Clinical Policy Bulletin: Wound Care - Aetna
Wound CarePage 1 of 96Clinical Policy Bulletin:Wound CareRevised February 2015Number: 0244(Replaces CPB 331)PolicyI. Aetna considers the following products for wound care medically necessary according to the criteria indicatA. Apligraf (graftskin)Aetna considers a culture-derived human skin equivalent (HSE) called Apligraf (graftskin) medicallynecessary for any of the following indications:1. For use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic difoot ulcers of greater than 3-weeks duration that have not adequately responded to conventiotherapy and which extend through the dermis but without tendon, muscle, capsule or bone exor2. In conjunction with standard therapy to promote effective wound healing of chronic, non-infectpartial and full-thickness venous stasis ulcers that have failed conservative measures of great-month duration using regular dressing changes and standard therapeutic compression.Aetna considers Apligraft experimental and investigational for all other indications (e.g., traumatic wobecause its effectiveness for indications other than the ones listed above has not been established.B. DermagraftAetna considers Dermagraft human fibroblast-derived dermal substitute medically necessary for usetreatment of full-thickness diabetic foot ulcers greater than 6-week duration that extend through the dbut without tendon, muscle, joint capsule or bone exposure, and (ii) in the treatment of wounds relatedystrophic epidermolysis bullosa. Note: Consistent with the Food and Drug Administration (FDA)-aplabeling of Dermagraft, the product should be used in conjunction with standard wound care regimenaddition, the product is not considered medically necessary in persons with an inadequate blood supinvolved foot.Aetna considers Dermagraft experimental and investigational for all other indications because itseffectiveness for indications other than the ones listed above has not been established.Dermagraft is contraindicated and has no proven value in infected ulcers and ulcers with /200 299/0244 draft.html01/28/2015
Wound CarePage 2 of 96C. Systemic Hyperbaric Oxygen Therapy (HBOT)Aetna considers systemic hyperbaric oxygen therapy (HBOT) medically necessary as an adjunctivefor treating non-healing, infected, deep lower extremity wounds in members with diabetes. See CPBHyperbaric Oxygen Therapy (HBOT).D. TransCyteAetna considers TransCyte (allogeneic human dermal fibroblasts), a biosynthetic dressing, medicallynecessary for the temporary wound covering for surgically excised full-thickness and deep partial-thicthermal burn wounds in persons who require such a covering before autograft placement; and for thetreatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and tbe expected to heal without autografting.Aetna considers TransCyte experimental and investigational for all other indications because its effefor indications other than the ones listed above has not been established.E. OrcelAetna considers Orcel (bilayered cellular matrix) medically necessary for healing donor site wounds ivictims, and for use in persons with dystrophic epidermolysis bullosa undergoing hand reconstructionto close and heal wounds created by the surgery, including those at donor sites.Aetna considers Orcel experimental and investigational for all other indications because its effectivenindications other than the ones listed above has not been established.F. Biobrane Biosynthetic DressingAetna considers Biobrane biosynthetic dressing medically necessary for temporary covering of a suppartial-thickness burn wound.Aetna considers Biobrane biosynthetic dressing experimental and investigational for all other indicatibecause its effectiveness for indications other than the one listed above has not been established.G. Integra Dermal Regeneration Template and Integra Bilayer Wound MatrixAetna considers Integra Dermal Regeneration Template, Integra Bilayer Matrix Wound Dressing, anMeshed Bilayer Wound Matrix (collagen-glycosaminoglycan copolymers) medically necessary for thetreatment of individuals with severe burns where there is a limited amount of their own skin to use foautografts or they are too ill to have more wound sites created.Aetna considers Integra Dermal Regeneration Template and Integra Bilayer Wound Matrix experimeinvestigational for all other indications because its effectiveness for indications other than the ones lisabove has not been established.H. AllodermAetna considers Alloderm and Alloderm-RTU acellular dermal tissue matrix medically necessary forreconstructive surgery; see CPB 0185 - Breast Reconstruction Surgery.Aetna considers the use of Alloderm experimental and investigational for all other indications (e.g., hrepair, reduction of incidence of Frey's syndrome following parotidectomy, and for use in reconstructiupper extremity) because its effectiveness for indications other than the one listed above has not beeestablished .http://qawww.aetna.com/cpb/medical/data/200 299/0244 draft.html01/28/2015
Wound CarePage 3 of 96I. ArtissAetna considers Artiss fibrin sealant medically necessary for the treatment of individuals with severeAetna considers Artiss fibrin sealant experimental and investigational for all other indications becauseffectiveness for indications other than the one listed above has not been established.J. Oasis Wound MatrixAetna considers Oasis Wound Matrix medically necessary for treatment of difficult-to-heal chronic vediabetic partial and full-thickness ulcers of the lower extremity that have failed standard wound therapleast 4-weeks duration.Aetna considers Oasis Wound Matrix experimental and investigational for all other indications becaueffectiveness for indications other than the ones listed above has not been established.K. Graftjacket Regenerative Tissue MatrixAetna considers Graftjacket Regenerative Tissue Matrix medically necessary for treatment of full-thicdiabetic foot ulcers greater than 3-week duration that extend through the dermis, but without tendon,joint capsule or bone exposure.Aetna considers Graftjacket Regenerative Tissue Matrix experimental and investigational for all otheindications because its effectiveness for indications other than the one listed above has not been estL. EpicelAetna considers Epicel cultured epidermal autograft medically necessary for members who have deedermal 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 whomthickness autografts may not be an option due to the severity and extent of their burns.Aetna considers Epicel cultured epidermal autograft experimental and investigational for all other indbecause its effectiveness for indications other than the one listed above has not been established.II. Aetna considers any of the following treatments for wound care experimental and investigational because thinadequate evidence in the peer-reviewed medical literature to support their clinical effectiveness:Adherus Dural Sealant;Affinity;AlloMax for indications other than breast reconstruction; for AlloMax for breast reconstruction, see CP- Breast Reconstruction Surgery;Allopatch for soft tissue augmentation and all other indications;Alloskin;Alloskin RT;AlloSource cryopreserved human cadaver /data/200 299/0244 draft.html01/28/2015
Wound CarePage 4 of 96AmnioMTM;AmnioShield;Amniotic fluid injection for corneal wound healing and for prevention of adhesions after orthopedic suAmniox (human embryonic membrane) for tarsel tunnel repair and all other indications;Architect ECM;Architect PX;Artelon (poly[urethane urea] elastomer) for anterior cruciate ligament reconstruction, rotator cuff repatrapezio-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, anautologous 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;BioDexcel;BioDfactor/BioDfence human amniotic allograft;BioDfence Dryflex;BioDmatrix;Biostat Biologx fibrin sealant for wound healing and all other indications;Biotape reinforcement matrix for soft tissue augmentation and all other x;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 (see also CPB 0253 - Vocal Cord ose RC continuous external tissue expander for facilitation of wound closure and all otherindications;Dermagraft for chronic foot ulcer secondary to necrotizing fasciitis;DermaMatrix for wound healing and other indications other than breast reconstruction; for DermaMatbreast reconstruction, see CPB 0185 - Breast Reconstruction Surgery;Dermapure;DermaSpan;Dermavest;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 indDuraSeal;Durepair Regeneration Matrix ;Endoform;ENDURAGen;Epidex;EpiFix amniotic membrane for indications other than ocular surface disorders (see CPB 0293 - Cornwith Amniotic Membrane Transplantation or Limbal Stem Cell Transplantation);EPIFLO transdermal continuous oxygen therapy for wound 0 299/0244 draft.html01/28/2015
Wound CarePage 5 of 96Equine-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;Excellagen;FlexHD acellular dermal matrix for wound healing; for FlexHD for breast reconstruction, see CPB 018Breast Reconstruction Surgery;FloGraft;Fortaderm;Fortaderm Antimicrobial;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;Guardian;Hyalomatrix (hMatrix);HydroFix;Inforce;Integra Neural Wrap for peripheral nerve repair and all other indications (see CPB 0416 - Nerve GrafSelected Indications);Integra Wound Matrix and Integra Flowable Wound Matrix for the management of wounds including pand 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-lassurgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degreeskin tears) and draining wounds and all other indications;LiquidGen;Marigen;Matriderm;MatriStem wound micromatrix powder;MediHoney;Medeor;Memoderm;Menaflex Collagen Meniscus Implant (see CPB 0786 - Menaflex);Meso BioMatrix;Neoform Dermis for wound healing; for NeoForm for breast reconstruction, see CPB 0185 - BreastReconstruction Surgery;Neox 1K;Neox 100;NeoxFlo;Neuragen;NeuraWrap (see CPB 0416 - Nerve Grafting: Selected Indications);Neuroflex;NeuroMatrix collagen nerve cuff for peripheral nerve repair and all other indications (see CPB 0416 Grafting: Selected Indications);NeuroMend collagen nerve wrap for peripheral nerve repair and all other indications (see CPB 0416Grafting: Selected 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 a/200 299/0244 draft.html01/28/2015
Wound CarePage 6 of 96OsseoGuard;Ovation;PalinGen membrane for wound healing;Parietex Composite (PCO) Mesh for the treatment of genito-urinary (e.g., uterine or vaginal vault) proPeri-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 reinforcrectal prolapse (including intussusception), rectocele repair, abdominal wall defects, plastic andreconstructive 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 composite wound dressing (e.g., Avaulta Plus);PriMatrix acellular dermal tissue matrix for wound healing and all other indications;Promogran;PTFE felt;Puracol;Radiofrequency stimulation devices (e.g., Provant Wound Closure System, MicroVas Vascular TreatSystem) for wound healing;Repriza;Revitalon;Seamguard;Silver-coated wound dressings (e.g., Acticoat, Actisorb, and Silversorb) for wound healing and all othindications;Solana allograft;SportMatrix;SportMesh;Strattice tissue matrix for wound healing; for Strattice for breast reconstruction, see CPB 0185 - BreaReconstruction Surgery;Suprathel;SurgiMend for plastic and reconstructive surgery, muscle flap reinforcement, hernia repair, reinforcemsoft tissues repaired by sutures or suture anchors, during tendon repair surgery (including reinforcemthe rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons), and all indications other thanreconstruction; for SurgiMend for breast reconstruction, see CPB 0185 - Breast Reconstruction SurgSurgisis (including Surgisis AFP Anal Fistula Plug, Surgisis Gold Hernia Repair Grafts, and SurgisisBiodesign);Talymed;TenoGlide tendon protector sheet (Tendon WrapTM tendon protector) for the management and protetendon injuries and all other indications;TenSix (acellular dermal matrix) for tendon repair and all other indications;TheraSkin;TissueMend for the repair or reinforcement of soft tissues repaired by sutures or suture anchors duritendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadricepother tendons, and all other indications;Tornier BioFiber Absorbable Biological Scaffold, and Tornier Collagen Coated BioFiber Scaffold;Vaso Shield;Veritas collagen matrix for use as an implant in the surgical repair of soft tissue deficiencies and all oindications;Vitagel surgical hemostat for wound healing and all other indications;X-Repair;XCM 00 299/0244 draft.html01/28/2015
Wound CarePage 7 of 96Xelma;XenMatrix.For Aetna’s policy on systemic and topical hyperbaric oxygen, see CPB 0172 - Hyperbaric Oxygen Therapy (HBOTSee also CPB 0334 - Negative Pressure Wound Therapy.BackgroundApligraf (Graftskin):In recent years, skin grafting has evolved from the initial autograft and allograft preparations to biosynthetic and tisengineered human skin equivalents (HSE). Apligraf (graftskin) (Organogenesis, Canton, MA) is a living, cellbased, bilayered skin construct. Like human skin, Apligraf has 2 primary layers, including an outer, epidermal layeof living human keratinocytes, the most common cell type of the human epidermis, to replicate the structure of theepidermis. The human keratinocytes and fibrobasts are derived from neonatal forsekins. The dermal layer of Apliconsists of living human fibroblasts and bovine type 1 collagen, the most common cell type in the human dermis, toa dermis-like structure that produces additional matrix proteins. Proponents state that Apligraf stimulates the patiecells to regenerate tissue and heal the wound through mechanisms that include the secretion of growth factors, cytand matrix proteins (Snyder, et al., 2012). Apligraf does not contain melanocytes, Landgerhans' cells, macrophagelymphocytes, or tissue structures such as blood vessels, hair follicles, and sweat glands.Apligraf has has received a premarket approval (PMA) by the U.S. Food and Drug Administration (FDA) in 1998 fotreatment of venous leg ulcers and in 2001 for treatment of diabetic ulcers. Apligraft has been approved for markeunder a premarket approval for "use with standard therapeutic compression for the treatment of noninfected partialthickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequatelyresponded to conventional ulcer therapy." Multiple supplemental approvals have been added since the first approvincluding an indication for treating diabetic foot ulcers. Several of the supplements involve approval of the use of nehuman keratinocyte or fibroblast cell strains in the manufacture of Apligraf (Snyder, et al., 2012). Venous ulceratiorelatively common manifestation of venous hypertension, is often refractory to conservative treatment and difficult tHuman skin equivalents appeared to promote wound healing in 3 ways: (i) apparent graft "take"; (ii) temporary wouclosure (persistence of HSE with subsequent wound re-epithelialization from wound margins); and (iii) stimulation ohealing without temporary persistence by acting as a biologic dressing.Apligraf was shown in clinical trials to heal even longstanding (greater than 1 year's duration) venous leg ulcers moeffectively and faster than compression therapy alone. The results of controlled, multi-center studies indicate that Hinteracts with the patient's own cells, responds to individual wound characteristics, and promotes healing. Furtherare underway to investigate its use for the treatment of pressure sores, dermatological surgery wounds and burns.time, there is insufficient information to extend coverage for the use of Apligraf in the treatment of these conditions.Dermagraft:Another product approved by the FDA for repair of diabetic foot ulcers is Advanced BioHealing, Inc. (La Jolla, CA)Dermagraft, composed of cryopreserved human-derived fibroblasts and collagen applied to a bioabsorbable meshto the material used in strong bioabsorbable sutures). The fibroblasts are obtained from human newborn foreskin tDuring the Dermagraft manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactinscaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrixgrowth factors and cytokines, to create a 3-dimensional human dermal substitute containing metabolically active, licells. Dermagraft does not contain macrophages, lymphocytes, blood vessels, or hair follicles. It comes frozen assheet (2 by 3 inches) for a single /200 299/0244 draft.html01/28/2015
Wound CarePage 8 of 96In September 2001, FDA approved Dermagraft for marketing under the premarket approval (PMA) process for “usetreatment of full-thickness diabetic foot ulcers greater than six weeks’ duration which extend through the dermis, btendon, muscle, joint capsule or bone exposure. Dermagraft should be used in conjunction with standard wound caregimens and in patients that have adequate blood supply to the involved foot.”In support of FDA approval, a 12-week multi-center clinical study was performed involving 314 patients with chronidiabetic ulcers who were randomized to Dermagraft or control. Patients in the Dermagraft group received up to 8applications of Dermagraft over the course of the 12-week study. All patients received pressure-reducing footwearwere encouraged to stay off their study foot as much as possible. By week 12, the median percent wound closureDermagraft group was 91 % compared to 78 % for the control group. The study also showed that ulcers treated wDermagraft closed significantly faster than ulcers
Integra Wound Matrix and Integra Flowable Wound Matrix for the management of wounds including p 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-las
The Wound Care Clinical Pathways are not to a substitute for wound care education or best practice guidelines, rather a tool for the South West LHIN and Service Provider Agencies to have a coordinated approach to the patient journey and reporting expectations to maximize patient healability. The Wound Care Clinical Pathways:
board-certified wound care nurse from 8am–5pm Central Standard Time Monday–Friday. 1-888-701-SKIN (7546) » The NE1 Wound Assessment Tool This proprietary wound assessment tool is designed to dramatically increase accuracy, consistency and transparency in wound assessment. » WoundRounds Wound Management System This unique wound management
Sloughy Wound (Pale layer of dead or fibrinous tissue over all or part of the wound bed) Macerated Skin (Soft, pale/white, wet or soggy skin surrounding wound) Granulating Wound (Wound bed filled with highly vascular, fragile tissue) Determine if present dressing regime is Goal of Treatment Keep woundRemove non-vital tissue and management of
Wound edges open Not healing Wound with 25% avascular tissue (eschar and/or slough) OR Signs/symptoms of infection OR Clean but nongranulating wound bed OR Closed/hyperkeratotic wound edges OR Persistent failure to improve despite appro-priate comprehensive wound management Note. Data from WOCN (2009).
Podiatrists provided the majority of wound care services (for the selected wound types) in office-based settings (Table 8). In outpatient facilities, a mix of specialties (e.g., podiatrists, surgeons, internists) provided wound care. The mean episode length for a wound care episode was 15.5 days (for the selected wound types), with a
Figure 1. The wound bed preparation care cycle. Figure 2. Fixed yellow slough on a wound bed. Prevention Healed Start with the patient Treat & evaluate TIME interventions Perform TIME assessment Agree goals Identifying wound Wound bed aetiology preparation Care cycle Yes No Wound bed preparation - TIME in contex 58-70TIME.indd 6 17/10/05 10 .
Triad was applied to the wound bed and periwound skin. Wound as presented on Day 2. Triad is applied to the wound bed. Wound as presented on Day 2. Triad is applied to wound bed and periwound skin. "After 1 application of Triad, wound was progressing and the patient was able to continue to use Triad at home for wound treatment."
Wound Management Procedure (Tissue Viability and Wound Care (TVWC) Manual) Page 2 of 19 1. INTRODUCTION A systematic approach to holistic wound care is essential for the delivery of high quality wound care. Holistic wound assessment considers the
