Skin Substitutes in the Outpatient Setting/media/a223df190bfd4d5bb70401ba7a...Skin Substitutes in the Outpatient Setting + Plan refers to Boston Medical Center Health Plan, Inc. and

Skin Substitutes in the Outpatient Setting + Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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bmchp.org | 888-566-0008 wellsense.org | 877-957-1300 Medical Policy

Skin Substitutes in the Outpatient Setting Policy Number: OCA 3.710 Version Number: 13 Version Effective Date: 04/01/17

Product Applicability

All Plan+ Products

Well Sense Health Plan New Hampshire Medicaid NH Health Protection Program

Boston Medical Center HealthNet Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊

Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options

only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options.

Policy Summary

Certain tissue-engineered skin substitutes utilized in the outpatient setting for wound healing, per the Medical Policy Statement, are considered medically necessary and do not require prior authorization. Other tissue-engineered skin substitutes utilized in the outpatient setting for wound healing, continuation of treatment after an inpatient admission, or certain products used for breast reconstruction, per the Medical Policy Statement, are considered medically necessary and do require prior authorization. See the Plan’s policy, Medically Necessary (policy number OCA 3.14), for the product-specific definitions of medically necessary treatment. An additional Plan prior authorization is not required for the use of skin substitutes utilized when the member is in an inpatient setting if the inpatient admission has already been authorized by the Plan.

http://www.seniorsgetmore.org/


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Description of Item or Service

Skin Substitutes: Tissue-engineered products that may be biological (i.e., using human cells, animal cells, or both, in a scaffold of natural or synthetic extracellular matrices) or biosynthetic (i.e., with both biological and synthetic elements comprising the scaffold or matrix). Types of skin substitutes include the following, as specified below in items 1 through 4:

1. Products derived from human donor tissue, minimally processed.

Examples include: AlloDerm Regenerative Tissue Matrix, Allopatch HD, Alloskin,

Cymetra Micronized AlloDerm, Dermacell, Arthroflex,

Flex HD,

GammaGraft,

GRAFTJACKET

Regenerative Tissue Matrix, Matrix HD, Memoderm,

Puros Dermis, Repliform, and TheraSkin.

2. Products derived from living human and/or animal tissues and cells.

Examples include: Apligraf/Graftskin and Dermagraft.

3. Acellular animal-derived products.

Examples include: ACell UBM Hydrated Wound Dressing, ACell UBM Lyophilized Wound Dressing, Aongen Collagen Matrix, Atlas Wound Matrix, Avagen Wound Dressing, Collagen Sponge (Innocoll), Collagen Wound Dressing (Oasis Research), Collaguard, CollaSorb, CollaWound, Collexa, Collieva, Coreleader Colla-Pad, Dermadapt Wound Dressing, DressSkin, E-Z Derm, EndoForm Dermal Template, Excellagen, FortaDerm Wound Dressing, HA Absorbent Wound Dressing, Helicoll, Integra/Bilayer Matrix Wound Dressing, Integra Flowable Wound Matrix, LTM Wound Dressing, MatriStem, MatriStem Wound Matrix, Matrix Collagen Wound Dressing, Medline Collagen Wound Dressing, Oasis, PriMatrix, PriMatrix Dermal Repair Scaffold, SIS Wound Dressing II, SS Matrix, Stimulen Collagen, TheraForm Standard/Sheet, Unite Biomatrix, and Unite Biomatrix.

4. Biosynthetic products:

Examples include: Hyalomatrix® (Laserskin®), Hyalomatrix, Jaloskin, Suprathel, and Talymed.

Medical Policy Statement

Tissue engineered skin substitutes are considered medically necessary when criteria are met, as stated below in items A through C. Medical criteria include the following components: Utilizing a product listed below for the specified indication (i.e., breast reconstruction or wound healing) and following the prior authorization requirements, when applicable.


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A. Breast Reconstruction:

The Plan considers ANY of the following products to be medically necessary when used for a covered, medically necessary breast reconstruction;+ prior authorization is REQUIRED for the products listed below in item 1 and item 2: 1. AlloDerm; OR 2. Strattice; OR + Note: See Plan medical policy, Breast Reconstruction, policy number OCA 3.43.

B. Wound Healing:

ONE (1) of the following criteria is met when the product is used for wound healing, as specified below in item 1 or item 2:

1. Prior Authorization is Not Required:

The Plan considers ANY of the following products to be medically necessary when used for wound healing; prior authorization is NOT required for the products listed below in items a through g:

a. Apligraf; OR b. Dermagraft; OR c. Integra Bilayer Matrix Wound Dressing; OR d. Integra Dermal Regeneration Template; OR e. Integra Matrix; OR f. OASIS Burn Matrix; OR g. OASIS Wound Matrix; OR


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2. Prior Authorization is Required:

The Plan considers ANY of the following products to be medically necessary when used for wound healing; prior authorization is REQUIRED for the products listed below in items a through c:

a. Biobrane; OR b. OrCel; OR

c. TransCyte; OR

C. Continuation of Treatment:

Requests for continuation of treatment for wound healing or breast reconstruction in the outpatient setting that began in the inpatient setting must include written documentation submitted to the Plan of continued progress over the course of the inpatient and ongoing treatment. Prior authorization is REQUIRED. (Note: Plan prior authorization is NOT required for skin substitutes used for wound healing in an outpatient setting if the product is listed as NOT requiring prior authorization, as specified above in item B of this section. See the Limitations section of this policy for the list of skin substitutes the Plan considers experimental and investigational for all indications and the contraindications for the use of skin substitutes.)

Limitations

A. Plan Medical Director review is required when the treating provider is requesting a skin substitute

product NOT listed as a medically necessary product for the member’s condition (i.e., breast reconstruction, wound healing, or another indication), as stated in the Medical Policy Statement section of this policy. Applicable clinical information must be submitted to the Plan by the treating provider that includes the member’s medical history, treatment to date for the member’s condition, verification of the clinical validity and clinical utility of the FDA-approved skin substitute product for the requested indication (and an explanation why this product is preferred for the member’s treatment when an alternative is documented in the Medical Policy Statement section), and an individualized treatment plan for the member.

B. Contraindications for the use of skin substitutes include ANY of the following, as specified below in

items 1 through 4: 1. Active Charcot disease; OR 2. Evidence of infection in ulcer(s) targeted for treatment; OR


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3. Exudate consistent with heavy bacterial contamination, or eschar or necrotic tissue that would interfere with graft take and healing; OR

4. Hypersensitivity or allergy to any components of the skin substitute.

C. ANY of the following tissue-engineered skin substitutes, when used for wound healing, breast reconstruction, or for any other indication except as listed the Medical Policy Statement section of this policy, are considered experimental and investigational (as specified below in items 1 through 43):

1. AlloDerm (except for indication specified in this Plan policy); OR 2. AlloSkin or AlloSkin RT; OR 3. AmnioBand/AmnioBand Membrane; OR 4. AmnioHeal Plus; OR 5. Artacent Wound; OR 6. Arthroflex; OR 7. Biobrane (except for indication specified in this Plan policy); OR 8. Cymetra; OR 9. CYGNUS (including CYGNUS MATRIX, CYGNUS MAX, and CYGNUS SOLO) 10. Cytal (including Cytal Wound Matrix, MatriStem Wound Matrix, and Multilayer Wound Matrix);

OR 11. DermACELL; OR

12. Epicel; OR

13. EpiFix; OR 14. E-Z Derm; OR

15. FlexHD or Allopatch; OR

16. GammaGraft; OR


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17. Grafix Core; OR

18. Grafix Prime; OR

19. GRAFTJACKET; OR

20. hMatrix; OR

21. Hyalomatrix; OR 22. Integra Flowable Wound Matrix; OR 23. Interfyl: OR 24. MatriStem burn matrix; OR 25. MatriStem micromatrix; OR 26. MatriStem wound matrix; OR 27. Mediskin; OR 28. Memoderm; OR 29. MIRODERM™ Biologic Wound Matrix; OR 30. OASIS® Ultra Tri-Layer Matrix 31. OrCel (except for indication specified in this Plan policy); OR

32. PalinGen (including PalinGen Membrane, PalinGen XPlus Membrane, PalinGen XPlus Hydromembrane, PalinGen Flow, PalinGen SportFlow, and ProMatrX ACF); OR

33. PriMatrix; OR 34. PuraPly (including PuraPly Antimicrobial Wound Matrix/PuraPly AM); OR 35. Strattice (except for indication specified in this Plan policy); OR 36. SurgiMend®; OR


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37. Talymed; OR 38. TissueMend; OR 39. TheraSkin; OR 40. Transcyte (except for indication specified in this Plan policy); OR 41. TruSkin; OR 42. Unite Biomatrix; OR 43. Any other skin substitute not specified in this policy as medically necessary (according to

criteria in the Medical Policy Statement section) are considered experimental and investigational by the Plan.

See the Plan’s policy, Experimental and Investigational Treatment (policy number OCA 3.12), for the product-specific definitions of experimental or investigational treatment.

Definitions

None.

Applicable Coding

The Plan uses and adopts up-to-date Current Procedural Terminology (CPT) codes from the American Medical Association (AMA), International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes developed by the World Health Organization and adapted in the United Stated by the National Center for Health Statistics (NCHS) of the Centers for Disease Control under the U.S. Department of Health and Human Services, and the Health Care Common Procedure Coding System (HCPCS) established and maintained by the Centers for Medicare & Medicaid Services (CMS). Because the AMA, NCHS, and CMS may update codes more frequently or at different intervals than Plan policy updates, the list of applicable codes included in this Plan policy is for informational purposes only, may not be all inclusive, and is subject to change without prior notification. Whether a code is listed in the Applicable Coding section of this Plan policy does not constitute or imply member coverage or provider reimbursement. Providers are responsible for reporting all services using the most up-to-date industry-standard procedure and diagnosis codes as published by the AMA, NCHS, and CMS at the time of the service. Providers are responsible for obtaining prior authorization for the services specified in the Medical Policy Statement section and Limitation section of this Plan policy, even if an applicable code appropriately describing the service that is the subject of this Plan policy is not included in the Applicable Coding section of this Plan policy. Coverage for services is subject to benefit eligibility under


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the member’s benefit plan. Please refer to the member’s benefits document in effect at the time of the service to determine coverage or non-coverage as it applies to an individual member. See Plan reimbursement policies for Plan billing guidelines. See Plan policy, Breast Reconstruction (policy number OCA 3.43), for applicable codes for breast reconstruction that are covered when medically necessary.

HCPCS Codes Codes Considered Medically Necessary for Wound Healing without Prior Authorization

Q4101 Apligraf, per sq cm

Q4102 Oasis wound matrix, per sq cm Plan note: Code used for OASIS Wound Matrix product per square centimeter (single layer OASIS Matrix product).

Q4103 Oasis burn matrix, per sq cm Plan note: Code used for OASIS Burn Matrix product per square centimeter.

Q4104 Integra bilayer matrix wound dressing (BMWD), per sq cm

Q4105 Integra dermal regeneration template (drt) or integra omnigraft dermal regeneration matrix, per square centimeter

Q4106 Dermagraft, per sq cm

Q4108 Integra matrix, per sq cm

Q4124 OASIS ultra tri-layer wound matrix, per sq cm

Plan note: Code used for OASIS Ultra Tri-Layer Matrix product per square centimeter (triple layer OASIS Matrix product).

HCPCS Codes Codes Considered Medically Necessary for Wound Healing with Prior Authorization

Q4100 Skin substitute, not otherwise specified Plan note: For Biobrane, OrCel and TransCyte only.

HCPCS Codes Codes Considered Medically Necessary for Breast Reconstruction with Prior Authorization

Q4116 AlloDerm, per sq cm

Q4130 Strattice TM, per sq cm


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HCPCS Codes Codes Considered Experimental and Investigational for Wound Healing or Any Other Indication

Q4100 Skin substitute, not otherwise specified Plan note: Except as listed above as medically necessary according to Plan guidelines.

This code could be used for products such as SurgiMend®.

Q4100 Skin substitute, not otherwise specified Plan note: Except as listed above; code could be used for products such as SurgiMend®.

Q4107 GRAFTJACKET, per sq cm

Q4110 PriMatrix, per sq cm

Q4111 GammaGraft, per sq cm

Q4112 Cymetra, injectable, 1 cc

Q4113 GRAFTJACKET XPRESS, injectable, 1 cc

Q4114 Integra flowable wound matrix, injectable, 1 cc

Q4115 AlloSkin, per sq cm

Q4116 AlloDerm, per sq cm Plan note: Code considered experimental and investigational when used for an indication other than breast reconstruction.

Q4116 AlloDerm, per sq cm Plan note: When used for indications other than breast reconstruction.

Q4117 HYALOMATRIX, per sq cm

Q4118 MatriStem micromatrix, 1 mg

Q4119 MatriStem Wound Matrix, PSMX, RS, or PSM, 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

Plan note: Code used for OASIS Ultra Tri-Layer Matrix product per square centimeter (triple layer OASIS Matrix product).

Q4125 Arthroflex, per sq cm

Q4126 MemoDerm, DermaSpan, TranZgraft or InteguPly, per sq cm

Q4127 Talymed, per sq cm


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Q4128 FlexHD AllopatchHD, or Matrix HD, per sq cm

Q4129 Unite biomatrix, per sq cm


Plan note: Code considered experimental and investigational when used for an indication other than breast reconstruction.


Plan note: When used for indications other than breast reconstruction.

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 square centimeter

Q4138 Biodfence dryflex, per square centimeter

Q4139 Amniomatrix or biodmatrix, injectable, 1 cc

Q4140 Biodfence, per square centimeter

Q4141 Alloskin AC, per square centimeter

Q4142 XCM biologic tissue matrix, per square centimeter

Q4143 Repriza, per square centimeter

Q4145 EpiFix, injectable, 1 mg

Q4146 Tensix, per square centimeter

Q4147 Architect extracellular matrix, per square centimeter

Q4148 Neox 1k, per square centimeter

Q4149 Excellagen, 0.1 cc

Q4150 Allowrap ds or dry, per square centimeter

Q4151 Amnioband or guardian, per square centimeter

Q4152 Dermapure, per square centimeter

Q4153 Dermavest, per square centimeter

Q4154 Biovance, per square centimeter

Q4155 Neoxflo or clarixflo, 1 mg

Q4156 Neox 100, per square centimeter


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Q4157 Revitalon, per square centimeter

Q4158 Marigen, per square centimeter

Q4159 Affinity, per square centimeter

Q4160 Nushield, per square centimeter

Q4161 Bio-connekt per sq cm

Q4162 Amnio bio and woundex flow

Q4163 Amnio bio and woundex sq cm

Q4164 Helicoll, per sq cm

Q4165 Keramatrix, per sq cm

Q4166 Cytal, per square centimeter

Q4167 TruSkin, per square centimeter

Q4168 AmnioBand, 1 mg

Q4169 Artacent wound, per square centimeter

Q4170 CYGNUS, per square centimeter

Q4171 Interfyl, 1 mg

Q4172 PuraPly or PuraPly am, per square centimeter

Q4173 PalinGen or PalinGen XPlus, per square centimeter

Q4174 PalinGen or Promatrx, 0.36 mg per 0.25 cc

Q4175 MIRODERM, per square centimeter

Clinical Background Information

Wounds that do not respond to aggressive, conventional treatment may improve with the application of skin substitutes, also referred to as human skin equivalents (HSE) and artificial skin. The U.S. Food and Drug Administration (FDA) does not refer to any product or class of products as “skin substitutes.” However, products commonly described as “skin substitutes” are regulated by FDA under the categories of human cells, tissues, and cellular and tissue-based products. These are tissue-engineered products using living cells, such as fibroblasts and keratinocytes, in a scaffold of natural or synthetic extracellular matrices. Some skin substitutes have a synthetic top layer that disappears and is replaced by new, healthy skin. The bottom layer is composed of a scaffold, or matrix, and supports and promotes new cell growth. As the healthy skin, blood vessels, fibroblasts, and nerve fibers cross into the matrix, it eventually dissolves. Tissue-engineered skin substitutes are categorized into biological or biosynthetic products. Biological tissue-engineered products use human cells, animal cells, or both, in a scaffold of natural or synthetic extracellular matrices. Biosynthetic, tissue-engineered products use both biological and synthetic elements to comprise the scaffold or matrix.


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The goals of wound treatment with tissue-engineered skin substitutes are to provide temporary wound coverage and complete wound closure, reduce healing time and pain, reduce postoperative contracture, improve appearance and functional abilities, prevent the need for more extensive treatments such as skin grafting or amputation, and improve overall quality of life. Examples of skin substitutes include but are not limited to ANY of the following, as specified below in items 1 through 36:

1. AlloDerm: An acellular dermal matrix derived from donated human skin. It is produced by processing donated human skin to remove cellular material that may trigger a tissue rejection reaction and is tested to reduce the likelihood of disease transmission. The FDA has classified AlloDerm as human tissue for transplantation.

2. AlloSkin: A human allograft is a meshed, biologic wound covering comprised of human

cadaveric dermis.

3. AmnioBand®/AmnioBand® Membrane: Dehydrated human placental bi-layer membrane product (by MTF Wound Care) comprised of amnion and chorion that facilitates native tissue restoration and remodeling. Its flexible properties allow it to conform to the wound site. Essential components present within the amniotic membrane support intrinsic functions, including providing a protective and physical barrier to infection, preventing bacteria infiltration, providing matrix proteins, and promoting tissue epithelization. The product is used for acute and chronic wounds, acute penetrating trauma, burns, venous ulcers, diabetic foot ulcers, pressure (decubitus) ulcers, vascular (arterial) ulcers, skin cancer surgical treatment, and scar revisions. The presence of severe vascular compromise, active or latent infection, and/or uncontrolled infection may compromise the usefulness of this product.

4. AmnioHeal® Plus: Amniotic membrane graft (by Tides Medical) that stimulates wound healing

and reduces scar tissue and inflammation. Product features include the following: Product can be applied with either side facing the wound, stores dry at room temperature instead of requiring cryopreservation, readily adheres to wound surface and stays in place, allows for repositioning by reverting to original shape when placed in saline, and surface layer dimpling when improves the ease of graft placement. This product is used with chronic wounds such as diabetic ulcers, pressure ulcers, venous stasis ulcers, and burns.

5. Apligraf (Graftskin): A cellular, bi-layered, human-skin equivalent produced from bovine

collagen and cells derived from human infant foreskins. Its special composition allows it to provide wound protection and foster the growth of healthy new skin. Apligraf is classified as a permanent human skin equivalent.

6. Artacent® Wound: Wound-specific amniotic patch (by Tides Medical) that allows for easy

manipulation with the following features: Product can be applied with either side facing the wound, stores dry at room temperature instead of cryopreservation, readily adheres to wound


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surface and stays in place, and allows for repositioning by reverting to original shape when placed in saline. This product is used for the treatment of chronic wounds such as diabetic ulcers, pressure ulcers, venous stasis ulcers, and burns.

7. Arthroflex™: A decellularized human skin allograft used for the treatment of chronic wounds,

such as diabetic foot ulcers and large surgical wounds.

8. Cymetra: An acellular dermal matrix derived from donated human skin that is injected as a dry powder.

9. CYGNUS™: Amniotic tissue matrix (by Vivex) used to facilitate wound healing by providing a

mechanical protection and anti-inflammatory, anti-scarring, and anti-microbial properties. Products include the CYGNUS MATRIX™, CYGNUS MAX™, and CYGNUS SOLO™.

10. Cytal™: Wound management products (by ACell Inc.) used to maintain and support a healing

environment through constructive remodeling for partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds. Products names include Cytal Wound Matrix, MatriStem® Wound Matrix, and Multilayer Wound Matrix.

11. DermACELL™: A regenerative human dermal allograft procured and processed from donated

human tissue.

12. Dermagraft: A biosynthetic dermal matrix with cells that multiply and secrete collagen and growth factors. It is considered a temporary skin substitute and is manufactured from human fibroblast cells derived from newborn foreskin tissue.

13. EpiFix®: A dehydrated Human Amnion/ Chorion Membrane (dHACM) allograft and is composed

of multiple layers including a single layer of epithelial cells, a basement membrane and an avascular connective tissue matrix. EpiFix® is a minimally manipulated, dehydrated, non-viable cellular amniotic membrane allograft that preserves and delivers multiple extracellular matrix proteins, growth factors, cytokines, and other specialty proteins present in amniotic tissue to help regenerate soft tissue.

14. E-Z Derm: A porcine-derived, biosynthetic xenograft in which the collagen has been chemically

cross-linked with an aldehyde to provide strength, durability, and a relatively long shelf life at room temperature.

15. FlexHD or Allopatch: A human allograft skin minimally processed to remove epidermal and

dermal cells.


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16. GammaGraft: An allograft; specifically human skin, consisting of the epidermal and dermal layers.

17. GRAFTJACKET: An acellular dermal matrix derived from donated human skin. It is produced by

processing donated human skin to remove cellular material that may trigger a tissue rejection reaction and is tested to reduce the likelihood of disease transmission. The FDA has classified GRAFTJACKET as human tissue for transplantation. Once implanted, the body’s natural repair process converts the matrix into living tissue. Over time, the tissue graft aids in the repair of the wound and is replaced by tissue like the patient's own.

18. HYALOMATRIX: A bi-layered, sterile, flexible, and conformable non-woven pad entirely

composed of HYAFF 11, a benzyl ester of hyaluronic acid. The hyaluronic acid is derived from bacterial fermentation. The HYAFF 11 serves as a scaffold to allow cell colonization and capillary growth.

19. Integra Dermal Regeneration Template, Integra Bilayer Matrix Wound Dressing: A collagen-

glycosaminoglycan copolymer or bi-layered membrane system that consists of a porous lattice of purified bovine collagen that acts as the dermis with a layer of silicone rubber or silastic that acts as a temporary epidermis. Integra requires a two-stage procedure with a minimum of three (3) weeks after application for the collagen layer to combine with the wound to form a vascular neodermis. After this stage is complete, the silastic membranes are removed and an ultra-thin split graft is applied.

20. Integra Flowable Wound Matrix: A porous matrix of cross-linked bovine tendon collagen and

glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer that is applied in difficult to access wound sites and tunneled wounds via injection with a syringe.

21. Interfyl: A connective tissue extracellular matrix (by Alliqua BioMedical, Inc.) that is derived

from human placental tissue. The product allows for cell adherence and growth during tissue repair. Interfyl provides mechanical and structural support to facilitate the tissue repair process while maintaining elasticity. The product is useful in several surgical applications and is used to treat deep and tunneling wounds by filling voids and correcting defects in soft tissue.

22. MatriStem: A porcine-derived, naturally occurring non cross-linked, completely resorbable,

acellular extracellular matrix derived from specific layers of porcine urinary bladder.

23. MemoDerm™: An acellular dermal allograft derived from aseptically processed cadaveric human skin tissue that is terminally sterilized. It is intended for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.


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24. MIRODERM™ Biologic Wound Matrix: A biological wound matrix (by Miromatrix Medical Inc.) derived from porcine liver which uses perfusion decellularization to remove cellular material while maintaining the native architecture, vasculature, and tissue structure. The product is indicated for the management of the following types of wounds: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, tunneled and undermined wounds, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), drainage wounds, and/or surgical wounds (donor sites/grafts, post-Mohs’, surgery, post-laser surgery, podiatric, wound dehiscence).

25. Oasis, E-Z Derm and Biobrane: Biological materials derived from porcine small intestine mucosa

and marketed as wound dressings; they are thought to act as dermal matrices, providing a scaffold for tissue growth and are intended for a one-time use.

26. OASIS® Ultra Tri-Layer Matrix: Biological material derived from porcine small intestinal

submucosa. The product is a triple-layer, extracellular matrix derived from porcine small intestinal submucosa. It is used for the management of wounds, including partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (i.e., abrasions, lacerations, second degree burns, and skin tears), drainage wounds, and surgical wounds. This product is not indicated for use in third-degree burns.

27. OASIS® Wound Matrix: Biological material derived from porcine small intestinal submucosa

intended for one-time use. The product functions as single-layer, extracellular matrix to provide a natural scaffold for tissue growth that is incorporated and absorbed into the wound environment. Chronic wounds are often difficult to heal because the body’s natural extracellular matrix (i.e., the structural complex that surrounds cells and binds them in tissue and services as a crucial component in the healing process) is damaged or failing. OASIS® Wound Matrix is used for the management of partial- and full-thickness wounds, tunneled and/or undermined wounds, draining wounds, and surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, and wound dehiscence). This product is not indicated for use in third-degree burns.

28. PalinGen: Amnion-derived human allografts recovered from living, prescreened donors after a

full-term pregnancy. The matrix includes residual proteins, carbohydrates, hyaluronic acid, growth factors, and other chemical compounds naturally present in amniotic fluid and tissue essential for fetal growth and development. Characteristics of the nutrient-rich amnion-derived products include anti-inflammatory, antimicrobial, and antifibrotic properties with low immunogenicity. PalinGen products (by Amnio Technology, LCC) include PalinGen® Membrane, PalinGen® XPlus Membrane, PalinGen® XPlus Hydromembrane, PalinGen® Flow, PalinGen® SportFlow, and ProMatrX® ACF. Amnion-derived allografts may be used for one (1) or more of the following indications: Repair of nerve/tendon/ligament, soft tissue defects, trauma, tendonitis, chronic wounds, and local inflammation.

29. PriMatrix: An acellular dermal matrix derived from fetal bovine skin.


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30. PuraPly™ Antimicrobial Wound Matrix/PuraPly™ AM: Porcine-derived wound management

product (by Organogenesis, Inc.) that serves as a barrier to resist microbial colonization within the dressing and reduce microbes penetrating through the dressing. This product is used for the treatment of partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled and undermined wounds, surgical wounds (donor sites and grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and/or draining wounds. PuraPly™ AM is not intended for use on third degree burns or with individuals with a known sensitivity to porcine material and/or polyhexamethylene biguanide hydrochloride (PHMB).

31. Strattice: A reconstructive tissue matrix derived from porcine dermis that is surgically

implanted as a treatment for full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcer, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, trauma wounds, draining wounds, or other bleeding surface wounds.

32. Talymed: A sterile wound matrix comprised of shortened fibers of poly-N-acetylglucosamine,

isolated from microalgae. Talymed™ is used for the management of wounds.

33. TheraSkin: A biologically active cryopreserved real human skin allograft with both epidermis and dermis layers.

34. TissueMend: An acellular soft tissue matrix (scaffold) made from fetal bovine dermis.

35. TruSkin™: Cryopreserved skin allograft (by Osiris Therapeutics, Inc.) that retains an

extracellular matrix rich supply of endogenous growth factors and living skin cells. The product serves as an alternative to fresh skin grafts for the treatment of vascular (arterial) ulcers, diabetic foot ulcers, pressure (decubitus) ulcers, trauma burns, radiation burns, chronic wounds, dermal lesions, venous leg ulcers. TruSkin™ should not be used in a wound suspected of having an acute or chronic infection.

36. Unite™ Biomatrix: A wound biomodulating extracellular matrix (ECM) that is sourced from

equine pericardium. Unite™ Biomatrix is indicated for local management of moderately to heavily exudating wounds.

At the time of the Plan’s most recent policy review, no clinical guidelines were found from the Centers for Medicare & Medicaid Services (CMS) specifically for skin substitutes for wound healing and/or breast reconstruction. According to national coverage determination (NCD) 270.5 for porcine skin and gradient pressure dressings, CMS covers for Medicare beneficiaries the use of porcine (pig) skin dressings if reasonable and necessary for the individual patient as an occlusive dressing for burns, donor sites of a homograft, and/or decubiti and other ulcers. Verify applicable CMS criteria are in effect for the specified service, tissue-engineered or biosynthetic product, and the indication for


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treatment in an NCD or local coverage determination (LCD) on the date of the prior authorization request for a Senior Care Options member.

References

ACell Inc. Cytal™ Wound Matrix. Accessed at: https://acell.com/wound-matrix/ Agency for Healthcare Research and Quality (AHRQ). Snyder DL, Sullivan N, Schoelles KM. AHRQ Technology Assessment Program. Skin Substitutes for Treating Chronic Wounds. Final Report. December 18, 2012. Accessed at: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0070329/ or http://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf Alliqua BioMedical, Inc. Alliqua BioMedical, Inc. Expands Regenerative Medicine Portfolio with the Commercial Introduction of Interfyl Connective Tissue Matrix. GlobeNewswire, Inc. September 19, 2016. Accessed at: https://globenewswire.com/ Alliqua BioMedical, Inc. Products. Interfyl. Accessed at: https://alliqua.com/products/interfyl/ Amani H, Dougherty WR, Blome-Eberwein S. Use of Transcyte and dermabrasion to treat burns reduces length of stay in burns of all size and etiology. Burns. 2006 Nov;32(7):828-32. American Diabetes Association. Standards of Medical Care in Diabetes - 2008. Diabetes Care. Accessed at: http://care.diabetesjournals.org/content/31/Supplement_1/S12.full American Society of Plastic Surgeons (ASPS). Evidence-Based Clinical Practice Guideline: Chronic Wounds of the Lower Extremity. May 2007. Accessed at: http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/evidence-practice/Evidence-based-Clinical-Practice-Guideline-Chronic-Wounds-of-the-Lower-Extremity.pdf Amnio Technology, LCC. Our Products. PalinGen® Membrane, PalinGen® XPlus Membrane, PalinGen® XPlus Hydromembrane, PalinGen® Flow, PalinGen® SportFlow, and ProMatrX® ACF. Accessed at: https://amniotechnology.com/palingen-membrane/ Ayeni OA, Ibrahim AM, Lin SJ, Slavin SA. Acellular dermal matrices in breast surgery: tips and pearls. Clin Plast Surg. 2012;39(2):177-186. Bank J, Phillips NA, Park JE, Song DH. Economic analysis and review of the literature on implant-based breast reconstruction with and without the use of the acellular dermal matrix. Aesthetic Plast Surg. 2013 Dec;37(6):1194-201.

https://acell.com/wound-matrix/

https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0070329/

http://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf

http://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf

https://globenewswire.com/

https://alliqua.com/products/interfyl/

http://care.diabetesjournals.org/content/31/Supplement_1/S12.full

http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/evidence-practice/Evidence-based-Clinical-Practice-Guideline-Chronic-Wounds-of-the-Lower-Extremity.pdf

http://www.plasticsurgery.org/Documents/medical-professionals/health-policy/evidence-practice/Evidence-based-Clinical-Practice-Guideline-Chronic-Wounds-of-the-Lower-Extremity.pdf

https://amniotechnology.com/palingen-membrane/


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Becker S et al. AlloDerm versus DermaMatrix in immediate expander-based breast reconstruction: a preliminary comparison of complication profiles and material compliance. Plast Reconstr Surg. 2009 Jan;123(1):1-6. Brigido SA. The use of an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16-week pilot study. Int Wound J. 2006 Sep;3(3):181-7. Brooke S, Mesa J, Uluer M, et al. Complications in tissue expander breast reconstruction: a comparison of AlloDerm, DermaMatrix, and FlexHD acellular inferior pole dermal slings. Ann Plast Surg. 2012;69(4):347-349. Cassidy C et al. Biobrane versus duoderm for the treatment of intermediate thickness burns in children: a prospective, randomized trial. Burns. 2005 Nov;31(7):890-3. Epub 2005 Jul 14. Centers for Medicare and Medicaid Services. National Coverage Determination (NCD) for Porcine Skin and Gradient Pressure Dressings (270.5). Accessed at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=139&ncdver=1&bc=AgAAQAAAAAAA& Centers for Medicare & Medicaid Services (CMS). Welcome to the Medicare Coverage Database. Accessed at: https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx Cheng A, Saint-Cyr M. Comparison of different ADM materials in breast surgery. Clin Plast Surg. 2012;39(2):167-175. Greer N, Foman N, Dorrian J, et al. Advanced Wound Care Therapies for Non-Healing Diabetic, Venous, and Arterial Ulcers: A Systematic Review. Washington (DC): Department of Veterans Affairs (US); 2012 Nov. Accessed at: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0054954/ Hayes Clinical Research Response. Clarix Regenerative Matrix. Winifred Hayes, Inc. January 15, 2015. Hayes Health Technology Brief. EpiFix (MiMedx Group) for Treatment of Nonhealing Wounds. Winifred Hayes, Inc. August 20, 2015. Annual Review June 16, 2016. Hayes Clinical Research Response. PalinGen Amniotic Tissue Allografts (Amnio ReGen Solutions LLC) for Orthopedic Indications. Winifred Hayes, Inc. December 3, 2015. Hayes Medical Technology Directory. Human Acellular Dermal Matrix Grafts for Breast Reconstruction. Winifred Hayes, Inc. April 28, 2014. Annual Review April 12, 2016. Hayes Search & Summary. TheraSkin (Soluble Systems LLC) for Chronic Non-healing Wounds. Winifred Hayes, Inc. September 1, 2016.

http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=139&ncdver=1&bc=AgAAQAAAAAAA&

http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=139&ncdver=1&bc=AgAAQAAAAAAA&

https://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx

https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0054954/


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Kumar RJ et al. Treatment of partial-thickness burns: a prospective, randomized trial using Transcyte. ANZ J Surg. 2004 Aug;74(8):622-6. Lal S, Barrow RE, Wolf SE, Chinkes DL, Hart DW, Heggers JP, et al. Biobrane improves wound healing in burned children without increased risk of infection. Shock. 2000;14(3):314-8. Lang EM, Eiberg CA, Brandis M, Stark GB. Biobrane in the treatment of burn and scald injuries in children. Ann Plast Surg. 2005 Nov;55(5):485-9. Miromatrix Medical Inc. Products. MIRODERM™ Biologic Wound Matrix. Accessed at: www.miromatrix.com Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venus Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005;41(5):837-843. 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. Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP. Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care. 2005;18(5 Pt 1):258-266. Organogenesis, Inc. PuraPly™ Antimicrobial Wound Matrix. About PuraPlay Antimicrobial. Accessed at: http://www.puraplyam.com/about-puraply-antimicrobial/wound-types/

Parks JW, Hammond SE, Walsh WA, Adams RL, Chandler RG, Luce EA. Human acellular dermis versus no acellular dermis in tissue expansion breast reconstruction. Plast Reconstr Surg. 2012;130(4):739-746. Potter S, Browning D, Savovic J, Holcombe C, Blazeby JM. Systematic review and critical appraisal of the impact of acellular dermal matrix use on the outcomes of implant-based breast reconstruction. Br J Surg. 2015 Aug;102(9):1010-25. Romanelli M, Dini V, Bertone M, Barbanera S, Brilli C. OASIS wound matrix versus Hyaloskin in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. Int Wound J. 2007;4(1):3-7. 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):34-38. Smith & Nephew, Inc. OASIS® Matrix Products. Accessed at: http://www.oasiswoundmatrix.com/

http://www.puraplyam.com/about-puraply-antimicrobial/wound-types/

http://www.oasiswoundmatrix.com/


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Smith & Nephew, Inc. OASIS® Matrix Reimbursement Services. Accessed at: https://reimbursement.oasismatrix.com/StaticPageContent.aspx?Category=StaticReimbursementForms Still J et al. The use of a collagen sponge/living cell composite material to treat donor sites in burn patients. Burns. 2003 Dec;29(8):837-41. Tides Medical. AmnioHealth® Plus and Artacent® Wound. Accessed at: www.tidesmedical.com U.S. Food and Drug Administration (FDA). Human cells, tissues, and cellular and tissue-based products. Silver Spring (MD): Apr 1, 2010. CFR - Code of Federal Regulations Title 21: Subchapter L--regulations under certain other acts administered by the Food and Drug Administration, Sec. 1271. 35 p. U. S. Food and Drug Administration (FDA). Medical Devices. Accessed at: http://www.fda.gov/MedicalDevices/ Vanstraelen P. Comparison of calcium sodium alginate (KALTOSTAT) and porcine xenograft (E-Z DERM) in the healing of split-thickness skin graft donor sites. Burns. 1992 Apr;18(2):145-8. Veves A et al. 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. Waymack P et al. The effect of a tissue engineered bilayered living skin analog, over meshed split-thickness autografts on the healing of excised burn wounds. The Apligraf Burn Study Group. Burns. 2000 Nov;26(7):609-19. Whitaker IS et al. The use of Biobrane by burn units in the United Kingdom: a national study. Burns. 2007 Dec;33(8):1015-20. Epub 2007 Aug 30. Whitaker IS, Prowse S, Potokar TS. A critical evaluation of the use of Biobrane as a biologic skin substitute: a versatile tool for the plastic and reconstructive surgeon. Ann Plast Surg. 2008 Mar;60(3):333-7. Wound Source. AmnioBand® Membrane. MTF Wound Care. Accessed at: http://www.woundsource.com/product/amnioband-membrane Wound Source. TruSkin™. November 17, 2016. Accessed at: http://www.woundsource.com/print/product/truskin

https://reimbursement.oasismatrix.com/StaticPageContent.aspx?Category=StaticReimbursementForms

https://reimbursement.oasismatrix.com/StaticPageContent.aspx?Category=StaticReimbursementForms

http://www.fda.gov/MedicalDevices/

http://www.woundsource.com/product/amnioband-membrane

http://www.woundsource.com/print/product/truskin


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Wu C, Cipriano J, Osgood G Jr, Tepper D, Siddiqui A. Human acellular dermal matrix (AlloDerm®) dimensional changes and stretching in tissue expander/implant breast reconstruction. J Plast Reconstr Aesthet Surg. 2013;66(10):1376-1381.

Original Approval Date

Original Effective Date* and Version

Number Policy Owner Approved by

Regulatory Approval: N/A Internal Approval: 02/24/09: MPCTAC 02/24/09: UMC 03/25/09: QIC

06/01/09 Version 1

Medical Policy Manager as Chair of Medical Policy, Criteria, and Technology Assessment Committee (MPCTAC) and member of Quality Improvement Committee (QIC)

MPCTAC, QIC, and Utilization Management Committee (UMC)

*Effective Date for the BMC HealthNet Plan Commercial Product(s): 01/01/12

*Effective Date for the Well Sense Health Plan New Hampshire Medicaid Product(s): 01/01/13 *Effective Date for the Senior Care Options Product(s): 01/01/16

Policy Revisions History

Review Date Summary of Revisions

Revision Effective Date and Version

Number

Approved by

02/01/10 Review for effective date 06/01/10. Updated references, coding, and criteria for Alloderm and Integra.

06/01/10 Version 2

02/22/10: MPCTAC 03/24/10: QIC

02/01/11 Added criteria for two new skin substitutes that are considered experimental and investigational: Hyalomatrix and MatriStem, added coverage criteria for Epicel that was previously considered investigational, updated references and coding.

Version 3 02/16/11: MPCTAC 03/23/11: QIC

01/01/12 Updated the definition for skin substitutes and the criteria for new skin substitutes that are investigational, removed criteria for skin substitutes that are covered without authorization, updated references and coding.


08/01/12 Off cycle review for Well Sense Health Plan, revised title to include reference to outpatient setting, revised Summary statement, reformatted Medical Policy



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Statement, revised Applicable Coding introductory paragraph, updated code list, revised Limitations.

01/01/13 Review for effective date 05/01/13. References updated and added, revised title and Summary section, reformatted Description of Item or Service section and Medical Policy Statement section, moved limitations from Medical Policy Statement section to Limitations section, and added skin substitute products to list in Limitations section. Referenced the following Plan policies: Breast Reconstruction, Experimental and Investigational Treatment, Medically Necessary. Examples of skin substitutes moved from Description of Item or Service section to Clinical Background Information section.

05/01/13 Version 6

01/16/13: MPCTAC 02/21/13: QIC

08/14/13 and 08/15/13

Off cycle review for Well Sense Health Plan and merged policy format. Incorporate policy revisions dated 01/01/13 (as specified above) for the Well Sense Health Plan product; these policy revisions were approved by MPCTAC on 01/16/13 and QIC on 02/21/13 for applicable Plan products.

Version 7 08/14/13: MPCTAC (electronic vote) 08/15/13: QIC

01/01/14 Review for effective date 05/01/14. Added categories of skin substitutes in the Description of Item or Service section. New codes added as experimental and investigational in the Applicable Coding section after researching products. Updated references. Revised Limitations section without changing criteria. Referenced Plan’s Breast Reconstruction policy (OCA: 3.43).

05/01/14 Version 8

01/15/14: MPCTAC 02/18/14: QIC

12/01/14 Review for effective date 03/01/15. Added the following HCPCS codes as experimental and investigational: Q4150 through Q4160.

03/01/15 Version 9

12/02/14: MPCTAC (electronic vote) 12/10/14: QIC

02/01/15 Review for effective date 06/01/15. 06/01/15 02/18/15: MPCTAC


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Updated criteria in the Medical Policy Statement and Limitations sections. Revised Summary and References sections. Removed Commonwealth Care, Commonwealth Choice, and Employer Choice from the list of applicable products because the products are no longer available.

Version 10 03/11/15: QIC

11/25/15 Review for effective date 01/01/16. Updated template with list of applicable products and corresponding notes. Updated references and language in the Applicable Coding section.

01/01/16 Version 11

11/18/15: MPCTAC 11/25/15: MPCTAC (electronic vote) 12/09/15: QIC

12/01/15 Review for effective date 04/01/16. Updated applicable code list.

04/01/16 Version 12

12/16/15: MPCTAC 01/13/16: QIC

11/01/16 and 12/01/16

Review for effective date 04/01/17. Administrative changes made to the Summary, Clinical Background Information, References, and Reference to Applicable Laws and Regulations. Criteria revised in the Limitations section. Updated the applicable code list.

01/01/17 Version 13

11/16/16: MPCTAC 12/21/16: MPCTAC 01/11/17: QIC

Last Review Date

12/01/16

Next Review Date

11/01/17

Authorizing Entity

QIC

Other Applicable Policies

Medical Policy – Breast Reconstruction, policy number OCA 3.43 Medical Policy – Experimental and Investigational Treatment, policy number OCA 3.12 Medical Policy – Medically Necessary, policy number OCA 3.14


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Reference to Applicable Laws and Regulations

78 FR 48164-69. Centers for Medicare & Medicaid Services (CMS). Medicare Program. Revised Process for Making National Coverage Determinations. August 7, 2013. Accessed at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf

Disclaimer Information: +

Medical Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the individual Member’s health care needs.

Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members.

The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.

https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR08072013.pdf