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Eleview ® BILLING AND CODING GUIDE NEW PAYMENT RATES FOR 2018 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.

Eleview · Introduction ... (HCPCS) Level II codes are used to describe certain products, ... Table 2. CPT Procedure Codes for Endoscopic Mucosal Resection

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Eleview®

BILLING AND CODING GUIDE NEW PAYMENT RATES FOR 2018

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.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

510(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) 2018 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Appendix D: Sample CM 1450, For Hospital Outpatient Department and Ambulatory Surgical Center Claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Appendix E: Sample CM 1500, For Physician Claims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

CONTENTS

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.

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 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

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CPT codes, descriptors and other data only are copyright of the American Medical Association. 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.

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.

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 Code System Description

International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) Codes

Describes patient condition, disease and/or reason for treatment

Healthcare Common Procedure Coding System (HCPCS) Level II Codes

Describes products, supplies, and services not included in the CPT code set

Current Procedural Terminology (CPT) Codes Describes medical services and procedures

ICD-10-CMThe 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 CodesCurrent 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) ProceduresWhen 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-1450. Retrieved March 6, 2017, from https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/837I-FormCMS-1450-ICN006926.pdf

3 Medicare Claims Processing Manual Chapter 23 - Fee Schedule Administration and Coding Requirements. 10.3 - Outpatient Claim Diagnosis Reporting. Retrieved March 6, 2017, from https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c23.pdf

4 2016 CPT Coding Updates. Retrieved March 6, 2017, from https://gi.org/wp-content/uploads/2016/03/2695-007COM_16-1-CPT-Coding-Updates_v3.pdf 3

CPT Code Code Description

Unlisted CPT

43499 Unlisted procedure, esophagus

43999 Unlisted procedure, stomach

44799 Unlisted procedure, small intestine

45399 Unlisted procedure, colon

45999 Unlisted procedure, rectum

Other CPT

43192 Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance

43201 Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance

43217Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique

43236Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance

43251Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique

45335 Sigmoidoscopy, flexible; with directed submucosal injection(s), any substance

45338Sigmoidoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique

44404 Colonoscopy through stoma; with directed submucosal injection(s), any substance

45381 Colonoscopy, flexible; with directed submucosal injection(s), any substance

45385Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique

CPT Coding for Endoscopic Submucosal Dissection (ESD) and Other Relevant Procedures Which Eleview® may be AdministeredCurrently, 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

Table 2. CPT Procedure Codes for Endoscopic Mucosal Resection

CPT Code Descriptor

43211 Esophagoscopy, flexible, transoral; with endoscopic mucosal resection

43254 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic mucosal resection

45349 Sigmoidoscopy, flexible; with endoscopic mucosal resection

44403 Colonoscopy through stoma; with endoscopic mucosal resection

45390 Colonoscopy, flexible; with endoscopic mucosal resection

4

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, capitalequipment, supplies, etc.

2. Physicians are paid for the medical professional services they provide in the treatment ofpatients based on time and complexity of those services

Calendar Year 2018 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 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 2018 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, 2018.

5

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.

Table 4. 2018 Medicare Physician Payment Rates for EMR Procedures and Other Gastrointestinal Endoscopic Procedures

CPT Code Code DescriptionPhysician Payment

Total RVUs5

2018 MPFS Payment6

EMR Procedures

43211 Esophagoscopy, flexible, transoral; with endoscopic mucosal resection 6.90 $248.40

43254 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic mucosal resection 7.95 $286.20

45349 Sigmoidoscopy, flexible; with endoscopic mucosal resection 5.85 $210.60

44403 Colonoscopy through stoma; with endoscopic mucosal resection 8.94 $321.84

45390 Colonoscopy, flexible; with endoscopic mucosal resection 9.79 $352.44

Unlisted

43499 Unlisted procedure, esophagus n/a n/a

43999 Unlisted procedure, stomach n/a n/a

44799 Unlisted procedure, small intestine n/a n/a

45399 Unlisted procedure, colon n/a n/a

45999 Unlisted procedure, rectum n/a n/a

Other

43192 Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance 4.85 $174.60

43201 Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance 3.01 $108.36

43217 Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 4.72 $169.92

43236 Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance 4.07 $146.52

43251 Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 5.78 $208.08

45335 Sigmoidoscopy, flexible; with directed submucosal injection(s), any substance 1.94 $69.84

45338 Sigmoidoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 3.54 $127.44

44404 Colonoscopy through stoma; with directed submucosal injection(s), any substance 5.08 $182.88

45381 Colonoscopy, flexible; with directed submucosal injection(s), any substance 5.91 $212.76

45385 Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 7.48 $269.28

6

5 CY 2018 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B (CMS-1676-F). Retrieved January 1, 2018,

from https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1676-F. html?DLPage=1&DLEntries=10&DLSort=2&DLSortDir=descending

6 Payment calculated by multiplying the facility RVUs by the Medicare Physician Fee Schedule update factor for 2018 (0.5%) and the 2018 conversion

factor (35.9996)

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.

Table 5. 2018 Medicare Physician and Facility Payment Rates for EMR Procedures and Other Gastrointestinal Endoscopic Procedures

CPT Code Code DescriptionFacility Payment

APC7*2018 HOPD Payment8

2018 ASC Payment9

EMR Procedures

43211 Esophagoscopy, flexible, transoral; with endoscopic mucosal resection 5302 $1,427.39 $627.43

43254 Esophagogastroduodenoscopy, flexible, transoral; with endoscopic mucosal resection 5302 $1,427.39 $627.43

45349 Sigmoidoscopy, flexible; with endoscopic mucosal resection 5312 $936.39 $487.78

44403 Colonoscopy through stoma; with endoscopic mucosal resection 5312 $936.39 $487.78

45390 Colonoscopy, flexible; with endoscopic mucosal resection 5312 $936.39 $487.78

Unlisted CPT

43499 Unlisted procedure, esophagus 5301 $734.49 n/a

43999 Unlisted procedure, stomach 5301 $734.49 n/a

44799 Unlisted procedure, small intestine 5301 $734.49 n/a

45399 Unlisted procedure, colon 5311 $709.98 n/a

45999 Unlisted procedure, rectum 5311 $709.98 n/a

Other

43192 Esophagoscopy, rigid, transoral; with directed submucosal injection(s), any substance 5302 $1,427.39 $627.43

43201 Esophagoscopy, flexible, transoral; with directed submucosal injection(s), any substance 5302 $1,427.39 $627.43

43217 Esophagoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 5302 $1,427.39 $627.43

43236 Esophagogastroduodenoscopy, flexible, transoral; with directed submucosal injection(s), any substance 5301 $743.49 $387.30

43251 Esophagogastroduodenoscopy, flexible, transoral; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 5302 $1,427.39 $627.43

45338 Sigmoidoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 5312 $936.39 $487.78

45335 Sigmoidoscopy, flexible; with directed submucosal injection(s), any substance 5311 $709.98 $369.84

44404 Colonoscopy through stoma; with directed submucosal injection(s), any substance 5312 $936.39 $487.78

45381 Colonoscopy, flexible; with directed submucosal injection(s), any substance 5312 $936.39 $487.78

45385 Colonoscopy, flexible; with removal of tumor(s), polyp(s), or other lesion(s) by snare technique 5312 $936.39 $487.78

7 Hospital Outpatient Prospective Payment- Correction Notice (CMS-1678-CN). 2018 Correction Notice OPPS Addendum B. Retrieved January 1, 2018, from https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1678-CN.html8 Hospital Outpatient Prospective Payment- Correction Notice (CMS-1678-CN). 2018 Correction Notice OPPS Addendum A. Retrieved January 1, 2018, from https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1678-CN.html 9 Ambulatory Surgical Center Payment- Correction Notice (CMS-1678-CN). Addenda AA. Retrieved January 1, 2018, from https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ASCPayment/ASC-Regulations-and-Notices-Items/CMS-1678-CN.html 7

* Ambulatory Payment Classification

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 codeto properly reflect the patient encounter during which Eleview® was administered as part of anendoscopic 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 2015. 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 proceduresinvolving Eleview®. However, health plans will generally cover procedures that are consideredreasonable and medically necessary. As policies change over time, it is a best practice to contactthe patient’s health plan to understand their coverage guidelines for a particular item or service inadvance of performing the procedure.

Q. There are no ASC fees listed in the payment table for the unlisted procedures. What doesthat 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 appropriateto report this as an EMR?

A. It is only appropriate to bill with the EMR CPT codes if the procedure includes all of the followingclinical 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 [email protected]

10 Medicare Claims Processing Manual Chapter 14 - Ambulatory Surgical Centers, page 28. Retrieved March 13, 2017, from https://www.cms.gov/

8

Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c14.pdf

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.

APPENDIX B:

Sample CM 1450, For Hospital Outpatient Department and Ambulatory Surgical Center ClaimsClinical 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: Enter the appropriate CPT codes, modifiers and billing units.

Example: 43211 Esophagoscopy, flexible, transoral; with endoscopic mucosal resection

Fields 67 and 67A-67Q: Enter the appropriate ICD-10-CM code(s).

Example: C15.3 Malignant neoplasm of upper third of esophagus

Disclaimer: This sample claim form 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.

C15.3

XX XX/XX/XX $XXXX.XXEndoscopic Mucosal Resection 43211 1

9

APPENDIX C:

Sample CM 1500, For Physician ClaimsClinical 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: Enter the appropriate ICD-10-CM code(s).

Example: C15.3 Malignant neoplasm of upper third of esophagus

Fields 24D and 24G: Enter the appropriate CPT codes, modifiers and billing units.

Example: 43211 Esophagoscopy, flexible, transoral; with endoscopic mucosal resection

Disclaimer: This sample claim form 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.

C15.3

XX XX XX XX XX XX 43211 $XXXX.XX 1

10

APPENDIX D:

Sample CM 1450, For Hospital Outpatient Department and Ambulatory Surgical Center ClaimsClinical 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: Enter the appropriate CPT codes, modifiers and billing units.

Example: 43211 Esophagoscopy, flexible, transoral; with endoscopic mucosal resection

Fields 67 and 67A-67Q: Enter the appropriate ICD-10-CM code(s).

Example: C15.3 Malignant neoplasm of upper third of esophagus

Disclaimer: This sample claim form 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.

C15.3

XX XX/XX/XX $XXXX.XXEndoscopic Submucosal Dissection 43499 1

11

APPENDIX E:

Sample CM 1500, For Physician ClaimsClinical 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: Enter the appropriate ICD-10-CM code(s).

Example: C15.3 Malignant neoplasm of upper third of esophagus

Fields 24D and 24G: Enter the appropriate CPT codes, modifiers and billing units.

Example: 43499 Unlisted procedure, esophagus

Disclaimer: This sample claim form 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.

C15.3

XX XX XX XX XX XX 43499 $XXXX.XX 1

12

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.

The Towers South9276 Scranton Road, Suite 600

San Diego, California 92121

T: (858) 202 6122 | Toll Free: 888-ARIES-08 | [email protected] www.aries-pharma.com

Aries is a trademark of Aries, Ltd. Eleview is a registered trademark of Cosmo Technologies, Ltd.

1-ELE17015-r1