ARCHIVED Integra ® Dermal Regeneration Template, Integra ® Bilayer Matrix Wound Dressing – Related to LCD L26003 (A46085)

Contractor Information

Contractor Name 

National Government Services, Inc. 

Contractor Number 

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00454	FI	AS, CA, CNMI, GU, HI, NV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Contractor Type 

MAC - Part A 

Article Information

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 2007 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 

Number	Type	State(s)
00130	FI	IN
00131	FI	IL
00160	FI	KY
00180	FI	ME
00181	FI	MA
00270	FI	NH, VT
00308	FI	CT, DE, NY
00332	FI	OH
00450	FI	WI
00452	FI	MI
00453	FI	VA, WV
00454	FI	AS, CA, CNMI, GU, HI, NV
00630	Carrier	IN
00660	Carrier	KY
00805	Carrier	NJ
13101	MAC	CT – Part A
13102	MAC	CT – Part B
13201	MAC	NY – Part A
13202	MAC	NY – Part B
13282	MAC	NY- Part B
13292	MAC	NY – Part B

Original Article Effective Date 

12/01/2007

Article Revision Effective Date 

07/18/2008

Revision Ending Date

09/30/2008

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:

709.2

Scar conditions and fibrosis of skin

Secondary Codes:

906.5	Late effect of burn of eye face head and neck
906.6	Late effect of burn of wrist and hand
906.7	Late effect of burn of other extremities
906.8	Late effect of burns of other specified sites
906.9	Late effect of burn of unspecified site

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. CPT codes 15002-15005 must be used to report the initial complete excision preparation of the recipient site. CPT code 15003 can be reported in combination with 15002. CPT code 15005 can be reported in combination with 15004.
2. During the second surgical encounter, the silicone layer is removed, a donor site is harvested and a thin epidermal autograft is then placed on the newly formed dermal tissue. These services must be reported using CPT codes 15110, 15111, 15115 and 15116 for the harvesting and placement of the autograft.
3. 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

Coding Information

CPT/HCPCS Codes 

HCPCS code J7343 was replaced in this article with HCPCS code J7345 for dates of service on or before 12/31/2007.
HCPCS code J7345 was deleted for dates of service on or after 01/01/2008.
HCPCS code J7347 is effective 01/01/2008.

15002	SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, TRUNK, ARMS, LEGS; FIRST 100 SQ CM OR 1% OF BODY AREA OF INFANTS AND CHILDREN
15003	SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, TRUNK, ARMS, LEGS; EACH ADDITIONAL 100 SQ CM OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
15004	SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET AND/OR MULTIPLE DIGITS; FIRST 100 SQ CM OR 1% OF BODY AREA OF INFANTS AND CHILDREN
15005	SURGICAL PREPARATION OR CREATION OF RECIPIENT SITE BY EXCISION OF OPEN WOUNDS, BURN ESCHAR, OR SCAR (INCLUDING SUBCUTANEOUS TISSUES), OR INCISIONAL RELEASE OF SCAR CONTRACTURE, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET AND/OR MULTIPLE DIGITS; EACH ADDITIONAL 100 SQ CM OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
15100	SPLIT-THICKNESS AUTOGRAFT, TRUNK, ARMS, LEGS; FIRST 100 SQ CM OR LESS, OR 1% OF BODY AREA OF INFANTS AND CHILDREN (EXCEPT 15050)
15101	SPLIT-THICKNESS AUTOGRAFT, TRUNK, ARMS, LEGS; EACH ADDITIONAL 100 SQ CM, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
15110	EPIDERMAL AUTOGRAFT, TRUNK, ARMS, LEGS; FIRST 100 SQ CM OR LESS, OR 1% OF BODY AREA OF INFANTS AND CHILDREN
15111	EPIDERMAL AUTOGRAFT, TRUNK, ARMS, LEGS; EACH ADDITIONAL 100 SQ CM, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
15115	EPIDERMAL AUTOGRAFT, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS; FIRST 100 SQ CM OR LESS, OR 1% OF BODY AREA OF INFANTS AND CHILDREN
15116	EPIDERMAL AUTOGRAFT, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS; EACH ADDITIONAL 100 SQ CM, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
15120	SPLIT-THICKNESS AUTOGRAFT, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS; FIRST 100 SQ CM OR LESS, OR 1% OF BODY AREA OF INFANTS AND CHILDREN (EXCEPT 15050)
15121	SPLIT-THICKNESS AUTOGRAFT, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS; EACH ADDITIONAL 100 SQ CM, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
15170	ACELLULAR DERMAL REPLACEMENT, TRUNK, ARMS, LEGS; FIRST 100 SQ CM OR LESS, OR 1% OF BODY AREA OF INFANTS AND CHILDREN
15171	ACELLULAR DERMAL REPLACEMENT, TRUNK, ARMS, LEGS; EACH ADDITIONAL 100 SQ CM, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
15175	ACELLULAR DERMAL REPLACEMENT, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS; FIRST 100 SQ CM OR LESS, OR 1% OF BODY AREA OF INFANTS AND CHILDREN
15176	ACELLULAR DERMAL REPLACEMENT, FACE, SCALP, EYELIDS, MOUTH, NECK, EARS, ORBITS, GENITALIA, HANDS, FEET, AND/OR MULTIPLE DIGITS; EACH ADDITIONAL 100 SQ CM, OR EACH ADDITIONAL 1% OF BODY AREA OF INFANTS AND CHILDREN, OR PART THEREOF (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)
J7347	DERMAL (SUBSTITUTE) TISSUE OF NONHUMAN ORIGIN, WITH OR WITHOUT OTHER BIOENGINEERED OR PROCESSED ELEMENTS, WITHOUT METABOLICALLY ACTIVE ELEMENTS (INTEGRA MATRIX), PER SQUARE CENTIMETER

ICD-9 Codes that are Covered 

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

941.30 - 941.39	FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF UNSPECIFIED SITE OF FACE AND HEAD - FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF MULTIPLE SITES (EXCEPT WITH EYE) OF FACE HEAD AND NECK
941.40 - 941.49	DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF UNSPECIFIED SITE OF FACE AND HEAD WITHOUT LOSS OF BODY PART - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF MULTIPLE SITES (EXCEPT WITH EYE) OF FACE HEAD AND NECK WITHOUT LOSS OF A BODY PART
942.30 - 942.39	FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF UNSPECIFIED SITE OF TRUNK - FULL-THICKNESS SKIN LOSS DUE TO BURN (THIRD DEGREE NOS) OF OTHER AND MULTIPLE SITES OF TRUNK
942.40 - 942.49	DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF TRUNK UNSPECIFIED SITE WITHOUT LOSS OF BODY PART - DEEP NECROSIS OF UNDERLYING TISSUES DUE TO BURN (DEEP THIRD DEGREE) OF OTHER AND MULTIPLE SITES OF TRUNK WITHOUT LOSS OF BODY PART