Contractor Name 

National Government Services, Inc.

Contractor Number 

Contractor Type 

Carrier

FI

MAC-Part A

MAC-Part B

Article ID Number 

A46085

Article Type 

Article

Key Article 

Yes

Article Title 

Integra ® Dermal Regeneration Template, Integra ® Bilayer Matrix Wound Dressing – Related to LCD L26003

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2008 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association.© 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

Primary Geographic Jurisdiction 

Original Article Effective Date 

12/01/2007

Article Revision Effective Date 

01/01/2009

Article Text 

Dermal Regeneration Template is a two-layer membrane system for skin replacement. The collagen Glycosaminoglycan (GAG) thermal layer functions as a biodegradable template that induces organized regeneration of dermal tissue (neodermis) by the body. The silicone layer provides immediate wound homeostasis by controlling moisture flux from the dermis in a manner comparable to normal skin and imparts strength to the product.

The application of the product is typically completed in two operative sessions:

• During the first operative procedure, the product is applied to the recipient site that has been thoroughly excised and where meticulous hemostasis has been achieved;
• During the second procedure, performed 3 to 6 weeks after the placement of the product on the wound, the silicone layer is removed, and a thin (.0004 - .0007 inch) epidermal autograft is applied to the neodermis;

During the period between the two operative sessions, it is expected that the collagen/GAG matrix would be totally absorbed as it promotes the formation of neodermis (new dermis). Within thirty days of engraftment, complete epithelialization of epidermis is achieved, resulting in histologically and functionally normal skin.

Indications

Dermal Regeneration Template will be considered reasonable and necessary when the following conditions are satisfied and documented:

1. The treatment is for postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries; or
2. The treatment may be used for the repair of scar contractures secondary to third degree burns when other therapies have failed, or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient. These scars must be documented to be disabling by limiting elasticity and immobilizing the skin; and
3. Sufficient autograft is not available at the time of excision, or is not desirable due to the physiological condition of the patient; and
4. The substitute skin product must be applied on the same day as the initial excision of the recipient site; and

Each piece of this product is for a single use in a single patient only. The device is intended for one-time use.

Limitations

• Integra ® Dermal Regeneration Template
• The use of this product in patients with chemical, radiation, or electrical burns should be limited and based on thorough evaluation of the wound by the surgeon. The wound must be documented to be suitable to excisional therapy and that there is likelihood that a viable wound bed will be created by excision.
• The product is contraindicated for patients with clinically diagnosed infected wounds.
• Integra ® Bilayer Wound Dressing
• This product has been recognized by the FDA through the 501(k) pre-market notification process and not through pre-market approval. NGS has received no clinical data to support the use of this product and at this time will not extend coverage for this product as per the Local Coverage
  Determination, Biologic Products for Wound Treatment and Surgical Interventions (L26003).

For the repair of scar contractures, the claims require the primary diagnosis listed below plus one of the listed secondary diagnosis.

Primary Code:

Secondary Codes:

Documentation Requirements

1. The medical record must confirm and support the diagnoses of life threatening injuries or deep partial thickness thermal injuries. It must also be documented that a sufficient autograft was not available at the time of the excision, or was not desirable due to the physiological condition of the patient.
2. When repairing scars that result from severe burns, the medical record must document that the scars are disabling (eg., by limiting and immobilizing the skin).
3. In a patient where a re-application is required, the documentation must describe the nature of the wound and the reason why the initial excision of the wound did not result in a clean wound bed.
4. Medical record documentation must clearly document the extent of site preparation procedures billed and the medical necessity for these procedures.
5. Documentation must be available to Medicare upon request.

Utilization Guidelines

• In the vast majority of patients, only one application of skin substitute product would be required.
• These codes are not intended to be reported for simple graft application alone or application stabilized with dressings (eg, by simple gauze wrap). The skin substitute/graft is anchored using the surgeon's choice of fixation (CPT 2007). If it is not medically reasonable and necessary to anchor the Integra ® Dermal Regeneration Template, (for example, due to size, depth or location of the wound), then the application is included in the appropriate E&M code and should not be submitted with the application codes.

Coding Guidelines

1. Payable places of service: office (11), inpatient hospital (21), outpatient hospital (22), hospital emergency room (23), ambulatory surgical center (24) and independent clinic (49).

Coverage Topic 

Surgical Dressings
 

CPT/HCPCS Codes 

ICD-9 Codes that are Covered 

For the treatment of thermal injuries, one of the ICD-9-CM codes listed below must be reported:

Other Comments 

Although the effective date for revision 1 (R1) is 03/01/2008, HCPCS code J7343 is replaced HCPCS code J7345 for dates of service on or before 12/31/2007; HCPCS code J7345 is deleted for dates of service on or after 01/01/2008 and HCPCS codes J7347 is added for dates of service on or after 01/01/2008.

HCPCS Q4114 (INTEGRA FLOWABLE WOUND MATRIX, INJECTABLE, 1CC) is not covered.

Sources of Information and Basis for Decision

1. Burke JF, Yannas IV, Quinby WC Jr, Bondoc CC, Jung WK, Successful Use of a Physiologically Acceptable Artificial Skin in the Treatment of Extensive Burn Injury, Ann Surg., 1981, Oct;194(4):413-28.
2. Integra ® Dermal Regeneration Template, Prescribing Information, Plainsboro, NJ: Marketed by: Johnson & Johnson, Wound Management Worldwide, A Division of Ethicon, Inc. - Manufactured by: Integra LifeSciences Corporation, 2007.
3. Naiem S. Moiemen, F.R.C.S., Jonathan J. Staiano, F.R.C.S., Nkemcho O. Ojeh, M. Res., Yi Thway, F.R.C.Path, and James D. Frame, F.R.C.S., Reconstructive Surgery with a Dermal Regeneration Template: Clinical and Histologic Study, St. Andrew's Centre for Burns and Plastic Surgery, May 30, 2000. Presented at the 32nd Annual Meeting, American Burn Association, Las Vegas, Nevada, March 14-17, 2000.
4. Molnar, DeFranzo, Hadaegh, Morykwas, Shen and Argenta, Acceleration of Integra Incorporation in Complex Tissue Defects with Subatmospheric Pressure, Plastics & Reconstructive Surgery, 2003: Vol 113(5).
5. Colleen M. Ryan, MD, David A. Schoenfeld PhD, Maryanne Malloy, RN, John T. Schulz, III, MD, Phd, Robert L. Sheridan, MD, Ronald G. Tompkins, MD. ScD, Use of Integra ® Artificial skin Is Associated With Decreased Length of Stay for Severely Injured Adult Burn Survivors, Summer Redstone Center, Department of Medicine, Massachusettes General Hospital, Harvard Medical School, and Shriners Burns Hospitals for Children, Boston Burn Unit.
6. R. Stern MD, M. McPherson, PharmD, and M. T. Longaker, MD, Histologic Study of Artificial Skin Used in the Treatment of Full-Thickness Thermal Injury, University of California, San Francisco, California and Marion Laboratories, Inc., Kansas City, Missouri.
7. U.S. Food and Drug Administration Center:
• Drug Evaluation and Research, New Device Approval - Integra ® Dermal Regeneration Template, April 19, 2003, http://www.fda.gov/cdrh/mda/docs/p900033s008.html;
• FDA Label (http://www.fda.gov/cdrh/pdf/P900033S008c.pdf);
• FDA CDRH Consumer Information (www.fda.gov/cdrh/mda/docs/p900033s008.html);
• FDA Consumer Label (http://www.fda.gov/cdrh/pdf/p900033s008d.pdf);
• FDA Bilayer Matrix Wound Dressing 510(k) Summary (K021792) (http://www.fda.gov/cdrh/pdf2/k021792.pdf).
  
  08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this LCD as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.
  
  11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.
  
  11/09/2008 - CPT/HCPCS code J7347 was deleted from group 1

Revision History Explanation 

R4 (effective 01/01/2009) 2009 HCPCS Annual Update - CPT/HCPCS Code J7347 deleted. CPT/HCPCS Code Q4104, Q4105, Q4108 and Q4114 added. Section “Other Comments”: HCPCS Q4114 (INTEGRA FLOWABLE WOUND MATRIX, INJECTABLE, 1CC) is not covered. No additional comment or notice periods required and none given.

R3 (effective 10/01/2008)Correction:
Removal of CPT codes 15002, 15003, 15004, 15005, 15100, 15101, 15110, 15111, 15115, 15116, 15120 and 15121 from the CPT/HCPC code list and coding guidelines. These CPT/HCPCs codes do not apply to this article.

R2 (effective 07/18/2008)
This Article was revised to add the Jurisdiction 13 (J-13) MAC contractor numbers.

This revised Article is effective for all National Government Services jurisdictions on July 18, 2008 with these exceptions: for Connecticut – Part B the Article is effective on August 1, 2008; for Upstate New York – Part B, the Article is effective on September 1, 2008; and for New York and Connecticut – Part A, the Article is effective on November 14, 2008. For New York – Part A (contract 00308), the content of this article is currently in effect but the article will be transferred to the J-13 contract number 13201 on November 14, 2008.

R1 (effective 03/01/2008):

• Removed the second bullet in the Utilization Guidelines.
• Replaced HCPCS code J7343, in this article, with HCPCS code J7345 for dates of service on or before 12/31/2007.
• Deleted HCPCS code J7345 for dates of service on or after 01/01/2008.
• Added HCPCS code J7347 for dates of service on or after 01/01/2008.
  
  08/18/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00454 was removed from this article as the claims processing for American Samoa, California, Guam, Hawaii, Nevada and Northern Mariana Islands was transitioned to Palmetto GBA, the Part A/Part B MAC contractor in these states.
  
  11/14/2008 - In accordance with Section 911 of the Medicare Modernization Act of 2003, fiscal intermediary number 00308 is removed from this article. Effective on this date, claims processing for Delaware is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state, and the claims processing for New York and Connecticut is performed by National Government Services under the J-13 MAC contract; carrier number 00805 is removed, and claims processing for New Jersey is performed by Highmark Medicare Services, the Part A/Part B MAC contractor for this state.
  
  11/09/2008 - CPT/HCPCS code J7347 was deleted from group 1

Related Documents 

Article(s)
A45056 - Biologic Products for Wound Treatment and Surgical Interventions - Supplemental Instructions Article

LCD(s)
L26003 - Biologic Products for Wound Treatment and Surgical Interventions