Medicare Appeal Packet for Integra® Wound Matrix (Thin)

As a service to our customers, Integra LifeSciences Corporation has assembled this packet of information to assist you 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 Clearance Letter  Bibliography of clinical articles relative to the Integra® Matrix Family of Products  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 [email protected]. 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.

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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

Monetary Level of Appeal Type Time Limit for Filing Threshold Appeal Request to be Met First Level Redetermination by a Within 120 days of None Medicare Contractor receipt of the notice of initial determination

Second Reconsideration by a Within 180 days from the None Level Qualified Independent date of receipt of the Contractor notice of the redetermination

Third Decision by Office of Within 60 days of receipt Minimum of Level Medicare Hearings and of the reconsideration $170 Appeals (OMHA) decision Fourth Review by the Medicare Within 60 days from the None Level Appeals Council date of receipt of the notice of OMHA’s decision or dismissal Fifth Judicial Review in Federal Within 60 calendar days Minimum of Level District Court from the date it receives $1670 notice of the Council’s decision

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 Integra® Wound Matrix (Thin) 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 treatment of the wound  Operative Reports specific to the treatment of the wound  Pictures of the wound  Documentation that may illustrate previous wound treatments

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 wound, a Letter of Medical Necessity should accompany the appeal to help further justify the use of Integra® Wound Matrix (Thin).

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 1 or email the literature request form to [email protected].

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

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:

(Please type on physician’s letterhead)

Date:

<< Insurance Company>> <

> <>

Re: <> Policy Number: << xxxxxx>> Group Number <>

To Whom It May Concern:

Enclosed for your review, are clinical articles documenting the effective use of Integra® Wound Matrix (Thin). The attached Statement of Medical Necessity and information pertaining to <> clinical history and diagnosis clearly demonstrate that Integra® Wound Matrix (Thin) is the treatment of choice.

Please send me written verification of coverage and payment for the procedure noted for <> as soon as possible. If you have any questions pertaining to the clinical history or my treatment plan, please call me directly at:

Thank you for your immediate attention to this matter.

Sincerely,

Enclosure: Statement of Medical Necessity Estimate of Professional and Facility Charges Patient Records

CC: <> Medical Record File <>

Sample Statement of Medical Necessity for Proposed Procedure Utilizing Integra® Wound Matrix (Thin)

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): ______SIZE OF WOUND: ______

ETIOLOGY OF WOUND: ______DATE OF DIAGNOSIS: ______

DETAILED DESCRIPTION OF WOUND: ______

OTHER MEDICAL CONDITIONS: ______

TREATMENT PLAN: ______

MEDICAL NECESSITY OF USING INTEGRA® WOUND MATRIX (THIN) FOR THIS WOUND: ______

PHYSICIAN NAME: (please print) ______

ADDRESS: ______

PHYSICIAN SIGNATURE: ______DATE: ______

Post-Application Integra® Wound Matrix 1. Change the secondary dressing as needed. Frequency of secondary dressing change will Integra® Wound Matrix (Thin) ® be dependent upon volume of exudate produced, type of dressing used and the clinician’s need to inspect the wound bed for signs of infection or healing. DESCRIPTION Note: If hematoma or excess exudate collect under the sheet, Integra® Wound Matrix and Integra® Wound Matrix (Thin) are collagen- small openings can be cut in the sheet to allow fluid to drain. glycosaminoglycan wound dressings that maintain and support a healing 2. As healing occurs, sections of Integra Wound Matrix and Integra Wound Matrix (Thin) environment for wound management. Integra Wound Matrix (Thin) has may gradually peel and may be removed during dressing changes. Do not forcibly remove 50% less collagen compared to each of the corresponding sq cm sizes sections of Integra Wound Matrix or Integra Wound Matrix (Thin) that may adhere to of Integra Wound Matrix. the wound. On inspection, if Integra Wound Matrix or Integra Wound Matrix (Thin) is no longer covering the wound, place an additional piece of Integra Wound Matrix or Integra INDICATIONS Wound Matrix (Thin) over the wound. Integra Wound Matrix and Integra Wound Matrix (Thin) are indicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, HOW SUPPLIED diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds Integra Wound Matrix and Integra Wound Matrix (Thin) is supplied sterile, in single use, (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), double peel packages containing phosphate buffer. Integra Wound Matrix trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining and Integra Wound Matrix (Thin) are available in the following sizes: wounds. The device is intended for one-time use.

CONTRAINDICATIONS Product Codes Size Quantity • This device should not be used in patients with known sensitivity to 52021 2 inch x 2 inch (5 cm x 5 cm) 1 unit/box bovine collagen or chondroitin materials. 52021T (Thin) 2 inch x 2 inch (5 cm x 5 cm) 1 unit/box • The device is not indicated for use in third degree burns. 52025 2 inch x 2 inch (5 cm x 5 cm) 5 units/box PRECAUTIONS • Do not resterilize. Discard all opened and unused portions of Integra 52025T (Thin) 2 inch x 2 inch (5 cm x 5 cm) 5 units/box Wound Matrix and Integra Wound Matrix (Thin). 54051 4 inch x 5 inch (10 cm x 12.5 cm) 1 unit/box • Device is sterile if the package is unopened and undamaged. 54051T (Thin) 4 inch x 5 inch (10 cm x 12.5 cm) 1 unit/box Do not use if the package seal is broken. 54055T 4 inch x 5 inch (10 cm x 12.5 cm) 5 units/box • Discard device if mishandling has caused possible damage or contamination. 54055T (Thin) 4 inch x 5 inch (10 cm x 12.5 cm) 5 units/box • Integra Wound Matrix and Integra Wound Matrix (Thin) should not 54101 4 inch x 10 inch (10 cm x 25 cm) 1 unit/box be applied until excessive exudate, bleeding, acute swelling and infection are controlled. 54101T (thin) 4 inch x 10 inch (10 cm x 25 cm) 1 unit/box • Debridement or excision must be done thoroughly to remove any remaining 54105 4 inch x 10 inch (10 cm x 25 cm) 5 units/box necrotic tissue that may cause infection. 54105T (Thin) 4 inch x 10 inch (10 cm x 25 cm) 5 units/box • The following complications are possible with the use of wound dressings. If any of the conditions occur, the device should be removed: infection, 58101 8 inch x 10 inch (20 cm x 25 cm) 1 unit/box chronic inflammation (initial application of wound dressings may be 58101T (Thin) 8 inch x 10 inch (20 cm x 25 cm) 1 unit/box associated with transient, mild, localized inflammation), allergic reaction, excessive redness, pain or swelling. 58105 8 inch x 10 inch (20 cm x 25 cm) 5 units/box 58105T (Thin) 8 inch x 10 inch (20 cm x 25 cm) 5 units/box SINGLE-USE DEVICE Integra Wound Matrix and Integra Wound Matrix (Thin) is supplied in a single-use STORAGE package and is guaranteed to be sterile and non-pyrogenic unless opened or damaged. Store flat at room temperature. Avoid excessive heat (greater than 40°C). Avoid freezing. The product is intended for use as an absorbable implant and is not to be reused. Any attempt to resterilize or reuse the product/components will damage the matrix PRODUCT INFORMATION DISCLOSURE and impair its ability to function as intended. All unused pieces must be discarded. INTEGRA LIFESCIENCES CORPORATION HAS EXERCISED REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE MANUFACTURE OF THESE PRODUCTS. INTEGRA LIFESCIENCES EXCLUDES ALL WARRANTIES, WHETHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED INSTRUCTIONS FOR USE WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. INTEGRA LIFESCIENCES SHALL NOT BE LIABLE FOR ANY INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE, DIRECTLY

Application OR INDIRECTLY ARISING FROM USE OF THIS PRODUCT. INTEGRA LIFESCIENCES NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME FOR IT ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY 1. Always handle Integra Wound Matrix and Integra Wound Matrix (Thin) IN CONNECTION WITH THESE PRODUCTS. using aseptic technique. SYMBOLS USED ON LABELING 2. Peel open the outer pouch and remove the inner foil pouch. 3. Place foil pouch flat on sterile surface and peel it open. 2 Do not re-use LOT Lot number 4. Remove product, including the protective polyethylene sheets. 5. Separate product from the polyethylene sheets by slowly and carefully peeling Consult Instructions for Use Expiration date back from one of the corner edges. Handle with care as product is fragile. 6. Place product into basin containing a sterile saline solution. +30ºC STERILE R Sterilized using irradiation Rinse the product free of storage buffer by immersion in sterile saline Temperature limitation for 1-2 minutes. +2ºC 7. Keep product in the basin until application. Caution: Federal (USA) law This product does not contain 8. Prepare wound bed using standard methods to ensure wound is free restricts this device to sale by LATEX and is not manufactured with or on the order of a physician Dry Natural Rubber or of debris and necrotic tissue. If necessary, surgically debride the wound or practitioner Natural Rubber Latex to ensure the wound edges contain viable tissue. 2 9. Cut the device to size and apply immediately following wound bed preparation. STERILIZE Do not re-sterilize Manufacturer 10. Smooth Integra Wound Matrix and Integra Wound Matrix (Thin) into place to ensure the sheet is in contact with the underlying wound bed. REF Catalog number Do not use if package 11. After application, use appropriate secondary dressings to maintain dressing is damaged adherence and protect the wound area. The optimum secondary dressing is Manufactured by: determined by wound location, size, depth and user preference. Integra LifeSciences Corporation 311 Enterprise Drive, Plainsboro, NJ 08536 ® Integra and the Integra logo are registered trademarks of Integra LifeSciences 800-997-4868 USA n 609-936-5400 outside USA Corporation in the United States and/or other countries. 888-980-7742 fax ©2012 Integra LifeSciences Corporation. All rights reserved. integralife.com U.S. Patent No: 7,993,679 Additional Patents Pending RMS No: 7200100000 Made in the U.S.A.

BIBLIOGRAPHY – Integra Matrix Family of Products

GENERAL WOUNDS Modifying Integra as a Regeneration Template in Deep Tissue Planes; J.D. Frame, J.E. Frame; Journal of Plastic, Reconstructive and Aesthetic Surgery 2006 59: 460-464 Current Concepts in Wound Healing; Jeffrey E. Janis, MD; Supplement to Plastic and Reconstructive Surgery; June 2006 Supplement

TRAUMA WOUNDS Simple Approach to the Radiated Scalp Wound Using INTEGRA Skin Substitute; Denis L. Gonyon, Jr., MD and Michael R. Zenn, MD, FACS; Annals of Plastic Surgery 2003, 50:315-320 Can a New Biologic Matrix Facilitate Improved Wound Healing?; J. Steinberg, A. Anderson; Podiatry Today, February 2005, 16-18 Bioartificial Dermal Substitute: A Preliminary Report on Its Use for the Management of Complex Combat-Related Soft Tissue Wounds; Melvin D. Helgeson, MD et al; Journal of Orthopaedic Trauma; July 2007: 394-399 The Use of Integra in an Upper Extremity Avulsion Injury: T.P. Wolter, et al; British Association of Plastic, Reconstructive & Aesthetic Surgeons, 2005 Volume 58: 416-418 The Use of a Dermal Regeneration Template for the Repair of Degloving Injuries: A Case Report; D. D. Lozano; Wounds 2003, 15 (12): 395-398

CHRONIC WOUNDS A Clinical Trial of Integra® Template for Diabetic Foot Ulcer Treatment; Vickie Driver, MS, DPM, et al; Wound Repair Regen. 2015 Nov-Dec23 (6); 891-900 Ease of Use, Safety, and Efficacy of Integra Bilayer Wound Matrix in the Treatment of Diabetic Foot Ulcers in an Outpatient Clinical Setting; Min Yao, MD, MPH, et al; Journal of the American Podiatric Medical Association: July 2013, Vol. 103, No. 4, pp. 274-280. Economic Study of Collagen-Glycosaminoglycan Biodegradable Matrix for Chronic Wounds; David W. Voigt, MD, C. N. Paul, MD, Paul Edwards, Philip Metz, MD; Wounds 2006, 18 (1): 1-7 Management of Complex and Pathological Wounds with Integra; Marc E. Gottlieb; The Wound Management Manual 2005: 226-289 Successful Management and Surgical Closure of Chronic and Pathological Wounds using INTEGRA; Marc E. Gottlieb, Jennifer Furman; Journal of Burns and Wounds, Volume 3, #2 Dermal Regeneration Template in the Surgical Management of Diabetic Foot Ulcers: A Series of 5 Cases; Glenn Silverstein, DPM; Journal of Foot and Ankle Surgery 2006, 45 (1): 28-33

COMBINED WITH NEGATIVE-PRESSURE THERAPY Development of New Reconstructive Techniques: Use of INTEGRA in Combination with Fibrin Glue and Negative-Pressure Therapy for Reconstruction of Acute and Chronic Wounds; M. G. Jeschke, C. Rose, P. Angele, B. Fuchtmeier, M. N. Nerlich, U. Bolder; Plastic and Reconstructive Surgery 2004, 113: 525 Acceleration of INTEGRA Incorporation in Complex Tissue Defects with Subatmospheric Pressure; Joseph A. Molnar, MD, PhD, Anthony J. DeFranzo, MD, Annoush Hadaegh, MD, Michael J. Morykwas, PhD, Perry Shen, MD, and Louis C. Argenta, MD; Plastic and Reconstructive Surgery 2004, 113: 1339

CANCER AND TUMORS Artificial Dermis as an Alternative for Coverage of Complex Scalp Defects following Excision of Malignant Tumors; E. Komorowska-Timek, A. Gabriel, D. Bennett, D. Miles, C. Garberoglio, C. Cheng, S. Gupta; Plastic and Reconstructive Surgery 2005, 115: 1010-1017 Artificial Skin for Closure and Healing of Wounds Created by Skin Cancer Excisions; Janet H. Prystowsky, MD, PhD, Daniel M. Siegel, MD, and Jeffrey A. Ascherman, MD; Dermatologic Surgery 2001, 27: 648-655 Stacking of a Dermal Regeneration Template for Reconstruction of a Soft-Tissue Defect After Tumor Excision from the Palm of the Hand: A Case Report; Joshua T. Carothers, MD, Brian E. Brigman, MD, Richard D. Lawson, MD, Marco Rizzo, MD; Journal of Hand Surgery 2005: 30A: 1322- 1326 The Use of Artificial Dermis in the Reconstruction of Oncologic Surgical Defects; Anthony P. Tufaro; Plastic and Reconstructive Surgery September 2007: 638-646

BURNS Histologic Study of Artificial Skin Used in the Treatment of Full-Thickness Thermal Injury; R. Stern, MD, M. McPherson, PharmD, and M. T. Longtaker, MD; Journal of Burn Care and Rehabilitation Jan/Feb 1990: 7-13 Artificial Dermis for Major Burns; Heimbach, MD et al; Annals of Surgery Sept 1998: 313-320 Successful Use of a Physiologically Acceptable Artificial Skin in the Treatment of Extensive Burn Injury; John F. Burke, MD, Ioannis V. Yannas, Ph.D, et al; Annals of Surgery Vol 194 No. 4: 413-428 Reconstruction of Burn Scan of the Upper Extremities with Artificial Skin; Trong-Duo Chou, MD, et al; Division of Plastic Surgery, Tri-Service General Hospital, May 2000 Dermal Regeneration Template for Deep Hand Burns: Clinical Utility for Both Early Grafting and Reconstructive Surgery; E. Dantzer, et al; The British Association of Plastic Surgeons; 2003 56: 764-774 Artificial Skin in Massive Burns – Results to Ten Years; R.L. Sheridan et al; European Journal of Plastic Surgery; 1994 17: 91-93 2

Burned Breast Reconstructive Surgery with Integra Dermal Regeneration Template; R. Palao, P. Gomez, P. Huguet; British Journal of Plastic Surgery; 2003 56: 252-259 Multicenter Postapproval Clinical Trial of Integra Dermal Regeneration Template for Burn Treatment; Daniel M. Heimbach, MD; Journal of Burn Care and Rehabilitation; Vol 24 No 1: 42-47 Integra in Lower Extremity Reconstruction after Burn Injury: Warren L. Garner, MD; Plastic and Reconstructive Surgery April 2008: 1256-1262 Longitudinal Assessment of Integra in Primary Burn Management: A Randomized Pediatric Clinical Trial: Ludwik K. Branski, MD et al; Critical Care Medicine 2007 Vol 35, No 11: 2615-2623

GENERAL RECONSTRUCTIVE SURGERY / SCAR CONTRACTURE Reconstructive Surgery with a Dermal Regeneration Template: Clinical and Histologic Study; Naiem S. Moiemen et al; Plastic & Reconstructive Surgery July 2001: 93-103 The Use of a Dermal Regeneration Template (Integra) for Acute Resurfacing and Reconstruction of Defects Created by Excision of Giant Hairy Nevi; B. Abai, MD, D. Thayer, DO, P. Glat, MD; Plastic and Reconstructive Surgery Vol 114 No 1: 162-168 Use of Dermal Regeneration Template in Contracture Release Procedures: a Multicenter Evaluation; James D. Frame; Plastic and Reconstructive Surgery Vol 113 No 5: 1330-1338

OTHER A Comparison of Polyglycolic Acid Versus Type 1 Collagen Bioabsorbable Nerve Conduits in a Rat Model: An Alternative to Autografting; Thomas E. Trumble, MD; The Journal of Hand Surgery December 2007: 1521-1529

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 [email protected]

*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)