Medicare Appeal Packet for Integra® Wound Matrix

Medicare Appeal Packet for

Integra

Wound Matrix

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.

Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the

reserved.

T – 1561033 – 1 (2020-04) 1564528

– 1 (2020-04)

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

ppeals

(

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 Integra

Wound Matrix 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.

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 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.

Integra and the Integra logo are registered trademarks of Integra LifeSciences Corporation in the

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

Integra

Wound Matrix. The attached Statement of Medical Necessity and

information pertaining to <<Patient’s Name>> clinical history and diagnosis clearly

demonstrate that Integra

Wound Matrix 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

Integra

Wound Matrix

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 FOR THIS WOUND:

______________________________________________________________________

PHYSICIAN NAME: (please print) _________________________________________

ADDRESS: ___________________________________________________________

PHYSICIAN SIGNATURE: ___________________________ DATE: _____________

Integra

Wound Matrix

Integra

Wound Matrix (Thin)

DESCRIPTION

Integra

Wound Matrix and Integra

Wound Matrix (Thin) are collagen-

glycosaminoglycan wound dressings that maintain and support a healing

environment for wound management. Integra Wound Matrix (Thin) has

50% less collagen compared to each of the corresponding sq cm sizes

of Integra Wound Matrix.

INDICATIONS

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,

diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds

(donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence),

trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining

wounds. The device is intended for one-time use.

CONTRAINDICATIONS

• This device should not be used in patients with known sensitivity to

bovine collagen or chondroitin materials.

• The device is not indicated for use in third degree burns.

PRECAUTIONS

• Do not resterilize. Discard all opened and unused portions of Integra

Wound Matrix and Integra Wound Matrix (Thin).

• Device is sterile if the package is unopened and undamaged.

Do not use if the package seal is broken.

•

Discard device if mishandling has caused possible damage

or contamination.

• Integra Wound Matrix and Integra Wound Matrix (Thin) should not

be applied until excessive exudate, bleeding, acute swelling

and infection are controlled.

• Debridement or excision must be done thoroughly to remove any remaining

necrotic tissue that may cause infection.

• The following complications are possible with the use of wound dressings.

If any of the conditions occur, the device should be removed: infection,

chronic inflammation (initial application of wound dressings may be

associated with transient, mild, localized inflammation), allergic reaction,

excessive redness, pain or swelling.

SINGLE USE DEVICE

Integra Wound Matrix and Integra Wound Matrix (Thin) is supplied in a single-use

package and is guaranteed to be sterile and non-pyrogenic unless opened or damaged.

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

and impair its ability to function as intended. All unused pieces must be discarded.

INSTRUCTIONS FOR USE

Application

1. Always handle Integra Wound Matrix and Integra Wound Matrix (Thin)

using aseptic technique.

2. Peel open the outer pouch and remove the inner foil pouch.

3. Place foil pouch flat on sterile surface and peel it open.

4. Remove product, including the protective polyethylene sheets.

5. Separate product from the polyethylene sheets by slowly and carefully peeling

back from one of the corner edges. Handle with care as product is fragile.

6. Place product into basin containing a sterile saline solution.

Rinse the product free of storage buffer by immersion in sterile saline

for 1-2 minutes.

7. Keep product in the basin until application.

8. Prepare wound bed using standard methods to ensure wound is free

of debris and necrotic tissue. If necessary, surgically debride the wound

to ensure the wound edges contain viable tissue.

9. Cut the device to size and apply immediately following wound bed preparation.

10. Smooth Integra Wound Matrix and Integra Wound Matrix (Thin)

into place to ensure the sheet is in contact with the underlying wound bed.

11. After application, use appropriate secondary dressings to maintain dressing

adherence and protect the wound area. The optimum secondary dressing is

determined by wound location, size, depth and user preference.

Post-Application

1. Change the secondary dressing as needed. Frequency of secondary dressing change will

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.

Note: If hematoma or excess exudate collect under the sheet,

small openings can be cut in the sheet to allow fluid to drain.

2. As healing occurs, sections of Integra Wound Matrix and Integra Wound Matrix (Thin)

may gradually peel and may be removed during dressing changes. Do not forcibly remove

sections of Integra Wound Matrix or Integra Wound Matrix (Thin) that may adhere to

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

Wound Matrix (Thin) over the wound.

HOW SUPPLIED

Integra Wound Matrix and Integra Wound Matrix (Thin) is supplied sterile, in single use,

double peel packages containing phosphate buffer. Integra Wound Matrix

and Integra Wound Matrix (Thin) are available in the following sizes:

Product Codes Size Quantity

52021 2 inch x 2 inch (5 cm x 5 cm) 1 unit/box

52021T (Thin) 2 inch x 2 inch (5 cm x 5 cm) 1 unit/box

52025 2 inch x 2 inch (5 cm x 5 cm) 5 units/box

52025T (Thin) 2 inch x 2 inch (5 cm x 5 cm) 5 units/box

54051 4 inch x 5 inch (10 cm x 12.5 cm) 1 unit/box

54051T (Thin) 4 inch x 5 inch (10 cm x 12.5 cm) 1 unit/box

54055T 4 inch x 5 inch (10 cm x 12.5 cm) 5 units/box

54055T (Thin) 4 inch x 5 inch (10 cm x 12.5 cm) 5 units/box

54101 4 inch x 10 inch (10 cm x 25 cm) 1 unit/box

54101T (thin) 4 inch x 10 inch (10 cm x 25 cm) 1 unit/box

54105 4 inch x 10 inch (10 cm x 25 cm) 5 units/box

54105T (Thin) 4 inch x 10 inch (10 cm x 25 cm) 5 units/box

58101 8 inch x 10 inch (20 cm x 25 cm) 1 unit/box

58101T (Thin) 8 inch x 10 inch (20 cm x 25 cm) 1 unit/box

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

STORAGE

Store flat at room temperature. Avoid excessive heat (greater than 40°C). Avoid freezing.

PRODUCT INFORMATION DISCLOSURE

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

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

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

IN CONNECTION WITH THESE PRODUCTS.

SYMBOLS USED ON LABELING

Made in the U.S.A.

Manufactured by:

Integra LifeSciences Corporation

311 Enterprise Drive, Plainsboro, NJ 08536

800-997-4868 USA

609-936-5400 outside USA

888-980-7742 fax

integralife.com

Integra and the Integra logo are registered trademarks of Integra LifeSciences

Corporation in the United States and/or other countries.

U.S. Patent No: 7,993,679 Additional Patents Pending

RMS No: 7200100000

+2ºC

+30ºC

Lot number

LOT

STERILE R

LATEX

Temperature limitation

Caution: Federal (USA) law

restricts this device to sale by

or on the order of a physician

or practitioner

STERILIZE

Manufacturer

This product does not contain

and is not manufactured with

Dry Natural Rubber or

Natural Rubber Latex

Do not re-sterilize

REF

Catalog number

Do not use if package

is damaged

Do not re-use

Consult Instructions for Use

Sterilized using irradiation

Expiration date

02-w

Integra Lifesciences Corporation

AVAGEN Wound Dressing

510(K)

SUMMARY

Submitter's name and address:

Integra Lifesciences Corporation

3 11 Enterprise Drive

Plainsboro, NJ 08536 USA

Contact person and telephone number:

Diana M. Bordon

Manager, Regulatory Affairs,

(609) 275-0500

Date:

June 28,2002

Name

the device:

Proprietary Name: AVAGEN Wound Dressing

Common Name: Wound Dressing

Classification Name: Unclassified, (79KMF)

AVAGEN Wound Dressing is substantially equivalent in function and intended use to the

following products which have been cleared to market under Premarket Notifications

lO(k):

OasisTM

SIS

Wound Dressing

(K993948) and FortadennTM Wound Dressing

(KO 14 129).

AVAGEN Wound Dressing is indicated for the management

wounds including: partial

and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular

ulcers, tunneledundermined wounds, surgical wounds (donor sitedgrafts, post-Moh's

surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions,

lacerations, second-degree bums, and skin tears) and draining wounds. The device is

intended for one-time use.

AVAGEN Wound Dressing is an advanced wound dressing comprised of a porous matrix

of cross-linked bovine tendon collagen and glycosaminoglycan. The biodegradable matrix

provides a scaffold for cellular invasion and capillary growth.

Biocompatibility studies have demonstrated AVAGEN Wound Dressing to be non-

cytotoxic, non-pyrogenic, non-irritating, non-sensitizing, non-hemolytic and non-toxic.

Valid scientific evidence through biocompatibility and physical property testing provide

reasonable assurance that AVAGEN Wound Dressing is safe and effective under the

proposed conditions of use, and is, with respect to intended use and technological

characteristics, substantially equivalent to the predicate devices.

Substantial Equivalence:

Intended Use:

Device Description:

Tests and Test Results

Conclusion

AOOOl

DEPARTMENT

HEALTH

HUMAN SERVICES

Puhlic

Health

Servicc

-~~_____

Food and

Drug

Administration

9200

Corporate Boulevard

Rockville

20850

Judith

O'Grady

Sknior Vice President, Regulatory Affairs

Integra Lifesciences Corporation

Enterprise Drive

Plainsboro, New Jersey

08536

Re: KO22127

Trade/Device Name: AVAGEN Wound Dressing

Regulatory Class: Unclassified

Product Code: KGN

Dated: June 28, 2002

Received: July

2002

Dear

Ms.

O'Grady:

We have reviewed your Section

O(k) premarket notification of intent to market the device

referenced above and have determined the device is substantially equivalent (for the indications for

use stated in the enclosure) to legally marketed predicate devices marketed in interstate coinniercc

prior to May 28,

1976,

the enactment date

the Medical Device Amendments, or to devices 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

the Act. The general

controls provisions of the Act include requirements for annual registration, listing of devices. good

manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

your device

classified (see above) into either class

(Special Controls) or class

I11

(PMA), it

may be subject to such additional controls. Existing major regulations affecting your device can be

found

in the Code

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA niaq publish

further announcenients concerning your device in the Federal Register.

Please be advised that

FDA's

issuance

a substantial equivalence determination does not mean

that FDA has made a determination that your device complies with other requirements of the Act

any Federal statutes and regulations administered by other Federal agencies. You must comply with

all the Act*s requirements, including, but not limited to: registration and listing

CFR

Part 807);

labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality

systems

(QS)

regulation (2

CFR Part

820);

and if applicable, the electronic product radiation

control

provisions (Sections

1-542

the

Act);

CFIi

1000-1050.

Page

Ms. Judith

O'Grady

This letter will allow you to begin marketing your device

described in your Section

O(k)

premarket notification. The FDA finding

substantial equivalence of your device to a legally

marketed predicate device results in a classification for your device and thus, permits your device to

proceed to the market.

you desire specific advice for your device

our labeling regulation (21 CFR Part 801 and

additionally

CFR Part 809.10 for

vitro diagnostic devices), please contact the Office

Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising

your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the

regulation entitled, "Misbranding by reference to premarket notification"

CFR

Part 807.97).

Other general information on your responsibilities under the Act may be obtained from the Division

Small Manufacturers, International and Consumer Assistance at its toll-free number

(800) 638-2041 or (301) 443-6597 or at its Internet address

http://www.

fda.gov/cdrh/dsma/dsmamain.

html

Director

Division of General, Restorative

and Neurological Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

Integra

LlfeSciences

Corporation

10(k)

Premarket

Notification

AVAGEN

Wound

Dressing

fide

INDICATIONS

FOR

USE

Page

O(k)

Number:

Device Name:

AVAGEN

Wound Dressing

Indications

for

Use:

AVAGEN Wound Dressing

indicated for the management

wollnds including: partial and

full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers,

tunneledundermined wounds, surgical wounds (donor sitedgrafts, post-Moh’s surgery, post-laser

surgery,

podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, skin

tears) and draining wounds. The device is intended for one-time use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE

NEEDED)

Concurrence

CDRH, Office

Device Evaluation

(ODE)

Prcscription

Use

er-thc-Counter

Use

(Per 21

CFR

801.109)

tional

Fomiat

1-2-96)

Division

General,

Restorative:

and

Neurological

Devices

1



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

2



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

3



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

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