I'm a provider

You will be redirected to myBlue. Would you like to continue?

be RxSmart

Medical & Coding Policies

Provider Network Application

Out-of-State & Non-Network

Provider Links

Healthy You! Provider Information »

E-solutions & Online Tools »

Provider Forms »

Articles & Updates »

National Provider Identifier »

Good Health Club for Kids »

Medical Policy Search

Printer Friendly Version Apligraf for Wound Healing

Apligraf for Wound Healing

DESCRIPTION

The field of wound healing has seen some recent advances, including the development of tissue-engineered, composite skin substitutes. Skin wounds can be caused by a variety of different events, such as thermal burns, venous stasis, ischemia, pressure, trauma, surgery, underlying skin disorders or burn injuries. Chronic wounds including venous ulcers, diabetic foot ulcers and pressure sores, are a major public health problem.

The goals of treating non-healing acute and chronic wounds with tissue-engineered human skin substitutes are to provide temporary wound coverage, provide complete wound closure, reduce healing time, reduce pain, reduce postoperative contracture, improve aesthetics and functional abilities, obviate the need for more extensive treatments such as skin grafting or amputation, and improve overall quality of life.

Skin substitutes are tissue-engineered products using living cells, such as fibroblasts and keratinocytes, in a scaffold of natural or synthetic extracellular matrices. Tissue-engineered skin substitutes can be broadly categorized into epidermal components alone, mainly dermal components, or composite grafts (containing both epidermal dermal components).

Dermal skin substitutes help prevent wound contraction and offer greater mechanical stability. Examples include allogeneic skin, bovine collagen, Biobrane®/Biobrane-L®, AlloDerm® and Dermagraft®. Dermagraft®, a cryopreserved dermal substitute composed of fibroblasts, received FDA approval September 28, 2001 and is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six (6) weeks' duration and extends through the dermis. Dermagraft® should be used in conjunction with standard wound care regimens in patients with type 1 or type 2 diabetes mellitus who have full-thickness, neuropathic diabetic ulcers of the plantar surface foot of greater than three (3) weeks' duration and in patients that have adequate blood supply to the involved foot.

Combined dermal and epidermal skin substitutes include OrCell^TM, TranCyte®/Dermagraft-TC®, and Apligraf® is an allogeneic, bilayered skin substitute containing both dermal and epidermal components.

The epidermal layer is composed of live, differentiating keratinocytes and a well differentiated stratum corneum, while the dermal layer consists of living fibroblasts. Apligraf® received approval by the Food and Drug Administration (FDA) for use with therapeutic compression in the treatment of noninfected partial and full-thickness skin ulcers due to venous insufficiency of greater than one (1) month duration that are refractory to conventional ulcer therapy. Apligraf® combined with standard wound care can improve healing in patients with chronic venous and diabetic foot ulcers.

Skin substitutes can also be broadly categorized as temporary wound cover or permanent wound closure. Biobrane® and TransCyte® are considered to be temporary skin replacement products while Integra®, AlloDerm®, Apligraf®, and Dermagraft® are considered to be permanent products.

POLICY

Apligraf®, and other skin substitutes, are considered medically necessary for:

For use in conjunction with standard therapy in patient with noninfected venous leg ulcers of more than 1 month duration that have not responded to standard compression therapy.
No specific contraindication to the use of skin substitutes
For use in conjunction with standard therapy in patient with type 1 or type 2 diabetes mellitus who have full thickness, neuropathic diabetic foot ulcers of > 3 weeks duration that have not adequately responded to standard therapy
Absence of tendon, muscle, capsule or bone exposure

The use of skin substitutes is investigational for the following:

In patients with evidence of arterial occlusive disease
Infection in ulcer(s) targeted for treatment
Exudates consistent with heavy bacterial contamination
Eschar or necrotic tissue that would interfere with graft take and healing
Active Charcot's disease
Hypersensitivity or allergy to any components of the skin substitute product or packing medium

POLICY EXCEPTIONS

None

POLICY GUIDELINES

Investigative service is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized by certifying boards and/or approving or licensing agencies or published peer review criteria as standard, effective medical practice for the treatment of the condition being treated and as such therefore is not considered medically necessary.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

POLICY HISTORY

5/2001: Approved by Medical Policy Advisory Committee (MPAC)

4/10/2002: Code Reference section updated, HCPCS J7340 added

4/18/2002: Type of Service and Place of Service deleted

5/30/2002: Code Reference section updated, ICD-9 280.82, 459.81, 459.89, 707.0, 707.10, 707.11, 707.12, 707.13, 707.14, 707.15, 707.19, 707.8, 707.9, 891.0, 891.1, 891.2, 892.0, 892.1, 892.2, 893.0, 893.1, 893.2, 894.0, 894.1, 894.2 added

8/1/2003: ICD-9 diagnosis code 433.9 typo corrected, ICD-9 diagnosis code ranges 443.0-443.9, 707.0-707.9, 891.0-894.2 listed separately

2/12/2004: Code Reference section updated; ICD-9 diagnosis code 443.0, 443.1, 443.21, 443.22, 443.23, 443.24, 443.29, 443.81, 443.89, 443.9 deleted; HCPCS C1305, Q0185 deleted

3/22/2005: Code Reference section updated, ICD-9 diagnosis code 707.0 5^th digit with effective date of 10/1/2004 added, HCPCS J7343 with effective date of 1/1/2005 added

8/1/2005: Code Reference section updated, CPT 15342, 15343 added, ICD-9 diagnosis code 250.80, 250.81 with note "use additional code to identify any associated ulceration (i.e., 707.10-707.9)" added, ICD-9 diagnosis 707.10-707.9 description revised, ICD-9 diagnosis code 891.0, 891.1, 891.2, 892.0, 892.1, 892.2, 893.0, 893.1, 893.2, 894.0, 894.1, 894.2 deleted

03/08/2006: Coding updated. CPT/HCPCS 2006 revisions added to policy

11/16/2006: Policy updated. Updates approved by Medical Policy Advisory Committee (MPAC). Added ICD-9 code 756.81

12/27/2006: Code Reference section updated per the 2007 CPT/HCPCS revisions

5/14/07: Policy reviewed, no changes

12/17/07: Coding updated. CPT/HCPCS 2008 revisions added to policy.

9/3/2008: Added ICD-9 codes 250.60 - 250.63

9/22/2008: Annual ICD-9 updates effective 10-1-2008 applied

12/24/2008: Code reference section updated per 2009 CPT/HCPCS revisions

6/30/2009: New HCPC codes Q4115 and Q4116 added to covered table.

03/09/2011: Removed the following deleted codes from the Code Reference section: 15342, 15343, J7340, J7343, J7345 - J7349.

04/24/2013: Policy reviewed; no changes.

SOURCE(S)

Hayes Medical Technology Directory

Blue Cross Blue Shield Association policy # 7.01.113

CODE REFERENCE

This is not intended to be a comprehensive list of codes. Some covered procedure codes have multiple descriptions.
The code(s) listed below are ONLY covered if the procedure is performed according to the "Policy" section of this document.

Covered Codes

Code Number	Description
CPT-4
15170	Acellular dermal replacement, trunk, arms, legs; first 100 sq cm or less, or one percent of body area of infants and children (new 1-1-2006)
15171	Acellular dermal replacement, trunk, arms, legs; each additional 100 sq cm or each additional one percent of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) (new 1-1-2006)
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 one percent of body area of infants and children (new 1-1-2006)
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 one percent of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) (new 1-1-2006)
15340	Tissue cultured allogeneic skin substitute; first 25 sq cm or less (new 1-1-2006)
15341	Tissue cultured allogeneic skin substitute; each additional 25 sq cm, or part thereof (List separately in addition to code for primary procedure) (new 1-1-2006) (description revised 1-1-2009)
15360	Tissue cultured allogeneic dermal substitute; trunk, arms, legs; first 100 sq cm or less or one percent of body area of infants and children (new 1-1-2006)
15361	Tissue cultured allogeneic dermal substitute; trunk, arms, legs; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof (List separately in additiona to code for primary procedure) (new 1-1-2006)
15365	Tissue cultured allogeneic dermal substitute; face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digit; first 100 sq cm or less, or one percent of body area of infants and children (new 1-1-2006)
15366	Tissue cultured allogeneic dermal substitute; face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digit; each additional 100 sq cm, or each additional one percent of body area of infants and children, or part thereof (List separately in addition to the code for primary procedure) Use 15366 in conjunction with 15365 (new 1-1-2006) (revised 1-1-2007)
ICD-9 Procedure

ICD-9 Diagnosis
250.60, 250.61, 250.62, 250.63	Diabetes with neurological manifestations code range (added 9-3-2008)
250.80, 250.81, 250.82	Type II (non-insulin dependent type) or unspecified type diabetes mellitus with other specified manifestations, uncontrolled (added 5-30-2002) (250.80, 250.81 added 8-1-2005) Note: Use additional code to identify any associated ulceration (i.e., 707.10-707.9) (added 8-1-2005)
454.0	Varicose veins of lower extremities with ulcer (added 2-12-2004)
459.81	Unspecified venous (peripheral) insufficiency (added 5-30-2002)
459.89	Other venous peripheral insufficiency (added 5-30-2002)
707.00, 707.01, 707.02, 707.03, 707.04, 707.05, 707.06, 707.07, 707.09	Pressure ulcer code range (added 5-30-2002) (5^th digit with effective date 10-1-2004 added 3-22-2005) (description revised 10-1-2008)
707.10, 707.11, 707.12, 707.13, 707.14, 707.15, 707.19, 707.8, 707.9	Ulcer of lower limb, except decubitus code range (added 5-30-2002) (description revised 8-1-2005)
707.20, 707.21, 707.22, 707.23, 707.24, 707.25	Pressure ulcer stages (new 10-1-2008)
756.81	Congenital absence of muscle and tendon (added 11-16-2006)
HCPCS
Q4100	Skin substitute, not otherwise specified (new 1-1-2009)
Q4101	Skin substitute, apligraf, per square centimeters (new 1-1-2009)
Q4102	Skin substitute, oasis wound matrix, per square centimeter (new 1-1-2009)
Q4103	Skin substitute, oasis burn matrix, per sq cm (new 1-1-2009)
Q4104	Skin substitute, integra bilayer matrix wound dressing burn matrix, (BMWD) per sq cm (new 1-1-2009)
Q4105	Skin substitute, integra regeneration template (DRT) per sq cm (new 1-1-2009)
Q4106	Skin substitute, dermagraft, per square centimeter (new 1-1-2009)
Q4107	Skin substitute, graftjacket, per square centimeter (new 1-1-2009)
Q4108	Skin substitute, integra matrix, per square centimeter (new 1-1-2009)
Q4109	Skin substitute, tissuemend, per square centimeter (new 1-1-2009)
Q4110	Skin substitute, primatrix, per square centimeter (new 1-1-2009)
Q4111	Skin substitute, gammagraft, per square centimeter (new 1-1-2009)
Q4115	Skin substitute, Alloskin, per square centimeter (new code 7-1-2009)
Q4116	Skin substitute, Alloderm, per square centimeter (new code 7-1-2009)

Top