2017 Eleview BILLING AND CODING GUIDE

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1 2017 Eleview BILLING AND CODING GUIDE

2 CONTENTS Introduction (k) Clearance... 2 Disclaimer... 2 CPT Disclaimer... 2 Coding... 3 ICD-10-CM... 3 HCPCS Level II Codes... 3 CPT Codes... 3 CPT Coding for Endoscopic Mucosal Resection (EMR) Procedures... 3 CPT Coding for Endoscopic Submucosal Dissection (ESD) and Other Relevant Procedures Which Eleview may be Administered... 4 Coverage... 5 Payment... 5 Calendar Year (CY) 2017 Payment Rates for Procedures Involving Eleview... 5 Appendix A: Frequently Asked Questions... 8 Appendix B: Sample CM 1450, For Hospital Outpatient Department and Ambulatory Surgical Center Claims... 9 Appendix C: Sample CM 1500, For Physician Claims Appendix D: Sample CM 1450, For Hospital Outpatient Department and Ambulatory Surgical Center Claims Appendix E: Sample CM 1500, For Physician Claims The information provided is general coding information only; it is not advice about how to code, complete, or submit any particular claim for payment. It is always the provider s responsibility to determine and submit appropriate codes, changes, modifiers, and bills for the services that were rendered. Payors may have their own coding and reimbursement requirements.

3 INTRODUCTION This guide provides general coding, coverage and payment information to hospitals and physicians submitting claims for gastrointestinal endoscopic procedures involving Eleview described in the product Instructions for Use, which are available upon request. Such procedures include endoscopic mucosal resection (EMR), endoscopic submucosal dissection (ESD) or other related procedures. This guide is not exhaustive of all the coding options for procedures involving Eleview and should be read in light of the disclaimers set forth below. INTENDED USE Eleview submucosal injectable composition is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. DISCLAIMER The information provided in this guide has been gathered from third-party sources and is subject to change without notice because of complex and frequently changing laws, regulations, rules, and policies. The information provided in this guide contains general reimbursement information only and is not legal advice nor is it advice about how to code, complete, or submit any claim for payment. Information provided is not intended to increase or maximize reimbursement by any health plan. This guide represents our understanding of current reimbursement policies. It is the provider s responsibility to determine appropriate codes, charges, and modifiers, and to submit bills for the services rendered consistent with the patient s health plan requirements. Health plans may have different policies and coding requirements. Aries Pharmaceuticals, Inc. (Aries) disclaims any responsibility for claims submitted by hospitals or physicians resulting from any reliance on the information contained in this guide. The key in all coding and billing is to be truthful and to make full disclosures in the most transparent and non-misleading manner possible about how the product has been used when seeking reimbursement from the health plan. It is recommended that you consult with your patient s health plan, reimbursement specialists and/or legal counsel regarding coding, coverage, and reimbursement matters. CPT DISCLAIMER CPT codes, descriptors and other data only are copyright 2017 American Medical Association. All Rights Reserved. CPT Copyright 2016 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. 2 The information provided is general coding information only; it is not advice about how to code, complete, or submit any particular claim for payment. It is always the provider s responsibility to determine and submit appropriate codes, changes, modifiers, and bills for the services that were rendered. Payors may have their own coding and reimbursement requirements.

4 CODING Coding is language by which providers communicate, on claim forms, why a patient needed treatment and what services or items were provided. The coding systems below are commonly used when billing for services provided in the hospital outpatient department or the ambulatory surgical center. Table 1. Coding Systems Coding System International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) Codes Healthcare Common Procedure Coding System (HCPCS) Level II Codes Current Procedural Terminology (CPT) Codes Code System Description Describes patient condition, disease and/or reason for treatment Describes products, supplies, and services not included in the CPT code set Describes medical services and procedures ICD-10-CM The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), is currently used to code diagnostic information on claims. 2 For outpatient claims, providers report the full diagnosis code for the diagnosis shown to be chiefly responsible for the outpatient services. 3 HCPCS Level II Codes The Healthcare Common Procedure Coding System (HCPCS) Level II codes are used to describe certain products, supplies, and services. There is no HCPCS code specific for Eleview. Providers should bill the appropriate CPT code to properly reflect the patient encounter during which Eleview was administered as part of an endoscopic procedure. However, the provider should not submit a HCPCS code for Eleview. CPT Codes Current Procedural Terminology (CPT) codes are used for reporting medical services and procedures. Providers should use the CPT code that most accurately reflects the service performed. Providers should also be mindful of proper use of modifiers to ensure correct claims submission. CPT Coding for Endoscopic Mucosal Resection (EMR) Procedures When billing with the EMR CPT codes provided in Table 2, the procedure should include all of the following clinical components: 1) submucosal injection to lift the lesion; AND 2) demarcation of the lesion, often by creating a pseudo polyp out of tissue; AND 3) endoscopic snare resection. If all three components are not performed, it is not appropriate to report an EMR CPT code. Rather, service(s) performed (submucosal injection, snare polypectomy) are reported, with modifier (-59) on the secondary procedure(s). 4 2 MLN Learning Network. Medicare Billing: 837I and Form CMS Retrieved March 6, 2017, from cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/837i-formcms ICN pdf 3 Medicare Claims Processing Manual Chapter 23 - Fee Schedule Administration and Coding Requirements Outpatient Claim Diagnosis Reporting. Retrieved March 6, 2017, from Guidance/Guidance/Manuals/Downloads/clm104c23.pdf CPT Coding Updates. Retrieved March 6, 2017, from 3

5 Table 2. CPT Procedure Codes for Endoscopic Mucosal Resection CPT Code Descriptor Esophagoscopy, flexible, transoral; with endoscopic mucosal resection Esophagogastroduodenoscopy, flexible, transoral; with endoscopic mucosal resection Sigmoidoscopy, flexible; with endoscopic mucosal resection Colonoscopy through stoma; with endoscopic mucosal resection Colonoscopy, flexible; with endoscopic mucosal resection CPT Coding for Endoscopic Submucosal Dissection (ESD) and Other Relevant Procedures Which Eleview may be Administered Currently, there are no CPT procedure codes that adequately describe ESD procedures or the administration of Eleview during ESD procedures. In the absence of an existing code, providers should bill an unlisted CPT code. Unlisted CPT codes are used when a procedure or component of a procedure is not reflected in the existing CPT code set. When unlisted CPT codes are used, the health plan or third party administrator may require documentation to justify use, coverage and payment for the unlisted CPT code. When Eleview is used during gastrointestinal endoscopic procedures for submucosal lift, choose the CPT code(s) that most closely describe the actual procedure(s) performed. Table 3 provides some of the available coding options. Table 3. Unlisted CPT Codes and CPT Codes for Other Gastrointestinal Endoscopic Procedures 4 CPT Code Unlisted CPT Code Description Unlisted procedure, esophagus Unlisted procedure, stomach Unlisted procedure, small intestine Unlisted procedure, colon Unlisted procedure, rectum Other CPT Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique Sigmoidoscopy, flexible; with directed submucosal injection(s), any substance Sigmoidoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique Colonoscopy through stoma; with directed submucosal injection(s), any substance Colonoscopy, flexible; with directed submucosal injection(s), any substance Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique

6 COVERAGE Coverage is the health plan s authority to cover, reimburse or exclude certain items or services. The health plan will generally cover procedures that are considered reasonable and medically necessary. Although Medicare, Medicaid, and most private health plans typically will provide coverage for these services when performed for the appropriate indications, health plans may have specific utilization management guidelines regarding frequency and patient selection. As policies change over time, it is a best practice to contact the patient s health plan to understand their coverage guidelines for a particular item or service in advance of performing the procedure. PAYMENT Payment is the method which the payer determines the amount of reimbursement, or dollar amount to the provider. For procedures performed in the hospital outpatient department (HOPD) or ambulatory surgery center (ASC), two types of payments are generally made: 1. Payment for facility resources such as operating room time, overhead expenses, capital equipment, etc. 2. Physicians are paid for the medical professional services they provide in the treatment of patients based on time and complexity of those services Calendar Year 2017 Payment Rates for Procedures Involving Eleview The CPT codes and payment rates listed below represent some of the procedures associated with the use of Eleview. Additional codes and procedures may apply. Though all of the information has been carefully researched and checked for accuracy, neither the author or Aries accepts responsibility or liability with regard to errors, omission, misuse or misinterpretations. Payment rates change periodically. Payment rates listed are 2017 Medicare National Averages. Check with your local Medicare Administrative Contractor or Medicaid or commercial health plan for allowable payments specific to your area or contract. The payment rates listed in Table 4 and 5 reflect the national unadjusted Medicare Fee Schedule amounts effective January 1, The information provided is general coding information only; it is not advice about how to code, complete, or submit any particular claim for payment. It is always the provider s responsibility to determine and submit appropriate codes, changes, modifiers, and bills for the services that were rendered. Payors may have their own coding and reimbursement requirements. 5

7 Table Medicare Physician Payment Rates for EMR Procedures and Other Gastrointestinal Endoscopic Procedures CPT Code EMR Procedures Code Description Physician Payment Total RVUs MPFS Payment Esophagoscopy, flexible, transoral; with endoscopic mucosal resection 6.93 $ Esophagogastroduodenoscopy, flexible, transoral; with endoscopic mucosal resection 7.96 $ Sigmoidoscopy, flexible; with endoscopic mucosal resection 5.83 $ Colonoscopy through stoma; with endoscopic mucosal resection 8.92 $ Colonoscopy, flexible; with endoscopic mucosal resection 9.77 $ Unlisted Unlisted procedure, esophagus n/a n/a Unlisted procedure, stomach n/a n/a Unlisted procedure, small intestine n/a n/a Unlisted procedure, colon n/a n/a Unlisted procedure, rectum n/a n/a Other Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance 4.92 $ Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance 3.02 $ Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 4.72 $ $ $ Sigmoidoscopy, flexible; with directed submucosal injection(s), any substance 1.95 $ Sigmoidoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 3.54 $ Colonoscopy through stoma; with directed submucosal injection(s), any substance 5.05 $ Colonoscopy, flexible; with directed submucosal injection(s), any substance 5.88 $ Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 7.48 $ CY 2017 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B (CMS-1654-F). Retrieved March 13, 2017, from 6 Payment calculated by multiplying the facility RVUs by the Medicare Physician Fee Schedule update factor for 2017 (0.5%) and the 2017 conversion factor ( ) 6 The information provided is general coding information only; it is not advice about how to code, complete, or submit any particular claim for payment. It is always the provider s responsibility to determine and submit appropriate codes, changes, modifiers, and bills for the services that were rendered. Payors may have their own coding and reimbursement requirements.

8 Table Medicare Physician and Facility Payment Rates for EMR Procedures and Other Gastrointestinal Endoscopic Procedures CPT Code EMR Procedures Code Description APC 7 * Facility Payment 2017 HOPD Payment ASC Payment Esophagoscopy, flexible, transoral; with endoscopic mucosal resection 5302 $1, $ Esophagogastroduodenoscopy, flexible, transoral; with endoscopic mucosal resection 5302 $1, $ Sigmoidoscopy, flexible; with endoscopic mucosal resection 5312 $ $ Colonoscopy through stoma; with endoscopic mucosal resection 5312 $ $ Colonoscopy, flexible; with endoscopic mucosal resection 5312 $ $ Unlisted CPT Unlisted procedure, esophagus 5301 $ n/a Unlisted procedure, stomach 5301 $ n/a Unlisted procedure, small intestine 5301 $ n/a Unlisted procedure, colon 5311 $ n/a Unlisted procedure, rectum 5311 $ n/a Other Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique Sigmoidoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 5302 $1, $ $1, $ $1, $ $ $ $1, $ $ $ Sigmoidoscopy, flexible; with directed submucosal injection(s), any substance 5311 $ $ Colonoscopy through stoma; with directed submucosal injection(s), any substance 5312 $ $ Colonoscopy, flexible; with directed submucosal injection(s), any substance 5312 $ $ * Ambulatory Payment Classification Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 5312 $ $ Hospital Outpatient Prospective Payment - Final Rule with Comment and Final CY2017 Payment Rates (CMS FC). Final Addendum B. Retrieved March 13, 2017, from html?dlpage=1&dlentries=10&dlsort=2&dlsortdir=descending 8 Hospital Outpatient Prospective Payment- Correction Notice (CMS-1656-CN).2017 CN Addendum A. Retrieved March 13, 2017, from Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1656-CN. html?dlpage=1&dlentries=10&dlsort=2&dlsortdir=descending 9 January 2017 ASC Approved HCPCS Code and Payment Rates. Addenda AA. Retrieved March 13, 2017, from Downloads/2017-January-ASC-Addenda.zip 7

9 APPENDIX A: Frequently Asked Questions Q. Is there a HCPCS code for Eleview? A. There is no HCPCS code specific for Eleview. Providers should bill the appropriate CPT code to properly reflect the patient encounter during which Eleview was administered as part of an endoscopic procedure. However, the provider should not submit a HCPCS code for Eleview. Q. I heard EMR procedures were reported with CMD G-Codes. Do I still use these for billing? A. CMS deleted the G-codes that were used in Providers should bill using the CPT codes only. Q. Will payers cover Eleview? A. Currently, there are no known coverage policies that restrict coverage for Eleview or procedures involving Eleview. However, health plans will generally cover procedures that are considered reasonable and medically necessary. As policies change over time, it is a best practice to contact the patient s health plan to understand their coverage guidelines for a particular item or service in advance of performing the procedure. Q. There are no ASC fees listed in the payment table for the unlisted procedures. What does that mean? A. For Medicare claims, surgical unlisted services are excluded from ASC payment. 10 Q. If I perform a colonoscopy and then perform a lift of a lesion using Eleview, is it appropriate to report this as an EMR? A. It is only appropriate to bill with the EMR CPT codes if the procedure includes all of the following clinical components: 1) submucosal injection to lift the lesion; AND 2) demarcation of the lesion, often by creating a pseudo polyp out of tissue; AND 3) endoscopic snare resection. If all three components are not performed, it is not appropriate to report an EMR CPT code. Rather, service(s) performed (submucosal injection, snare polypectomy) are reported, with modifier (-59) on the secondary procedure(s). Q. Who can I contact for assistance with reimbursement? A. Aries has dedicated support for customers with reimbursement questions or concerns. Please contact Reimbursement@aries-pharma.com 10 Medicare Claims Processing Manual Chapter 14 - Ambulatory Surgical Centers, page 28. Retrieved March 13, 2017, from Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c14.pdf 8 The information provided is general coding information only; it is not advice about how to code, complete, or submit any particular claim for payment. It is always the provider s responsibility to determine and submit appropriate codes, changes, modifiers, and bills for the services that were rendered. Payors may have their own coding and reimbursement requirements.

10 APPENDIX B: Sample CM 1450, For Hospital Outpatient Department and Ambulatory Surgical Center Claims Clinical Scenario: Endoscopic Mucosal Resection (EMR) + Eleview A flexible esophagoscope is passed through the patient s mouth and into the esophagus to locate the lesion in the inner lining of the esophagus. Eleview is injected into the submucosa around the lesion to raise it from the surrounding deep muscle layer. Once the lesion is raised, it is removed using a snare, banding, or ligation and sent for pathology. Fields 44 and 46: CPT codes, modifiers and billing units Esophagoscopy, flexible, transoral; with endoscopic mucosal resection XX Endoscopic Mucosal Resection XX/XX/XX 1 $XXXX.XX Fields 67 and 67A-67Q: ICD-10-CM code(s). C15.3 Malignant neoplasm of upper third of esophagus C15.3 Disclaimer: This sample claim for is an example only. Aries disclaims any responsibility for claims submitted by hospitals or physicians. The key in all coding and billing is to be truthful and to make full disclosures in the most transparent and non-misleading manner possible about how the product has been used when seeking reimbursement from the health plan. It is recommended that you consult with your patient s health plan, reimbursement specialists and/ or legal counsel regarding coding, coverage, and reimbursement matters. 9

11 APPENDIX C: Sample CM 1500, For Physician Claims Clinical Scenario: Endoscopic Mucosal Resection (EMR) + Eleview A flexible esophagoscope is passed through the patient s mouth and into the esophagus to locate the lesion in the inner lining of the esophagus. Eleview is injected into the submucosa around the lesion to raise it from the surrounding deep muscle layer. Once the lesion is raised, it is removed using a snare, banding, or ligation and sent for pathology. Field 21: ICD-10-CM code(s). C15.3 Malignant neoplasm of upper third of esophagus Fields 24D and 24G: CPT codes, modifiers and billing units Esophagoscopy, flexible, transoral; with endoscopic mucosal resection C15.3 XX XX XX XX XX XX $XXXX.XX 1 10 Disclaimer: This sample claim for is an example only. Aries disclaims any responsibility for claims submitted by hospitals or physicians. The key in all coding and billing is to be truthful and to make full disclosures in the most transparent and non-misleading manner possible about how the product has been used when seeking reimbursement from the health plan. It is recommended that you consult with your patient s health plan, reimbursement specialists and/ or legal counsel regarding coding, coverage, and reimbursement matters.

12 APPENDIX D: Sample CM 1450, For Hospital Outpatient Department and Ambulatory Surgical Center Claims Clinical Scenario: Endoscopic Submucosal Dissection (ESD) + Eleview A flexible esophagoscope is passed through the patient s mouth and into the esophagus to locate the lesion in the inner lining of the esophagus. Cautery is used to mark the perimeter of the lesion, Eleview is injected into the submucosa around the lesion to raise it from the surrounding deep muscle layer. An electrosurgical knife is used to incise the mucosa and cut circumferentially around the lesion and to dissect in a freehand manner until the whole specimen has been completely resected. Fields 44 and 46: CPT codes, modifiers and billing units Esophagoscopy, flexible, transoral; with endoscopic mucosal resection XX Endoscopic Submucosal Dissection XX/XX/XX 1 $XXXX.XX Fields 67 and 67A-67Q: ICD-10-CM code(s). C15.3 Malignant neoplasm of upper third of esophagus C15.3 Disclaimer: This sample claim for is an example only. Aries disclaims any responsibility for claims submitted by hospitals or physicians. The key in all coding and billing is to be truthful and to make full disclosures in the most transparent and non-misleading manner possible about how the product has been used when seeking reimbursement from the health plan. It is recommended that you consult with your patient s health plan, reimbursement specialists and/ or legal counsel regarding coding, coverage, and reimbursement matters. 11

13 APPENDIX E: Sample CM 1500, For Physician Claims Clinical Scenario: Endoscopic Submucosal Dissection (ESD) + Eleview A flexible esophagoscope is passed through the patient s mouth and into the esophagus to locate the lesion in the inner lining of the esophagus. Cautery is used to mark the perimeter of the lesion, Eleview is injected into the submucosa around the lesion to raise it from the surrounding deep muscle layer. An electrosurgical knife is used to incise the mucosa and cut circumferentially around the lesion and to dissect in a freehand manner until the whole specimen has been completely resected. Field 21: ICD-10-CM code(s). C15.3 Malignant neoplasm of upper third of esophagus Fields 24D and 24G: CPT codes, modifiers and billing units Unlisted procedure, esophagus C15.3 XX XX XX XX XX XX $XXXX.XX 1 12 Disclaimer: This sample claim for is an example only. Aries disclaims any responsibility for claims submitted by hospitals or physicians. The key in all coding and billing is to be truthful and to make full disclosures in the most transparent and non-misleading manner possible about how the product has been used when seeking reimbursement from the health plan. It is recommended that you consult with your patient s health plan, reimbursement specialists and/ or legal counsel regarding coding, coverage, and reimbursement matters.

14 Aries Pharmaceuticals, Inc. (Aries) is a specialty pharmaceutical and medical device company focused on developing and commercializing best in class products in endoscopy and to treat gastrointestinal diseases. Aries first commercialized product, Eleview, is an injectable composition intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other mucosal lesions prior to excision. Aries Pharmaceuticals, Inc. is a wholly owned subsidiary of Aries Pharmaceuticals, Ltd., which is a wholly owned Subsidiary of Cosmo Pharmaceuticals, NV, a specialty pharmaceutical and medical device company focused on developing and commercializing best in class products in endoscopy and to treat gastrointestinal diseases.

15 The Towers South 9276 Scranton Road, Suite 600 San Diego, California T: (858) Toll Free: 888-ARIES-08 Aries is a trademark of Aries, Ltd. Eleview is a trademark of Cosmo Technologies, Ltd. 1-ELE17015

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