Medical Policy: 02.01.17 

Original Effective Date: May 1999 

Reviewed: March 2019 

Revised: March 2019 

 

Notice:

This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

A wide variety of wound care products are available for clinicians to choose from when treating chronic wounds and during breast reconstruction. Many of these products are said to mimic or substitute for some aspect of the skin's structure and function to promote healing and wound closure. The materials used to produce these products may be derived from human or animal tissue and may undergo extensive or minimal processing to make the finished product. The extent of processing and the source of the material used in the product also determines what regulatory pathway may be required before the product can be marketed.

 

Skin substitutes are classified into the following types:

  • Human skin allografts: derived from donated human skin (cadavers) that has been processed to remove the cellular components and retain the structural proteins of the dermis, and to avoid immunologic rejection. They are available in different forms to allow scaffolding, soft tissue filling, growth factors, and other bioavailable hormonal or enzymatic activity.
  • Allogeneic matrices: derived from human neonatal fibroblasts of the foreskin that may contain metabolically active or regenerative components primarily used for soft tissue support, though some have been approved for the treatment of full-thickness skin and soft tissue loss. Most are biodegradable and disappear after 3-4 weeks of implantation.
  • Composite matrices: derived from human keratinocytes and fibroblasts supported by a scaffold of synthetic mesh or xenogeneic collagen. These are also referred to as human skin equivalent but are unable to be used as autografts due to immunologic rejection or degradation of the living components by the host. Active cellular components continue to generate bioactive compounds and protein that may accelerate wound healing and epithelial regrowth.
  • Acellular matrices: derived from sources other than human skin and include the majority of skin substitutes. All are composed of allogeneic (i.e., from another human) or xenogeneic (i.e., from nonhuman species, such as bovine and porcine) derived collagen, membrane, or cellular remnants proposed to simulate or exaggerate the characteristics of human skin. All are proposed to promote healing by the creation of localized intensification of an array of hormonal and enzymatic activity to accelerate closure by migration of native dermal and epithelial components, rather than function as distinctly incorporated tissue closing the skin defect.

 

Breast Reconstruction

For individuals who are undergoing breast reconstruction who receive allogeneic ADM products, the evidence incudes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. A systematic review found no difference in overall complication rates with ADM allograft compared with standard procedures for breast reconstruction. Reconstructions with ADM have been reported to have higher seroma, infection, and necrosis rates than reconstructions without ADM. However, capsular contracture and malposition of implants may be reduced. Thus, in cases where there is limited tissue coverage, the available evidence may inform patient decision making about reconstruction options. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

 

Diabetic Lower-Extremity Ulcers

For individuals who have diabetic lower-extremity ulcers who receive skin substitues, the evidence includes several RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and quality of life. RCTs have demonstrated the efficacy of products over the standard of care.

 

Studies are needed to further define the population who might benefit from this treatment with various products. Additional studies with a larger number of subjects is needed to evaluate the effects compared with current SOC or other advanced wound therapies.

 

Lower-Extremity Ulcers due to Venous Insufficiency

For individuals who have lower-extremity ulcers due to venous insufficiency who receive certain products, the evidence includes RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, and quality of life. RCTs have demonstrated the efficacy over the standard of care for certain products.

 

Standard wound therapy includes:

  • control of edema, venous hypertension or lymphedema;
  • control of any nidus of infection or colonization with bacterial or fungal elements;
  • elimination of underlying cellulitis, osteomyelitis, foreign body or malignant process;
  • appropriate debridement of necrotic tissue or foreign body (exposed bone or tendon);
  • maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings;
  • optimization of glucose control (when applicable);
  • for diabetic foot ulcers, appropriate non-weight bearing or off-loading pressure;
  • assessment of a patient’s vascular status and correction of any vascular problems in the affected limb if possible;
  • for venous stasis ulcers, compression therapy provided with documented diligent use of multilayer dressings, compression stockings of > 20mmHg pressure, or pneumatic compression;
  • provision of wound environment to promote healing (protection from trauma and contaminants, elimination of inciting or aggravating processes); and
  • optimization of nutritional status.

 

Dystrophic Epidermolysis Bullosa


For individuals who have dystrophic epidermolysis bullosa who receive certain products, the evidence includes only case series. Relevant outcomes are symptoms, change in disease status, morbid events, and quality of life. OrCel was approved under a humanitarian drug exemption for use in patients with dystrophic epidermolysis bullosa undergoing hand reconstruction surgery, to close and heal wounds created by the surgery, including those at donor sites. Outcomes have been reported in small series (eg, 5 patients). The evidence is insufficient to determine the effects of the technology on health outcomes.

 

Burns

For individuals who have deep dermal burns who receive bioengineered skin substitutes, the evidence includes RCTs. Relevant outcomes are disease-specific survival, symptoms, change in disease status, morbid events, functional outcomes, quality of life, and treatment-related morbidity. Overall, few skin substitutes have been approved, and the evidence is limited for each product. Epicel (living cell therapy) has received Food and Drug Administration approval under a humanitarian device exemption for the treatment of deep dermal or full-thickness burns comprising a total body surface area of 30% or more.

 

Prior Approval:

Not applicable

 

Policy:

For information regarding the use of amniotic patches for ophthalmologic use, amniotic fluid, and amniotic fluid injectable products please see policy 02.01.60

 

Breast Reconstruction

Breast reconstructive surgery following mastectomy utilizing one of the specific products:

  • AlloDerm® or
  • AlloMend® or
  • Cortiva® [AlloMax™] or
  • DermACELL™ or
  • FlexHD® or
  • GraftJacket® Regenerative Tissue Matrix

when the following criteria is met may be considered medically necessary:

  • when there is insufficient tissue expander or implant coverage by the pectoralis major muscle and additional coverage is required OR
  • when there is viable but compromised or thin post-mastectomy skin flaps that are at risk of dehiscence or necrosis OR
  • the infra-mammary fold and lateral mammary folds have been undermined during mastectomy and re-establishment of these landmarks is needed

Use of skin substitues specifically to make the reconstructive procedure more convenient in the absence of the above conditions is considered not medically necessary.

 

Venous Ulcers

Treatment of chronic, non-infected, partial or full-thickness lower extremity skin ulcers due to venous insufficiency utilizing the following specific products:

  • Apligraf®
  • Oasis™ Wound Matrix'

May be considered medically necessary when the following criteria is met:

  • Wounds which have not adequately responded following a one month period of conventional ulcer therapy (there has been no improvement of the wound with regular dressing changes and wound care AND
  • The ulcer must be free of infection, osteomyelitis, surrounding cellulitis, tunnels and tracts. AND
  • The ulcer must extend through the dermis but not expose tendon, muscle, joint capsule, or bone. AND
  • There must be adequate blood supply as evidenced by a palpable pedal pulse or by an ankle-brachial index (ABI) of 0.65 or greater. AND
  • Repeat application without improvement of the wound is considered not medically necessary. (Improvement must be evidenced by measurements and additional documentation.)

 

Epidermolysis bullosa

Treatment of dystrophic epidermolysis bullosa wounds using the following tissue-engineered skin substitutes

  • OrCel™

May be considered medically necessary for the treatment of mitten-hand deformity when standard wound therapy has failed and when provided in accordance with the Humanitarian Device Exemption (HDE) specifications of the FDA:

Treatment of children with recessive epidermolysis bullosa who are undergoing reconstructive hand surgery using the following tissue-engineered skin substitute may be considered medically necessary:

  • OrCel™

 

Burns

Treatment of second and third degree burns using the following tissue-engineered skin substitutes may be considered medically necessary:

  • Epicel® (for the treatment of deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30% when provided in accordance with the HDE specifications of the FDA)
  • Integra® Dermal Regeneration Template
  • TransCyte™ (for temporary covering of a surgically excised deep partial or full-thickness burn wound prior to autografting)
  • Biobrane® (for temporary covering of partial thickness, freshly debrided or excised burn wounds)

Treatment of fresh, clean, split-thickness donor site wounds in burn victims using the following tissue-engineered skin substitute may be considered medically necessary:

  • OrCel™

 

Diabetic Foot Ulcers

Treatment of diabetic foot using the following tissue-engineered skin substitutes:

  • AlloPatch®
  • Apligraf®
  • Dermagraft®
  • Biovance®
  • Epifix®
  • Grafix™

May be considered medically necessary when the following criteria is met:

  • Full-thickness neuropathic diabetic foot ulcers; AND
  • Extends through the dermis but without tendon, muscle, joint capsule, or bone exposure; AND
  • At least one month of conventional ulcer therapy (such as surgical debridement, complete off-loading and standard dressing changes) has been ineffective when using Apligraf, at least six weeks therapy when using any other approved product AND
  • Diabetes must be medically managed: Meaning there are no other comorbidities due to diabetes AND
  • Patient’s current HbA1C does not exceed 12% AND
  • Ulcer is free of infection, including osteomyelitis and surrounding cellulitis (Grade 3-6 would infer infection)AND
  • Must measure a minimum of 1 cm2 AND
  • Wound must have adequate circulation with presence of acceptable peripheral pulses or as evidenced by ankle-brachial index (ABI) of 0.65 or greater in the limb being treated.

If any of the following characteristics are not met, the use of a skin substitute does not have an ideal environment for success. The use of a skin substitute will be denied as not medically necessary.

 

Repeat Application

Repeat applications of skin substitutes are not indicated when previous applications were unsuccessful. Unsuccessful treatment is defined in this situation as increase in size or depth of a wound or ulcer, or no change in baseline size or depth and no sign of improvement. Retreatment in this scenario is considered not medically necessary.

 

Doumentation Requirements

  • Medical record documentation must clearly document the medical necessity of the bioengineered skin substitute application. This would include wound measurements and evidence of prior ineffective wound care, or for repeat application prior care with skin substitute that demonstrates success.
  • Documentation must confirm and support characteristics of the ulcer, the presence of qualifying or disqualifying conditions, and the nature of and the duration of pretreatment conservative treatment.

 

Failed Response — defined as an ulcer or skin deficit that has failed to respond to documented appropriate wound-care measures, has increased in size or depth, or has not changed in baseline size or depth and has no indication that improvement is likely (i.e., granulation, epithelialization or progress towards closing).

 

The following grading system for diabetic ulcers is frequently utilized:

 

Wagner Grading System
  1. Grade 1: Superficial Diabetic Ulcer
  2. Grade 2: Ulcer extension
    • Involves ligament, tendon, joint capsule or fascia
    • No abscess or Osteomyelitis
  3. Grade 3: Deep ulcer with abscess or Osteomyelitis (infection inferred)
  4. Grade 4: Gangrene to portion of forefoot (infection inferred)
  5. Grade 5: Extensive gangrene of foot (infection inferred)

 

Repeat use of any skin substitute when treatment has been unsuccessful is considered not medically necessary.

 

Unsuccessful treatment — defined as increase in size or depth of an ulcer or no change in baseline size or depth and no sign of improvement or indication that improvement is likely (such as granulation, epithelialization or progress towards closing) for a period of 4 weeks past start of therapy.

 

All other uses of the bio-engineered skin and soft tissue substitutes are considered investigational, including but not limited to:

  • surgical wounds
  • hernia repair
  • abdominal wall reconstruction
  • wound covering
  • tendon repair
  • ligament and meniscus repair
  • plantar fasciitis
  • tissue repair
  • dental procedures
  • pressure ulcers/decubitus ulcers
  • fistula repair
  • tympanoplasty
  • vocal cord repair

 

The literature is inadequate and frequently biased for the studies that do exist. This doesn’t enable further conclusions concerning safety and efficacy for individual products or expanded indications. There is an inability to define the success of one product vs another in many of the conditions listed. In spite of their clinical efficacy in some clinical trials, there remains a paucity of good quality randomized controlled trials (RCTs) contributing to the evidence based use of skin substitutes and even fewer studies comparing products to each other.

 

Products that have been FDA approved/cleared for one indication (e.g., lower extremity ulcers) have been used off-label in place of other FDA approved/cleared products (e.g., for burns). The evidence of efficacy is insufficient and therefore, these indications are considered investigational.

 

All other skin/tissue substitutes not listed above are considered investigational, including, but not limited to:

  • Actishield™
  • ActiveBarrier®
  • ActiveMatrix®
  • Affinity
  • AlloGen-LI™
  • AlloGen™
  • AlloSkin™/ Alloskin ac
  • AlloSkin™ RT
  • Allowrap
  • Alphaplex™ with MariGen Omega3™
  • AmnioCare®
  • AmnioGen
  • AmnioHeal®
  • Amnioband
  • Amnioexcel or biodexcel
  • Amniofix
  • AmnioPro
  • Amniostrip™
  • Amniovisc
  • AmnioWound
  • Aongen™ Collagen Matrix
  • Architect extracellular matrix
  • Artacent cord, per square centimeter
  • Artacent® Flex
  • Artacent® Wound
  • Artelon®
  • ArthroFlex™ (FlexGraft)
  • Avaulta Plus™
  • BellaCell HD or Surederm, per square centimeter
  • Belladerm®
  • Bio-ConneKt®
  • BioDDryFlex® Resorbable Adhesion Barrier
  • BioDExCel™
  • BioDfence/BioDfactor
  • BioDOptix™
  • BioFiber™
  • BioRenew
  • Bioskin
  • BioVance®
  • CellerateRX®
  • CollaGUARD®
  • CollaMend™
  • Conexa™
  • CorMatrix®
  • CRXa™
  • CryoMatrix®
  • Cymetra®
  • Cytal® Burn Matrix
  • Cytal® Multilayer Matrix
  • Cytal® Wound Matrix
  • DeNovo® NT Graft
  • DermaMatrix Acellular Dermis
  • Derma-gide, per square centimeter
  • Dermapure
  • Durepair Regeneration Matrix®
  • Dermavest2
  • DressSkin™
  • Endobon® Xenograft Granules
  • Endoform Dermal Template™
  • ENDURAgen™
  • Epiburn
  • Epicord
  • Excellagen
  • E-Z Derm™
  • Flowerderm
  • Flograft
  • Floweramniopatch
  • FloGraft™
  • Fortiva™ Porcine Dermis
  • GammaGraft
  • GraftJacket™, injectable form
  • GraftJacket® Xpress, injectable
  • GraftRope™
  • HA Absorbent Wound Dressing
  • Helicoll
  • HeliMEND
  • Hyalomatrix® PA (hMatrix)
  • Integra™ Flowable Wound Matrix
  • Integra™ Bilayer Wound Matrix
  • InteguPly™
  • Keramatrix®
  • Kerecis omega3
  • Menaflex™ Collagen Meniscus Implant
  • Matrix HD™
  • MatrixDerm™ (formerly Cytal)
  • MediHoney®
  • Mediskin®
  • MemoDerm™
  • MIRODERM™
  • Miromatrix Biological Mesh
  • MyOwn skin
  • Neopatch
  • Neox 100/1k/Neox Cord 1K/ Clarix Cord 1K
  • NuCel™
  • Nushield
  • OrthoFlo
  • PalinGen
  • PriMatrix
  • Progenamatrix, per square centimeter
  • Oasis® Burn Matrix
  • Oasis® Ultra Tri-Layer Matrix
  • PX50® and X50® Plus
  • Permacol™
  • PuraPly
  • Puracol®
  • ReNu
  • Repriza™
  • Repliform™
  • Restore® Orthobiologic Soft Tissue Implant
  • Revita
  • Revitalon
  • Rx Membrane
  • Seamguard®
  • SportFlow
  • SportMatrix
  • SportMesh™
  • Strattice™ (xenograft)
  • SurgiMend®
  • Surgicord, per sq cm
  • Talymed®
  • TenoGlide™
  • Tensix
  • Theraform
  • TissueMend®
  • TheraSkin®Unite™
  • TruSkin™
  • Veritas® Collagen Matrix
  • VersaShield™
  • Xcm biologic tissue matrix
  • Xwrap™ (Hydro, DRY, and ECM)
  • Woundex/Bioskin
  • Woundex Flow/Bioskin Flow

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • Q4100 Skin substitute, not otherwise specified
  • Q4101 Skin substitute, Apligraf, per sq cm
  • Q4102 Skin substitute, Oasis wound matrix, per sq cm
  • Q4103 Skin substitute, Oasis burn matrix, per sq cm
  • Q4104 Skin substitute, Integra bilayer matrix wound dressing (BMWD), per sq cm
  • Q4105 Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm
  • Q4106 Skin substitute, Dermagraft, per sq cm
  • Q4107 Skin substitute, GRAFTJACKET, per sq cm
  • Q4108 Skin substitute, Integra matrix, per sq cm
  • Q4110 Skin substitute, PriMatrix, per sq cm
  • Q4111 Skin substitute, GammaGraft, per sq cm
  • Q4112 Cymetra, injectable, 1 cc
  • Q4113 GRAFTJACKET XPRESS, injectable, 1cc
  • Q4114 Integra flowable wound matrix, injectable, 1 cc
  • Q4115 AlloSkin, per sq cm    
  • Q4116 Skin substitute, AlloDerm, per square centimeter
  • Q4117 HYALOMATRIX, per sq cm
  • Q4118 MatriStem micromatrix, 1 mg
  • Q4121 TheraSkin, per sq cm     
  • Q4122 Dermacell, dermacell awm or dermacell awm porous, per square centimeterQ4123 AlloSkin RT, per sq cm
  • Q4124 Oasis ultra tri-layer wound matrix, per sq cm
  • Q4125 Arthroflex, per sq cm
  • Q4126 MemoDerm, per sq cm
  • Q4127 Talymed, per sq cm
  • Q4128 FlexHD or AllopatchHD, per sq cm
  • Q4130 Strattice TM, per sq cm
  • Q4132 Grafix Core and GrafixPL Core, per sq cm
  • Q4133 Grafix Prime and GrafixPL Prime, per sq cm
  • Q4134 hMatrix, per sq cm
  • Q4135 Mediskin, per sq cm
  • Q4136 E-Z Derm, per sq cm
  • Q4137 Amnioexcel or biodexcel, per sq cm
  • Q4138 Biodfence dryflex, per sq cm
  • Q4140 Biodfence, per sq cm
  • Q4141 Alloskin AC, per sq cm
  • Q4142 XCM biologic tissue matrix, per sq cm
  • Q4143 Repriza, per sq cm
  • Q4146 Tensix, per sq cm
  • Q4147 Architect extracellular matrix, per sq cm
  • Q4148 Neox Cord 1K, Neox Cord RT, or Clarix Cord 1K, per sq cm
  • Q4149 Excellagen, 0.1 cc
  • Q4150 Allowrap DS or dry, per sq cm
  • Q4151 Amnioband or guardian, per sq cm
  • Q4152 Dermapure, per sq cm
  • Q4153 Dermavest and Plurivest, per sq cm
  • Q4154 Biovance, per sq cm
  • Q4156 Neox 100 or Clarix 100, per sq cm
  • Q4157 Revitalon, per sq cm
  • Q4158 Kerecis Omega3, per sq cm
  • Q4159 Affinity, per sq cm
  • Q4160 Nushield, per square centimeter  
  • Q4161 Bio-ConneKt wound matrix, per sq cm
  • Q4163 WoundEx, BioSkin, per sq cm
  • Q4164 Helicoll, per sq cm
  • Q4165 Keramatrix or kerasorb, per square centimeter
  • Q4166 Cytal, per sq cm
  • Q4167 Truskin, per sq cm
  • Q4168 AmnioBand, 1 mg
  • Q4169 Artacent wound, per sq cm
  • Q4170 Cygnus, per sq cm
  • Q4171 Interfyl, 1 mg
  • Q4172 PuraPly or PuraPly AM, per sq cm
  • Q4173 PalinGen or PalinGen XPlus, per sq cm
  • Q4175 Miroderm, per sq cm
  • Q4176 NeoPatch, per sq cm
  • Q4178 FlowerAmnioPatch, per sq cm
  • Q4179 FlowerDerm, per sq cm
  • Q4180 Revita, per square cm
  • Q4181 Amnio Wound, per sq centimeter
  • Q4182 Trancyte, per sq cm
  • Q4183 Surgigraft, per square centimeter
  • Q4184 Cellesta or cellesta duo, per square centimeter
  • Q4186 Epifix, per square centimeter
  • Q4187 Epicord, per square centimeter
  • Q4188 Amnioarmor, per square centimeter
  • Q4189 Artacent ac, 1 mg
  • Q4190 Artacent ac, per square centimeter
  • Q4191 Restorigin, per square centimeter
  • Q4193 Coll-e-derm, per square centimete
  • Q4194 Novachor, per square centimeter
  • Q4195 Puraply, per square centimeter
  • Q4196 Puraply am, per square centimeter
  • Q4197 Puraply xt, per square centimeter
  • Q4198 Genesis amniotic membrane, per square centimeter
  • Q4200 Skin te, per square centimeter
  • Q4201 Matrion, per square centimeter
  • Q4203 Derma-gide, per square centimeter
  • Q4204 Xwrap, per square centimeter
  • Q4205 Membrane graft or membrane wrap, per square centimeter
  • Q4216 Artacent cord, per square centimeter
  • Q4217 Woundfix, BioWound, Woundfix Plus, BioWound Plus, Woundfix Xplus or BioWound Xplus, per square centimeter
  • Q4218 Surgicord, per square centimeter
  • Q4220 BellaCell HD or Surederm, per square centimeter
  • Q4222 Progenamatrix, per square centimeter
  • Q4226 MyOwn skin, includes harvesting and preparation procedures, per square centimeter
  • C5271 Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq sm; first 25 sq cm or less wound surface area
  • C5272 Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq sm; each additional 25 sq cm wound surface area, or part thereof
  • C5273 Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
  • C5274 Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof
  • C5275 Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
  • C5276 Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof
  • C5277 Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
  • C5278 Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof
  • C9356 Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (TenoGlide Tendon Protector Sheet), per sq cm
  • C9358 Dermal substitute, native, nondenatured collagen, fetal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm
  • C9360 Dermal substitute, native, nondenatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm
  • C9361 Collagen matrix nerve wrap (NeuroMend Collagen Nerve Wrap), per 0.5 cm length
  • C9363 Skin substitute (Integra Meshed Bilayer Wound Matrix), per square cm
  • C9364 Porcine implant, Permacol, per sq cm
  • 15271 Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
  • 15272 Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)
  • 15273 Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
  • 15274 Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)
  • 15275 Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area
  • 15276 Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)
  • 15277 Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children
  • 15278 Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)

 

Selected References:

  • The Medical Policy Reference Manual (MPRM) developed by the Blue Cross and Blue Shield Association Health Management Systems, based on Technology Evaluation Center (TEC) criteria.
  • Veves A, Falanga V, Armstrong DG, Sabolinski ML; The Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care 2001 Feb;24(2):290-5.
  • Streit M, Barathen LR. Apligraf-a living human skin equivalent for the treatment of chronic wounds. International Journal of Artificial Organs 2000 Dec;23(12):831-3.
  • Falanga VJ. Tissue engineering in wound repair. Advances in Skin Wound Care 2000 May-Jun;13(2 Suppl): 15-9.
  • Gohari S, Gambla C, Healy M, Spaulding G, Gordon KB, Swan J, Cook B, West DP, Lapiere JC.  Evaluation of tissue-engineered skin (human skin substitute) and secondary intention healing in the treatment of full thickness wounds after Mohs micrographic or excisional surgery.  Dermatol Surg. 2002 Dec;28(12):1107-14; discussion 1114.
  • Bello YM, Phillis TJ.  Recent Advances in Wound Healing. JAMA 2000; 283,(6): 716-718.
  • TARGET [database online]. Plymouth Meeting (PA): ECRI; January 2002; Bioengineered composite skin substitute for donor sites in burn victims.
  • ECRI. Bioengineered skin and dermal cell replacement for chronic diabetic ulcers. Plymouth Meeting (PA): ECRI Health Technology Assessment Information Service; 2002 Feb. 26 p. (Windows on medical technology; no. 65).
  • ECRI. Acellular allograft membrane (GraftJacket) for ligament and tendon repair. Plymouth Meeting (PA): ECRI Institute  2005 December 20. 6 p. (ECRI Custom Hotline Response).
  • Ehrenreich M, Ruszczak Z. Update on Tissue-Engineered Biological Dressings. Tissue Eng. 2006 Sep;12(9):2407-24.
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  • Barber C, Watt A, Pham C, Humphreys K et al. Influence of bioengineered skin substitutes on diabetic foot ulcer and venous leg ulcer outcomes. J Wound Care. 2008 Dec;17(12):517-27.
  • ECRI Institute. AlloDerm versus Autograft for Tissue Regeneration. Plymouth Meeting (PA): ECRI Institute; 2008 Dec 19. 8 p. [ECRI hotine response].
  • ECRI Institute. Bioengineered Skin and Dermal Cell Replacement for Chronic Diabetic and Venous Ulcers. Plymouth Meeting (PA): ECRI Institute 2009 Jan 16. 12 p. [ECRI hotine response].
  • ECRI Institute. Platelet-derived Growth Factors for Chronic, Nonhealing Wounds. Plymouth Meeting (PA): ECRI Institute 2009 Feb 24. 10 p. [ECRI hotine response].
  • ECRI Institute. Porcine-derived Extracellular Matrix (OASIS Wound Matrix) for Wound Management. Plymouth Meeting (PA): ECRI Institute 2009 April 24. 9p. [ECRI hotine response].
  • ECRI Institute. Skin Substitutes for Treatment of Burns. Plymouth Meeting (PA): ECRI Institute >2009 May 12. 10 p. [ECRI hotine response].
  • Romanelli M, Dini V, Bertone MS. Randomized comparison of OASIS wound matrix versus moist wound dressing in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. Adv Skin Wound Care 2010; 23(1):34-8.
  • ECRI Institute. Bioengineered Skin and Dermal Cell Replacement for Managing Chronic Diabetic and Venous Ulcers. Plymouth Meeting (PA): ECRI Institute 2012 March 21. [Hotline Response].
  • ECRI Institute. Alloderm Tissue Matrix (LifeCell Corp.) for Repairing or Replacing Skin Tissue. Plymouth Meeting (PA): ECRI Institute 2012 February 3. [Hotline Product Brief].
  • ECRI Institute. BioDfactor Human Amniotic Allograft (BioDlogics, LLC) for Covering Wounds and Filling Bone Voids. Plymouth Meeting (PA): ECRI Institute 2012 February 6. [Product Brief].
  • ECRI Institute. NuCel Human Amniotic Allograft (Nutech Medical) for Use in Surgical Wounds and Orthopedic Procedures. Plymouth Meeting (PA): ECRI Institute 2012 February 6. [Product Brief].
  • National Institute for Health and Clinical Excellence (NICE). Diabetic foot problems: Inpatient management of diabetic foot problems (Draft). NICE clinical guideline. London, UK: NICE; November 2011.
  • ECRI Institute. Skin Substitutes for Treating Chronic Wounds. ECRI Institute 2012 December 18. [Technology Assessment] Prepared for AHRQ
  • Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006) revision. J Foot Ankle Surg. 2006;45(5 Suppl):S1-66.
  • Association for the Advancement of Wound Care (AAWC) Venous Ulcer Guideline. Malvern, Pennsylvania: Association for the Advancement of Wound Care (AAWC).December 2010.
  • Zelen CM, Snyder RJ, Serena TE, et al. The Use of Human Amnion/Chorion Membrane in the Clinical Setting for Lower Extremity Repair: A Review. Clin Podiatr Med Surg. Jan 2015;32(1):135-146. PMID 25440424
  • Butterfield JL. 440 Consecutive immediate, implant-based, single-surgeon breast reconstructions in 281 patients:a comparison of early outcomes and costs between SurgiMend fetal bovine and AlloDerm human cadaveric acellular dermal matrices. Plast Reconstr Surg. May 2013;131(5):940-951. PMID 23629076
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  • Zelen CM, Serena TE, Fetterolf DE. Dehydrated human amnion/chorion membrane allografts in patients withchronic diabetic foot ulcers: a long term follow-up study. Wound Medicine 2014;4:1-4.
  • Driver VR, Lavery LA, Reyzelman AM, et al. A clinical trial of Integra Template for diabetic foot ulcer treatment. Wound Repair Regen. Nov 12 2015;23(6):891-900. PMID 26297933
  • Smiell JM, Treadwell T, Hahn HD, et al. Real-world experience with a decellularized dehydrated human amniotic membrane allograft. Wounds. Jun 2015;27(6):158-169. PMID 26061491
  • Kirsner RS, Sabolinski ML, Parsons NB, et al. Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting. Wound Repair Regen. Sep 2015;23(5):737-744. PMID 26100572
  • Lavery LA, Fulmer J, Shebetka KA, et al. The efficacy and safety of Grafix((R)) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. Oct 2014;11(5):554-560. PMID 25048468
  • Serena TE, Carter MJ, Le LT, et al. A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair Regen. Nov-Dec 2014;22(6):688-693. PMID 25224019
  • Davidson A, Jina NH, Marsh C, et al. Do functional keratin dressings accelerate epithelialization in human partial thickness wounds? A randomized controlled trial on skin graft donor sites. Eplasty. 2013;13:e45. PMID 24058716
  • Wagner FW, The diabetic foot. Orthopedics. 1987 Jan;10(1):163-72.
  • Vu, Michael M., De Oliveira, Jr., Gildasio S., Mayer, Kristen E., Blough, Jordan T., Kim, John Y.S., (2015) A Prospective Study Assessing Complication Rates and Patient-Reported Outcomes in Breast Reconstructions Using a Novel, Deep Dermal Human Acellular Dermal Matrix. Plast Reconstr Surg Glob Open, 3(12):e585;
  • Rosenberg MH, Palaia DA, Cahan AC, Arthur KS, DeLuca-Pytell DM, Bonanno PC. (2014) Breast Reconstruction With or Without Human Acellular Dermal Matrices: A Single-Clinic, Review of Esthetic Outcomes and Risk Factors for Complications. The Am J Cosm Surg, 31(1): 7-17.
  • Liu D, Mathes D, Neligan P, Chir B, Said H, Louie O. (2014) Comparison of Outcomes Using AlloDerm Versus FlexHD for Implant-Based Breast Reconstruction. Ann Plast Surg, 72(5):503-507.
  • Driver VR, Lavery LA, Reyzelman AM, et al. A clinical trial of Integra template for diabetic foot ulcer treatment, Wound Rep Reg (2015) 00 00–00 VC 2015 by the Wound Healing Society.
  • Zelen CM, Serena TE, Gould L, Le L, Carter MJ, Keller J, Li WW. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J 2015; doi: 10.1111/iwj.12566
  • Zelen CM, Serena TE, Gould L, Le L, Carter MJ, Keller J, Li WW. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J 2015; doi: 10.1111/iwj.12566
  • Serena TE, Carter MJ, Le LT, Sabo MJ, DiMarco DT; EpiFix VLU Study Group. A Multi-center Randomized Controlled Clinical Trial Evaluating the Use of Dehydrated Human Amnion/Chorion Membrane Allografts and Multi-layer Compression Therapy vs. Multi-layer Compression Therapy Alone in the Treatment of Venous Leg Ulcers. Wound Repair Regen. 2014 Nov;22(6):688-93. doi: 10.1111/wrr.12227. Epub 2015 Jan 8.
  • Zelen CM, Poka A, Andrews J. Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study. Foot Ankle Int. Oct 2013;34(10):1332-1339. PMID 23945520
  • Hanselman AE, Tidwell JE, Santrock RD. Cryopreserved human amniotic membrane injection for plantar fasciitis: a randomized, controlled, double-blind pilot study. Foot Ankle Int. Feb 2015;36(2):151-158. PMID 25249320
  • Vines JB, Aliprantis AO, Gomoll AH, et al. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. Dec 18 2015. PMID 26683979
  • Lee SM, Stewart CL, Miller CJ, et al. The histopathologic features of Integra dermal regeneration template. J Cutan Pathol. 2015;42(5):368–9. doi: 10.1111/cup.12488.
  • Verbelen J, Hoeksema H, Pirayesh A, et al. Exposed tibial bone after burns: flap reconstruction versus dermal substitute. Burns. 2015. doi:10.1016.
  • Frykberg, R., Cazzell, S., et. al. Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: an interim analysis. J Wound Care. 2016 Jul;25 Suppl 7:S18-25. doi: 10.12968/jowc.2016.25.7.S18.
  • Guest J, Weidlich D, et. al. Cost-effectiveness of using adjunctive porcine small intestine submucosa tri-layer matrix compared with standard care in managing diabetic foot ulcers in the US. J Wound Care. 2017 Jan 2;26(Sup1):S12-S24. doi: 10.12968/jowc.2017.26.Sup1.S12.
  • Driver V, Lavery L, et. al. A clinical trial of Integra Template for diabetic foot ulcer treatment. Wound Repair Regen. 2015 Nov-Dec;23(6):891-900. doi: 10.1111/wrr.12357. Epub 2015 Oct 19.
  • Snyder R, Shimozaki K, Tallis A, et. al. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds. 2016 Mar;28(3):70-7.
  • ECRI Institute Dermacell Advanced Decellularized Dermis for Breast Reconstruction. Health Technology Assessment, March 2018. 
  • Hinchcliff KM, Orbay H, Busse BK, et al. Comparison of two cadaveric acellular dermal matrices for immediate breast reconstruction: A prospective randomized trial. J Plast Reconstr Aesthet Surg. May 2017;70(5):568-576. PMID 28341592
  • Mendenhall SD, Anderson LA, Ying J, et al. The BREASTrial Stage II: ADM breast reconstruction outcomes from definitive reconstruction to 3 months postoperative. Plast Reconstr Surg Glob Open. Jan 2017;5(1):e1209. PMID 28203509
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  • Wound Source. DermACELL. [Wound Source Web site]. 
  • Wood BC, Kirman CN, Molnar JA. Skin Grafts and Biologic Skin Substitutes. [Medscape Web site]. 03/27/2015. 
  • Genesis Biologics. Genesis Amnion. 2018. 
  • Integra LifeSciences. AmnioExcel amniotic allograft membrane. 2018. 
  • PolartityTE®. SkinTE™ for providers. 2018. Accessed Nov 8, 2019. 
  • Ananian CE, Dhillon YS, Van Gils CC, Lindsey DC, Otto RJ, Dove CR, Pierce JT, Saunders MC. A multicenter, randomized, single-blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast-derived dermal substitute for the treatment of chronic diabetic foot ulcers. Wound Repair Regen. 2018 Aug 11.
  • Arthrex® Inc. Arthrex amnion™ matrix and viscous. 2018. 
  • Axogen. Avive soft tissue membrane. 2018. 
  • Boston Scientific™. Repliform™ Tissue Regeneration Matrix. 2017. 
  • Cazzell S, Stewart J, Agnew PS, Senatore J, Walters J, Murdoch D, Reyzelman A, Miller SD. Randomized controlled trial of micronized dehydrated human amnion/chorion membrane (dHACM) injection compared to placebo for the treatment of plantar fasciitis. Foot Ankle Int. 2018 Oct;39(10):1151-1161.
  • Musculoskeletal Transplant Foundation (MTF). Amnioband® and AlloPatch Pliable. 2017.  
  • Raspovic KM, Wukich DK, Naiman DQ, Lavery LA, Kirsner RS, Kim PJ, Steinberg JS, Attinger CE, Danilkovitch A. Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real world setting. Wound Repair Regen. 2018 Mar;26(2):213-220.
  • Michael A. Towler, Elaine W. Rush, Melissa K. Richardson, Calvin L. Williams, Randomized, Prospective, Blinded-Enrollment, Head-To-Head Venous Leg Ulcer Healing Trial Comparing Living, Bioengineered Skin Graft Substitute (Apligraf) with Living, Cryopreserved, Human Skin Allograft (TheraSkin), Clinics in Podiatric Medicine and Surgery, Volume 35, Issue 3, 2018, Pages 357-365.
  • Santema, K., Poyck, P. et al. Systematic review and meta-analysis of skin substitutes in the treatment of diabetic foot ulcers: Highlights of a Cochrane systematic review. Wound Rep Reg (2016) 24 737–744. 
  • Cazelle, S., Vayser, D., Pham, H. et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Rep Reg (2017).

 

Policy History:

  • March 2019 - Annual Review, Policy Revised
  • March 2018 - Annual Review, Policy Revised
  • March 2017 - Annual Review, Policy Revised
  • November 2016 - Annual Review, Policy Revised
  • September 2016 - Interim Review, Policy Revised
  • March 2016 - Annual Review, Policy Revised
  • April 2015 - Annual Review, Policy Revised
  • June 2014 - Annual Review, Policy Revised
  • July 2013 - Annual Review, Policy Revised
  • May 2013 - Annual Review, Policy Renewed
  • August 2012 - Annual Review, Policy Renewed
  • September 2011 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.