Humana Skin and Tissue Substitutes - Medicare Advantage Form

Please refer to CMS website for the most current applicable National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/CMS Online Manual System/ Transmittals.TypeTitleID NumberJurisdiction Medicare AdministrativeApplicable States/TerritoriesSkin and Tissue Substitutes Page: 2 of 81

NCD	Porcine Skin and Gradient . Pressure Dressings	270.5 ~	(MACs)
LCD LCA	Amniotic and Placental Derived Product Injections and/or Applications for Musculoskeletal Indications, Non-Woun	L39624 A59434	J5 - Wisconsin Physicians Service Insurance Corporation J8 - Wisconsin Physicians Service Insurance Corporation	1A, KS, MO, NE IN. MI
LCD LCA	Amniotic and Placental-Derived Product Injections and/or . oe Applications for Musculoskeletal - ge Indications, Non-Wound	L39116 | A58865	JE - Noridian Healthcare : Solutions, LLC	CA, HI, NV, American Samoa, Guam, Northern . Mariana Islands
LCD LCA	‘Amnioti er mniotic and Placental Derived | Product Injections and/or Applications for Musculoskeletal ge	139118 | A58867	JE - Noridian Healthcare : Solutions, LLC	AK, AZ, ID, MT, ND, OR, SD, UT, WA, WY
LCD LCA	Indications, Non-Wound		JJ - Palmetto AB
		Amniotic and Placental-Derived | Product Injections and/or Replications for Musculoskeletal ”	L39128 AS58883	pen (Part JM-Palmetto GBA (Part A/B MAC	AL. GA, TN ie | NC, SC, VA, WV
LCD LCA	Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities		15 -cGs _ Administrators, LLC (Part A/B MAC)	KY, OH
		ays F . Billing and Coding: Skin Substitutes Grafts/Cellular Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers			L36690 TT A56696

Billing and Coding: Skin Substitutes Grafts/Cellular Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg UlcersJH - Novitas Solutions, Inc. (Part A/B MAC)LCD LCAAR, CO, NM, OK, TX, LA, MSL35041A54117DE, D.C., MD, NJ, PASkin and Tissue Substitutes Page: 3 of 81

	Billing and Coding: Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers		JL - Novitas Solutions, Inc. (Part A/B MAC)
LCD LCA	Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Billing and Coding: Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers	L36377 AS57680	JN - First Coast Service Options, Inc. (Part A/B MAC)	FL, PR, U.S. VI

DescriptionBioengineered skin and soft tissue substitutes are acellular (no biological component) or cellular (contain living cells) matrices. Acellular dermal matrices (ADM) or extracellular matrices (ECM) have had all cellular material removed during the manufacturing process and contain a matrix or scaffold composed of materials such as collagen, elastin, fibronectin and hyaluronic acid. These products vary in a number of ways including source (eg, biological tissue, synthetic materials or a combination), additives (eg, antibiotics, surfactants), hydration (eg, freeze dried, wet) and required preparation (eg, multiple rinses, rehydration).Cellular matrices contain living cells such as fibroblasts and keratinocytes within a matrix which are derived from either human tissue (autologous or allogeneic) or animal tissue (xenographic), synthetic materials or a composite of these materials.Manufacturing processes of bioengineered skin and tissue substitutes vary by company, but generally involve seeding selected cells onto a matrix, where they receive proteins and growth factors necessary for them to multiply and develop into the desired tissue. The tissue may be used for a variety of conditions and procedures including breast reconstruction, healing of lower extremity ulcers (eg, diabetic and/or venous ulcers), ocular defects, plantar fasciitis, surgical wounds and treatment of severe burns.Coverage DeterminationHumana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.Skin and Tissue Substitutes Page: 4 of 81In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:Skin and tissue substitutes will be considered medically reasonable and necessary when the following requirements are met:

Skin / Tissue Substitute	Indication(s) / Criteria	Associated HCPCS Code(s)
AlloDerm Select RTM Processed from human cadaver skin with the cells responsible for immune response and graft rejection removed. The remainder is a matrix or framework of natural biological components, ready to enable the | body to mount its own tissue regeneration | process.	e For use in association with a covered, medically necessary breast reconstruction procedure (For information regarding coverage determination/limitations for breast reconstruction, please refer to Breast Reconstruction Medicare Advantage Medical Coverage Policy)	Q4116
Apligraf Much like human skin as it has two primary layers; the epidermal (outer) layer consists of live human keratinocytes, while the dermal (inner) layer contains living fibroblasts. Also referred to as human skin equivalent.	e Use with standard therapeutic compression for the treatment of noninfected partial- and full-thickness skin ulcers due to venous insufficiency of greater than 4 weeks duration and have not adequately responded to	Q4101
		standard wound therapy; OR e Individual with type 1 or type 2 diabetes mellitus, who have full-thickness, neuropathic diabetic foot ulcers of greater than 4 weeks duration that have not adequately responded to standard wound therapy, where there is no bone, muscle tendon
Biobrane/Biobrane-L Constructed using collagen (porcine type 1) that is incorporated with both silicone and nylon and mechanically bonded to a flexible knitted nylon fabric.	capsule, exposure e Full-thickness (third-degree) burns; OR e Partial-thickness (second-degree) burns	Q4100
Cortiva and Cortiva 1 mm Allograft Dermis Non-crosslinked acellular dermal matrix.	e For use in association with a covered, medically necessary breast reconstruction procedure	Q4100, C1763

(For information regarding coverage determination/limitations for breastSkin and Tissue Substitutes Page: 5 of 81

	reconstruction, please refer to Breast Reconstruction Medicare Advantage Medical Coverage Policy)
DermACELL Acellular human dermis.	e For use in association with a covered, medically necessary breast reconstruction procedure (For information regarding coverage determination/limitations for breast reconstruction, please refer to Breast Reconstruction Medicare Advantage Medical Coverage Policy)	Q4122
Dermagraft Manufactured from human fibroblast cells derived from newborn foreskin tissue. The ‘ibroblasts are cultured on a bioarbsorbable 9olyglactin mesh. Proteins and growth ‘actors are secreted during the culture 9eriod and generate a three dimensional 3D) human dermis.	e Full-thickness, neuropathic diabetic ulcers of the plantar surface of the foot, of greater than 4 weeks duration that have not adequately responded to standard wound therapy, where there is no bone, capsule, muscle or tendon exposure; AND e Used in conjunction with standard wound therapy	Q4106
E pifix 3iologic human amniotic membrane.	e Full-thickness diabetic foot ulcers greater than 4 weeks duration that extend through the dermis, but without bone, capsule, muscle or tendon exposure; AND e Used in conjunction with standard wound therapy	Q4186
FlexHD duman allograft skin minimally processed ‘0 remove epidermal and dermal cells and oreserve the ECM of the dermis.	e For use in association with a covered, medically necessary breast reconstruction procedure (excluding implant-based breast reconstruction) (For information regarding coverage	Q4128

Grafix Core/Grafix Prime ECM containing growth factors.(For information regarding coverage determination/limitations for breast reconstruction, please refer to Breast Reconstruction Medicare Advantage Medical Coverage Policy) • Treatment of partial- and full-thicknessneuropathic diabetic foot ulcers that are greater than 4 weeks in duration, with no bone, capsule or tendon exposed,Q4132, Q4133Skin and Tissue Substitutes Page: 6 of 81

	when used in conjunction with standard wound therapy
GraftJacket Regenerative Tissue Matrix Derived from cadaveric skin, which undergoes a process that removes the epidermis and dermal cells. The human dermal tissue is preserved. Over time, the body’s natural repair process converts the matrix into living tissue.	Full-thickness diabetic foot ulcers greater than 4 weeks duration that extend through the dermis, but without bone, capsule, muscle or tendon exposure; AND Used in conjunction with standard wound therapy	Q4107
Integra Bilayer Matrix Wound Dressing Comprised of a porous matrix of cross- linked bovine tendon collagen and glycosaminoglycan and a semipermeable polysiloxane (silicone layer). The collagen- glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.	Treatment of chronic venous or diabetic partial- and full-thickness ulcers, of greater than 4 weeks duration that have not adequately responded to standard wound therapy, where there is no bone, capsule, muscle or tendon exposure; OR Partial-thickness (second-degree) burns	Q4104
Integra Dermal Regeneration Template/Omnigraft Bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate). The epidermal substitute layer is made of thin polysiloxane (silicone) layer.	Postexcisional treatment of life- threatening, full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the individual; OR Repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the OR	Q4105
		individual; Treatment of partial- and full-thickness neuropathic diabetic foot ulcers that are greater than 4 weeks in duration, with no bone, capsule or tendon exposed, when used in conjunction with standard

neuropathic diabetic foot ulcers that are greater than 4 weeks in duration, with no bone, capsule or tendon exposed, when used in conjunction with standard wound therapyIntegra Meshed Bilayer Wound Matrix Porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth. The meshed bilayer matrix allows drainage of woundTreatment of chronic venous or diabetic partial- and full-thickness ulcers, of greater than 4 weeks duration that have not adequately responded to standard wound therapy, where there is no bone, capsule, muscle or tendon exposure; ORQ4104, C9363Skin and Tissue Substitutes Page: 7 of 81

exudate and provides a flexible adherent covering for the wound surface.	Partial-thickness (second-degree) burns
Oasis Ultra Tri-Layer Matrix and Oasis Wound Matrix A naturally derived, ECM created from the submucosal layer of porcine small intestine.	For treatment of difficult to heal chronic venous or diabetic partial- and full- thickness ulcers of the lower extremity that have failed standard wound therapy of at least 4 weeks duration	Q4124, Q4102
Transcyte Combines a synthetic epidermis with a bioengineered human dermal layer that contains fibronectin growth factors and collagen	For use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in an individual who requires such a covering prior to autograft placement; OR Treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting	Q4182

The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms. Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.Coverage LimitationsUS Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverageThe following will not be considered medically reasonable and necessary for ANY other indication or when the above criteria are not met including, but may not be limited to:AlloDerm Select RTM; OR • Apligraf; OR • Biobrane/Biobrane-L; OR • Cortiva and Cortiva 1 mm Allograft Dermis; OR • DermACELL; OR • Dermagraft; OR • Epifix; OR • FlexHD; OR • Grafix Core/Grafix Prime; ORSkin and Tissue Substitutes Page: 8 of 81GraftJacket Regenerative Tissue Matrix; OR • Integra Bilayer Matrix Wound Dressing; OR • Integra Dermal Regeneration Template/Omnigraft (Integra DRT); OR • Integra Meshed Bilayer Wound Matrix; OR • Oasis Ultra-Tri-Layer Matrix; OR • Oasis Wound Matrix; OR • TranscyteA review of the current medical literature shows that the evidence is insufficient and there remains an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of this service in clinical management.The following, or any other skin or tissue substitutes, not addressed in the Coverage Determination section will not be considered medically reasonable and necessary for ANY indication. A review of the current medical literature shows that there is no evidence to determine that these services are standard medical treatments. There is an absence of randomized, blinded clinical studies examining benefit and long-term clinical outcomes establishing the value of these services in clinical management.

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
AC5 Advanced Wound System Lyophilized peptide in sterile water for	Topical dressing for the management of wounds including:	A2020
injection. Biocompatible and resorbable
peptides that self-assemble into a nanofiber network which resembles the construct of	o Diabetic ulcers
the extracellular matrix.	o Partial- and full-thickness wounds
		o Pressure ulcers
		o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence) o Venous ulcers
ACTISHIELD, ACTISHIELD CF Allografts derived from dehydrated human	Homologous use to cover and protect tissue	Q4100
amniotic tissue. ActiveBarrier, ActiveMatrix, CryoMatrix Placental connective tissue matrix.	Surgical use to supplement or replace damaged or inadequate connective	Q4100
Affinity	tissue Onlay graft for:	Q4159

Skin and Tissue Substitutes Page: 9 of 81

Skin / Tissue Substitute	Purported Indications	Associated
Minimally processed amniotic fluid membrane allograft.	o Acute and chronic wounds including	CPT® Code(s)
			neuropathic ulcers, pressure ulcers and venous stasis ulcers
			o Burns
			o Postsurgical wounds
	o Posttraumatic wounds
Allogen Liquid	Burns	Q4212
Human liquid amnion. AlloMax A sterile regenerative human collagen matrix.	Chronic, nonhealing wounds Soft tissue repair including: o Breast reconstruction	Q4100
	o Chest wall defect o Hernia repair
Allopatch HD Acellular human dermis derived from human allograft skin that is processed to preserve and maintain the natural biomechanical, biochemical and matrix properties of the dermal graft.	Provision of ECM scaffold for tendon augmentation	Q4128
AlloSkin, AlloSkin AC, AlloSkin RT Allograft derived from epidermal and dermal cadaveric tissue.	Acute and chronic wound therapy	Q4115, Q4141, Q4123
Allowrap DS or dry Double-sided epithelial layer human amniotic membrane.	Onlay and/or wrapping tissue applications following surgical repair	Q4150
AltiPly, AMNIOREPAIR Lyophilized placental membrane allografts.	Acute and chronic wound therapy	Q4235
Amnio wound	Intended for the following conditions:	Q4181

Allopatch HD Acellular human dermis derived from human allograft skin that is processed to preserve and maintain the natural biomechanical, biochemical and matrix properties of the dermal graft. AlloSkin, AlloSkin AC, AlloSkin RT Allograft derived from epidermal and dermal cadaveric tissue. Allowrap DS or dry Double-sided epithelial layer human amniotic membrane. AltiPly, AMNIOREPAIR Lyophilized placental membrane allografts. Amnio wound Lyophilized human amniotic membrane allograft comprised of an epithelial layer and two fibrous connective tissue layers specifically processed to be used for the repair and replacement of lost or damaged dermal tissue.o Adhesion barrier o Burn wounds o Diabetic ulcers o Neuropathic ulcers o Post-traumatic wounds o Pre- and post-surgical wounds o Pressure injuries o Scar tissue o Venous stasis ulcersSkin and Tissue Substitutes Page: 10 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Amnio-Maxx Dual layered, dehydrated, amniotic tissue membrane graft. Amnio-Maxx Lite Single layer, dehydrated, amniotic tissue membrane graft.	e Chronic wound covering for: o Diabetic ulcers o Soft tissue defects o Venous stasis ulcers	Q4239
AmnioAMP-MP Decellularized dehydrated human amniotic membrane (DDHAM) which is derived from the placental amnion.	e Partial- or full-thickness skin wounds such as: o Burns o Diabetic ulcers o Pressure ulcers o Venous ulcers e Repair of skin over any wound including those with exposed bone, muscle or tendon	Q4250
Amnioarmor Dehydrated human amniotic membrane allograft derived from the submucosa of placental tissue.	e Acute and chronic wound therapy	Q4188
Amnioband or Guardian - Membrane, Particulate Human tissue allografts made of donated placental membranes.	e Soft tissue defects e Surgical sites e Ulcers e Wounds	04151, Q4168
AmnioBind Dehydrated, full thickness placental membrane (PM) allograft consisting of amnion, chorion, and the associated intermediate (spongy) layer (IL).	e Acute and chronic wound therapy	Q4225
AmnioCord, EpiCord Dehydrated, nonviable cellular umbilical cord	e Connective tissue matrix to replace or supplement damaged inadequate	Q4100

Amnioarmor Dehydrated human amniotic membrane allograft derived from the submucosa of placental tissue. Amnioband or Guardian – Membrane, Particulate Human tissue allografts made of donated placental membranes. AmnioBind Dehydrated, full thickness placental membrane (PM) allograft consisting of amnion, chorion, and the associated intermediate (spongy) layer (IL). AmnioCord, EpiCord Dehydrated, nonviable cellular umbilical cord allograft.Connective tissue matrix to replace or supplement damaged or inadequate integumental tissueAmnioCore Dual layer amniotic tissue allograft. AmnioCyte Minimally manipulated human tissue allograft derived from the extracellular matrix of the amniotic membrane.Surgical wrap or barrier • Acute and chronic wound therapyReplace or supplement damaged orinadequate tissueQ4227Q4242Skin and Tissue Substitutes Page: 11 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
AmnioFill -ellular tissue matrix allograft that contains nultiple ECM proteins, growth factors, -ytokines, and other specialty proteins.	e Modulate inflammation in the surgical site e Reduce scar tissue formation e Replace or supplement damaged or inadequate integumental tissue for acute and chronic wounds	Q4100
AmnioFix duman amniotic membrane comprises the nnermost layer of the placenta and lines the amniotic cavity.	e Modulate inflammation in the surgical site e Reduce scar tissue formation e Surgical wrap or barrier	Q4100
AmnioFLEX, ASG Barrier, ASG Fluid duman tissue, chorion free allograft, -omprised of minimally manipulated amniotic nembrane derived from placental tissue.	e Aid in the healing and repair of wounds | e Construct a natural scaffold for new tissue growth	Q4100
AmnioGraft Viinimally manipulated, cryopreserved amniotic membrane.	e Any indication other than ocular use (eg, diabetic ulcer) (For information regarding coverage determination/ limitations for ocular indications, please refer to Ocular Surface Disease Diagnosis and Treatments Medical Coverage Policy)	Q4100, V2790
AmnioHeal Plus Amniotic membrane graft	e Chronic wound covering for: Burns Diabetic ulcers Pressure ulcers Venous stasis ulcers |O O00 0	Q4100

AmnioMatrix Cryopreserved (frozen) complex of amniotic tissue, liquid human allograft.Anti-inflammatory wound dressingHollow regions of boneQ4139Amnion Bio, AxoBioMembrane Human amnion allograft.Soft tissue injuries • Acute and chronic wounds • Partial- or full-thickness skin woundsQ4211Skin and Tissue Substitutes Page: 12 of 81

/	Purported (Not covered for ANY indication)	HCPCS/ CPT® Code(s)
Amniopro, Amniogen-45, Amniogen-200, BioRenew, BioSkin, WoundEx Human ECM placental tissue allografts.	Wounds and soft tissue defects	Q4163
Amniopro Flow, Amniogen-a, Amniogen-c, BioRenew Flo, BioSkin Flo, WoundEx Flo Human ECM placental tissue injectable allografts.	Wounds and soft tissue defects	Q4162
Amniotext Minimally manipulated, amniotic membrane derived human tissue allograft.	Provides a barrier and support function to aid in healing of defect	Q4245
Amniotext patch Minimally manipulated amniotic membrane derived human tissue allograft.	Management of chronic wounds including: o Diabetic foot ulcers o Venous ulcers	Q4247
AmnioWrap2 Amniotic/chorionic tissue allograft.	Management of wounds including: o Acute and chronic wounds o Chronic vascular ulcers o Diabetic ulcers o Venous ulcers	Q4221
Amniply Collagenous membrane derived from the submucosa of the placenta. Apis	Chronic wound covering for: o Diabetic foot ulcers o Pressure ulcers o Venous leg ulcers Management of wounds including:	Q4249 A2010

o Surgical wounds (eg, donorsites/grafts)o Trauma wounds (eg, abrasions, healing by secondary intention)o Venous ulcersSkin and Tissue Substitutes Page: 13 of 81

	(Not covered for ANY indication)	HCPCS/ CPT® Code(s)
Architect, Architect PX, Architect FX ECM Stabilized collagen matrix.	e Partial- or full-thickness skin wounds such as: o Diabetic foot ulcers o Second-degree burns	Q4147
Artacent AC Human amnion/chorion membrane graft.	o Venous leg ulcers	Q4189, Q4190
			o
			e Acute and chronic wounds such as: Burns o Diabetic ulcers o Pressure ulcers o Venous stasis ulcers
			o Wounds that are refractory to more
			conservative care
Artacent Cord Umbilical cord allograft.	e Acute and chronic wounds such as:	Q4216
			o Burns
			o Diabetic ulcers
			o Venous stasis ulcers
			o Wounds that are refractory to more
Artacent — Flex, Wound Amniotic tissue graft with an epithelial layer of native membrane facing out on both sides.	e Surgical barrier for these types of surgeries: fe) fe) fe) Extremity Orthopedic Plastics	Q4169

o Extremity o Orthopedic o Plastics o Spinal o Urological o VascularArthroFlex Decellularized dermis patch. AscentAchilles tendon repair and shoulderreconstructionBurns • Chronic, nonhealing woundsQ4125Q4213Skin and Tissue Substitutes Page: 14 of 81

	(Not covered for ANY indication)	HCPCS/ CPT® Code(s)
Dehydrated cell and protein concentrate (dCPC) injectable derived from human amniotic fluid.
Avance Nerve Graft Processed, decellularized nerve allograft.	Alternative to nerve conduits for nerve repair procedures	64912, 64913
Axograft Dual layer amniotic membrane.	Promote bone healing, spinal fusion and wound treatment in spinal arthrodesis procedures	Q4100
AxoGuard — Nerve Connector, Nerve Protector Porcine submucosa ECM.	Coaptation aid for close approximation and reinforcement of severed nerve ends Isolate nerve tissue during the healing process	C1763
Axolotl Ambient, Axolotl Cryo Human amniotic flowable allografts.	Soft tissue injuries	Q4215
Axolotl DualGraft, Axolotl Graft Human amniotic allograft, decellularized, dehydrated placental membrane.	Wound barrier Nerve wrap	Q4210
Barrera SL, Barrera DL Dehydrated human amniotic membrane allograft.	Barrier or cover for wounds including surgically created wounds	Q4281
BellaCell HD Human acellular dehydrated dermis regenerative tissue matrix.	Abdominal wall and hiatal hernia repair Breast reconstruction Burns Skin ulcers	Q4220
Bio-ConneKt Conformable and porous wound dressing made of reconstituted collagen derived from	Management of moderately to heavily exuding wounds including:	Q4161

o Diabetic ulcerso Draining woundso Partial- and full-thickness woundsSkin and Tissue Substitutes Page: 15 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	o Pressure ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
Biodesign — Dural Graft, Duraplasty Graft,	o Venous ulcers e Repair of soft tissue defects including:	C1763
ENT Repair Graft, Otologic Repair Graft Nonporous, absorbable multi-layer sheet of extracellular collagen matrix derived from porcine SIS.	o Dura mater o Sinonasal o Tympanic membrane
Biodesign — Enterocutaneous Fistula Plug and Fistula Plug Cone-shaped plug made of connective tissue from porcine small intestine submucosa (SIS).	e The plug is absorbed into the body in 6 — 8 weeks ¢ The plug is inserted into the fistula and sutured into place, where it is intended to provide a framework for the body's own cells and blood vessels to infiltrate and promote healing	C1763, 46707
Biodesign — Hernia, Hiatal Hernia, Incision Graft Multilayered sheet of extracellular collagen matrix derived from porcine small intestinal	e Abdominal wall reconstruction and hernia repair	C1763

Biodesign – Hernia, Hiatal Hernia, Incision Graft Multilayered sheet of extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). Biodesign Nipple Reconstruction Cylinder Rolled cylinder of extracellular collagen matrix derived from porcine small intestinal submucousa (SIS). Biodesign Tissue Graft – 1 layer, 4 layer Dried single or multilayer porcine SIS sheet. BioDExCel (AmnioExCel)Support weakened soft tissue duringnipple reconstructionReinforcement of soft tissueC1763C1763Scaffold for tissue repair andQ4137regenerationSkin and Tissue Substitutes Page: 16 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Amniotic extracellular membrane is a sterile, resorbable, noncross-linked tissue allograft derived from the human amnion.
BioDFactor, BioDFence, BioDDryFlex ECM and flowable tissue allografts derived from human placental tissues.	Localized areas of inflammation Supports soft tissue regeneration Tissue voids and defects	Q4140, Q4138
BioFix, BioFix Plus, BioFix Flow	Wound covering for:	Q4100
placental tissue. Biovance	o Surgical sites o Tissue defects o. Tissue voids Treatment or replacement of damaged	Q4154
Dehydrated, decellularized human amniotic membrane. Biovance Biovance 3L	or lost soft tissue Cover or from the	Q4283
Tri-layer, Triple-layer decellularized, dehydrated human amniotic membrane.	protect, surrounding environment, in wound, surgical repair and reconstruction procedures
BioWound, BioWound Plus, BioWound XPlus, WoundFix, WoundFix Plus, WoundFix XPlus	Repair of acute and chronic wounds including, but may not be limited to:	Q4217
Human amnion-based membranes.	fe) Burns
		Chronic vascular ulcers
		Diabetic ulcers
		Partial- and full-thickness wounds
		Pressure ulcers
		Surgical wounds (eg, donor

sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)o Trauma wounds (eg, abrasions,lacerations, second-degree burns, skin tears)o Venous ulcersSkin and Tissue Substitutes Page: 17 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	Repair of skin over any wound including those with exposed bone, capsule, muscle or tendon
Celera Dual Membrane, Celera Dual Layer Amniotic and/or chorionic allograft derived from placental tissue.	Wound covering or barrier membrane	Q4259
Cellesta Minimally manipulated amniotic membrane allograft.	Burns Chronic wound repair Urologic and gynecological surgeries	Q4184
Cellesta Cord Umbilical cord allograft product.	Acute and chronic wound therapy Surgical wounds	Q4214
Cellesta Flowable Amnion Minimally manipulated, chorion-free human amniotic membrane.	Application in difficult to access wound sites, deep dermal wounds, irregularly shaped crevassing and tunneling wounds	Q4185
Cocoon Membrane Human amnionic membrane allograft.	Acute and chronic wounds Partial- or full-thickness skin wounds	Q4264
Cogenex Amniotic Membrane Minimally manipulated, amniotic membrane allograft.	Burns Chronic, nonhealing wounds Urologic and gynecological surgeries	Q4229
Cogenex Flowable Amnion Minimally manipulated, amniotic membrane allograft.	Application in difficult to access wound sites, deep dermal wounds, irregularly shaped crevassing and tunneling wounds	Q4230

Coll-e-derm Allograft derived from human dermal tissue. Complete FT Resorbable full-thickness amnion/chorion allograft. Complete SL Resorbable single layer amniotic allograft. CopiOs Pericardium MembraneburnsWound covering or barrier membrane,over acute and chronic woundsWound covering or barrier membrane,over acute and chronic woundsGuided tissue and bone regeneration inQ4271Q4270C1763oral surgery proceduresSkin and Tissue Substitutes Page: 18 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
30vine pericardium-based, noncross-linked collagen matrix.
coreCyte Nharton’s jelly allograft.	Aid in the healing and repair of wounds	Q4240
coreText, ProText Nharton’s jelly allograft.	Cartilage tears Muscle tears Soft tissue defects Wounds	Q4246
CorMatrix ECM Acellular biomaterial (porcine small intestine submucosa processed to remove cells) the ‘emaining ECM is composed of structural oroteins such as collagen, elastin, etc.	Support cardiac repairs and gradually replace tissue as it is remodeled, leaving no foreign material behind	C1763
Corplex duman umbilical cord allograft composed of he epithelial layer and the Wharton’s jelly.	Acute and chronic wound therapy	Q4232
Corplex P Nharton’s jelly allograft.	Wound covering for connective tissue voids	Q4231
cryo-Cord Minimally manipulated umbilical cord allograft.	Chronic, nonhealing wounds	Q4237
Cygnus Dual Amniotic tissue matrix.	Barrier or cover for wounds	Q4282
cygnus Matrix Amniotic tissue matrix.	Burn care Dermatology Foot and ankle surgery Oral surgery Reconstructive surgery Spine and neurosurgery Urology Wound care	Q4199

Burn care • Dermatology • Foot and ankle surgery • Oral surgery • Reconstructive surgery • Spine and neurosurgery • Urology • Wound care • Burn care • Dermatology • Foot and ankle surgery • Oral surgery • Reconstructive surgery • Spine and neurosurgery • Urology • Wound careCygnus – Max, Solo Amniotic tissue matrix.Skin and Tissue Substitutes Page: 19 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associatec HCPCS/ CPT® Code(s)
Cymetra Micronized Alloderm Tissue Matrix Micronized particulate form of AlloDerm, delivered by injection containing collagens, elastin, proteins and proteoglycans.	e Correction of soft tissue defects requiring minimally invasive techniques	Q4112
Cytal —- Burn Matrix, Micro Matrix and Wound Matrix	Management of topical wounds including, but may not be limited to:	Q4166
(formerly MatriStem Wound Matrix and Multilayer Wound Matrix)	o Chronic vascular ulcers
Noncross-linked urinary bladder matrix (UBM) that maintains an epithelial basement	o Diabetic ulcers
membrane and numerous collagens.	o Draining wounds
		o Partial- and full-thickness wounds
		o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound
		dehiscence) o Trauma wounds (eg, abrasions,
		lacerations, second-degree burns, skin tears)
		o Tunneled wounds
		o Undermined wounds
		o Venous ulcers
Derm-Maxx Freeze-dried decellularized dermal matrix	Repair or replacement of damaged or inadequate integumental tissue	Q4238

o Undermined wounds

Derm-Maxx	Repair or replacement of damaged or	Q4238
Freeze-dried decellularized dermal matrix allograft.	inadequate integumental tissue	Q4203
Derma-Gide Comprised of a porcine derived, porous, purified collagen matrix.	Management of wounds including, but
			may not be limited to:
			o Diabetic ulcers
			o Full- and partial-thickness wounds

o Venous ulcersQ4238Repair or replacement of damaged or inadequate integumental tissueSkin and Tissue Substitutes Page: 20 of 81

	(Not covered for ANY indication)	HCPCS, CPT® Code(s
	Pressure ulcers
	Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	[e} Venous ulcers
Dermabind SL Dehydrated human amniotic membrane allograft.	e Acute and chronic wounds including, but may not be limited to:	Q4284
		fe) Chronic vascular ulcers
		Diabetic ulcers
		Draining wounds
		Partial- and full-thickness wounds
		Pressure ulcers
		Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
		Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)

Associated HCPCS/ CPT® Code(s)Dermacyte Amniotic membrane allograft.DermaMatrix Allograft derived from donated human skin. DermaPureo Venous ulcers • Diabetic foot ulcers • Partial-thickness wounds • Venous stasis ulcers • Repair, replacement or reinforcement ofsoft tissue for grafting purposes • Acute and chronic wounds such as:Q4248Q4100Q4152Skin and Tissue Substitutes Page: 21 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Derived from split-thickness grafts harvested from human cadaver tissue donors.	o Diabetic foot ulcers Venous stasis ulcers
DermaSpan ACD ADM derived from allograft human skin.	conservative care Covering, protection, reinforcement or supplemental support of tendon Homologous uses of human integument Repair or replacement of damaged or	Q4126
Dermavest, Plurivest Amnion/chorion, umbilical cord and placental disk tissue preserved with attachment proteins, growth factors and cytokines.	inadequate integumental tissue Skin replacement or supplement for damaged or inadequate integumental tissue such as surgical sites, ulcers or wounds	Q4153
DermMatrix (formerly InteXen) Porcine Dermal Matrix Pyrogen free, porcine dermis.	Implantation to reinforce soft tissues in gastroenterological, gynecological and urological anatomy Treatment of hernias where the connective tissue has ruptured	Q4100
Dual Layer Impax Membrane Dehydrated dual layered human amniotic membrane allograft.	Wound covering or barrier membrane	Q4262
DuraGen Onlay graft comprised of a porous, purified collagen matrix.	Absorbable implant for the repair of dura mater	Q4100
E-Z Derm Porcine derived xenograft in which the collagen has been chemically cross-linked	Alternative to allografts in the treatment of burn wounds, especially for partial- thickness skin losses	Q4136

Protection for meshed autograftsEndoForm Dermal Template, Myriad ECM derived from ovine forestomach.Temporary coverage prior to autograft • Management of wounds including, butmay not be limited to:A6021, A6022o Chronic vascular ulcersSkin and Tissue Substitutes Page: 22 of 81

	(Not covered for ANY indication)
	o Diabetic ulcers
	o Draining wounds
	o Partial- and full-thickness wounds
	o Pressure ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound
	dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Undermined wounds o Venous ulcers
Enverse	Wound covering or barrier membrane,
Dehydrated human amniotic membrane.	over acute and chronic wounds, including dermal ulcers or defects
Epicel Skin cells are grown or cultured from a postage stamp sized sample of the individual’s own healthy skin.	Replace the epidermis on a severely burned individual
Epicord, Epifix Biologic human amniotic membrane. Epieffect	Burns Plastic surgery Wound care Barrier for and chronic

Associated HCPCS/ CPT® Code(s)Q4258Q4100Q4145, Q4187Epieffect Human amniotic membrane allograft. Esano A Single-layer, decellularized, dehydrated human amniotic membrane allograft. Esano AAA Tri-layer, decellularized, dehydrated human amniotic membrane allograft.woundsBarrier or cover for acute and chronicwoundsBarrier or cover for acute and chronicwoundsQ4278Q4272Q4273Skin and Tissue Substitutes Page: 23 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Esano AC Dual-layer, decellularized, dehydrated human amniotic membrane allograft.	Barrier or cover for acute and chronic wounds	Q4274
Esano ACA Tri-layer, decellularized, dehydrated human amniotic membrane allograft. Excellagen Pharmaceutically formulated fibrillar Type | bovine collagen gel.	Barrier or cover for acute and chronic wounds	Q4275
		Applied immediately following wound debridement Purported to promote: o Cellular adhesion o Chemotaxis o Migration and proliferation to stimulate granulation tissue	Q4149
		formation
FloGraft Cryopreserved, injectable, liquid amniotic fluid derived allograft.	Soft tissue repair	Q4100
Floweramnioflo Premixed, ambient temperature placental tissue matrix allograft.	Replace or supplement damaged or integumental tissue	Q4177
Floweramniopatch Dehydrated amniotic membrane allograft.	Wound covering	Q4178
Flowerderm Acellular dermal allograft ECM composed of proteoglycans, hyaluronic acid, collagen, fibronectin and elastin.	Reinforcement of tendons and supplemental support Wound covering	Q4179
Fluid Flow, Fluid GF	Acute and chronic wound therapy	Q4206

Fortify Flowable Extracellular matrix (ECM) derived from porcine small intestinal submucosa.Soft tissue injuries • Management of wounds including, butmay not be limited to:A4100, Q4100o Chronic vascular ulcerso Diabetic ulcerso Draining woundsSkin and Tissue Substitutes Page: 24 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associate HCPCS/ CPT® Code(s)
	o Partial- and full-thickness wounds
	o Pressure ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Undermined wounds
	o Venous ulcers
Fortiva Porcine Dermis	e Soft tissue repair procedures such as	Q4100
Noncross-linked porcine dermis, designed to act as a scaffold that allows for neovascularization and reincorporation with the individual’s own tissue.	hernia repair
GalaFLEX, GalaFLEX 3D and GalaFLEX 3DR Bioresorbable surgical scaffold made of monofilament fibers of the biopolymer, poly-	e Reinforcing scaffold in soft tissue repair procedures such as:	A4100, Q4100
4-hydroxybutarate (P4HB).	o General soft tissue reconstruction
	o Plastic and reconstructive surgery
GammaGraft	e Temporary graft for treating:	Q4111

Associated HCPCS/ CPT® Code(s)GammaGraft Irradiated human skin allograft acquired from cadaveric donors.o Burns o Chronic wounds o Full-thickness wounds o Partial-thickness woundsGenesis Amniotic Membrane Dehydrated, collagenous human tissue allograft.Acute and chronic wound therapySoft tissue injuriesQ4198Skin and Tissue Substitutes Page: 25 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Gentrix Surgical Matrix (formerly MatriStem Surgical Matrix Composed of a porcine derived ECM, also known as UBM and supplied in multilayer sheet configurations.	|e Reinforcement of soft tissue within gastroenterological, plastic, reconstructive or urological surgery including, but may not be limited to, the following procedures:	C1763, C1781
		o Colon and rectal prolapse repair o Esophageal repair o Hernia and body wall repair o Tissue repair
GraftJacket Xpress Injectable allograft treatment that is mixed with sterile saline.	e Facilitate the rapid formation of granulation tissue and reduce infection risk	Q4113
Helicoll Helicoll is an ADM derived from bovine Type- 1 collagen.	e Full- and partial-thickness wounds e Second-degree burns e Skin donor sites e Skin ulcers e Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)	Q4164
hMatrix Acellular, dermal scaffold processed from donated human skin.	e Replace damaged or inadequate integumental tissue such as: o Abdominal wall repair Breast reconstruction	Q4134

o Abdominal wall repair o Breast reconstruction o Wound coveringHuman Health Factor 10 Amniotic Patch (hhf10-p) Single-layer amniotic allograft derived from full-term human birth tissue, specifically the immunoprivileged amnion layer. HyalomatrixWound covering or barrier membraneFull-thickness wounds and burnsQ4224Q4117Skin and Tissue Substitutes Page: 26 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associatet HCPCS/ CPT® Code(s)
Bioresorbable, dermal substitute made of HYAFF, a long-acting derivative of hyaluronic acid providing a microenvironment.	e Provides a wound preparation to support the implantation of autologous skin grafts
InnovaBurn, InnovaMatrix XL Decellularized extracellular matrix (ECM) derived from porcine placental tissue. InnovaMatrix AC Decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue.	Management of wounds including, but may not be limited to:	A2022
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o Partial- and full-thickness wounds
		o Pressure ulcers
		o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
		o Trauma wounds (eg, abrasions, lacerations, second-degree burns,
		skin tears) o Tunneled wounds
		o Undermined wounds
		o Venous ulcers Management of wounds including, but may not be limited to: o Chronic vascular ulcers	A2001

Associated HCPCS/ CPT® Code(s)o Diabetic ulcerso Draining woundso Partial- and full-thickness woundsSkin and Tissue Substitutes Page: 27 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	Pressure ulcers
	Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	Tunneled wounds
	Undermined wounds
	fe} Venous ulcers
InnovaMatrix FS	Management of wounds including, but	A2013
Decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue.	may not be limited to:
		fe) Chronic vascular ulcers
		Diabetic ulcers
		Draining wounds
		Full- and partial-thickness wounds
		Pressure ulcers
		Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)

o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)o Tunneled woundso Undermined woundsSkin and Tissue Substitutes Page: 28 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associat HCPCS, CPT® Code(s
o Venous ulcers
InnovaMatrix PD	e Management of wounds including, but	A2023
Decellularized extracellular matrix (ECM) derived from porcine placental tissue.	may not be limited to:
	o Chronic vascular ulcers
	o Diabetic ulcers
	o Draining wounds
	o Partial- and full-thickness wounds ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser post-Mohs wound
	dehiscence) o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Undermined wounds
	o Venous ulcers
Integra Flowable Wound Matrix Comprised of granulated cross- linked bovine tendon collagen and glycosaminoglycan; hydrated with saline.	e Difficult to access wound sites, as well as tunneled wounds.	Q4114

Integra Flowable Wound Matrix Comprised of granulated cross- linked bovine tendon collagen and glycosaminoglycan; hydrated with saline. Integra HuMend ADM Human dermal allograft that has been decellularized while preserving the noncellular natural biologic components and structure of the dermal matrix.procedures such as:o Abdominal wall reconstruction o Breast reconstructionAssociated HCPCS/ CPT® Code(s)Tendon protectionSkin and Tissue Substitutes Page: 29 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Integra Matrix Wound Dressing Biodegradable, porous matrix of cross-linked bovine tendon and glycosaminoglycan.	Scaffold for cellular invasion and capillary growth	Q4108
Interfyl — Flowable, Particulate Decellularized, connective ECM derived from human placental tissue.	Correct defects and fill voids and in soft tissue, providing mechanical and structural support to facilitate the tissue repair process	Q4171
Keramatrix Absorbable matrix made from a combination of keratin technology that dissolves into wounds.	Full- and partial-thickness wounds with low to high exudate	Q4165
Kerecis Omega3 Acellular intact fish skin that contains proteins, lipids (including omega3) and other skin elements and bioactive lipid content.	Reconstruction of: o Breast o Burns o Chronic wounds o Dura mater o Hernia repair	Q4158
Kerecis Omega3 MariGen Shield	o Oral wounds Management of wounds including:	A2019
Acellular intact fish skin that contains proteins, lipids (including omega3) and other skin elements and bioactive lipid content.
		o Diabetic ulcers
		o Draining wounds
		o Chronic vascular ulcers o Partial- and full-thickness wounds o Pressure ulcers

o Surgical wounds (eg, donorsites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)o Trauma wounds (eg, abrasions,lacerations, second-degree burns, skin tears)Skin and Tissue Substitutes Page: 30 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
o Venous ulcers
Keroxx Flowable matrix made from a combination of keratin technology that dissolves into wounds.	e Chronic wounds such as: o Diabetic ulcers o Donor sites/grafts o Pressure ulcers	Q4202
Leneva Allograft adipose extracellular matrix (ECM).	e Soft tissue reconstruction	Q4100 Q4100
MatriDerm	e Management of wounds including, but
Acellular dermal substitute composed of bovine collagen and elastin.	may not be limited to:
			fe) Chronic vascular ulcers
			Diabetic ulcers
			Draining wounds
			Partial- and full-thickness wounds
			Pressure ulcers
			Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
			Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
			Venous ulcers

Matrion Matrix scaffold derived from an intact decellularized placental membrane comprising both amniotic and chorionic layers. MatriStem MicroMatrix Noncross-linked basement membrane compromised of urinary bladder matrix (UBM) and various collagens.o Venous ulcers • Chronic woundsManagement of wounds including, butmay not be limited to:Q4201Q4118o Chronic vascular ulcersSkin and Tissue Substitutes Page: 31 of 81

	(Not covered for ANY indication)
o Diabetic ulcers
	o Draining wounds
	o Partial- and full-thickness wounds
	o Pressure ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound
	dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears) Tunneled wounds
	o o Undermined wounds
	o Venous ulcers
Matrix HD Acellular human dermis allograft retains the three-dimensional intertwined multidirectional fibers and mechanical properties of the native tissue architecture.	Protect, reinforce or cover soft tissue and provide a scaffold to support regenerative processes	Q41
Mediskin Frozen irradiated porcine xenograft with a dermal and epidermal layer.	Meshed autograft protection Partial-thickness skin ulcerations and abrasions	Q41:

Associated HCPCS/ CPT® Code(s)Q4128Q4135skin lossMembrane Graft, Membrane Wrap Human amniotic allograft.Toxic epidermal necrolysis (TEN) • Management of wounds including, butmay not be limited to:Q4205o BurnsSkin and Tissue Substitutes Page: 32 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	Chronic vascular ulcers
	Diabetic ulcers
	Pressure ulcers
	Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	Ulcers caused by mixed vascular etiologies
	fe} Venous ulcers
MemoDerm ADM derived from human allograft skin tissue.	Repairs (eg, rotator cuff) and wounds (eg, chronic diabetic ulcer)	Q4126
Microlyte Matrix Synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver.	Management of wounds including, but may not be limited to:	A2005
		fe) Diabetic ulcers
		First and second-degree burns
		Partial- and full-thickness wounds
		Pressure ulcers
		Surgical wounds (eg, donor sites/grafts)

o Trauma wounds (eg, abrasions,lacerations, skin tears)o Venous ulcersMiro3D Decellularized extracellular matrix (ECM) derived from porcine liver tissue.Management of wounds including, butmay not be limited to:A2025o Chronic vascular ulcersSkin and Tissue Substitutes Page: 33 of 81

	(Not covered for ANY indication)	HCPCS, CPT® Code(s
	Diabetic ulcers
	Draining wounds
	Partial- and full-thickness wounds
	Pressure ulcers
	Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	Trauma wounds (eg, abrasions, lacerations, second-degree burns,
	skin tears)
	Tunneled wounds
	Undermined wounds
	fe} Venous ulcers
Miroderm, Miromesh	Management of wounds including, but	Q4175
Noncross-linked acellular wound matrix derived from porcine liver and is processed and stored in a phosphate buffered aqueous solution.		may not be limited to:
		fe) Chronic vascular ulcers
		Diabetic ulcers
		Draining wounds
	Partial- and full-thickness wounds

Associated HCPCS/ CPT® Code(s)o Surgical wounds (eg, donorsites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)Skin and Tissue Substitutes Page: 34 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Undermined wounds
	o Venous ulcers
Mirragen Advanced Wound Matrix Biocompatible and resorbable borate glass	Management of wounds including, but may not be limited to:	A2002
fibers and particulate.	fe) Chronic vascular ulcers
		Diabetic ulcers
		Draining wounds
		Partial- and full-thickness wounds
		Pressure ulcers
		Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
		Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)

o Undermined woundso Venous ulcersMLG-Complete Full thickness amnion-chorion derived allograft.Management of wounds including, butmay not be limited to:Q4256o Chronic vascular ulcersSkin and Tissue Substitutes Page: 35 of 81

		(Not covered for ANY indication)	HCPCS CPT® Code(:
		o Diabetic ulcers
			o Draining wounds
			o Full- and partial-thickness wounds
			o Pressure ulcers
			o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
			o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
			o Tunneled wounds
			o Undermined wounds
			o Venous ulcers
MyOwn Skin Autologous, homologous human skin	e e	Chronic wounds Postsurgical wounds	Q4221
product. Wound
NeoMatriX Matrix Acellular axolotl dermal extracellular matrix.
			o
		e	Management of wounds including: Chronic vascular ulcers o Diabetic ulcers o Draining wounds Partial- and full-thickness wounds	A202:

Associated HCPCS/ CPT® Code(s)Q4226A2021o Pressure ulcerso Surgical wounds (eg, donorsites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)Skin and Tissue Substitutes Page: 36 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears) o Tunneled/undermined wounds
Neopatch Terminally sterilized, dehydrated human placental membrane tissue comprised of	o Venous ulcers External wound covering for dermal ulcerations including:	Q4176
both amnion and chorion.	o Chronic venous ulcers o Diabetic ulcers
allograft.	o Chronic vascular ulcers
		o Diabetic ulcers
		o Partial- and full-thickness wounds
		o Pressure ulcers
		o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
		o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)

o Tunneled/undermined woundso Venous ulcersNeostim Membrane Single layer dehydrated amniotic membrane allograft.Acute and chronic wounds including, butmay not be limited to:Q4266o Chronic vascular ulcersSkin and Tissue Substitutes Page: 37 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associatec HCPCS/ CPT® Code(s)
	o Diabetic ulcers
	o Partial- and full-thickness wounds
	o Pressure ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled/undermined wounds
	o Venous ulcers
Neostim TL	Acute and chronic wounds including, but	Q4265
Triple layer dehydrated amniotic membrane allograft.	may not be limited to:
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Partial- and full-thickness wounds
		o Pressure ulcers
		o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)

Associated HCPCS/ CPT® Code(s)o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)o Tunneled/undermined woundso Venous ulcersSkin and Tissue Substitutes Page: 38 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Neox 100; OR cryopreserved human amniotic membrane and umbilical cord. Clarix 100 cryopreserved human amniotic membrane, Ambilical cord and additional proteins.	Surgical wrap or barrier, quick-peel matrix Wound covering for dermal ulcers and defects, quick-peel matrix	Q4156
Neox Cord 1K; OR cryopreserved human amniotic membrane and umbilical cord. Clarix Cord 1K cryopreserved human amniotic membrane, Ambilical cord and additional proteins.	Surgical wrap or barrier, 1 mm thick form Wound covering for dermal ulcers and defects, 1 mm thick form	Q4148
NeuraGen Nerve Guide, NeuraWrap Nerve Protector 3ovine derived collagen conduit.	Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity	C1763
NeuroMend Nerve Wrap Resorbable, semipermeable, type | collagen verve wrap.	Peripheral nerve repair	C9361
Novachor chorion layer of the placental membranes.		Onlay graft for:	Q4194
		o Acute and chronic wounds including neuropathic ulcers, pressure ulcers and venous stasis ulcers
		o Burns
	o Postsurgical wounds

o Posttraumatic woundsNovafix Dehydrated human amniotic membrane allograft.Management of wounds including, butmay not be limited to:Q4208o Chronic vascular ulcerso Diabetic ulcersSkin and Tissue Substitutes Page: 39 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associate HCPCS/ CPT® Code(s)
	o Draining wounds
	o Partial- and full-thickness wounds
	o Pressure ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Undermined wounds
	o Venous ulcers
Novafix DL	Management of wounds including, but	Q4254
Dehydrated human amnion chorion membrane allograft.	may not be limited to:
		fe) Chronic vascular ulcers
		Diabetic ulcers
		Draining wounds
		Partial- and full-thickness wounds
		Pressure ulcers

Associated HCPCS/ CPT® Code(s)o Surgical wounds (eg, donorsites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)o Trauma wounds (eg, abrasions,lacerations, second-degree burns, skin tears)Skin and Tissue Substitutes Page: 40 of 81

Skin / Tissue Substitute		Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
		fe) Tunneled wounds
		fe) Undermined wounds
		fe} Venous ulcers
NovoSorb Matrix Acellular, synthetic dermal matrix of biodegradable polyurethane foam bonded with a polyurethane adhesive layer. NuCel Allograft derived from human amnion and amniotic fluid.	e	Management of wounds including, but	A2006
			may not be limited to:
			fe) Chronic vascular ulcers
			Diabetic ulcers
			Draining wounds
			Partial- and full-thickness wounds
			Pressure ulcers
			Surgical wounds (eg, donor
			sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
			Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears) Venous ulcers
		e	fe} Provides an environment for tissue growth, repair and healing	Q4100

NuCel Allograft derived from human amnion and amniotic fluid. NuDyn, SurFactor Acellular, flowable human amniotic membrane allograft.NuDYN DL, NuDYN DL MESH Human amnion/chorion membrane allografts.Acute and chronic wounds • Burns • Soft tissue injuries • Surgical wounds • Barrier or cover for acute and chronic wounds including, but may not be limited to:Q4285o Chronic vascular ulcersSkin and Tissue Substitutes Page: 41 of 81

	(Not covered for ANY indication)	HCPCS, CPT® Code(s
	o Diabetic ulcers
	o Draining wounds
	o Partial- and full-thickness wounds
	o Pressure ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	o Trauma wounds (eg, abrasions,
	lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Undermined wounds
	o Venous ulcers
NuDYN SL, NuDYN SLW Human amnion membrane allografts.	Barrier or cover for acute and chronic wounds including, but may not be limited to:	Q4286
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o Partial- and full-thickness wounds

Associated HCPCS/ CPT® Code(s)o Pressure ulcerso Surgical wounds (eg, donorsites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)Skin and Tissue Substitutes Page: 42 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Undermined wounds
	o Venous ulcers
NuShield Allograft derived from amniotic and chorionic membranes.	Assist in healing of soft tissue injuries Barrier protection of dura, nerves and tendons Burns	Q4160
	Wound covering
Oasis Burn Matrix Naturally derived, ECM created from the submucosal layer of porcine small intestine.	Acellular scaffold that accommodates remodeling of host tissue	Q4103
ologen Collagen Matrix Biodegradable porcine-derived collagen matrix.	Management of wounds including, but may not be limited to:	Q4100
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o Oral wounds/sores

o Partial- and full-thickness woundso Pressure ulcerso Surgical woundso Trauma wounds (eg, second-degreeburns)Skin and Tissue Substitutes Page: 43 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associa HCPC CPT‘ Code(
Omeza Collagen Matrix Hydrolyzed fish collagen infused with cod liver oil.	o Venous ulcers
		e Management of wounds including, but	A201
		may not be limited to:
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o Full- and partial-thickness wounds
		o Pressure ulcers
		o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound
		dehiscence)
		o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
		o Tunneled wounds
		o Undermined wounds
		o Venous ulcers
Orion	e Barrier or cover for acute and chronic	Q427
Dual-layer, dehydrated human amniotic	wounds
membrane allograft.
OrthoFlo Allograft derived from amniotic fluid.	e For use in joints to:	Q410
	fe) Modulate inflammation

Associated HCPCS/ CPT® Code(s)A2014Q4276Q4100o Protect and cushiono Provide lubrication for enhancedmobilityOviTexReinforce and/or repair soft tissueQ4100where weakness existsSkin and Tissue Substitutes Page: 44 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Bio scaffold composed of ovine (sheep) derived ECM and polyglycolic acid (PGA).	Repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material
PalinGen — Flow, SportFlow, XPlus or ProMatrX Human amniotic tissue allograft comprised of amnion and amniotic fluid containing growth Factors, cytokines and ECM proteins naturally found in amniotic tissue.	Aid in healing and repair of wounds Wound covering and support for native tissue	Q4173, Q4174
Permacol A porcine dermal collagen implant.	Patch to reinforce soft tissue where weakness occurs Surgical repair of damaged or ruptured soft tissue	C9364
PermeaDerm B Monofilament nylon knitted fabric bonded to a thin slitted silicone membrane. The nylon side of this dressing is coated with a mixture of porcine gelatin and a pure fraction of aloe vera.	Partial-thickness burns Skin donor sites	A2016
PermeaDerm CW Monofilament nylon knitted fabric bonded to a thin slitted silicone membrane. The nylon side of this dressing is coated with a mixture of porcine gelatin and a pure fraction of aloe vera.	Management of wounds including, but may not be limited to:	A2018
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o Partial-thickness wounds

o Surgical wounds (eg, donorsites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)Skin and Tissue Substitutes Page: 45 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears) Venous ulcers
PermeaDerm Glove Monofilament nylon knitted fabric bonded to a thin slitted silicone membrane. The nylon side of this dressing is coated with a mixture of porcine gelatin and a pure fraction of aloe vera.	o e Debrided partial-thickness hand burns	A2017
Phoenix Wound Matrix Bioabsorbable, conformable, non-woven, fibrous, three-dimensional matrix. Composed of poly(lactide-co-caprolactone) and polyglycolic acid.	e Management of wounds including, but may not be limited to:	A2015
			fe) Chronic vascular ulcers
			Diabetic ulcers
			Draining wounds
			Full- and partial-thickness wounds
			Pressure ulcers
			Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
			Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)

o Tunneled woundso Undermined woundso Venous ulcersPolyCyte Minimally manipulated human tissue allograft derived from the Wharton's jelly of the umbilical cord.Replace or supplement damaged orinadequate tissueQ4241Skin and Tissue Substitutes Page: 46 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
PRECLUDE Vessel Guard Three-layer construction with two outer layers consisting of a tight expanded polytetrafluoroethylene (ePTFE) microstructure.	e Cover for vessels following anterior vertebral surgery, providing a plane of dissection	Q4100
PriMatrix ADM derived from fetal bovine skin.	e Scaffold capable of being integrated, remodeled and eventually replaced by functional host tissue	Q4110
Procenta Acellular, sterile human placental derived allograft.	e Chronic wound covering for: o Diabetic foot ulcers o Venous stasis ulcers	Q4244
ProgenaMatrix Human keratin matrix derived from human	e Management of wounds including, but may not be limited to:	Q4222
hair.	o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o First and second-degree burns
		o Partial- and full-thickness wounds
		o Surgical wounds (eg, donor sites/grafts)
		o Trauma wounds (eg, abrasions, lacerations, skin tears)
		o Venous ulcers

ProLayer Human acellular dermal matrix.Reinforcement of soft tissue including:o Breast reconstructionPromogran Matrix Freeze-dried composite prepared from bone collagen and oxidized regenerated cellulose.Bind and protect the functionality ofgrowth factors, such as platelet-derived growth factors (PDGF) in hostile proteolytic environmentsQ4100Skin and Tissue Substitutes Page: 47 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
PuraPly, PuraPly AM, PuraPly XT Purified Type 1 native collagen matrix creates a durable biocompatible scaffold.	Barrier against a wide array of microorganisms Inhibit formation of biofilm on the wound surface	Q4195, Q4196, Q4197
Puros Dermis A natural biological matrix.	Periodontal/peri-implant soft tissue management	Q4100
REGUaRD Hydrated acellular human dermal allograft	Soft tissue enhancement Burns wounds	Q4255
matrix. Relese	Chronic, nonhealing Acute and chronic wounds including	Q4257
Dehydrated human amniotic membrane obtained from donated placental tissue.	dermal ulcers and other defects
Repliform Acellular human dermis.	Pelvic floor repair	Q4100
Repriza Pre hydrated, ready to use, ADM prepared from human skin allograft.	Reconstructive surgery wherever an ADM may be used including, but may not be limited to: o Abdominal wall reconstruction o Augmentation of soft tissue irregularities o Breast reconstruction	Q4143
Resolve Matrix Non-crosslinked acellular wound dressing derived from porcine peritoneum membrane.	Management of topical wounds including, but may not be limited to: o Chronic vascular ulcers	A2024

o Draining woundso Partial- and full-thickness woundso Pressure ulcersSkin and Tissue Substitutes Page: 48 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Undermined wounds
	o Venous ulcers
Restorigin	e Burns	Q4191,
Amnion umbilical cord tissue.	e Chronic, nonhealing wounds	Q4192
Restrata	e Management of wounds including, but	A2007
Resorbable nanofiber wound matrix.	may not be limited to:
		fe) Chronic vascular ulcers
		Diabetic ulcers
		Draining wounds
		Partial- and full-thickness wounds
		Pressure ulcers
		Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)

o Trauma wounds (eg, abrasions,lacerations, second-degree burns, skin tears)o Tunneled woundso Undermined woundsSkin and Tissue Substitutes Page: 49 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
o Venous ulcers
Revita Dehydrated, sterile human amniotic membrane and chorionic membrane.	Acute and chronic wounds, including defects and dermal ulcers Wound covering or barrier membrane	Q4180
Revitalon Composed of native human amnion and chorion in addition to collagen and growth factors.	Damaged membranes Dressing for burns Full-thickness wounds	Q4157
RX Flow, RX Membrane Placental connective tissue matrix.	Surgical use to supplement or replace damaged or inadequate connective tissue	Q4100
Signature APatch	Repair of acute and chronic wounds	Q4260
	o Burns
			o Diabetic foot ulcers
			o Pressure ulcers
			o Surgical wounds
			o Venous leg ulcers Wounds with exposed bone, muscle and/or tendon
SimpliDerm Human acellular dermal matrix.	Replacement of damaged or inadequate integumental tissue Soft tissue defects	Q4100

SkinTE Autologous, homologous, full –thickness skin product composed of viable skin cells and an organized extracellular matrix.Soft tissue defects • BurnsChronic woundsQ4200StrataGraft Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat.Homologous uses of human integument • Adults with thermal burns containingintact dermal elements (eg, deep partial- thickness burns)Q4100Skin and Tissue Substitutes Page: 50 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
Strattice Reconstructive Tissue Matrix Derived from porcine dermis, which undergoes nondamaging processing that removes cells and reduces the key component in the xenogeneic rejection response.	Surgical repair of damaged or ruptured soft tissue Surgically implanted patch to reinforce where weakness exists	Q4130
Stravix Cryopreserved human placental tissue composed of umbilical amnion and Wharton’s jelly.	Wrap to aid in surgical procedures and wound repair	Q4100
Supra SDRM Biodegradable matrix wound dressing fabricated from a tri-polymer of polylactide, trimethylene carbonate, €-caprolactone and polyvinyl alcohol.	Acute and chronic wounds such as: Burns	A2011
			o o Chronic vascular ulcers
			o Diabetic ulcers
			o Partial- and full-thickness wounds
			o Pressure ulcers
			o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
			o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
			o Venous ulcers

Suprathel Bioresorbable dermal covering, composed entirely of synthetic materials, including a tripolymer of polylactide, s-caprolactone and trimethylene carbonate.Dermal wounds such as:o Abrasionso Burnso Split-thickness skin graft donor sitesSureDermBurnsQ4220Skin and Tissue Substitutes Page: 51 of 81

	(Not covered for ANY indication)	HCPCS/ CPT® Code(s)
Human acellular dermal matrix.	Periodontal soft tissue management Skin ulcers
SurgiCORD Umbilical tissue membrane allograft.	Management of wounds including, but may not be limited to: o Neuropathic ulcers o Post-traumatic wounds o Pressure injuries o Venous stasis ulcers	Q4218
Surgigraft Human amnion-only regenerative extracellular tissue matrix.	Management of wounds including, but may not be limited to: o Adhesion barrier o Burn wounds o Diabetic ulcers o Neuropathic ulcers o Post-traumatic wounds o Pre- and post-surgical wounds o Pressure injuries o Scar tissue o Venous stasis ulcers	Q4183
SurgiGRAFT-DUAL	Management of wounds including, but	Q4219
Minimally processed bilayer allograft.	may not be limited to: o Neuropathic ulcers o Post-traumatic wounds o Pressure injuries
SurgiMend Collagen Matrix	Breast reconstruction	C9358,
Acellular tissue matrix of either fetal or neonatal bovine origin.	Reinforcement for weak or damaged	C9360

SurGraft Dehydrated amniotic membrane sheet.Management of wounds including, butmay not be limited to:Q4209o Burnso Diabetic ulcerso Full- and partial-thickness woundsSkin and Tissue Substitutes Page: 52 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)		Associated HCPCS/ CPT® Code(s)
		o o	Pressure wounds Surgical wounds
	o	Venous ulcers
SurGraft FT Full-thickness amnion/chorion tissue allograft.	e	Acute and chronic wounds including, but	Q4268
			may not be limited to: Chronic vascular ulcers
		o o	Diabetic ulcers
		o	Draining wounds
		o	Partial- and full-thickness wounds
		o	Pressure ulcers
		o	Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
		o	Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
		o o	Tunneled/undermined wounds Venous ulcers
SurGraft TL Triple layer amniotic tissue allograft.		Repair of acute and chronic wounds including, but be limited	Q4263

o Chronic vascular ulcerso Diabetic ulcerso Draining woundso Partial- and full-thickness woundsSkin and Tissue Substitutes Page: 53 of 81

	(Not covered for ANY indication)	HCPCS, CPT® Code(s
	o Pressure ulcers
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled wounds
	o Venous ulcers
SurGraft XT	Acute and chronic wounds including, but	Q4269
Dual layer amniotic tissue allograft.	may not be limited to:
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o Partial- and full-thickness wounds
		o Pressure ulcers
		o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)

Associated HCPCS/ CPT® Code(s)lacerations, second-degree burns, skin tears)o Tunneled/undermined woundso Venous ulcersSkin and Tissue Substitutes Page: 54 of 81

Skin Tissue Substitute	Indications	Associ
/	Purported (Not covered for ANY indication)	HCP CP" Code
Symphony Extracellular matrix (ECM) derived from ovine forestomach tissue.	e Management of wounds including, but	A20
		may not be limited to:
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o Partial- and full-thickness wounds
		o Pressure ulcers wounds donor
		o Surgical (eg, sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
		o Trauma wounds (eg, abrasions,
		lacerations, second-degree burns, skin tears) o Tunneled wounds
		Undermined wounds
	o o Venous ulcers
TAG Triple layer amniotic allograft derived from placental tissue.	e Wound covering or barrier membrane, over acute and chronic wounds	Q42
Talymed Advanced matrix composed of shortened fibers isolated from microalgae.	e Management of wounds including, but may not be limited to: o Abrasions	Q41

Associated HCPCS/ CPT® Code(s) A2009Q4261Q4127o Chronic vascular ulcerso Dehisced surgical woundso Diabetic ulcersSkin and Tissue Substitutes Page: 55 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associatec HCPCS/ CPT® Code(s)
	o Donor sites/grafts
		o Full- and partial-thickness wounds
		o Lacerations
		o Post-laser surgery and other bleeding surface wounds
		o Post-Mohs surgery
		o Pressure wounds
		o Second-degree burns
		o Surgical wounds
		o Traumatic wounds healing by secondary intention
		o Ulcers caused by mixed vascular etiologies
		o Venous ulcers
TenSIX Acellular Dermal Matrix Acellular matrix with natural	Tendon and wound coverage	Q4146
histomorphology preserved. TheraGenesis	Management of wounds including, but	A2008
Bilayered wound matrix comprised of a porcine tendon-derived atelocollagen layer and a silicone film layer.	may not be limited to: fe) fe) Chronic vascular ulcers Diabetic ulcers

o Draining woundso Partial- and full-thickness woundso Pressure ulcersSkin and Tissue Substitutes Page: 56 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
TheraSkin Biologically active cryopreserved human skin allograft with both epidermis and dermis layers; the cellular and extracellular composition provides a supply of collagen, cytokines and growth factors.	e Management of wounds including, but may not be limited to: o Dehisced surgical wounds o Diabetic foot ulcers o Necrotizing fasciitis o Pressure ulcers o Radiation burns o Venous leg ulcers e Repair of skin over any wound including those with exposed bone, capsule, muscle or tendon	Q4121
TissueMend Remodeled collagen matrix created from bovine skin.	e Reinforcement of soft tissue that is repaired using sutures or anchors during tendon repair surgery	Q4100
TranZgraft AC (InteguPly) Acellular collagen matrix derived from human allograft skin tissue.	e Replace or supplement damaged or inadequate integumental tissue for acute and chronic wounds including, but may not be limited to: Diabetic foot ulcers	Q4126

o Diabetic foot ulcers o Pressure ulcers o Venous leg ulcersTruskin Split-thickness, cryopreserved skin allograft extracellular matrix with growth factors and endogenous living skin cells.Repair of acute and chronic wounds including, but may not be limited to:o Diabetic foot ulcersQ4167o Pressure ulcersSkin and Tissue Substitutes Page: 57 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
	o Surgical wounds
	o Venous leg ulcers
	o Wounds with exposed bone and tendon
Tutomesh, Tutopatch Noncross-linked acellular collagen matrices derived from bovine pericardium.	Pericardial repair Soft tissue reconstruction	C1763
Vendaje Dehydrated human amniotic membrane composed of the amnion layer.	Support and serve as a barrier for integumental tissue	Q4252
Veritas Collagen Matrix Acellular tissue matrix derived from bovine pericardium.	Hernia repair Pelvic floor procedures Plastic and reconstructive procedures	C9354
Viaflow, Viaflow C	Breast reconstruction	Q4100
Flowable placental tissue matrices.	Tissue voids and defects for the of
VIM Allograft sheet of human amnion.	Barrier following types surgeries: o Ophthalmic o Orthopedic Wound covering	Q4251
WoundPlus Membrane, E-graft Single-layer, dehydrated and devitalized human amniotic membrane allograft.	Barrier or cover for acute and chronic wounds	Q4277
Xcell Amnio Matrix Lyophilized amniotic membrane allograft.	Acute and chronic wounds including, but may not be limited to:	Q4280

o Chronic vascular ulcerso Diabetic ulcerso Partial- and full-thickness woundso Pressure ulcersSkin and Tissue Substitutes Page: 58 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT®
	o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound	Code(s)
	dehiscence)
	o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)
	o Tunneled/undermined wounds
	o Venous ulcers
XCellerate Lyophilized human amniotic membrane	e Burns e Chronic, nonhealing wounds	Q4234
allograft. XCelliStem Extracellular matrix (ECM) composed of porcine collagen.	e Management of wounds including, but may not be limited to:	A2004
		o Chronic vascular ulcers
		o Diabetic ulcers
		o Draining wounds
		o Partial- and full-thickness wounds
		o Pressure ulcers
		o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence)

o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears)o Tunneled woundso Undermined woundsSkin and Tissue Substitutes Page: 59 of 81

Skin / Tissue Substitute	Purported Indications (Not covered for ANY indication)	Associated HCPCS/ CPT® Code(s)
o Venous ulcers
XCM Biologic Tissue Matrix Noncross-linked 3-D matrix derived from porcine dermis.	Reinforcement and repair of soft tissue where weakness exists, including plastic and reconstructive surgical applications Reinforcement of soft tissues which are repaired by suture or suture anchors	Q4142
Xelma ECM protein	Hard to heal wounds such as venous leg ulcers	Q4100
XenMatrix Acellular noncross-linked porcine collagen scaffold with open collagen structure.	Surgical repair of damaged or ruptured soft tissue, including, but may not be limited to:	C1763
			o Hernia repair including abdominal, diaphragmatic, femoral, incisional, inguinal, scrotal and umbilical hernias
			o Muscle flap reinforcement
XWrap Dry or Hydro Plus Resorbable, chorion-free, human amnion allograft.	Soft tissue defects and wounds	Q4204, Q4100
Zenapro Combination of ultra-lightweight polypropylene and small intestinal submucosa (SIS).	Repair of a body wall defect or hernia requiring the addition of a reinforcing or bridging material	Q4100, 49560, 49561, 49565, 49566, 49568, 49652,

Q4100, 49560, 49561, 49565, 49566, 49568, 49652, 49653, 49655, 49656, 49657 Q4253Zenith Amniotic Membrane Dehydrated amniotic membrane allograft.Acute and chronic wound therapyApplication in difficult to access woundsites, deep dermal wounds and irregularly shaped woundsSkin and Tissue Substitutes Page: 60 of 81