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Skin Substitutes for Wound Care AHM

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Skin Substitutes for Wound Care AHM Skin Substitutes for Wound Care AHM Clinical Indications • Any 1 or more of the following products for wound care are considered medically necessary if the individual criteria are met • Apligraf (graftskin) aculture-derived human skin equivalent (HSE) is considered medically necessary for 1 or more of the following indications: . For use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers of greater than three-weeks duration that have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure . In conjunction with standard therapy to promote effective wound healing of chronic, non-infected, partial and full-thickness venous stasis ulcers that have failed conservative measures of greater than one-month duration using regular dressing changes and standard therapeutic compression • Dermagraft, a human fibroblast-derived dermal substitute, is considered medically necessary for any 1 or more of the following [A] [B] . Treatment of full-thickness diabetic foot ulcers greater than six-week duration that extend through the dermis, but without tendon, muscle, joint capsule or bone exposure . Treatment of wounds related to dystrophic epidermolysis bullosa • Systemic Hyperbaric Oxygen Therapy (HBOT ) - Refer to the Hyperbaric Oxygen Therapy Guideline. • TransCyte, made up of allogeneic human dermal fibroblasts, a biosynthetic dressing, is considered medically necessary for any 1 or more of the following . Temporary wound covering for surgically excised full-thickness and deep partial- thickness thermal burn wounds in persons who require such a covering before autograft placement . Treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting • Orcel, a bilayered cellular matrix, is considered medically necessary for any 1 or more of the following . Healing donor site wounds in burn victims AC-AESKI082011 Page 1 of 105 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines . Dystrophic epidermolysis bullosa undergoing hand reconstruction surgery to close and heal wounds created by the surgery, including those at donor sites. • Biobrane biosynthetic dressing is considered medically necessary for temporary covering of a superficial partial-thickness burn wound. • Integra Dermal Regeneration Template, Integra Bilayer Matrix Wound Dressing, and Integra Meshed Bilayer Wound Matrix (collagen- glycosaminoglycan copolymers) is considered medically necessary for the treatment of individuals with severe burns where there is a limited amount of their own skin to use for autografts or they are too ill to have more wound sites created. • Alloderm, acellular dermal tissue matrix, is considered medically necessary for breast reconstructive surgery • Artiss fibrin sealant is considered medically necessary for the treatment of individuals with severe burns • Oasis Wound Matrix is considered medically necessary for treatment of difficult-to- heal chronic venous or diabetic partial and full-thickness ulcers of the lower extremity that have failed standard wound therapy of at least 4-weeks duration. • Graftjacket Regenerative Tissue Matrix is considered medically necessary for treatment of full-thickness diabetic foot ulcers greater than 3-week duration that extend through the dermis, but without tendon, muscle, joint capsule or bone exposure. • Epicel cultured epidermal autograft is considered medically necessary for members who have deep dermal or full thickness burns comprising a total body surface area of greater than or equal to 30%. Note: Epicel may be used in conjunction with split-thickness autografts, or alone in persons for whom split-thickness autografts may not be an option due to the severity and extent of their burns. • Current role remains uncertain. Based on review of existing evidence, there are currently no clinical indications for this technology. See Inappropriate Uses for more detailed analysis of the evidence base. The following substitutes are considered investigational because there is inadequate evidence in the peer reviewed medical literature to support their clinical effectiveness Examples include • Allopatch for soft tissue augmentation and all other indications • Alloskin • Alloskin RT • AlloSource cryopreserved human cadaver skin • AmnioCare • AmnioExCel • AmnioFix • Amniomatrix AC-AESKI082011 Page 2 of 105 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines • AmnioMTM • AmnioShield • Amniotic fluid injection for corneal wound healing and for prevention of adhesions after orthopedic surgery • Amniox (human embryonic membrane) for tarsel tunnel repair and all other indications • Artelon (poly[urethane urea] elastomer) for anterior cruciate ligament reconstruction, rotator cuff repair, trapezio-metacarpal joint osteoarthritis and all other indications • Arthres GraftRope for acromio-clavicular joint separation reconstruction • Arthroflex (FlexGraft) • Autologous blood-derived products (e.g., autologous platelet-rich plasma, autologous platelet gel, and autologous platelet-derived growth factors (e.g., Autologel, Procuren, and SafeBlood)) • Autologous fat for the treatment of scars • Axogen 2 nerve wrap • Avotermin for improvement of skin scarring • BioDfactor/BioDfence human amniotic allograft • Biostat Biologx fibrin sealant for wound healing and all other indications; • Biotape reinforcement matrix for soft tissue augmentation and all other indications • CellerateRX • CollaFix • Conexa reconstructive tissue matrix • CorMatrix Patch for cardiac tissue repair and all other indications • C-QUR biosynthetic mesh • CRXa • Cymetra injectable allograft for wound healing • Dermacell • DermaClose RC continuous external tissue expander for facilitation of wound closure and all other indications • Dermagraft for chronic foot ulcer secondary to necrotizing fasciitis • DermaMatrix for wound healing and other indications other than breast reconstruction • DermaSpan • DryFlex (human amnion allograft) for shoulder repair and all other indications • DuraGen Plus dural regeneration matrix for surgical repair of soft tissue deficiencies and all other indications • DuraSeal • Durepair Regeneration Matrix • Endoform AC-AESKI082011 Page 3 of 105 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines • ENDURAGen • Epidex • EpiFix amniotic membrane for indications other than ocular surface disorders • EPIFLO transdermal continuous oxygen therapy for wound healing • Equine-derived decellularized collagen products (e.g., OrthADAPT, Unite, and Unite Biomatrix) • E-Z Derm for wound healing and all other indications • Evicel fibrin sealant for repair of cerebrospinal fluid leakage and all other indications • FlexHD acellular dermal matrix for wound healing; for FlexHD for breast reconstruction • FloGraft • Gammagraft skin substitute for wound healing and all other indications • GORE BIO-A Fistula Plug • Grafix Core and Grafix Prime • Graftjacket express injectable allograft for wound healing and all other indications • Hyalomatrix (hMatrix) • HydroFix • Inforce • Integra Neural Wrap for peripheral nerve repair and all other indications • Integra Wound Matrix and Integra Flowable Wound Matrix for the management of wounds including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears) and draining wounds and all other indications • LiquidGen • Matriderm • MatriStem wound micromatrix powder • MediHoney • Medeor • Memoderm • Menaflex Collagen Meniscus Implant • Meso BioMatrix • Neoform Dermis for wound healing; for NeoForm for breast reconstruction • Neox 1K • Neox 100 • Neuragen • NeuraWrap • Neuroflex AC-AESKI082011 Page 4 of 105 Copyright 2016 No part of this document may be reproduced without permission ActiveHealth Management Medical Management Guidelines • NeuroMatrix collagen nerve cuff for peripheral nerve repair and all other indications • NeuroMend collagen nerve wrap for peripheral nerve repair and all other indications • NuCel liquid wound covering • NuShield, NuShield Orthopaedics, and NuShield Spine • Oasis burn matrix for wound healing and all other indications • Oasis Tri-Layer Matrix • OrthADAPT Bioimplant (type I collagen scaffold) for tendon repair and all other indications • OsseoGuard • Ovation • PalinGen membrane for wound healing • Parietex Composite (PCO) Mesh for the treatment of genito-urinary (e.g., uterine or vaginal vault) prolapse • Peri-Guard Repair Patch • Peri-Strips Dry, and Peri-Strips Dry with Veritas Collagen Matrix • Permacol Biologic Implant for soft tissue surgical repairs, including hernia repair, muscle flap reinforcement, rectal prolapse (including intussusception), rectocele repair, abdominal wall defects, plastic and reconstructive surgery, complex abdominal wall repair and all other indications • Porcine-derived decellularized collagen products (e.g., Collamend, Cuffpatch, Pelvicol, and Pelvisoft) • Porcine-derived decellularized fetal skin products (e.g., Mediskin) • Porcine-derived polypropylene
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