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Billing and Coding Guide: PEPAXTO® (Melphalan Flufenamide)

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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 sele2 END OF CYCE intravenously over 30 minutes on Day 1 of each 28-day treatment WEE 1 DA 1 WEE DA WEE DA 1 WEE 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
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