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DESCRIPTIONThe 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 OrCellTM, 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.
POLICYApligraf®, and other skin substitutes, are considered medically necessary for:
The use of skin substitutes is investigational for the following:
POLICY GUIDELINESInvestigative 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 HISTORY5/2001: 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 5th 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 REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.