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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-10000-11

Original Effective Date: 01/01/01

Reviewed: 02/23/17

Revised: 08/15/17

Subject: Bio-Engineered Skin and Soft Tissue Substitutes; Amniotic Membrane and Amniotic Fluid

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Bio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), non-human tissue (xenographic), synthetic materials, or a composite of these materials.

Bio-engineered skin and soft tissue substitutes may be either acellular or cellular. Acellular products (i.e., cadaveric human dermis with cellular material removed) contain a matrix or scaffold composed of materials such as collagen, hyaluronic acid, and fibronectin. Cellular products contain living, cells such as fibroblasts and keratinocytes within a matrix. The cells contained within the matrix may be autologous, allogeneic, or derived from other species (e.g., bovine, porcine). Skin substitutes may also be composed of dermal cells, epidermal cells, or a combination of dermal and epidermal cells, and may provide growth factors to stimulate healing. Tissue-engineered skin substitutes can be used as either temporary or permanent wound coverings.

There are a large number of artificial skin products that are commercially available or in development. The following summary of commercially available skin substitutes describes those products that have substantial relevant evidence on efficacy. This list (not all inclusive) demonstrates the wide range of types of products available:

Acellular Dermal Matrix

Allograft acellular dermal matrix products derived from donated human skin tissue are supplied by U.S. AATB-compliant tissue banks using the standards of the American Association of Tissue Banks (AATB) and U.S. Food and Drug Administration’s (FDA) guidelines. The processing removes the cellular components (i.e., epidermis and all viable dermal cells) that can lead to rejection and infection. Acellular dermal matrix products from human skin tissue are regarded as minimally processed and not significantly changed in structure from the natural material; the FDA classifies it as banked human tissue and therefore does not require FDA approval.

Collagen Scaffold

OASIS™ Wound Matrix (Cook Biotech) is a xenogeneic collagen scaffold derived from porcine small intestinal mucosa. It was cleared by the FDA’s 510(k) process in 2000 for the management of partial- and full-thickness wounds including pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled undermined wounds, surgical wounds, trauma wounds, and draining wounds.

Living Cell Therapy

Apligraf® (Organogenesis) is a bi-layered living cell therapy composed of an epidermal layer of living human keratinocytes and a dermal layer of living human fibroblasts. Apligraf® is supplied as needed, in 1 size, with a shelf-life of 10 days. It was FDA-approved in 1998 for use in conjunction with compression therapy for the treatment of non-infected, partial- and full-thickness skin ulcers due to venous insufficiency and in 2001 for full-thickness neuropathic diabetic lower extremity ulcers nonresponsive to standard wound therapy.

Dermagraft® (Advanced Tissue Sciences) is composed of cryopreserved human-derived fibroblasts and collagen applied to a bioabsorbable mesh. Dermagraft has been approved by the FDA for repair of diabetic foot ulcers.

Epicel® (Genzyme Biosurgery) is a cultured epithelial autograft and is FDA-approved under a humanitarian device exemption (HDE) for the treatment of deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30%. It may be used in conjunction with split-thickness autografts or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

OrCel™ (Forticell Bioscience) (formerly called Composite Cultured Skin) is an absorbable allogeneic bi-layered cellular matrix, made of bovine collagen, in which human dermal cells have been cultured. It was approved by the FDA premarket approval (PMA) for healing donor site wounds in burn victims and under a humanitarian device exemption (HDE) for use in patients with recessive dystrophic epidermolysis bullosa undergoing hand reconstruction surgery to close and heal wounds created by the surgery, including those at donor sites.

Biosynthetic

Integra® Dermal Regeneration Template (Integra LifeSciences) is a bovine, collagen/glycosaminoglycan dermal replacement covered by a silicone temporary epidermal substitute. It is FDA-approved for use in postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injury where sufficient autograft is not available at the time of excision or not desirable because of the physiologic condition of the patient. Integra™ Matrix Wound Dressing and Integra™ meshed Bilayer Wound Matrix are substantially equivalent skin substitutes that are FDA- 510(k) approved for other indications.

TransCyte™ (Advanced Tissue Sciences) consists of human dermal fibroblasts grown on nylon mesh, combined with a synthetic epidermal layer and was approved by the FDA in 1997. TransCyte is intended to be used as a temporary covering over burns until autografting is possible. It can also be used as a temporary covering for some burn wounds that heal without autografting.

Amniotic Membrane and Amniotic Fluid

Several commercially available forms of human amniotic membrane (HAM) and amniotic fluid can be administered by patches, topical application, or injection. Amniotic membrane and amniotic fluid are being evaluated for the treatment of various conditions, including chronic full thickness diabetic lower extremity ulcers, venous ulcers, knee osteoarthritis, plantar fasciitis, and ophthalmic conditions.

POSITION STATEMENT:

Note: This guideline does not address the use of meshes or patches of non-biologic origin used for standard repair procedures such as hernia repairs.

Bio-Engineered Skin and Soft Tissue Substitutes

Breast reconstructive surgery using allogeneic acellular dermal matrix products* (i.e. AlloDerm®, AlloMax™, DermaMatrix™, FlexHD®, GraftJacket®) meets the definition of medical necessity for ONE of the following indications:

Treatment of chronic, non-infected, full-thickness diabetic lower extremity ulcers using the following tissue-engineered skin substitutes meets the definition of medical necessity:

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, using the following tissue-engineered skin substitutes meets the definition of medical necessity:

Treatment of dystrophic epidermolysis bullosa using the following tissue-engineered skin substitutes meets the definition of medical necessity:

Treatment of second- and third-degree burns using the following tissue-engineered skin substitutes meets the definition of medical necessity:

* Banked Human Tissue

** FDA premarket approval

*** FDA 510(k) cleared

**** FDA-approved under a humanitarian device exemption (HDE).

All other uses of bio-engineered skin and soft tissue substitutes listed above are considered experimental or Investigational. The scientific evidence does not permit conclusions on health outcomes.

Amniotic Membrane and Amniotic Fluid

Treatment of nonhealing diabetic lower-extremity ulcers using the following human amniotic membrane products meets the definition of medical necessity:

All other human amniotic membrane products and indications not listed above are considered experimental or investigational. The evidence is insufficient to determine the effects of the technology on health outcomes.

The following is considered experimental or investigational for all indications:

The evidence is insufficient to determine the effects of the technology on health outcomes.

All other bio-engineered skin substitutes, soft tissue substitutes, amniotic membranes and amniotic fluids are considered experimental or Investigational, including, but not limited to:

There is a lack of clinical data to permit conclusions on clinical utility and net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

Application of skin replacements and skin substitutes is reported with CPT codes 15040-15278. Codes 15040-15261 are specific to autografts and tissue-cultured autografts, codes 15271-15278 are specific to skin substitute grafts.

HCPCS Coding:

C9354

Acellular pericardial tissue matrix of nonhuman origin (Veritas), per sq cm (Investigational)

C9356

Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (TenoGlide Tendon Protector Sheet), per sq cm (Investigational)

C9358

Dermal substitute, native, nondenatured collagen, fetal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm (Investigational)

C9360

Dermal substitute, native, nondenatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm (Investigational)

C9363

Skin substitute (Integra Meshed Bilayer Wound Matrix), per square cm (Investigational)

C9364

Porcine implant, Permacol, per sq cm (Investigational)

Q4100

Skin substitute, not otherwise classified

Q4101

Apligraf, per square centimeter

Q4102

Oasis Wound Matrix, per square centimeter

Q4103

Oasis Burn Matrix, per square centimeter (Investigational)

Q4104

Integra Bilayer Matrix Wound Dressing (BMWD), per square centimeter (Investigational)

Q4105

Integra dermal regeneration template (drt) or integra omnigraft dermal regeneration matrix, per square centimeter

Q4106

Dermagraft, per square centimeter

Q4107

Graftjacket, per square centimeter

Q4108

Integra Matrix , per square centimeter (Investigational)

Q4110

PriMatrix, per square centimeter (Investigational)

Q4111

Gammagraft, per square centimeter (Investigational)

Q4112

Cymetra, injectable, 1 cc (Investigational)

Q4113

Allograft, Graftjacket Xpress, injectable, 1 cc (Investigational)

Q4114

Integra Flowable Wound Matrix, injectable, 1 cc (Investigational)

Q4115

Alloskin, per square centimeter (Investigational)

Q4116

Alloderm, per square centimeter

Q4117

Hyalomatrix, per square centimeter (Investigational)

Q4118

Matristem Micromatrix, 1 MG (Investigational)

Q4121

Theraskin, per square centimeter (Investigational)

Q4122

Dermalcell, per square centimeter (Investigational)

Q4123

AlloskinRT, per square centimeter (Investigational)

Q4124

Oasis Ultra Tri-layer wound matrix, per square centimeter (Investigational)

Q4125

Arthroflex, per square centimeter (Investigational)

Q4126

Memoderm, Dermospan, Tranzgraft or Integuply, per square centimeter (Investigational)

Q4127

Talymed, per square centimeter (Investigational)

Q4128

FlexHD, AllopatchHD, or Matrix HD, per square centimeter

Q4130

StratticeTM, per square centimeter (Investigational)

Q4131

EpiFix or epicord, per square centimeter

Q4132

Grafix Core, per sq cm

Q4133

Grafix Prime, per sq cm

Q4134

hMmatrix, per square centimeter (Investigational)

Q4135

Mediskin, per square centimeter (Investigational)

Q4136

EZ-Derm, per square centimeter (Investigational)

Q4137

AmnioExCel per square centimeter (Investigational)

Q4138

BioDfence Dryflex per square centimeter (Investigational)

Q4139

AmnioMatrix or BioDMatrix, injectable, 1 cc (Investigational)

Q4140

BioDfense, per square centimeter (Investigational)

Q4141

Alloskin AC, per square centimeter (Investigational)

Q4142

XCM Biologic Tissue Matrix, per square centimeter (Investigational)

Q4143

Repriza, per square centimeter (Investigational)

Q4145

Epifix, injectable, 1 mg (Investigational)

Q4146

TenSIX, per square centimeter (Investigational)

Q4147

Architect, Architect PX, or Architect FX, extracellular matrix, per square centimeter (Investigational)

Q4148

Neox 1K, per square centimeter (Investigational)

Q4149

Excellagen, 0.1 cc (Investigational)

Q4150

Allowrap ds or dry, per square centimeter (Investigational)

Q4151

Amnioband or guardian, per square centimeter

Q4152

Dermapure, per square centimeter (Investigational)

Q4153

Dermavest and plurivest, per square centimeter (Investigational)

Q4154

Biovance, per square centimeter

Q4155

Neoxflo or clarixflo, 1 mg (Investigational)

Q4156

Neox 100, per square centimeter (Investigational)

Q4157

Revitalon, per square centimeter (Investigational)

Q4158

Marigen, per square centimeter (Investigational)

Q4159

Affinity, per square centimeter (Investigational)

Q4160

Nushield, per square centimeter (Investigational)

Q4161

Bio-connekt wound matrix, per square centimeter (Investigational)

Q4162

Amniopro flow, bioskin flow, biorenew flow, woundex flow, amniogen-a, amniogen-c, 0.5 cc (Investigational)

Q4163

Amniopro, bioskin, biorenew, woundex, amniogen-45, amniogen-200, per square centimeter (Investigational)

Q4164

Helicoll, per square centimeter (Investigational)

Q4165

Keramatrix, per square centimeter (Investigational)

Q4166

Cytal, per square centimeter (Investigational)

Q4167

Truskin, per square centimeter (Investigational)

Q4168

Amnioband, 1 mg (Investigational)

Q4169

Artacent wound, per square centimeter (Investigational)

Q4170

Cygnus, per square centimeter (Investigational)

Q4171

Interfyl, 1 mg (Investigational)

Q4172

Puraply or puraply am, per square centimeter (Investigational)

Q4173

Palingen or palingen xplus, per square centimeter (Investigational)

Q4174

Palingen or promatrx, 0.36 mg per 0.25 cc (Investigational)

Q4175

Miroderm, per square centimeter (Investigational)

ICD-10 Diagnoses Codes That Support Medical Necessity:

C50.011 – C50.019
C50.111 – C50.119
C50.211 – C50.219
C50.311 – C50.319
C50.411 – C50.519
C50.611 – C50.619
C50.811 – C50.819
C50.911 – C50.919

Malignant neoplasm of breast

D05.00 – D05.92

Carcinoma in situ of breast

E08.621

Diabetes mellitus due to underlying condition with foot ulcer

E08.622

Diabetes mellitus due to underlying condition with other skin ulcer

E09.621

Drug or chemical induced diabetes mellitus with foot ulcer

E09.622

Drug or chemical induced diabetes mellitus with other skin ulcer

E10.621

Type 1 diabetes mellitus with foot ulcer

E10.622

Type 1 diabetes mellitus with other skin ulcer

E11.621

Type 2 diabetes mellitus with foot ulcer

E11.622

Type 2 diabetes mellitus with other skin ulcer

E13.621

Other specified diabetes mellitus with foot ulcer

E13.622

Other specified diabetes mellitus with other skin ulcer

I83.001 – I83.029

Varicose veins of lower extremities with ulcer

I83.201 – I83.229

Varicose veins of lower extremities with both ulcer and inflammation

Q81.2

Epidermolysis bullosa dystrophica

T20.20xA – T20.39xS
T20.60xA – T20.79xS

Burn and corrosion of head, face and neck

T21.20xA – T21.39xS
T21.60xA – T21.79xS

Burn and corrosion of trunk

T22.20xA – T22.399S
T22.60xA – T22.799S

Burn and corrosion of shoulder and upper limb except wrist and hand

T23.201A – T23.399S
T23.601A – T23.799S

Burn and corrosion of wrist and hand

T24.201A – T24.399S
T24.601A – T24.799S

Burn and corrosion of lower limb, except ankle and foot

T25.211A – T25.399S
T25.611A – T25.799S

Burn and corrosion of ankle and foot

T30.0 – T32.99

Burns classified according to extent of body surface involvement

REIMBURSEMENT INFORMATION:

Apligraf® is limited to five (5) applications per ulcer. The safety and the effectiveness of Apligraf have not been established for patients receiving greater than 5 applications.

Dermagraft® is limited to eight (8) applications per treatment site over a twelve (12) week period. Dermagraft has not been studied in patients receiving greater than 8 device applications.

OrCel™ is limited to a single, one-time application per donor site. No more than eight (8) pieces should be used per donor site. The safety and effectiveness of OrCel has not been evaluated in burn patients with split thickness donor sites larger than 288cm (8 pieces of Orcel).

Safety and effectiveness of re-treatment of a single wound using Apligraf®, Dermagraft® or OrCel™ has not been established and is considered experimental or Investigational.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Porcine skin and Gradient Pressure Dressing (270.5) located at cms.gov.

The following was reviewed on the last guideline reviewed date: CMS issues hospital outpatient department and ambulatory surgical center policy and payment changes for 2014, located at cms.gov.

The following Local Coverage Determinations (LCDs) were reviewed on the last guideline reviewed date and are located at fcso.com:

• Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities (L36377)

• Amniotic Membrane- Sutureless Placement on the Ocular Surface (L36237).

DEFINITIONS:

Nonhealing- less than a 20% decrease in wound area with standard wound care for at least 2 weeks.

RELATED GUIDELINES:

None.

OTHER:

None.

REFERENCES:

  1. Agency for Healthcare Research and Quality (AHRQ), Negative Pressure Wound Therapy Devices, Technology Assessment Report, 2009. Accessed at ahrq.gov 08/02/12.
  2. Agency for Healthcare Research and Quality (AHRQ), Skin Substitutes for Treating Chronic Wounds, 12/18/12.
  3. American Diabetes Association, Diabetes Care- Graftskin, A Human Skin Equivalent, Is Effective in the Management of Noninfected Neuropathic Diabetic Foot Ulcers, 2001.
  4. American Society of Plastic Surgeons. Evidence-Based Clinical Practice Guideline: Breast Reconstruction with Expanders and Implants. 2013; accessed at plasticsurgery.org 01/21/14.
  5. American Society of Plastic Surgeons (ASPS). Evidence-based Clinical Practice Guideline: Chronic Wounds of the Lower Extremity. 2007. Accessed at plasticsurgery.org 05/14/13.
  6. Athavale SM, Phillips S, Mangus B et al. Complications of alloderm and dermamatrix for parotidectomy reconstruction. Head Neck 2011.
  7. Bastidas N, Ashjian PJ, Sharma S, Acellular Dermal Matrix for Temporary Coverage of Exposed Critical Neurovascular Structures in Extremity Wounds, Annals of Plastic Surgery, April 2009, Vol 62, Issue 4, pp 410-413.
  8. Bergstrom N, Bennett MA, Carlson CE, et al., Treatment of Pressure Ulcers, Clinical Practice Guideline, Agency for Healthcare Research and Quality (AHRQ), 12/94.
  9. Blue Cross Blue Shield Association, Medical Policy Reference Manual: 7.01.149 Amniotic Membrane and Amniotic Fluid Injections, 01/17.
  10. Blue Cross Blue Shield Association, Medical Policy Reference Manual: 7.01.113 Bio-Engineered Skin and Soft Tissue Substitutes, 06/17.
  11. Blue Cross and Blue Shield Technology Evaluation Center. Grafskin for the treatment of skin ulcers. TEC Assessments 2001; Volume 16, Tab 12.
  12. Brantley JN, Verla TD, Use of Placental Membranes for the Treatment of Chronic Diabetic Foot Ulcers. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):545-559.
  13. Budny AM, Ley A, Cryopreserved Allograft as an Alternative Option for Closure of Diabetic Foot Ulcers, Podiatry Management, 2013; 131-136.
  14. 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.
  15. Cazzell SM, et al, The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial. Adv Wound Care (New Rochelle). 2015 Dec 1;4(12):711-718.
  16. Centers for Medicare and Medicaid Services (CMS). Newsroom: CMS issues hospital outpatient department and ambulatory surgical center policy and payment changes for 2014; release 11/27/13; accessed at cms.gov.
  17. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Porcine skin and Gradient Pressure Dressing (270.5), accessed at cms.gov 02/24/16.
  18. ClinicalTrials.gov, Clinical and Histologic Evaluation of Acellular Dermal Matrix Substitute in Breast Reconstruction, sponsored by University of Utah, accessed 06/01/09.
  19. ClinicalTrials.gov, The Effect of OASIS Ultra on Critical Sized Wound Healing, sponsored by Massachusetts General Hospital, accessed 01/30/14.
  20. ClinicalTrials.gov, OASIS Mechanism of Action, sponsored by Healthpoint, accessed 06/01/09.
  21. ClinicalTrials.gov, Skin Substitutes in Burn Care, sponsored by The University of Texas, Galveston, accessed 06/01/09.
  22. ClinicalTrials.gov, Study of OASIS Ultra in Diabetic Foot Ulcers, sponsored by Healthpoint, accessed 01/30/14.
  23. ClinicalTrials.gov, Study of Root Coverage with Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®, sponsored by Zimmer Inc, accessed 06/01/09.
  24. ClinicalTrials.gov, Tissue Expander/Implant Reconstruction: A Single-Blinded, Randomized, Controlled Trial, sponsored by Memorial Sloan-Kettering Cancer Center, University of Michigan and the University of North Carolina, Chapel Hill, accessed 06/01/09.
  25. ClinicalTrials.gov, Use of Graft Jacket for Rotator Cuff Repair, sponsored by Fowler Kennedy Sport Medicine Clinic and Wright Medical Technology, accessed 06/01/09.
  26. ClinicalTrials.gov, VA MERIT: A Comparative Study: Treatment of Non-Healing Diabetic Foot Ulcers (DOLCE), sponsored by VA Northern California Health Care System, accessed 01/30/14.
  27. Derderian CA, Karp NS, Choi M, Wise-Pattern Breast Reconstruction: Modification Using Alloderm and a Subcutaneous Pedicle, Annals of Plastic Surgery, May 2009 – Vol 62, Issue 5, pp 528-532.
  28. DiDomenico L, Emch KJ, et al, A Prospective Comparison of Diabetic Foot Ulcers Treated With Either a Cryopreserved Skin Allograft or a Bioengineered Skin Substitute WOUNDS 2011;23(7):184–189.
  29. DiDomenico LA, Orgill DP, et al, Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial. Plast Reconstr Surg Glob Open. 2016 Oct 12;4(10):e1095.
  30. Duan-Arnold Y, Gyurdieva A, et al; Soluble Factors Released by Endogenous Viable Cells Enhance the Antioxidant and Chemoattractive Activities of Cryopreserved Amniotic Membrane. Advances in Wound Care. May 2015, 4(6): 329-338.
  31. Duan-Arnold Y, Uveges TE, et al; Angiogenic Potential of Cryopreserved Amniotic Membrane Is Enhanced Through Retention of All Tissue Components in Their Native State. Advances in Wound Care. August 2015, 4(9): 513-522.
  32. ECRI Institute Product Brief, Oasis Wound Matrix (Healthpoint Biotherapeutics) for Managing Chronic Wounds, March 2013.
  33. ECRI Institute Product Brief, Strattice tissue Matrix (lifeCell Corp.) for Reconstructive Surgery, April 2013.
  34. ECRI Institute, Porcine-derived Extracellular Matrix (Oasis Wound Matrix) for Wound Management, updated 04/12/07.
  35. ECRI Windows Report. “Bioengineered Skin and Dermal Cell Replacement for Chronic Diabetic Ulcers”, 02/02.
  36. Fetterolf D, Savage R, Dehydrated Human Amniotic Tissue Improves Healing Time, Cost of Care. Today’s Wound Clinic, Jan/Feb 2013.
  37. First Coast Service Options, Inc. (FCSO), LCD for Amniotic Membrane- Sutureless Placement on the Ocular Surface (L36237), 10/16.
  38. First Coast Service Options, Inc. (FCSO), LCD for Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities (L36377),10/15.
  39. Fleshman JW, Beck DE, et al. A prospective, multicenter, randomized, controlled study of non-cross-linked porcine acellular dermal matrix fascial sublay for parastomal reinforcement in patients undergoing surgery for permanent abdominal wall ostomies. Dis Colon Rectum. May 2014;57(5):623-631.
  40. Frykberg RG, Banks J; Challenges in the Treatment of Chronic Wounds. Advances in Wound Care. August 2015, 4(9): 560-582.
  41. Frykberg RG, Gibbons, GW, et al, A prospective, randomized, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane; Int Wound J. 2016 Aug 3. doi: 10.1111/iwj.12649.
  42. 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. Accessed at acfas.org 05/14/13.
  43. Gaster RS, Berger AJ, Monica SD, et al, Histologic Analysis of Fetal Bovine Derived Acellular Dermal Matrix in Tissue Expander Breast Reconstruction, Annals of Plastic Surgery, Vol.70, Number 4, April 2013.
  44. Gibson GW, Grafix®, a Cryopreserved Placental Membrane, for the Treatment of Chronic/Stalled Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):534-544.
  45. Hankin CS, Knispel J, Lopes M, et al, Clinical and Cost Efficacy of Advanced Wound Care Matrices for Venous Ulcers, J Manag Care Pharm. 2012;18(5):375-84.
  46. Hayes Medical Technology Directory. Skin Substitutes for Wound Healing (SKIN0301.19) 02/01/04, update 02/09/07.
  47. Hopf HW, Ueno C, Aslam R et al. Guidelines for the treatment of arterial insufficiency ulcers. Wound Repair Regen 2006; 14(6)693-710. 2007/01/04, accessed at plasticsurgery.org 05/14/13.
  48. Hsu GS, Utilizing Dehydrated Human Amnion/Chorion Membrane Allograft in Transcanal Tympanoplasty, 4:161. doi: 10.4172/2161-119X.1000161.
  49. Karr JC, Retrospective Comparison of Diabetic Foot Ulcer and Venous Stasis Ulcer Healing Outcome Between a Dermal Repair Scaffold (PriMatrix) and a Bilayered Living Cell Therapy (Apligraf), Adv Skin Wound Care. 2011 Mar;24(3):119-25.
  50. Kavros SJ, Dutra T, et al. The use of PriMatrix, a fetal bovine acellular dermal matrix, in healing chronic diabetic foot ulcers: a prospective multicenter study. Adv Skin Wound Care. Aug 2014;27(8):356-362.
  51. Kirsner RS, Warriner R, Michela M et al. Advanced biological therapies for diabetic foot ulcers. Arch Dermatol 2010; 146(8):857-62.
  52. Komorowska-Timek E, Oberg KC, Timek TA, et al, The Effect of AlloDerm Envelopes on Periprosthetic Capsule Formation With and Without Radiation, Plastic & Reconstructive Surgery, 123(3): 807-816, March 2009.
  53. Koob TJ, et al, Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. International Wound Journal ISSN 1742-4801.
  54. Koob TJ, Rennert R, et al, Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500.
  55. Koob TJ, Lim JJ, et al, Angiogenic properties of dehydrated human amnion/chorion allografts: therapeutic potential for soft tissue repair and regeneration. Vasc Cell. 2014 May 1;6:10.
  56. Landsman A, Living Cell Therapy for Wounds- What’s the Big Deal? Podiatry Management;Nov/Dec2013, Vol. 32 Issue 9, p75-80.
  57. Landsman A, Cook J, et al, Retrospective Study of 188 consecutive patients treated with a Biologically Active Human Skin Allograft (TheraSkin®) for Diabetic Foot and Venous Leg Ulcers, Foot Ankle Spec. 2011 Feb;4(1):29-41.
  58. Landsman A, Rosines E, et al, Characterization of a Cryopreserved Split-Thickness Human Skin Allograft-TheraSkin. Adv Skin Wound Care. 2016 Sep;29(9):399-406.
  59. Lavery LA, Fulmer J, et al, The efficacy and safety of Grafix(®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomized, blinded, clinical trial. Int Wound J. 2014 Oct;11(5):554-60.
  60. Lavery LA, Weir D, Advances in Wound Therapy:Understanding Differences Between Cellular and Acellular Therapies in the Treatment of Chronic Wounds. Wounds, 2014; Suppl 8. Accessed at woundsresearch.com 06/02/16.
  61. Lipsky BA, Berendt AR, Cornia PB et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-173. 2012, accessed at idsociety.org 01/22/14.
  62. Lullove E, Acellular Fetal Bovine Dermal Matrix in the Treatment of Nonhealing Wounds in Patients with Complex Comorbidities, Journal of the American Podiatric Medical Association, Vol 102, No 3, May/June 2012.
  63. Marston WA, et al, The Efficacy and Safety of Dermagraft in Improving the Healing of Chronic Diabetic Foot Ulcers, Diabetes Care 26: 1701-1705, 2003.
  64. Massee M, Chinn K, et al, Dehydrated human amnion/chorion membrane regulates stem cell activity in vitro. J Biomed Mater Res B Appl Biomaster. 2015 Jul 14.
  65. Maus EA, Successful Treatment of Two Refractory Venous Stasis Ulcers Treated with a Novel Poly-N-Acetyl Glucosamine-Derived Membrane, BMJ Case Reports 2012; doi:10.1136/bcr.03.2012.6091.
  66. Mrugala A, Sui A, et al, Amniotic membrane is a potential regenerative option for chronic non-healing wounds: a report of five cases receiving dehydrated human amnion/chorion membrane allograft. Int Wound J. 2015 May 14. doi: 10.1111/iwj.12458.
  67. National Institute for Health and Clinical Excellence (NICE). Diabetic foot problems: Inpatient management of diabetic foot problems. 2011.
  68. National Institute for Health and Clinical Excellence (NICE). Diabetic Foot Problems- Prevention and Management, 2015.
  69. Nemeth NL, Butler CE, Complex Torso Reconstruction with Human Acellular Dermal Matrix: Long-Term Clinical Follow-up, Plastic & Reconstructive Surgery, 123(1): 192-196, January 2009.
  70. Ohkuma R, et al Initial experience with the use of foetal/neonatal bovine acellular dermal collagen matrix (SurgiMend™) for tissue-expander breast reconstruction. Journal of Plastic, Reconstructive & Aesthetic Surgery (2013)1-7.
  71. Penny H, Rifkah M, et al, Dehydrated human amnion/chorion tissue in difficult-to-heal DFUs: a case series. J Wound Care. 2015 Mar;24(3):104; 106-9; 111. doi: 10.12968/jowc.2015.24.3.104.
  72. Requlski M, Jacobstein DA, et al, A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. Ostomy Wound Manage. 2013 Dec;59(12):38-43.
  73. Robson MC, Cooper DM, Aslam R et al. Guidelines for the treatment of venous ulcers. Wound Repair Regen 2006; 14(6): 649-62. 2006; 2007/01/04. Accessed at plasticsurgery.org 05/14/13.
  74. 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.
  75. Saudek CD, Kalyani RR, et al, Johns Hopkins Diabetes Guide 2012: Treatment and Management of Diabetes (Johns Hopkins Medicine), accessed at hopkinsmedicine.org 06/02/14.
  76. Serena T, Bates-Jensen B, et al, Consensus principles for wound care research obtained using a Delphi process, Wound Repair Regen. 2012 May-Jun;20(3):284-93.
  77. Serena TE, et al, Dehydrated human amnion/chorion membrane treatment of venous leg ulcers: correlation between 4-week and 24-week outcomes. J Wound Care. 2015 Nov;24(11):530-4.
  78. Serena TE, Carter MJ, 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. 2014 Nov;22(6):688-93.
  79. Shah AP, Using amniotic membrane allografts in the treatment of neuropathic foot ulcers. J Am Podiatr Med Assoc. 2014 Mar;104(2):198-202.
  80. Sheikh ES, Sheikh ES, et al, Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds. Int Wound J 2013.
  81. Steed DL, Attinger C, Colaizzi T et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen 2006; 14(6):680-92. 2006; 2007/01/04. Accessed at plasticsurgery.org 05/14/13.
  82. Subach BR, Copay AG. The use of a dehydrated amnion/chorion membrane allograft in patients who subsequently undergo reexploration after posterior lumbar instrumentation. Adv Orthop. 2015;2015:501202.
  83. U.S. Food and Drug Administration (FDA), Apligraf®, accessed at fda.gov 06/13/16.
  84. U.S. Food and Drug Administration (FDA), Dermagraft® - P000036, accessed at fda.gov 06/13/16.
  85. U.S. Food and Drug Administration (FDA), Integra® Omnigraft Dermal Regeneration Matrix, accessed at fda.gov 06/02/16.
  86. U.S. Food and Drug Administration (FDA), Medical Devices Requiring Refrigeration, last updated 08/29/12, accessed at fda.gov/medicaldevices 05/14/13.
  87. U.S. Food and Drug Administration (FDA), OrCel Bilayered Cellular Matrix -— P010016, accessed 06/13/16.
  88. Wilson TC, Wilson JA, et al, The Use of Cryopreserved Human Skin Allograft for the Treatment of Wounds With Exposed Muscle, Tendon, and Bone. Wounds. 2016 Apr;28(4):119-25.
  89. Zelen CM, et al, Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: A long-term follow-up study. Wound Medicine 4 (2014) 1–4; available online 11/19/13.
  90. Zelen CM, An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. J Wound Care. 2013 Jul;22(7):347-8, 350-1.
  91. Zelen CM, Orgill DP, et al, prospective, randomized, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers. Int Wound J. 2016 Apr 12. doi: 10.1111/iwj.12600.
  92. Zelen CM, Poka A, et al, Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis -— a feasibility study. Foot Ankle Int. 2013 Oct;34(10):1332-9.
  93. Zelen CM, Serena TE, et al, A prospective, randomized comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers. Int Wound J. 2014 Apr;11(2):122-8.
  94. Zelen CM, Serena TE, Denoziere G et al. A prospective randomized comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J 2013.
  95. Zelen CM, Serena TE, et al, Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomized, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J. 2016 Apr;13(2):272-82.
  96. Zelen CM, Snyder RJ, et al, The use of human amnion/chorion membrane in the clinical setting for lower extremity repair: a review. Clin Podiatr Med Surg. 2015 Jan;32(1):135-46.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/23/17.

GUIDELINE UPDATE INFORMATION:

01/01/01

New Medical Coverage Guideline.

01/01/02

Annual HCPCS coding update.

01/01/03

Annual HCPCS coding update.

02/15/03

Annual Review.

06/15/04

Unscheduled review and revision to guideline; consisting of updated references, deleted J7350 and changed name of MCG from Apligraf (Graftskin) to Human Skin Equivalent Grafts.

01/01/05

Annual HCPCS coding update: consisting of addition of J7343 and J7344 and deletion of Q0182 and Q0183.

01/01/06

Annual HCPCS coding update: added 15000, 15340, 15341, 15360, 15361, 15365, and 15366. Deleted: 15342, 15343, J7343. Revised: J7340, J7342, and J7344.

08/15/06

Biennial review; new information added for Integra, TransCyte, allograft, OrCel, xenograft, AlloDerm; revision to code information; code J7343 added.

01/01/07

Annual HCPCS coding update: added J7345, J7346; deleted 15000 – 15400 & changed to 15002 – 15005 to describe codes used for graft site preparation & graft application.

03/15/07

Revision to guideline; consisting of addition of OASIS Wound Matrix (J7341), revision to criteria for Apligraf (J7340), revision to code information for J7344 and J7343, updated references.

06/15/07

Reformatted guideline.

08/15/07

Review, coverage statements maintained, references updated.

01/01/08

Annual HCPCS coding update: deleted J7345; added J7347, J7348, J7349.

01/01/09

Annual HCPCS coding update: added HCPCS codes Q4100 – Q4114; updated ICD-9 codes 707.10 – 707.19 & 707.8; and deleted HCPCS codes J7340-J7349.

07/01/09

Biennial review: description section, Alloderm position statement, coding and references updated. HCPCS 3rd quarter coding update: added new codes Q4115 and Q4116.

10/15/10

Revision; related ICD-10 codes added.

01/01/11

Annual HCPCS coding update. Added Q4117 – Q4121; revised Q4101 – Q4116; deleted Q4109.

07/15/11

Scheduled review; position statements maintained, coding section and references updated.

01/01/12

Annual HCPCS coding update; added HCPCS codes Q4122-Q4130; CPT coding section updated.

07/15/12

Annual review; position statements, billing/coding information, description section, Medicare program exception, and references updated; formatting changes.

01/01/13

Annual HCPCS update; added Q4131-Q4136; revised Q4119, Q4126, & Q4128. Experimental list updated; formatting changes.

07/15/13

Annual review; description section, position statement, and references updated; formatting changes.

01/01/14

Annual HCPCS update. Added codes Q4137-Q4149. Position statement updated; formatting changes.

03/15/14

Annual review; position statements, Coding, Description, and references updated; formatting changes.

06/15/14

Revision; references updated.

01/01/15

Annual HCPCS/CPT update. Added codes Q4150-Q4160; revised codes Q4119 & Q4147.

03/15/15

Annual review; description and position statement section updated; coding and references updated; formatting changes.

10/01/15

Revision; ICD9 and ICD10 coding sections updated.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/16

Annual HCPCS/CPT update; codes Q4161-Q4165 added; code Q4153 revised.

08/15/16

Revision; policy title, description section, position statement section, coding, and references updated; formatting changes.

10/01/16

Revision; formatting changes. Investigational product list updated.

11/15/16

Revision; coding section updated.

01/01/17

Annual CPT/HCPCS update. Added Q4166-Q4175; revised Q4105 & Q4131; deleted Q4119, Q4120, Q4129.

03/15/17

Revision; Position statements including treatment of diabetic ulcers, amniotic membrane, and investigational product list updated; Code Q4151, program exception, and references updated.

04/15/17

Revision; code C9349 deleted.

08/15/17

Revision; Integra Omnigraft deleted from investigational product list and added to bullet for Integra® Dermal Regeneration Template.

Date Printed: October 20, 2017: 08:41 AM