Medical Policy: 02.01.17
Original Effective Date: May 1999
Reviewed: March 2017
Revised: March 2017
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.
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. Several commercially available forms of human amniotic membrane (HAM) and amniotic fluid can be administered by injection. Amniotic membrane and amniotic fluid injections are being evaluated for the treatment of various conditions, including tendonitis, plantar fasciitis, and osteoarthritis.
There are numerous commercially available forms of human amniotic tissue that are available in a micronized form that can be suspended in liquid and administered by injection. They include AmnioFix® Injectable (MiMedx), Clarix® Flo and Neox® Flo (Amniox), AmnioMatrix® (Derma Sciences), AmnioPro™ (Human Regenerative Technologies), and AmnioGen™ (US Biologix). Amniotic fluid products that are cryopreserved and contain living cells include AmnioVisc™ (previously named AmnioClear® LCT from Liventa Bioscience) and OrthoFlo™ (MiMedx). PalinGen® Flow and Sport Flow™ (Amnio ReGen Solutions) contains cryopreserved amniotic fluid and cryofractured amniotic membrane. ReNu™ (NuTech Medical) is composed of a human amniotic membrane suspension along with amniotic fluid derived cells.
Breast reconstructive surgery using AlloDerm®/AlloDerm Ready to Use, FlexHD, 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®/AlloDerm Ready to Use 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.
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:
- 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 or by ankle-brachial index (ABI) of 0.65 or greater.
- Repeat application without improvement of the wound is considered not medically necessary. (Improvement must be evidenced by measurements and additional documentation.)
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:
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:
Diabetic Foot Ulcers
Treatment of diabetic foot ulcers may be considered medically necessary with the following tissue-engineered skin substitutes and characteristics:
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 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 1cm2 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 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.
- Medical record documentation must clearly document the medical necessity of bioengineered skin substitute application. This would include wound measurement 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.
The following grading system for diabetic ulcers is frequently utilized:
Wagner Grading System
- Grade 1: Superficial Diabetic Ulcer
- Grade 2: Ulcer extension
- Involves ligament, tendon, joint capsule or fascia
- No abscess or Osteomyelitis
- Grade 3: Deep ulcer with abscess or Osteomyelitis (infection inferred)
- Grade 4: Gangrene to portion of forefoot (infection inferred)
- Grade 5: Extensive gangrene of foot (infection inferred)
Repeat use of any skin substitute without signs of improvement is considered not medically necessary.
Injection of micronized amniotic membrane is considered investigational for all indications.
Injection of amniotic fluid is considered investigational for all indications.
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
- plantar fasciitis
- tissue repair
- dental procedures
- pressure ulcers/decubitus ulcers
- fistula 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.
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:
- AlloPatch HD™
- AlloSkin™/ Alloskin ac
- AlloSkin™ RT
- Amnio Wound
- Amnioexcel or biodexcel
- Architect extracellular matrix
- ArthroFlex™ (FlexGraft)
- Avaulta Plus™
- Cortiva Allograft Dermis
- DermaMatrix Acellular Dermis
- Durepair Regeneration Matrix®
- Endoform Dermal Template™
- E-Z Derm™
- FlexHD® Acellular Hydrated Dermis
- GraftJacket® Xpress, injectable
- Hyalomatrix® PA (hMatrix)
- Integra™ Flowable Wound Matrix
- Integra™ Bilayer Wound Matrix
- Kerecis Omega3
- MatriStem® Micromatrix
- MatriStem® Wound Matrix
- MatriStem® Burn Matrix
- Matrix HD™
- Neox 100/1k
- Neoxflo (Amniox)
- PalinGen Flos
- Oasis® Burn Matrix
- Oasis® Ultra Tri-Layer Matrix
- Strattice™ (xenograft)
- Veritas® Collagen Matrix
- Xcm biologic tissue matrix
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
- 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
- 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 or Epicord, 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
- 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 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
- Q4155 Neoxflo or clarixflo 1 mg
- 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
- Q4162 WoundEx Flow, BioSkin Flow, 0.5 cc
- Q4163 WoundEx, BioSkin, per sq cm
- Q4164 Helicoll, per sq cm
- Q4165 Keramatrix, per sq cm
- 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
- Q4174 PalinGen or ProMatrX, 0.36 mg per 0.25 cc
- Q4175 Miroderm, per sq cm
- Q4176 NeoPatch, per sq cm
- Q4177 FlowerAmnioFlo, 0.1 cc
- 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
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.