Cellular wound dressings promote the healing of burns and chronic wounds by decreasing the risk of infection, protecting against fluid loss, reducing the need for skin grafts and promoting the healing process. The following bio-engineered skin substitutes are eligible for reimbursement based on the following guidelines:
Apligraf (Graftskin)
Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency (454.0, 459.31) of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
Apligraf is also indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers (707.14-707.15) of greater than three weeks duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
Apligraf used for all other indications is considered experimental/investigational. Participating, preferred, and network providers can bill the member for the denied services.
Apligraf is contraindicated in the following conditions:
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in clinically infected wounds;
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in patients with known allergies to bovine collagen; and,
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in patients with a known hypersensitivity to the components of the Apligraf agarose shipping medium.
Determination of eligibility will be made based on the following criteria:
Prior to the use of this product, the patient's medical record should demonstrate that conventional therapy, e.g., wet/dry dressings, compression dressings, Unna boots, control of edema, etc., has been utilized for at least 1 month for venous stasis ulcers and 3 weeks for diabetic foot ulcers without significant improvement.
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Diabetic patients should be receiving adequate medical care for the management of this systemic disease.
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If the patient is a smoker, there should be evidence that efforts were made to decrease cigarette consumption.
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The patient should have demonstrated compliance with wound care.
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The ulcer bed should be free of infection.
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The affected extremity should be free of active Charcot's arthropathy.
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There should be documentation of adequate blood supply and absence of significant arterial disease, e.g., an ankle/brachial index greater than or equal to 0.65, palpable dorsalis pedis or posterior tibial pulse.
Services for eligible conditions, provided to patients who fail to meet the criteria listed above will be denied as not medically necessary. Participating, preferred, or network providers cannot bill for these denied services.
Reapplication may be approved eight weeks after the initial application. Ulcers that show good wound healing do not require re-application.
Apligraf should be reported with procedure code J7340.
Date Last Reviewed - 10/2004
Dermagraft
Dermagraft is FDA approved for the treatment of full-thickness diabetic foot ulcers (707.14-707.15) greater than six weeks duration which extend through the dermis, but without tendon, muscle, joint capsule or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients who have adequate blood supply to the involved foot.
Dermagraft is contraindicated in the following conditions:
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in ulcers that have signs of clinical infection;
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in ulcers that have sinus tracts; and,
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in patients with known allergies to bovine collagen.
Determination of eligibility will be made based on the following criteria:
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Prior to the use of this product, the patient's medical record should demonstrate that conventional therapy, e.g., wet/dry dressings, compression dressings, debridement, pressure-reducing footwear, control of edema, etc., has been utilized for at least six weeks.
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Diabetic patients should be receiving adequate medical care for the management of their systemic disease.
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If the patient is a smoker, there should be evidence that efforts were made to decrease cigarette consumption.
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The patient should have demonstrated compliance with wound care.
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The ulcer bed should be free of debris and infection and comprised of healthy vascularized tissue.
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The affected extremity should be free of active Charcot's arthropathy.
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There should be documentation of adequate blood supply and absence of significant arterial disease in the affected extremity, e.g., an ankle/brachial index greater than or equal to 0.7, palpable dorsalis pedis or posterior tibial pulse.
Dermagraft should be reported with code J7342.
Date Last Reviewed - 10/2004
TransCyte (formerly Dermagraft TC)
TransCyte is FDA approved as a temporary dressing for full and partial thickness burns (941.20 - 941.39, 942.20 - 942.39, 943.20-943.39, 944.20-944.38, 945.20-945.39, 946.2-946.3, 948.00-948.99 and 949.2-949.3).
TransCyte should be reported with code J7342.
Date Last Reviewed - 10/2004
OrCel
OrCel is indicated in the treatment of fresh, clean split thickness donor site wounds in burn patients. It also has FDA approval as a Humanitarian Use Device (HUD) for the treatment of epidermolysis bullosa, 757.39.
OrCel is contraindicated for use:
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on clinically infected wounds;
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in patients with known allergies to bovine collagen.; and,
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in patients who are allergic to penicillin, streptomycin, gentamicin or fungizone (amphotericin B).
OrCel should be reported with code J7340.
Date Last Reviewed - 10/2004
All Products
Biological dressings should be utilized based on the conditions for which they have received FDA approval. Biological dressings applied for conditions for which they are not FDA approved are considered investigational for these conditions. Participating, preferred and network providers can bill the member for services that are not FDA approved.
When bio-engineered tissue is used for FDA approved conditions in wounds that do not meet the medical necessity criteria outlined in this policy or when the condition is contraindicated, the service is considered not medically appropriate. Participating, preferred and network providers cannot bill the member for services that are not medically necessary.
Codes 15342 and 15343 should be used to report the application of these bio-engineered tissues.
Date Last Reviewed - 10/2004
Coverage for the tissue itself is based on individual and group member benefits for prosthetics.
For information on Procuren, see MPB Z-24.
For information on topical HBO, see MPB Z-3.
Description
Bioengineered skin substitutes have been developed to replace autografts, allograft and xenograft in the treatment of extensive burn injuries and hard-to-heal, chronic wounds associated with non-burn etiologies such as venous ulcers and diabetic foot ulcers. The goal of skin substitute therapy is to provide a temporary biologic dressing that encourages skin tissue regeneration and wound healing through its own natural contingent of growth factors and proteins. It delivers new cells to the wound, which are able to adjust to the microenvironment of the wound and stimulate healing.
Apligraf
Apligraf (Graftskin) is composed of two layers, an epidermis-like layer composed of living human keratinocytes and a dermis-like layer composed of fibroblasts. The outer layer keeps the wound moist while protecting it from infection. The fibroblasts found in the inner layer seed the wound bed with the cellular components necessary for wound healing.
Stimulation of cell growth appears to continue after the bio-engineered tissue is no longer evident in the wound. This re-epithelialization appears to continue for several weeks following the application of the tissue even if no primary take is apparent.
Dermagraft
Dermagraft is a dermal substitute composed of human fibroblasts (living human cells) seeded onto a bioabsorbable polyglactin mesh scaffold. The fibroblasts secrete collagen, proteins, growth factors and cytokines necessary for wound healing.
TransCyte
TransCyte is a frozen cellular wound dressing made of living human cells which die during cryopreservation. The human cells are grown on a nylon mesh. TransCyte is used as a temporary wound covering for burns until autografting is possible. Some burns treated with TransCyte heal without the autograft.
OrCel
OrCel is a bilayered, allogeneic product consisting of both a dermis composed of cultured fibroblasts and an epidermis comprised of cultured keratinocytes. OrCel may also contain trace amounts of penicillin, streptomycin, gentamicin or fungizone (amphotericin B.)
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