX 3 FL 47: Enter the total amount the facility 4 4

5 5 actually charged for the product. FL 43: 6 For commercial claims, use 6 7 7 8 codes J3490 or J9999. Please check 8 9 individual payor requirements. 9 For commercial claims: Please check 10 10 FL 44: Enter C9399 for hospital outpatient individual payor requirements. 11 11 billing for Medicare claims. Include 12 12 13 13 the appropriate CPT code to report the 14 14

15 15 administration procedure (e.g., 96413).

16 16

17 17

18 18 Enter the appropriate 19 19 FL 67A-67Q: 20 20 ICD-10-CM diagnosis code. Code to the 21 21 22 22 highest level of specificity. 23 PAGE OF CREATION DATE TOTALS XXX XX 23 52 REL . 53 ASG. 50 PAYER NAME 51 HEALTH PLAN ID 54 PRIOR PAYMENTS 55 EST. AMOUNT DUE 56 NPI INFO BEN. A Medicare 123456789XYZ 57 A B OTHER B

C PRV ID C FL 80: This area may be used to list 58 INSURED’S NAME 59 P.REL 60 INSURED’S UNIQUE ID 61 GROUP NAME 62 INSURANCE GROUP NO. the drug name, strength, total amount A A B B administered, the route of administration, C C 63 TREATMENT AUTHORIZATION CODES 64 DOCUMENT CONTROL NUMBER 65 EMPLOYER NAME

and NDC. Payor requirements may vary A A and can include requests for additional B B NOC, not otherwise classified. C C

66 68 documentation (e.g., prescribing DX C90.0067 A B C D E F G H I J K L M N O P Q The healthcare provider is responsible for verifying information) to accompany the claim.* 69 ADMIT 70 PATIENT 71 PPS 72 73 DX REASON DX a b c CODE ECI a b c the applicable coverage, coding, and payment rules 74 PRINCIPAL PROCEDURE a. OTHER PROCEDURE b. OTHER PROCEDURE 75 QUAL CODE DATE CODE DATE CODE DATE 76 ATTENDING NPI 123-456-7890 LAST Jones FIRST Jack with each applicable payor. This includes choosing c. OTHER PROCEDURE d. OTHER PROCEDURE e. OTHER PROCEDURE QUAL CODE DATE CODE DATE CODE DATE 77 OPERATING NPI the correct diagnostic and procedure codes based *A payor may request additional information when LAST FIRST 81CC QUAL submitting a claim, such as the FDA approval letter for 80 REMARKS a 78 OTHER NPI on the diagnosis and treatment of each individual PEPAXTO (melphalan flufenamide) b LAST FIRST 73657-0020-01, 40MG IV PEPAXTO, invoice for PEPAXTO, patient medical history/ c 79 OTHER NPI QUAL patient. Even if a claim is properly completed, d LAST FIRST UB-04 CMS-1450 APPROVED OMB NO. 0938-0997 THE CERTIFICATIONS ON THE REVERSE APPLY TO THIS BILL AND ARE MADE A PART HEREOF. Oncopeptides makes no warranty regarding medical documentation, letter of medical necessity, ™ National Uniform NUBC Billing Committee etc. Please check individual payor requirements. whether there will be payment on such claim. For additional reimbursement assistance, please contact ON COURSE at 844-300-ONCO (6626), Monday through Friday 8AM-8PM ET, or visit www.oncoursesupport.com. Please see Important Safety Information on page 15.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 14

General Resources Visit www.PEPAXTO.com for detailed product information. How Oncopeptides supports your patients Throughout their journey with PEPAXTO, Oncopeptides offers your patients assistance through ON COURSE, our patient support program. Program benefits for your patients include: • Financial assistance to help with treatment costs • Assistance navigating the insurance process, including benefits investigations, claims assistance, and more • Support and resources including patient access to a dedicated Oncology nurse to help answer questions

Learn more about ON COURSE at www.oncoursesupport.com.

For additional reimbursement assistance, please contact ON COURSE at 844-300-ONCO (6626), Monday through Friday 8AM-8PM ET, or visit www.oncoursesupport.com.

Please see Important Safety Information on page 15.

PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES ® 15

INDICATION2 PEPAXTO is indicated in combination with dexamethasone for the treatment of adult Based on its mechanism of action, PEPAXTO can cause fetal harm when administered patients with relapsed or refractory multiple myeloma who have received at least to a pregnant woman because it is genotoxic and targets actively dividing cells. four prior lines of therapy and whose disease is refractory to at least one proteasome Advise pregnant women of the potential risk to a fetus. Advise females of reproductive inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal potential to use effective contraception during treatment with PEPAXTO and for antibody. This indication is approved under accelerated approval based on response 6 months after the last dose. Advise males with female partners of reproductive rate. Continued approval for this indication may be contingent upon verification and potential to use effective contraception during treatment with PEPAXTO and for 3 description of clinical benefit in a confirmatory trial. months after the last dose. Limitation of Use The most common adverse reactions (≥20%; Grade 1-4) were fatigue (55%), nausea PEPAXTO is not indicated and is not recommended for use as a conditioning regimen (32%), diarrhea (27%), pyrexia (24%), and respiratory tract infection (24%). for transplant outside of controlled clinical trials. Special Considerations IMPORTANT SAFETY INFORMATION2 PEPAXTO is contraindicated in patients with a history of serious allergic reaction to Use in Pregnancy melphalan flufenamide or melphalan. Based on the mechanism of action, PEPAXTO can cause fetal harm when administered to a pregnant woman. There are no available data on PEPAXTO use in PEPAXTO may cause thrombocytopenia, which may lead to hemorrhage. Monitor pregnant women to evaluate for a drug-associated risk. PEPAXTO is a genotoxic drug. platelets at baseline, during treatment, and as clinically indicated. Monitor more Advise a woman of childbearing potential of the potential risks to the fetus. frequently during the first 2 months of treatment with PEPAXTO. Do not administer PEPAXTO if the platelet count is less than 50 × 109/L. Withhold PEPAXTO until platelet Lactation count is 50 × 109/L or greater and resume at same or reduced dose based on duration There is no information regarding the presence of melphalan flufenamide or its of interruption. Adjust dose and/or dose schedule based on signs and symptoms of metabolites in human breast milk, or the effects on the breastfed child or on milk bleeding. production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with PEPAXTO and for 1 week after PEPAXTO may cause neutropenia, which may lead to infection. Monitor neutrophil the last dose. counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first 2 months of treatment with PEPAXTO. Do not administer Females and Males of Reproductive Potential PEPAXTO if absolute neutrophil count is less than 1 × 109/L. Withhold PEPAXTO until PEPAXTO can cause fetal harm when administered to a pregnant woman. Advise absolute neutrophil count is 1 × 109/L or greater and resume at same or reduced dose females of reproductive potential to use effective contraception during treatment based on duration of interruption. Consider leukocyte growth factor as clinically with PEPAXTO and for 6 months after the last dose. appropriate. PEPAXTO may damage the developing male germ cells, resulting in possible genetic PEPAXTO may cause anemia. Monitor red blood cell counts at baseline, during fetal abnormalities. Advise males with a female partner of reproductive potential to treatment, and as clinically indicated. Monitor more frequently during the first 2 use effective contraception during treatment with PEPAXTO and for 3 months after months of treatment with PEPAXTO. Treat anemia as clinically indicated. Dosage the last dose. modification and dose delay of PEPAXTO may be required to allow for recovery of red PEPAXTO can cause amenorrhea in premenopausal women and result in infertility. blood cells. Based on findings of melphalan flufenamide in animals, PEPAXTO may impair male Patients taking PEPAXTO experienced infections, including fatal infections. Consider fertility. Alkylating drugs, such as PEPAXTO, can also cause irreversible testicular antimicrobials as clinically appropriate. suppression in patients. Nonclinical safety studies with melphalan flufenamide at dosages exceeding the Please click here for full Prescribing Information. recommended dose for PEPAXTO were associated with mortality. The safety and efficacy of PEPAXTO has not been established for use as a conditioning regimen in patients receiving transplant. Secondary malignancies such as myelodysplastic syndromes or acute leukemia have been reported in patients with multiple myeloma who were treated with PEPAXTO. Monitor patients long term for the development of secondary malignancies. ® 16

References 1. Company in brief. Oncopeptides website. https://oncopeptides.se/en/company-in-brief. Accessed February 20, 2021. 2. PEPAXTO [prescribing information]. Waltham, MA: Oncopeptides, Inc.; 2021. 3. Centers for Medicare & Medicaid Services. Medicare Intermediary Manual. Transmittal 1875. February 7, 2003. https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1875A3. pdf. Accessed February 20, 2021. 4. Multiple myeloma and malignant plasma cell neoplasms. ICD10Data.com website. https://www.icd10data.com/ICD10CM/Codes/C00-D49/C81-C96/C90-. Accessed February 20, 2021. 5. 2020 HCPCS Codes Level II. HCPCS.codes website. https://hcpcs.codes/search. Accessed February 20, 2021. 6. Chemotherapy administration and other highly complex drug or highly complex biologic agent administration. Codify by American Association of PC website. https://www.aapc.com/codes/cpt-codes-range/2855. Accessed February 20, 2021. 7. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 26 – Completing and Processing Form CMS-1500 Data Set. Revision 4472. December 5, 2019. CMS website. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads /clm104c26.pdf. Accessed February 20, 2021. 8. [Red Book WAC reference.] 9. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 25 – Completing and Processing the Form CMS-1450 Data Set. Revision 4194. January 11, 2019. http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c25.pdf. Accessed February 20, 2021.

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PEPAXTO PEPAXTO DOSAGE AND BILLING AND COMMON BILLING CODING SAMPLE GENERAL ORDERING ADMINISTRATION CODING SUMMARY CODES CONSIDERATIONS CLAIM FORMS RESOURCES