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Bio-Engineered Skin and Soft Tissue Substitutes

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 02.01.17 
Original Effective Date: May 1999 
Reviewed: April 2015 
Revised: April 2015 


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. 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 can be divided into two broad categories: biomaterial and cellular. Biomaterial skin substitutes do not contain cells (acellular) and are derived from natural or synthetic sources. Natural sources include human cadaver skin processed to remove the cellular components and retain the structural proteins of the dermis and collagen matrix obtained from bovine and porcine sources. Synthetic sources include various degradable polymers such as polylactide and polyglycolide. Whether natural or synthetic, the biomaterial provides an extracellular matrix that allows for infiltration of surrounding cells. Cellular skin substitutes are distinguished by their origin: xenogeneic (from nonhuman species), autologous (from the patient), and allogenic (from another human).

 

Bio-engineered skin and soft tissue substitutes are being evaluated for a variety of conditions, including breast reconstruction and to aid healing of lower extremity ulcers and severe burns. Acellular dermal matrix products are also being evaluated in the repair of a variety of soft tissues.


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Prior Approval: 

 

Not applicable


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Policy: 

Breast Reconstruction

Breast reconstructive surgery using AlloDerm® or GraftJacket® Regenerative Tissue Matrix may be considered medically necessary for any of the following:

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

Use of AlloDerm® or GraftJacket® Regenerative Tissue Matrix 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 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) using the following tissue-engineered skin substitutes may be considered medically necessary:

  • Apligraf®
  • Oasis™ Wound Matrix

The ulcer must be free of infection, osteomyelitis, surrounding cellulitis, tunnels and tracts.

 

The ulcer must extend through the dermis but not expose tendon, muscle, joint capsule, or bone.

 

There must be adequate blood supply as evidenced by a palpable pedal pulse.

 

Repeat application without improvement of the wound is considered not medically necessary.

 

Epidermolysis bullosa

Treatment of dystrophic epidermolysis bullosa using the following tissue-engineered skin substitutes may be considered medically necessary:

  • OrCel™ (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 ulcersmay be considered medically necessary with the following tissue-engineered skin substitutes and characteristics:

  • Apligraf®
  • Dermagraft®

Diabetic foot ulcers must have all the following characteristics:

  • 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 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 AND
  • Must measure a minimum of 1cm2

 

Repeat use of any skin substitute without signs of improvement is considered not medically necessary.

 

 

All other uses of the bio-engineered skin and soft tissue substitutes including but not limited to, surgical wounds, hernia repair, abdominal wall reconstruction, wound covering, tendon repair, dental procedures, and pressure ulcers/decubitus ulcers are considered investigational.

 

 

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. 

 

 

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:

  • Affinity
  • AlloPatch HD™
  • AlloMax™
  • AlloSkin™/ Alloskin ac
  • AlloSkin™ RT
  • Allowrap
  • Amnioband
  • Amnioexcel or biodexcel
  • Amniofix
  • Architect extracellular matrix
  • ArthroFlex™ (FlexGraft)
  • Avaulta Plus™
  • BioDfence/BioDfactor
  • Biovance
  • CellerateRX®
  • ClarixFlo
  • Conexa™
  • CorMatrix®
  • Cortiva Allograft Dermis
  • CRXa™
  • Cymetra®
  • DermaMatrix Acellular Dermis
  • Dermapure
  • Durepair Regeneration Matrix®
  • Dermavest
  • Endoform Dermal Template™
  • ENDURAgen™
  • Epifix
  • Excellagen
  • E-Z Derm™
  • FlexHD® Acellular Hydrated Dermis
  • GammaGraft
  • GraftJacket® Xpress, injectable
  • Hyalomatrix® PA (hMatrix)
  • Integra™ Flowable Wound Matrix
  • Integra™ Bilayer Wound Matrix
  • Marigen
  • MatriStem® Micromatrix
  • MatriStem® Wound Matrix
  • MatriStem® Burn Matrix
  • Matrix HD™
  • MediHoney®
  • Mediskin®
  • MemoDerm™
  • Neox 100/1k
  • Neoxflo
  • NuCel™
  • Nushield
  • PriMatrix
  • Oasis® Burn Matrix
  • Oasis® Ultra Tri-Layer Matrix
  • Permacol™
  • Repriza™
  • Revitalon
  • Strattice™ (xenograft)
  • SurgiMend®
  • Talymed®
  • TenoGlide™
  • Tensix
  • Theraform
  • TheraSkin®Unite™
  • Veritas® Collagen Matrix
  • Xcm biologic tissue matrix




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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 Skin substitute, Integra dermal regeneration template (DRT), 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
  • Q4109 Skin substitute, TissueMend, 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
  • Q4119 MatriStem wound matrix, per sq cm
  • Q4120 MatriStem burn matrix, per sq cm
  • Q4121 TheraSkin, per sq cm     
  • Q4122 DermACELL, per sq cm
  • Q4123 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
  • Q4129 Unite biomatrix, per sq cm
  • Q4130 Strattice TM, per sq cm
  • Q4131 EpiFix, per sq cm
  • Q4132 Grafix core, per sq cm
  • Q4133 Grafix 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
  • Q4139 Amniomatrix or biodmatrix, injectable, 1 cc
  • Q4140 Biodfence, per sq cm
  • Q4141 Alloskin AC, per sq cm
  • Q4142 XCM biologic tissue matrix, per sq cm
  • Q4143 Repriza, per sq cm
  • Q4145 Epifix, injectable, 1 mg
  • Q4146 Tensix, per sq cm
  • Q4147 Architect extracellular matrix, per sq cm
  • Q4148 Neox 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, per sq cm
  • Q4154 Biovance, per sq cm
  • Q4155 Neoxflo or clarixflo 1 mg
  • Q4156 Neox 100, per sq cm
  • Q4157 Revitalon, per sq cm
  • Q4158 Marigen, per sq cm
  • Q4159 Affinity, per sq cm
  • Q4160 Nushield, per square centimeter  
  • 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    
  • C9363 Skin substitute (Integra Meshed Bilayer Wound Matrix), per square cm
  • C9364 Porcine implant, Permacol, per sq cm          

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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.
  • A review of the medical literature and recommendations from the Medical Policy Advisory Council (MPAC), which assists Wellmark's medical directors in the development of medical policies.  MPAC is comprised of practicing physicians from Iowa and South Dakota.
  • 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. Available:http://www.ecri.org.
  • 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 Health Technology Information Service; 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.
  • Pham C, Greenwood J, Cleland H et al. Bioenginnered skin substitutes for the management of burns: A systematic review. Burns. 2007 Dec;33(8):946-57.
  • 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. Accessible at http://aawconline.org/professional-resources/resources
  • 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
  • Sanders L, Landsman AS, Landsman A, et al. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft. Ostomy Wound Manage. Sep 2014;60(9):26-38. PMID 25211605
  • 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.

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Policy History: 

 

Date                                        Reason                              Action

September 2011                     Annual review                   Policy renewed

August 2012                           Annual review                   Policy renewed

May 2013                               Interim review                   Policy renewed

July 2013                               Annual review                   Policy revised

June 2014                              Annual review                   Policy revised

April 2015                              Annual review                   Policy revised


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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.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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