Pre-Certification/Appeal Packet for NeuraWrap™ Nerve Protector

As a service to our customers, Integra LifeSciences Corporation has assembled this packet of information to assist with the pre-certification or appeal process. Included in this packet are as follows:

Information on how to appeal a Medicare Claim Determination Sample Letter of Medical Necessity Sample Statement of Medical Necessity 2020 Coding and Reimbursement Guide for NeuraWrap™

Nerve Protector Package Insert FDA 510k Clearance Letter Literature Request Form

If you would like to obtain clinical articles to help support the appeal, please contact the reimbursement hotline at 1-877-444-1122, Option 3, option 1 or email the literature request form to reimbursement@integralife.com. Please have readily available, the specific Integra® product that is being appealed and the indication for which the product was used in order for us to provide you with relevant clinical literature. Thank you. Disclaimer: Integra has used reasonable efforts to provide accurate coding advice, but this advice should not be construed as providing clinical advice, dictating reimbursement policy or substituting for the judgment of a practitioner. Integra LifeSciences Corporation assumes no responsibilities or liabilities for the timeliness, accuracy and completeness of the information contained herein. Since reimbursement laws, regulations and payor policies change frequently, it is recommended that providers consult with their payors, coding specialists and/or legal counsel regarding coverage, coding and payment issues. Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries. ©2020 Integra LifeSciences Corporation. All rights reserved.

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Appealing a Claim Determination General Information: Individuals enrolled in Medicare may file an appeal if they believe Medicare should have paid for, or did not pay enough for, an item or service that they received. An individual’s appeal rights are on the back of the Medicare Summary Notice (MSN) mailed to Medicare beneficiaries after they receive services. The MSN explains why a bill was not paid and how to file an appeal. The providers and suppliers of services that file claims on behalf of Medicare beneficiaries may also file appeals. The Medicare Part B Fee-for-Service Appeals Process: Https://www.cms.gov/Medicare/Appeals-and-Grievances/OrgMedFFSAppeals/RedeterminationbyaMedicareContractor

Level of Appeal

Appeal Type Time Limit for Filing

Request

Monetary Threshold to be Met

First Level Redetermination by a Medicare Contractor

Within 120 days of receipt of the notice of initial determination

None

Second Level Reconsideration by a Qualified Independent Contractor

Within 180 days from the date of receipt of the notice of the redetermination

None

Third Level

Decision by Office of Medicare Hearings and Appeals (OMHA)

Within 60 days of receipt of the reconsideration decision

Minimum of $170

Fourth Level Review by the Medicare Appeals Council

Within 60 days from the date of receipt of the notice of OMHA’s decision or dismissal

None

Fifth Level

Judicial Review in Federal District Court

Within 60 calendar days from the date it receives notice of the Council’s decision

Minimum of $1670

Documentation to include with your Appeal request: In an effort to present a solid case to Medicare or any other insurance carrier that the use of NeuraWrap™ Nerve Protector was/is in the best interest of the patient, it is important to submit with the appeal, pertinent health information pertaining to the treatment of the wound. Examples of relevant information to include would be:

History and Physical documentation Progress/Office notes specific to the peripheral nerve injury Operative Reports specific to the peripheral nerve injury

Letter of Medical Necessity:

If a procedure was deemed by the insurer as “not medically necessary,” it may be required that you prove medical necessity as part of your appeal. In addition to providing relevant health information specific to the treatment of the patient’s nerve injury, a Letter of Medical Necessity should accompany the appeal to help further justify the use of NeuraWrap™ Nerve Protector

If a Letter of Medical Necessity has been requested, we have available a sample letter, as well as a sample template (on the following two pages) to assist you in the process. Also available, upon request, Integra LifeSciences Corporation can provide you with clinical articles to help support your claim. Please feel free to contact our Reimbursement department at 1-877-444-1122 option 3, option 2 or email the literature request form to reimbursement@integralife.com.

For more information regarding Medicare, please go to http://www.cms.hhs.gov/

Integra has used reasonable efforts to provide accurate coding advice, but this advice should not be construed as providing clinical advice, dictating reimbursement policy or substituting for the judgment of a practitioner. Integra LifeSciences Corporation assumes no responsibilities or liabilities for the timeliness, accuracy and completeness of the information contained herein. Since reimbursement laws, regulations and payor policies change frequently, it is recommended that providers consult with their payors, coding specialists and/or legal counsel regarding coverage, coding and payment issues. Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries. ©2020 Integra LifeSciences Corporation. All rights reserved.

Sample Letter of Medical Necessity:

Sample Letter of Medical Necessity (Please type on physician’s letterhead)

Date: << Insurance Company>> <<Address>> <<City, State, Zip Code>> Re: <<Patient’s Name>> Policy Number: << xxxxxx>> Group Number <<xxxxxx>> To Whom It May Concern: Enclosed for your review, are clinical articles documenting the effective use of NeuraWrap® Nerve Protector. The attached Statement of Medical Necessity and information pertaining to <<Patient’s Name>> clinical history and diagnosis clearly demonstrate that NeuraWrap® Nerve Protector was medically necessary. Please send me written verification of coverage and payment for the procedure noted for <<Patient’s Name>> as soon as possible. If you have any questions pertaining to the clinical history or my treatment plan, please call me directly at: <<Office Phone Number>> Thank you for your immediate attention to this matter. Sincerely, <<MD’s Name>> Enclosure: Statement of Medical Necessity Estimate of Professional and Facility Charges Patient Records CC: <<Patient Name>> Medical Record File <<Facility billing contract>>

Sample Statement of Medical Necessity for Proposed Procedure Utilizing NeuraWrap™ Nerve Protector PATIENT NAME: _____________________ GENDER: M or F ADDRESS: _________________________ DATE OF BIRTH: _______ _________________________ FACILITY NAME: ______________ PHONE: _________________________

INSURANCE CO: _________________ SUBSCRIBER: ________________ GROUP NAME: ___________________ DATE OF DIAGNOSIS: _________

DIAGNOSIS: ___________________________________________________________ ICD-10 DIAGNOSIS CODE(S): _______________ DATE OF DIAGNOSIS: ________ DETAILED DESCRIPTION AND HISTORY OF TREATMENT FOR THIS PERIPHERAL NERVE INJURY: ______________________________________________________________________ ____________________________________________________________________________________________________________________________________________ ______________________________________________________________________ OTHER MEDICAL CONDITIONS: __________________________________________ ______________________________________________________________________ TREATMENT PLAN: ____________________________________________________ ______________________________________________________________________ MEDICAL NECESSITY FOR USING NEURAWRAP® NERVE PROTECTOR FOR THIS PERIPHERAL NERVE INJURY: ______________________________________________________________________ ____________________________________________________________________________________________________________________________________________ ______________________________________________________________________ PHYSICIAN NAME: (please print) ______________________________________ ADDRESS: ________________________________________________________ PHYSICIAN SIGNATURE: ___________________________ DATE: _____________

Coding and Reimbursement Guide for Integra® NeuraWrap™ Nerve Protector- For Use In Neuroplasty and/or Nerve Wrapping Procedures – 2020 Disclaimer: While Integra LifeSciences Corporation intends to use reasonable efforts to provide accurate coding information, this information should not be construed as providing clinical advice, dictating reimbursement policy, or substituting for the judgment of a practitioner. It is always the Provider’s responsibility to determine and submit appropriate codes, charges, and modifiers for services that are rendered. Integra LifeSciences Corporation assumes no responsibilities or liabilities for the timeliness, accuracy, and completeness of the information contained herein. Since reimbursement laws, regulations, and payor policies change frequently, it is recommended that providers consult with their payors, coding specialists, and/or legal counsel regarding coverage, coding and payment issues. Potential Procedures Using Integra® NeuraWrap™ Nerve Protector **- Inpatient Setting Potential ICD-10 PCS Procedures

ICD-10 Code Description

Potential MS-DRG Assignment

01N30ZZ Release Brachial Plexus, Open Approach 040-042, 515-517, 907-909, 957,959

01N40ZZ Release Ulnar Nerve, Open Approach

01N50ZZ Release Median Nerve, Open Approach 040-042, 513-514, 906, 957-959

01N60ZZ Release Radial Nerve, Open Approach

040-042 515-517, 907-909 957-959

01N90ZZ Release Lumbar Plexus, Open Approach

01ND0ZZ Release Femoral Nerve, Open Approach

01NF0ZZ Release Sciatic Nerve, Open Approach 01NG0ZZ Release Tibial Nerve, Open Approach 01NH0ZZ Release Peroneal Nerve, Open Approach 01S40ZZ Reposition Ulnar Nerve, Open Approach 040-042,

957-959 01S50ZZ Reposition Median Nerve, Open Approach

*Note: The Root Operation typically associated with the use of NeuraWrap is Release or Reposition. This is not an exhaustive list of all the ICD-10 PCS Codes associated with the use of NeuraWrap, just the more common codes

Potential MS-DRG’s Using Integra® NeuraWrap™ Nerve Protector **- Inpatient Setting

MS-DRG DRG

Description Medicare National Average Payment

040 Peripheral/Cranial Nerve and Other Nervous System Procedures with MCC

$23,998.32

041 Peripheral/Cranial Nerve and Other Nervous System Procedures with CC or Peripheral Neurostimulator

$14,408.03

042 Peripheral/Cranial Nerve and Other Nervous System Procedures without CC/MCC

$11,433.44

513 Hand or Wrist Procedures, Except Major Thumb or Joint Procedures with CC/MCC $10,016.71 514 Hand or Wrist Procedures, Except Major Thumb or Joint Procedures without CC/MCC $6,108.02 515 Other Musculoskeletal System and Connective Tissue O.R. Procedure with MCC $18,828.68 516 Other Musculoskeletal System and Connective Tissue O.R. Procedures with CC $11,518.36 517 Other Musculoskeletal System and Connective Tissue O.R. Procedures without

CC/MCC $8,436.25

906 Hand Procedures for Injuries $11,260.55 907 Other O.R. Procedures for Injuries with MCC $25,757.17 908 Other O.R. Procedures for Injuries with CC $12,174.49 909 Other O.R. Procedures for Injuries without CC/MCC $8,097.19 957 Other O.R. Procedures for Multiple Significant Trauma with MCC $46,421.06 958 Other O.R. Procedures for Multiple Significant Trauma with CC $25,535.40 959 Other O.R. Procedures for Multiple Significant Trauma without CC/MCC $14,971.91

Potential Procedures Using Integra® NeuraWrap™ Nerve Protector **- Hospital Outpatient/Ambulatory Surgical Center Setting CPT Code

Code Description

APC Relative Weight

2020 Medicare Base Payment Rate – Hospital Outpatient

2020 Medicare Payment Rate – Ambulatory Surgical Center

64702 Neuroplasty; digital, 1 or both, same digit 5431

21.2809

$1,719.35

$796.79

64704 Neuroplasty; nerve of hand or foot

64708 Neuroplasty, major peripheral nerve, arm or leg, open; other than specified

64712 Neuroplasty, major peripheral nerve, arm or leg, open; sciatic nerve

64713 Neuroplasty, major peripheral nerve, arm or leg, open; brachial plexus

64714 Neuroplasty, major peripheral nerve, arm or leg, open; lumbar plexus

64718 Neuroplasty and/or transposition; ulnar nerve at elbow

64719 Neuroplasty and/or transposition; ulnar nerve at wrist

64721 Neuroplasty and/or transposition; median nerve at carpal tunnel

64722 Decompression; unspecified nerve(s) (specify)

64726 Decompression; plantar digital nerve

64727 Internal neurolysis, requiring use of operating microscope (List separately in addition to code for neuroplasty) (Neuroplasty includes external neurolysis)

N/A N/A N/A N/A

Potential Procedures Integra® NeuraWrap™ Nerve Protector **- Physician Fee Schedule – Facility CPT Code

Code Description

Work Relative Value Unit

2020 National Medicare Payment Rate - Facility

64702 Neuroplasty; digital, 1 or both, same digit 6.26 $522.94

64704 Neuroplasty; nerve of hand or foot 4.69 $334.19

64708 Neuroplasty, major peripheral nerve, arm or leg, open; other than specified

6.36 $523.66

64712 Neuroplasty, major peripheral nerve, arm or leg, open; sciatic nerve 8.07 $611.72

64713 Neuroplasty, major peripheral nerve, arm or leg, open; brachial plexus 11.40 $814.54

64714 Neuroplasty, major peripheral nerve, arm or leg, open; lumbar plexus 10.55 $762.57

64718 Neuroplasty and/or transposition; ulnar nerve at elbow 7.26 $618.58

64719 Neuroplasty and/or transposition; ulnar nerve at wrist 4.97 $418.28

64722 Decompression; unspecified nerve(s) (specify) 4.82 $373.53

64726 Decompression; plantar digital nerve 4.27 $278.97

64727 Internal neurolysis, requiring use of operating microscope (List separately in addition to code for neuroplasty) (Neuroplasty includes external neurolysis)

3.10 $190.19

Potential Procedures Integra® NeuraWrap™ Nerve Protector ** – Physician Fee Schedule – Facility and Non-Facility CPT Code

Code Description

Work Relative Value Unit

2020 National Medicare Payment Rate – Facility

2020 National Medicare Payment Rate Non-Facility

64721 Neuroplasty and/or transposition; median nerve at carpal tunnel

4.97 $446.43 $452.56

When performing Neuroplasty in conjunction with wrapping a nerve, use CPT codes 64702-64727 in addition to CPT code 64999. Currently there are no CPT procedure codes for wrapping a nerve. If you are trying to seek reimbursement for wrapping the nerve, it is recommended that you use CPT code 64999 to account for the procedure. When using an unlisted procedure code such as CPT code 64999, it is necessary to provide supporting documentation when submitting the claim. Supporting documentation may include an Operative report or an Operative note. **Note: It is not appropriate to bill Medicare for procedures involving implantable biologicals such as Integra® NeuraWrap™ Nerve Protector using CPT Procedure Code 15777 - Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (ie, breast, trunk) (List separately in addition to code for primary procedure) if the product is not being used in the breast or trunk. This code is to be used exclusively for reporting of implantation of biologic implant for the breast and trunk only per the guidance provided in CPT Assistant Jan 12:10, Oct 13:15; CPT Changes: An Insider’s View 2012, 2014.

HCPCS Code

Product HCPCS Code

Code Description

NeuraWrap™ C9353 Microporous collagen implantable slit tube (NeuraWrap™ Nerve Protector), per cm length

Reference: CPT® Code Book 2020, Current Procedural Terminology (CPT) copyright 2019 American Medical Association (AMA). All rights reserved. CPT is a registered trademark of the AMA. 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. ICD-10-PCS codes and descriptors and DRG payment groups are effective October 1, 2019. Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. NeuraWrap is a trademark of Integra LifeSciences Corporation ©2020 Integra LifeSciences Corporation. All rights reserved.

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For assistance with coding and reimbursement, please contact our Integra Reimbursement Hotline at 1-877-444-1122, option 3, option 2, Monday to Friday, 8 am to 6 pm, or via email at reimbursement@integralife.com

Appeal Packet Literature

Request Form*

Facility Type

Facility Name

Contact First Name

Contact Last Name

Department

Job Title

Street Address (where you want information sent)

City

State

Zip Code

Contact Phone

Contact Email Address

Product used requiring appeal assistance

Briefly describe how the product was used (for what indication)

Please list the payer who denied the claim

Form should be emailed to smartreimbursement@integralife.com *Providing available on-label literature is a courtesy and in no way guarantees reimbursement or the overturning of a denial or negative coverage determination. Integra LifeSciences Corporation uses reasonable efforts to provide literature support for your appeal request. Integra LifeSciences Corporation assumes no responsibility for the timeliness, accuracy, and completeness of the information contained herein. Since reimbursement laws, regulations, and payor policies change frequently, it is recommended that providers consult with their payers, coding specialists, and/or legal counsel regarding coverage, coding, and payment issues. Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the United States and/or other countries. ©2016 Integra LifeSciences Corporation. All rights reserved 0505353 -1 (6/16)