Notification



Notification Issue Date:



Policy Attachment

Attachment to Policy # MA11.015i


Attachment:A

Policy #:MA11.015i

Description:Skin substitutes and their approved indications.

Title:Wound Care: Skin Substitutes for the Treatment of Burns and Chronic, Non-Healing Wounds

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.


The table below lists skin substitutes, which are represented by a specific HCPCS code, and their approved indications. This list does not include all FDA approved/regulated skin substitutes.

Skin Substitute
Approved Indications
AffinityIntended to be applied as an on-lay graft for acute and chronic wounds, including, but not limited to, neuropathic ulcers, venous stasis ulcers, pressure ulcers, burns, post-traumatic wounds and post-surgical wounds.
AlloPatch HDUsed as a wound care scaffold for the replacement of damaged or inadequate integumental tissue such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, and vascular ulcers.
AlloSkinIndicated for use in chronic wounds, dehisced wounds, diabetic foot ulcers, non/minimally exudating wounds, pressure ulcers, surgical wounds, and venous ulcers.
AlloSkin ACIndicated for use in chronic wounds, dehisced wounds, diabetic foot ulcers, non/minimally exudating wounds, pressure ulcers, surgical wounds, and venous ulcers.
AlloSkin RTIndicated for use in chronic wounds, dehisced wounds, diabetic foot ulcers, non/minimally exudating wounds, pressure ulcers, surgical wounds, and venous ulcers.
Amnio WoundIntended for use in the following conditions: neuropathic ulcers, venous stasis ulcers, post-traumatic wounds, pre-and post-surgical wounds, pressure ulcers, and diabetic wounds.
AmnioArmorIntended for use in chronic wounds.
AmnioBand ParticulateIntended for use in a variety of wounds: diabetic foot ulcers, venous leg ulcers, pressure ulcers, vascular ulcers, traumatic wounds, and surgical wounds.
AmnioBand Membrane or GuardianIntended for interior or exterior wounds including use as a covering for the surgical site. Usage includes various wounds and ulcers and other soft tissue defects.
AmnioExCel, AmnioExCel Plus, or BioDExCelUsed in the treatment of wounds including: diabetic ulcers, venous and arterial ulcers, pressure ulcers, traumatic injuries, surgical wounds, and burns.
AmnioMatrix or BioDMatrixUsed in the treatment of wounds including: diabetic ulcers, venous and arterial ulcers, pressure ulcers, traumatic injuries, surgical wounds, and burns.
ApligrafIndicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency.

Indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness neuropathic diabetic foot ulcers and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
Architect Extracellular Collagen Matrix

Architect Px Extracellular Collagen Matrix

Architect Fx Extracellular Collagen Matrix
Indicated for the local management of moderately to heavy exuding wounds, including: partial and full thickness wounds, draining wounds, pressure sores/ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Moh's surgery, podiatric wounds, dehisced surgical incisions).
Artacent ACIndicated for use in partial- and full-thickness chronic wounds, such as, traumatic and complex wounds, burns, surgical and Moh's surgery sites, diabetic ulcers, venous ulcers, arterial ulcers, and pressure ulcers.
Artacent AC PowderIndicated for use in chronic wounds such as diabetic ulcers, pressure ulcers, venous stasis ulcers, and burns.
Artacent WoundIndicated for use as a wound cover on chronic wounds such as diabetic ulcers, pressure ulcers, venous stasis ulcers, and burns.
Bio-ConneKt Wound MatrixIndicated for the local management of
moderately to heavily exuding wounds, including: partial and full-thickness wounds, draining wounds, tunneling wounds, pressure sores/ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions).
BioDFenceUsage includes allograft application to wounds including: traumatic injuries, burns, Moh's procedures or surgical wounds, diabetic ulcers, venous and arterial leg ulcers, pressure ulcers or cutaneous ulcers.
BioSkinIntended to be used as a wound covering and is surgically applied to the skin in the treatment of
chronic acute and surgical wounds.
BioSkin FlowIntended to replace or supplement damaged or inadequate integument. For use in difficult to reach, irregularly shaped or tunneled wounds.
BiovanceIndicated for a broad range of wound types, including: Moh's surgery, burns, trauma, surgical, venous leg ulcers, diabetic ulcers, pressure ulcers, arterial ulcers.
Cellesta Amniotic MembraneIndicated for: diabetic ulcers, pressure ulcers, surgical wounds, venous ulcers.
Cellesta Flowable AmnionIndicated for: diabetic ulcers, pressure ulcers, surgical wounds, venous ulcers.
Clarix FloUsed in the treatment of partial- and full-thickness wounds including: diabetic foot ulcers, venous leg ulcers, arterial ulcers, and pressure ulcers.
Coll-e-dermIndicated for use in chronic, non-infected, full-or partial thickness diabetic or venous insufficiency ulcers.
CygnusIndicated for use in chronic wounds and burns.
Cytal Wound MatrixIntended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post- Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.
DermACELLIndications for use include: arterial ulcers, chronic wounds, deep wounds, diabetic foot ulcers, and pressure ulcers.
DermagraftIndicated for use in the treatment of full-thickness diabetic foot ulcers, which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.
DermaPureUsed as a covering for difficult or hard to heal, acute and chronic wounds.
DermaSpan Acellular Dermal MatrixIntended use is for the repair or replacement of
damaged or inadequate integumental tissue
(wound coverage).
DermavestIndicated for the management of wounds that include: partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears), drainage wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric).
EpiCordIndicated for use to replace or supplement damaged or inadequate integumental tissue.
EpiFixUsed in the treatment of partial and full-thickness wounds including, but not limited to: diabetic foot ulcers, venous leg ulcers, arterial ulcers, pressure ulcers, and inflammatory ulcers.
EpiFix, InjectableUsage includes injectable applications for neuropathic ulcers, venous stasis ulcers, post traumatic ulcers, post-surgical ulcers and pressure ulcers.
ExcellagenIndicated for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/ undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
E-Z Derm Biosynthetic Wound DressingIndicated for use on partial-thickness skin loss, donor sites, skin ulcerations and abrasions. Other applications may include temporary covering for full-thickness skin loss.
FlowerDermIndicated for use on chronic, non-infected, full thickness diabetic lower extremity ulcers, and chronic, non-infected, partial or full-thickness diabetic lower extremity skin ulcers due to venous insufficiency which have not adequately responded following conventional ulcer therapy.
FlowerFlo (FlowerAmnioFlow)Indicated for use on chronic, non-infected, full thickness diabetic lower extremity ulcers, and chronic, non-infected, partial or full-thickness diabetic lower extremity skin ulcers due to venous insufficiency which have not adequately responded following conventional ulcer therapy.
FlowerPatch (FlowerAmnioPatch)Indicated for use on chronic, non-infected, full thickness diabetic lower extremity ulcers, and chronic, non-infected, partial or full-thickness diabetic lower extremity skin ulcers due to venous insufficiency which have not adequately responded following conventional ulcer therapy.
GammaGraftIndications for use include: venous stasis ulcers, diabetic foot ulcers, full thickness ulcers, Moh's surgery sites, skin graft donor sites, partial thickness wounds, and areas of dermabrasion.
Geistlich Derma-GideIndicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (e.g., abrasions, lacerations, skin tears, second-degree burns), surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, post laser surgery, podiatric, wound dehiscence).
Genesis Amniotic MembraneIndicated for use on chronic wounds and skin ulcers.
Grafix CoreIndications for use include: diabetic foot ulcers, burns, deep tunneling wounds, pressure ulcers, pyoderma gangrenosum, surgical dehiscence, surgical incisions, and venous leg ulcers.
GrafixPL CoreIndications for use include: diabetic foot ulcers, burns, deep tunneling wounds, pressure ulcers, pyoderma gangrenosum, surgical dehiscence, surgical incisions, and venous leg ulcers.
Grafix PrimeIndications for use include: diabetic foot ulcers, burns, deep tunneling wounds, pressure ulcers, pyoderma gangrenosum, surgical dehiscence, surgical incisions, and venous leg ulcers.
GrafixPL PrimeIndications for use include: diabetic foot ulcers, burns, arterial ulcers, deep tunneling wounds, pressure ulcers, pyoderma gangrenosum, surgical dehiscence, trauma, surgical incisions, and venous leg ulcers.
Graftjacket Xpress Flowable Soft Tissue ScaffoldFor repair or replacement of damaged or inadequate integumental tissue, such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or for other homologous uses of human integument.
Graftjacket Regenerative Tissue Matrix (RTM)For repair or replacement of damaged or inadequate integumental tissue, such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or for other homologous uses of human integument.
HelicollIndicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (e.g., abrasions, lacerations, skin tears, second-degree burns), surgical wounds (e.g., donor sites/grafts, post-Mohs' surgery, post laser surgery, podiatric, wound dehiscence).
hMatrix Acellular DermisIndicated for use to replace damaged or inadequate integumental tissue.
Hyalomatrix

Hyalomatrix PA
Indicated for the management of wounds including: partial and full-thickness wounds, second-degree burns, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undetermined wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, skin tears), and draining wounds.
Integra Bilayer Matrix Wound Dressing (BMWD)Indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
Integra Dermal Regeneration Template (DRT) Integra Omnigraft Dermal Regeneration MatrixIndicated for the treatment of partial and full-thickness neuropathic diabetic foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed, when used in conjunction with standard diabetic ulcer care.
Integra Flowable Wound MatrixIndicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds, (e.g., donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
Integra Matrix Wound DressingIndicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
Integra Meshed Bilayer Wound DressingIndicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (e.g., donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.
InteguplyTypically used in conjunction with a chronic wound care management regimen for the treatment of diabetic ulcers, charcot foot ulcers, venous ulcers, trauma wounds, pressure ulcers, partial and full thickness wounds, and surgical wounds.
InterfylIntended for use as the replacement or supplementation of damaged or inadequate integumental. Indications for include treatment of deep dermal wounds, irregularly-shaped and tunneling wounds, augmentation of deficient/inadequate soft tissue, and the repair of small surgical defects.
KeramatrixIndicated for the following types of chronic wounds: pressure ulcers, venous stasis ulcers,
ulcers caused by mixed vascular etiologies, diabetic ulcers, and donor sites and grafts.
Kerecis Omega3 WoundIndicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears), surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), and draining wounds.
Keroxx Flowable Wound MatrixIntended for use on chronic wounds, surgical wounds, donor sites/grafts, diabetic ulcers, chronic ulcers of mixed vascular etiologies, venous stasis ulcers, pressure ulcers (stages I-IV), partial & full thickness wounds, and donor sites/grafts.
MatrionIntended to be used as a wound covering for chronic wounds.
MatriStem MicroMatrixIntended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, and skin tears), and draining wounds.
Matrix HDUsed in diabetic ulcers, Charcot foot ulcers, venous ulcers, trauma wounds, pressure sores/ulcers, partial and full thickness wounds and surgical wounds.
MediskinIntended for the management of wounds that
include: partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers chronic vascular ulcers, second-degree burns, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, skin tears), tunneled/undermined wounds, and draining wounds.
MemoDerm Acellular Dermal MatrixIntended use is for chronic diabetic foot ulcers.
MirodermIndicated for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, tunneled/undermined wounds, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), drainage wounds, and surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence).
NeoPatchUsed in the treatment of lower extremity ulcerations caused by diabetes, chronic venous disease, and other chronic conditions.
Neox 100 Wound MatrixUsed in the treatment of partial- and full-thickness wounds including: diabetic foot ulcers, venous leg ulcers, arterial ulcers, and pressure ulcers.
Neox Cord 1k Wound MatrixUsed in the treatment of partial- and full-thickness wounds including: diabetic foot ulcers, venous leg ulcers, arterial ulcers, and pressure ulcers.
Neox Cord RTUsed in the treatment of partial- and full-thickness wounds including: diabetic foot ulcers, venous leg ulcers, arterial ulcers, and pressure ulcers.
Neox FloUsed in the treatment of partial- and full-thickness wounds including: diabetic foot ulcers, venous leg ulcers, arterial ulcers, and pressure ulcers.
NovachorIntended to be applied as a graft for chronic wounds, including, but not limited to, neuropathic ulcers, venous stasis ulcers, pressure ulcers, burns, post-traumatic wounds and post-surgical wounds.
NuShieldIntended to be applied as an on-lay graft for acute and chronic wounds, including, but not limited to, neuropathic ulcers, venous stasis ulcers, pressure ulcers, burns, post-traumatic wounds and post-surgical wounds.
Oasis Burn MatrixIntended use is for the management of second-degree burns and donor sites.
Oasis Ultra Tri-Layer Wound MatrixIndicated for the management of: partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, diabetic ulcers, trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears), surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), and draining wounds.
Oasis Wound MatrixIntended use is for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, and skin tears), and draining wounds.
PalinGen Flow

PalinGen ProMatrX ACF

PalinGen SportFlow
Used in the treatment of chronic wounds that are most prevalent in older populations, particularly in patients with Type I diabetes.
PalinGen Membrane

PalinGen XPlus Membrane
Used in the treatment of chronic wounds, including venous leg ulcers, diabetic ulcers, and pressure ulcers.
PlurivestIndicated for the management of wounds that include: partial and full thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears), drainage wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric).
PriMatrix Dermal Repair ScaffoldIntended for the management of wounds that include: partial and full thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, second-degree burns, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, and skin tears), tunneled/undermined wounds, and draining wounds.
PuraPly (formerly called Fortaderm Wound Dressing)Indicated for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
PuraPly Antimicrobial Wound Dressing (formerly called Fortaderm Antimicrobial Wound Dressing)Indicated for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
PuraPly Antimicrobial XT Wound MatrixIndicated for the management of: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, second-degree burns, skin tears) and draining wounds.
Restorgin AFTIntended to be used in chronic, non-healing wounds and burns.
Restorgin Amnion PatchIntended to be used in chronic, non-healing wounds and burns.
RevitaIntended to be used as a wound covering for chronic wounds, including dermal ulcers or defects.
RevitalonIndicated for the management of wounds including: diabetic ulcers and venous ulcers.
SkinTEIntended to be used as a wound covering for chronic wounds.
surgiGRAFTIntended for use in the following conditions: neuropathic ulcers, venous stasis ulcers, post-traumatic wounds, pre- and post- surgical wounds and pressure ulcers, diabetic wounds, anf burn wounds.
TalymedIndicated for the management of wounds including: diabetic ulcers, venous ulcers, pressure wounds, ulcers caused by mixed vascular etiologies, full thickness and partial thickness wounds, second degree burns, surgical wounds (e.g., donor sites/grafts, post-Moh's surgery, post-laser surgery), abrasions, lacerations, traumatic wounds healing by secondary intention, chronic vascular ulcers, and dehisced surgical wounds.
TenSIX Acellular Dermal MatrixChronic diabetic foot ulcers
TheraSkinCan be used to replace or repair skin over any wound, including those with exposed muscle, tendon, bone and joint capsule. This includes, but is not limited to, diabetic foot ulcers, venous leg ulcers, arterial ulcers, pressure sores, dehisced surgical wounds, and wounds that might otherwise require an autograft.
TranZgraft Acellular Dermal MatrixIntended use is for ulcer repair.
TruSkinIndicated for the management of wounds including: diabetic foot ulcers, venous leg ulcers, pressure ulcers, dehisced surgical wounds, traumatic burns, and radiation burns.
WoundExIntended to be used as a wound covering and is surgically applied to the skin in the treatment of
chronic acute and surgical wounds.
WoundEx FlowIntended to replace or supplement damaged or inadequate integument. For use in difficult to reach, irregularly shaped or tunneled wounds.
XWRAPIndicated for chronic wounds, diabetic ulcers, pressure ulcers, and venous ulcers.



Version Effective Date: 10/01/2019
Version Issued Date: 10/03/2019
Version Reissued Date: N/A

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