Medicare Appeal Packet for SurgiMend® Collagen Matrix For Soft Tissue Reconstruction

As a service to our customers, Integra LifeSciences Corporation has assembled this packet of information to assist with the Medicare 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 Package Insert FDA Approval Letter Bibliography of clinical articles relative to the SurgiMend® (for

use in hernia repair only) 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 or email the literature request form to reimbursement@integralife.com Please have readily available the specific SurgiMend® product that is being appealed in order for us to provide you with the relevant clinical literature. Thank you. 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. SurgiMend is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2017 Integra LifeSciences Corporation. All rights reserved. 0571138 – 1 (2016-12)

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/index.html 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

Hearing by an Administrative Law Judge (ALJ)

Within 60 days after receipt of the reconsideration notice

Minimum of $150

Fourth Level

Review by the Medicare Appeals Council

Within 60 days from the date of receipt of the ALJ decision

None

Fifth Level

Judicial Review in Federal District Court

Within 60 days from the date of receipt of the DAB’s decision

Minimum of $1500

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 SurgiMend® 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 hernia Operative Reports specific to the treatment of the hernia Documentation that may illustrate previous attempts to treat the hernia

with other products 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 hernia repair, a Letter of Medical Necessity should accompany the appeal to help further justify the use of SurgiMend®.

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 contact the reimbursement hotline at 1-877-444-1122, option 3 or email the literature request form to reimbursement@integralife.com

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

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. SurgiMend is a registered trademark of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2017 Integra LifeSciences Corporation. All rights reserved.

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 SurgiMend®. The attached Statement of Medical Necessity and information pertaining to <<Patient’s Name>> clinical history and diagnosis clearly demonstrate that SurgiMend® is the treatment of choice. 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 SurgiMend® 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 OF HERNIA: _____________________________________ ____________________________________________________________________________________________________________________________________________ OTHER MEDICAL CONDITIONS: __________________________________________ ______________________________________________________________________ TREATMENT PLAN: ____________________________________________________ ______________________________________________________________________ MEDICAL NECESSITY OF USING SURGIMEND® FOR THIS HERNIA REPAIR: __________________________________________________________________________________________________________________________________________________________________________________________________________________ __________________________________________________________________________________________________________________________________________________________________________________________________________________ PHYSICIAN NAME: (please print) _________________________________ ADDRESS: ____________________________________________________ PHYSICIAN SIGNATURE: ___________________________ DATE: _____________

SurgiMend®

Collagen Matrix for Soft Tissue Reconstruction

2

SurgiMend® Collagen Matrix for Soft Tissue Reconstruction DescriptionSurgiMend® is an acellular dermal tissue derived from bovine dermis. The device is supplied sterile in a variety of sizes, shapes, and thicknesses to be trimmed by the physician to meet the individual patient’s needs.

IndicationsSurgiMend® is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue membranes.

SurgiMend® is specifically indicated for:• Plastic and reconstructive surgery• Muscle flap reinforcement• Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.

Contraindications• SurgiMend® should not be used for patients with a known history of hypersensitivity to collagen or bovine products.• SurgiMend® is not designed, sold, or intended for use except as indicated.

Warnings and PrecautionsCAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

• Consider the loading environment when selecting the product thickness; thicker product tends to have greater initial strength.

• Fenestrated product will stretch more than non-fenestrated product.• Meshing of fenestrated product is not recommended.• Do not expose to chemicals or substances other than sterile, room temperature 0.9% saline.• Excessive heat can damage collagen. Do not hydrate in 0.9% saline warmed above room temperature. If, when hydrated, the product shrinks in size, DO NOT use the product as it may be damaged.• SurgiMend® should be used with caution where any pre-existing pathology may limit blood supply and compromise healing.• Treat any existing infection appropriately in an attempt to eliminate infection. If used in

contaminated or infected wounds collagen-based implants can weaken or break down if exposed to bacterial enzymes.

• SurgiMend® should be used with caution in surgical locations where the product may be exposed to stomach and/or intestinal contents. Collagen-based implants can be susceptible to degradation by digestive enzymes and conditions of acidic (low) pH.• Do not resterilize as this may damage SurgiMend®.• SurgiMend® is for single patient use only and is to be implanted surgically.• SurgiMend® has not been evaluated in pregnant women.• The patient’s medical condition may adversely impact healing of the deficient tissue. These conditions may include, but are not limited to: smoking, diabetes, insufficient blood supply at the implant site, and exposure of the implant site to radiotherapy.• Do not use product past the date of expiration.

Potential ComplicationsGeneral risks may include, but are not limited to: infection, allergic reactions, pain, swelling or bruising, foreign body reactions, acute or chronic inflammatory reactions, adhesions, seromas, hematomas, and repair laxity. The patient should be made aware of these risks and others associated with general surgery and the use of anesthesia.

PHYSICIAN NOTE: The physician must convey the indications, contraindications, warnings and precautions, and potential complications given in this document to the patient.

3

Instructions for Use• Inspect packaging and reject product if packaging is previously damaged or opened.• Peel open outer foil package and aseptically deliver inner, sterile package to sterile field.• Rinse surgical gloves, if necessary, to remove any glove powder prior to touching product.• Remove product from package using sterile, atraumatic forceps or gloved hand.• Soak SurgiMend® in sterile, room temperature, 0.9% saline until hydrated (typically a few minutes; thicker product may take longer than thinner product). Hydration is indicated by a color change from white (dry) to gray (wet). To facilitate wetting, pressure can be applied with gloved fingers across the surface of the device until SurgiMend® has a uniform gray, wet appearance.• While dry, or following soaking in sterile, room temperature, 0.9% saline, cut SurgiMend® to the size and shape needed.• Keep SurgiMend® immersed in sterile, room temperature, 0.9% saline until ready for use.• For best results, SurgiMend® should be applied and fixed in place carefully.• Adequate overlap of SurgiMend® with healthy host tissue is recommended.• SurgiMend® should be fixed in place using standard suturing techniques or staples encompassing both graft and host tissue.• Discard any unused pieces of SurgiMend®.

SafetySurgiMend® is manufactured from bovine skin. The source material is processed and solely derived from cattle in compliance with United States and European regulatory requirements.

Storage• Store at room temperature: 15 - 30°C (59 - 86°F).• Keep away from heat sources.• Keep away from direct sunlight.

How Supplied• SurgiMend® is supplied sterile in single use, double-peel packages in a variety of sizes.• So long as the package has not been damaged or opened, the contents are guaranteed sterile and non-pyrogenic.

4

Do not use if package is damaged Catalog number

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or practitioner

Lot Number

STERILE EO Sterilized using Ethylene Oxide Quantity

Manufacturer Do not Re-Use

Temperature Limitation STERILIZE2 Do not resterilize

Consult Instructions For UseExpiration date (YYYY-MM-DD)

15C° 59F°

30C° 86F°

Symbols Used on Labeling

Manufactured by:TEI Biosciences Inc.7 Elkins StreetBoston, MA 02127 n USATel: (877) 444-1122 n Fax: (866) 800-7742integralife.com

Integra, the Integra logo, and SurgiMend are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2016 Integra LifeSciences Corporation. All Rights Reserved. 0536877-1-EN

Made in USATEI Biosciences Inc., is a subsidiary of Integra LifeSciences Corporation.

TEI BIOSCIENCES INC. SurgiMend1/23/2008 Special 510(k) Premarket Notification

510(k) Summary

This 510(k) summary for SurgiMend is being submitted in accordance withthe requirements of 21 CFR 807.92.

FEB -4 2009Submitted byTE! Biosciences Inc.7 Elkins StreetBoston, MA 02127(617) 268-1616(617) 268-3282 (fax)

Contact PersonKenneth James, Ph.D.Vice President, Product Sciences and Regulatory Affairs

Date PreparedJuly 31, 2007

Device InformationProprietary name: SurgiMend Collagen Matrix

for Soft Tissue ReconstructionClassification name: Surgical MeshDevice classification: Class II

Device DescriptionSurgiMend is an acellular dermal tissue matrix derived from bovinedermis. The device is supplied sterile in a variety of sizes to betrimmed by the surgeon to meetthe individual patient's needs.

Intended UseSurgiMend is intended for implantation to reinforce soft tissue whereweakness exists and for the surgical repair of damaged or rupturedsoft tissue membranes.

SurgiMend is specifically indicated for:* Plastic and reconstructive surgery* Muscle flap reinforcement· Hernia repair including abdominal, inguinal, femoral,

diaphragmatic, scrotal, umbilical, and incisional hernias

-4 -

TEX BIOSCIENCES INC. /632 8' SurgiMend1/23/2008 '/ Special 510(k) Premarket Notification

Legally Marketed Devices to which Equivalence is Being ClaimedSurgiMend is substantially equivalent in function and intended use to:

Predicate Device Manufacturer 510(k) NumberSurgiMend TEI Biosciences K071807TissueMend TEI Biosciences K020488

Summary of Technological Characteristics and BiocompatibilitySurgiMend is substantially equivalent to other surgical meshes withrespect to its design and intended use.

A rigorous biocompatibility assessment performed by an independentlaboratory demonstrated the biocompatibility of SurgiMend. The testsperformed included: cytotoxicity, sensitization, intracutanebusreactivity, acute systemic toxicity, genotoxicity, intramuscularimplantation, hemolysis, and pyrogenicity. The manufacturingmethods for SurgiMend have also been tested by an independentlaboratory to assure appropriate levels of viral inactivation.

-5-

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug AdministrationFEB -4 2009 9200 Corporate Boulevard

Rockville MD 20850

TEI Biosciences, Inc.% Kenneth James, Ph.D.VP, Product Sciences and

Regulatory Affairs7 Elkins StreetBoston, Massachusetts 02127

Re: K083898Trade/Device Name: SurgiMend Collagen Matrix for Soft Tissue ReconstructionRegulation Number: 21 CFR 878.3300Regulation Name: Surgical meshRegulatory Class: IIProduct Code: FTMDated: January 23, 2009Received: January 26, 2009

Dear Dr. James:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmay be subject to such additional controls. Existing major regulations affecting your device canbe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but noi limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

Page 2 - Kenneth'James, Ph.D.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k)premarket notification. The FDA finding of substantial equivalence of your device to a legallymarketed predicate device results in a classification for your device and thus, permits your deviceto proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasecontact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at(240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference topremarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance,please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of PostmarketSurveillance at (240) 276-3474. For questions regarding the reporting of device adverse events(Medical Device Reporting (MDR)), please contact the Division of Surveillance Systemsat (240) 276-3464. You may obtain other general information on your responsibilities under theAct from the Division of Small Manufacturers, International and Consumer Assistanceat its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet addresshttp://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,'

Mark N. MelkersonDirectorDivision of General, Restorative

and Neurological DevicesOffice of Device EvaluationCenter for Devices and

Radiological Health

Enclosure

TEI BIOSCIENCES INC. SurgiMend1/23/ 2008 Special 510(k) Premarket Notification

Indications for Use

510(k) Number (if known): K083898

Device Name:. SurgiMend Collagen Matrix for Soft Tissue Reconstruction

Indications for Use:

SurgiMend is intended for implantation to reinforce soft tissue whereweakness exists and for the surgical repair of damaged or rupturedsoft tissue membranes.

SurgiMend is specifically indicated for:; Plastic and reconstructive surgery: Muscle flap reinforcement

Hernia repair including abdominal, inguinal, femoral,diaphrag atic, scrotal, umbilical, and incisional hernias

Prescription Use AND/OR Over-The-Counter Use(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

/

· (Division $ign_"ui, .~""--Div 0ison of Generai, Restorative,and Neurological Devices

510(k) Number V· ' ~

-2-

Hernia Repair• Booth JH, Garvey PB, Baumann DP, et al. Primary Fascial

Closure with Mesh Reinforcement Is Superior to Bridged Mesh Repair for Abdominal Wall Reconstruction. J Am Coll Surg. 2013;217(6):999-1009.

• Clemens M, Selber J, Liu J, Adelman D, Baumann D, Garvey P, Butler C. Bovine versus porcine acellular dermal matrix for complex abdominal wall reconstruction. Plast Reconstr Surg. 2012 Jul;130(1S):64.

• Garvey PB, Martinez R a., Baumann DP, Liu J, Butler CE. Outcomes of Abdominal Wall Reconstruction with Acellular Dermal Matrix Are Not Affected by Wound Contamination. J Am Coll Surg. 2014;219(5):853-864.

• Ghali S, Turza K, Baumann D, Butler C. Minimally invasive component separation results in fewer wound-healing complications than open component separation for large ventral hernia repairs. J Am Coll Surg. 2012 Jun;214(6):981-9.

• Janfaza M, Martin M, Skinner R. A preliminary comparison study of two noncrosslinked biologic meshes used in complex ventral hernia repairs. World J Surg. 2012 Aug;36(8):1760-4.

• Lineaweaver W. Improvement of success rates for abdominal component reconstructions using bovine fetal collagen. Ann Plast Surg. 2012 May;68(5):438-41.

• Soares KC, Baltodano P a., Hicks CW, et al. Novel wound management system reduces surgical site morbidity after ventral hernia repairs: a critical analysis. Am J Surg. August 2014.

• Wietfeldt E, Hassan I, Rakinic J. Utilization of bovine acellular dermal matrix in abdominal wall reconstruction: a retrospective case series. Ostomy Wound Manag. 2009 Jul;55(8):52-6.

Technology• Adelman DM, Selber JC, Butler CE. Bovine versus Porcine

Acellular Dermal Matrix: A Comparison of Mechanical Properties. Plast Reconstr Surg Glob Open. 2014;2(5):e155.

• Cornwell K, Landsman A, James K. Extracellular matrix biomaterials for soft tissue repair. Clin Podiatr Med Surg. 2009;26(4):507-23.

• Cornwell KG, Zhang F, Lineaweaver W. Bovine fetal collagen reinforcement in a small animal model of hernia with component repair. J Surg Res. 2016;201(2):416-424.

• Deeken CR, Eliason BJ, Pichert MD, Grant S a, Frisella MM, Matthews BD. Differentiation of Biologic Scaffold Materials Through Physicomechanical, Thermal, and Enzymatic Degradation Techniques. Ann Surg. 2012;255(3):595-604.

SurgiMend products have been studied in a broad range of clinical applications. Peer-reviewed and published clinical references are listed here.

SurgiMend® 1.0 2.0 3.0 4.0 Collagen Matrix for Soft Tissue Reconstruction

SurgiMend®-eCollagen Matrix for Hernia Repair

SurgiMend® PRSCollagen Matrix for Plastic & Reconstructive Surgery

SURGIMEND® CLINICAL REFERENCES

SurgiMend, Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation or its subsidiaries in the United States and/or other countries. ©2016 Integra LifeSciences Corporation. All rights reserved. Printed in USA. 0M 0541549-1-EN

United States, Canada, Asia, Pacific, Latin AmericaUSA 800-654-2873 n 888-980-7742 faxInternational +1 609-936-5400 n +1 609-750-4259 faxintegralife.com/contact

For more information or to place an order, please contact:

Availability of these products might vary from a given country or region to another, as a result of specific local regulatory approval or clearance requirements for sale in such country or region. n Non contractual document. The manufacturer reserves the right, without prior notice, to modify the products in order to improve their quality.n Warning: Applicable laws restrict these products to sale by or on the order of a physician.n Consult product labels and inserts for any indication, contraindications, hazards, warnings, precautions, and instructions for use.

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 reimbursement@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)