Skin and Soft Tissue Substitutes Form

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Skin and Soft Tissue Substitutes - Medical Policy
Updated Revision Effective: July 1, 2025 Policy Number:

UM696POL

Approval Date:

Line(s) of Business: Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Skin Substitutes also known as bioengineered, tissue-engineered, or artificial skin are a heterogeneous group of biologic, synthetic, or biosynthetic materials that can provide temporary or permanent coverage of open skin wounds. The aim of skin substitutes is to replicate the properties of the normal skin. Skin substitutes are an important adjunct in the management of acute or chronic wounds and can be used to cover defects following burns or other injuries, or for reconstruction, such as for release of extensive severe post-burn contractures, or for treatment of open diabetic foot ulcers or chronic venous ulcers to promote wound healing, with the goals of improving quality of life and preventing further morbidity such as infection or amputation.
Each skin substitute has its own unique set of advantages and disadvantages. Since wound healing tends to be unique to the individual, the use of skin substitutes is highly personalized with the choice of skin substitute depending upon the type of wound (i.e., acute, chronic), its etiology (eg, trauma, chronic inflammation), and the skin component (i.e., epidermis, dermis, or both) that requires replacement. In addition, the desired functional and aesthetic outcomes need to be considered. Other factors that determine the choice of skin substitute depend on whether wound coverage is temporary or permanent.

 Line of Business

Commercial:
Refer to criteria under the Policy section in this medical policy.

Medicaid – BeHealthy:
Refer to criteria under the Policy section in this medical policy.

Medicare:
• For porcine skin substitutes Health New England follows National Coverage Determination (NCD) 270.5 Porcine Skin and Gradient Pressure Dressings available at https://www.cms.gov/medicare-coverage- database/search.aspx
• For all other skin and soft tissue substitutes refer to criteria under the Policy section in this medical policy. Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for these products.

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Policy

I. Skin and soft tissue substitutes are considered MEDICALLY NECESSARY for the following indications (see below for covered skin or soft tissue substitutes):

1. Uninfected diabetes-associated full-thickness foot ulcers that have not healed with standard wound care in adults with good glucose control and adequate blood flow to the extremities.
2. Chronic non-infected partial or full thickness lower extremity skin ulcers due to venous insufficiency which have not healed with standard wound care.
3. Breast reconstruction surgery following cancer treatment using allogenic acellular dermal matrix products.

4. Treatment of second- and third-degree burns.

   II. Medicare

5. HNE follows Medicare National Coverage Determination (NCD) 270.5 Porcine Skin and Gradient Pressure Dressings available at https://www.cms.gov/medicare-coverage-database/search.aspx

6. Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for Skin and soft tissue substitutes used for breast reconstruction or the treatment of burns. The codes listed below are covered for those indications.

   IV. Skin Substitutes for conditions that do not meet above criteria are considered EXPERIMENTAL and INVESTIGATIONAL.

   V. Only the following skin substitutes are covered when used according to FDA approved indication and/or labeling guidelines as per criteria noted above and billed with a covered diagnosis:

   Diabetic Foot Ulcer (DFU) Only A2019 Kerecis Omega3 MariGen Shield, per sq cm Q4105 Integra dermal regeneration template or Integra omnigraft dermal regeneration matrix Q4107 Graftjacket Q4110 PriMatrix, per sq cm Q4121 TheraSkin, per sq cm Q4122 Dermacell Q4124 Oasis ultra tri-layer wound matrix Q4128 Flex hd, allopatch hd, madtrix hd Q4132 Grafix core and grafixpl core, per square centimeter Q4133 Grafix prime Q4137 Amnioexcel, amnioexcel plus or biodexcel, per square centimeter Q4151 Amnioband or guardian, per square centimeter Q4154 Biovance, per square centimeter Q4158 Kerecis Omega3, per sq cm Q4160 NuShield, per sq cm Q4168 Amnioband, 1 mg Q4186 Epifix, per square centimeter Q4187 Epicord, per sq cm Q4203 Derma-Gide, per sq cm Applicable diagnosis codes: E08.621, E09.621, E10.621, E11.621, E13.621, E13.622

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Diabetic Foot Ulcer (DFU) or Venous Leg Ulcers (VLU)
Q4101 Apligraf Q4102 Oasis wound matrix Q4106 Dermagraf Q4151 AmnioBand or Guardian, per sq cm Q4159 Affinity
Q4186 Epifix Q4196 Puraply (MassHealth only) Applicable diagnosis codes: E08.621, E09.621, E10.621, E11.621, E13.621, I83.011-I83.018, I83.021-I83.028, I83.211-I83.218, I83.221-I83.228, I87.011-I87.013, 187.031-187.033,I87.311-I87.313, I87.331-I87.333

Breast Reconstruction Q4100 AlloMax, AlloMend, DermaMatrix, NeoForm dermis, Q4107 Graftjacket Q4116 AlloDerm Q4122 Dermacell Q4128 Flex hd, allopatch hd, madtrix hd Q4130 Strattice TM Covered diagnosis codes: C50, C79.81, Z80.3, Z80.41, Z85.3, Z90.10-Z90.13, Z93.3

Burns Q4100 Epicel, Biobrane, Biobrane-L Q4104 Integra Bilayer Matrix Wound Dressing Q4105 Integra dermal regeneration template or Integra omnigraft dermal regeneration matrix Q4108 Integra matrix
Q4182 Transcyte Covered Diagnosis Codes: T20 -T25.799

Ophthalmic Indications Q4132
Grafix core and grafixpl core, per square centimeter
Q4133
Grafix prime, grafixpl prime, stravix and stravixpl, per square centimeter
Q4137
Amnioexcel, amnioexcel plus or biodexcel, per square centimeter
Q4151
Amnioband or guardian, per square centimeter
Q4154
Biovance, per square centimeter
Q4159
Affinity, per square centimeter
Q4168
Amnioband, 1 mg
Q4186
Epifix, per square centimeter
Q4187
Epicord, per sq cm
Covered Diagnosis Codes: H04.121 - H04.129, H11.001 - H11.069, H16.001-H16.109, H16.12-H16.239, H18.10- H18.13, H18.831-H18.839, L51.1, T26.50XA-T26.92XS

Other indications Q4116 Alloderm`: Complex abdominal wounds, Ear drum augmentation Q4122 Dermacel: Oro-nasal fistula following cleft palate repair Q4107 Graftjacket: Oro-nasal fistula following cleft palate repair Q4106 Dermagraf: Dystrophic epidermolysis bullosa. Q4100 Orcel: Dystrophic epidermolysis bullosa.

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Policy Guidelines and Definitions

Definitions:

Acellular Matrix: A Matrix that is derived from sources other than human skin. Acellular Matrices are the most frequently used skin substitute. Acellular Matrices are composed of allogeneic or xenogeneic derived collagen, membrane, or cellular remnants (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017).

Allogeneic Matrix: A Matrix that is derived from human tissue such as neonatal fibroblasts of the foreskin (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017).

Composite Matrix: A Matrix that is derived from human keratinocytes and fibroblasts supported by a scaffold of synthetic mesh or xenogeneic collagen. These Matrices contain active cellular components that continue to generate compounds and protein that may accelerate wound healing (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017).

Full-Thickness Thermal Burn (Third Degree Burn): A burn with destruction of all layers of the skin. These burns involve all of the epidermal and dermal layers, with varying amounts of the sub-cutaneous layer involvement (Gomez and Cancio, 2007).

Human Skin Allograft: An Allograft that is derived from donated human skin (e.g., cadavers) that has been processed to remove the cellular components (Debels et al., 2015; Ferreira et al., 2011; Nicholas et al., 2016; Vig et al., 2017).

Xenograft: Skin from another species (e.g., cows, pigs, horses, fish, etc.).

Human amniotic membrane (HAM) graft: An allograft in which the HAM is harvested immediately after birth, cleaned, sterilized, and either cryopreserved or dehydrated. Many products utilizing amnion, chorion, amniotic fluid, and umbilical cord are being studied for the treatment of myriad conditions, including chronic full-thickness diabetic lower-extremity ulcers, venous ulcers, knee osteoarthritis, plantar fasciitis, and ophthalmic conditions. Fresh amniotic membrane contains collagen, fibronectin, and hyaluronic acid, along with a combination of growth factors, cytokines, and anti-inflammatory proteins such as interleukin-1 receptor antagonist. Evidence suggests that this tissue has anti-inflammatory, antifibroblastic, and antimicrobial properties, which is retained in cryopreserved HAM and HAM products, resulting in a readily available tissue with regenerative potential. HAM graft is an established treatment for disorders of the corneal surface, including neurotrophic keratitis, corneal ulcers and melts, following pterygium repair, Stevens-Johnson syndrome, and persistent epithelial defects.

Coding Guidance

Code Description PA A2019 Kerecis Omega3 MariGen Shield, per sq cm No Q4100 AlloMax, AlloMend, DermaMatrix, NeoForm dermis, Orcel No Q4101 Apligraf No Q4102 Oasis wound matrix No Q4104 Integra Bilayer Matrix Wound Dressing No Q4105 Integra dermal regeneration template or Integra omnigraft dermal regeneration matrix No Q4106 Dermagraf No Q4107 Graftjacket No Q4108 Integra matrix
No Q4110 PriMatrix, per sq cm No

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Q4116 AlloDerm No Q4121 TheraSkin, per sq cm No Q4122 Dermacel No Q4124 Oasis ultra tri-layer wound matrix No Q4128 Flex hd, allopatch hd, madtrix hd No Q4130 Strattice TM No Q4132 Grafix Core and GrafixPL Core, per sq cm No Q4133 Grafix prime No Q4137 AmnioExcel, AmnioExcel Plus or BioDExcel, per sq cm No Q4151 AmnioBand or Guardian, per sq cm No Code Description Code Q4154
Biovance, per sq cm No Q4158 Kerecis Omega3, per sq cm No Q4159 Affinity No Q4160 NuShield, per sq cm No Q4168 AmnioBand, 1 mg No Q4182 Transcyte No Q4186 Epifix No Q4187 Epicord, per sq cm No Q4196 Puraply (MassHealth only) No Q4203 Derma-Gide, per sq cm No

The following codes are considered EXPERIMENTAL and INVESTIGATIONAL, hence not covered. PA is not required

E&I= Experimental and Investigational Code Description Coverage A2001 Innovamatrix ac, per square centimeter E&I A2002 Mirragen advanced wound matrix, per square centimeter E&I A2004 Xcellistem, 1mg E&I A2005 Microlyte matrix, per square centimeter E&I A2006 Novosorb synpath dermal matrix, per square centimeter E&I A2007 Restrata, per square centimeter E&I A2008 Theragenesis, per square centimeter E&I A2009 Symphony, per square centimeter E&I A2010 Apis, per square centimeter E&I A2011 Supra sdrm, per square centimeter E&I A2012 Suprathel, per square centimeter
E&I A2013 Innovamatrix fs, per square centimeter E&I

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A2014 Omeza collagen matrix, per 100 mg E&I A2015 Phoenix wound matrix, per square centimeter E&I A2016 Permeaderm B, per square centimeter E&I A2017 Permeaderm glove, each E&I A2018 Permeaderm C, per square centimeter E&I A2020 Ac5 advanced wound system (ac5) E&I A2021 Neomatrix, per square centimeter E&I A2022 Innovaburn or innovamatrix xl, per square centimeter E&I A2023 Innovamatrix pd, 1 mg E&I A2024 Resolve matrix, per square centimeterF E&I A2025 Miro3d, per cubic centimeter E&I A2026 Restrata MiniMatrix, 5 mg E&I A2027 Matriderm, per square centimeter E&I A2028 Micromatrix flex, per mg E&I A2029 Mirotract wound matrix sheet, per cubic centimeter E&I A2030 Miro3d fibers, per milligram E&I A2031 Mirodry wound matrix, per square centimeter E&I A2032 Myriad matrix, per square centimeter E&I A2033 Myriad morcells, 4 milligrams E&I A2034 Foundation drs solo, per square centimeter E&I A2035 Corplex p or theracor p or allacor p, per milligram E&I A4100 Skin substitute, fda cleared as a device, not otherwise specified E&I Q4103 Oasis burn matrix, per sq cm E&I Q4111 GammaGraft, per sq cm E&I Q4112 Cymetra, injectable, 1cc E&I Q4113 GRAFTJACKET XPRESS, Injectable, 1cc E&I Q4114 Integra flowable wound matrix, injectable, 1 cc E&I Q4115 AlloSkin, per sq cm E&I Q4117 HYALOMATRIX E&I

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Q4118 MatriStem micromatrix, E&I Q4123 AlloSkin RT E&I Q4125 ArthroFlex, per sq cm E&I Q4126 MemoDerm, DermaSpan, TranZgraft or InteguPly, E&I Q4127 Talymed E&I Q4132 Grafix Core and GrafixPL Core, per sq cm E&I Q4133 Grafix PRIME, GrafixPL PRIME, Stravix and StravixPL, per sq cm E&I Q4134 HMatrix, per sq cm E&I Q4135 Mediskin, per sq cm E&I Q4136 EZ Derm, per sq cm E&I Q4138 BioDFence DryFlex, per sq cm E&I Q4139 AmnioMatrix or BioDMatrix, injectable, 1 cc E&I Q4140 BioDFence, per sq cm E&I Q4141 AlloSkin AC, per sq cm E&I Q4142 XCM biologic tissue matrix, per sq cm E&I Q4143 Repriza, per sq cm E&I Q4145 EpiFix, injectable, 1 mg E&I Q4146 TENSIX, per sq cm E&I Q4147 Architect, Architect PX, or Architect FX, extracellular matrix, per sq cm E&I Q4148 Neox Cord 1K, Neox Cord RT, or Clarix Cord 1K, per sq cm E&I Q4149 Excellagen, 0.1 cc E&I Q4150 AlloWrap DS or dry, per sq cm E&I Q4152 DermaPure, per sq cm E&I Q4153 Dermavest and Plurivest, per sq cm E&I Q4154 Biovance, per sq cm E&I Q4155 Neox Flo or Clarix Flo 1 mg E&I Q4156 Neox 100 or Clarix 100, per sq cm E&I Q4157 Revitalon, per sq cm E&I Q4161 bio-ConneKt wound matrix, per sq cm E&I

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Q4162 WoundEx Flow, BioSkin Flow, 0.5 cc E&I Q4163 WoundEx, BioSkin, per sq cm E&I Q4164 Helicoll, per sq cm E&I Q4165 Keramatrix or Kerasorb, per sq cm E&I Q4166 Cytal, per sq cm E&I Q4167 Truskin, per sq cm E&I Q4168 AmnioBand, 1 mg E&I Q4169 Artacent wound, per sq cm E&I Q4170 Cygnus, per sq cm E&I Q4171 Interfyl, 1 mg E&I Q4173 PalinGen or PalinGen XPlus, per sq cm E&I Q4174 PalinGen or ProMatrX, 0.36 mg per 0.25 cc E&I Q4175 Miroderm, per sq cm E&I Q4176 NeoPatch or Therion, per sq cm E&I Q4177 FlowerAmnioFlo E&I Q4178 FlowerAmnioPatch E&I Q4179 FlowerDerm E&I Q4180 Revita E&I Q4181 Amino Wound E&I Q4183 Surgigraft E&I Q4184 Cellesta or cellesta duo E&I Q4185 Cellesta Flowable Amnion E&I Q4188 AmnioArmor E&I Q4189 Artacent AC, 1mg E&I Q4190 Artacent AC, per sq cm E&I Q4191 Restorigin, persq cm E&I Q4192 Restorigin, 1 cc E&I Q4193 Coll-e-Derm E&I Q4194 Novachor E&I

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Q4195 PuraPly E&I Q4196 PuraPly AM E&I Q4197 PuraPly XT E&I Q4198 Genesis Amniotic Membrane E&I Q4199 Cygnus matrix E&I Q4200 SkinTE E&I Q4201 Matrion E&I Q4202 Derma-gide E&I Q4204 Xwrap E&I Q4205 Membrane Graft or Membrane Wrap E&I Q4206 Fluid Flow or Fluid GF E&I Q4208 Novafix E&I Q4209 Surgraft E&I Q4211 Amnion Bio or AxoBiomembrane E&I Q4212 Allogen E&I Q4313 Ascent E&I Q4214 Cellesta Cord E&I Q4215 Axolotl Ambient or Axolotl Cyro E&I Q4216 Artacent Cord E&I Q4217 Woundfix, Biowound, Woundfix Plus, Biowound Plus, Woundfix Xplus
or BioWound Xplus E&I Q4218 Surgicord E&I Q4219 Surgigraft-Dual E&I Q4220 Bellacell HD or Surederm E&I Q4221 Amniowrap2 E&I Q4222 Progenamatrix E&I Q4224 Human Health Factor 10 Amniotic Patch E&I Q4225 AmnioBind or DermaBind TL E&I Q4226 MyOwn skin, includes harvesting and preparation procedures E&I

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Q4227 Amniocore E&I Q4229 Cogenex amniotic membrane E&I Q4230 Cogenex flowable amnion E&I Q4233 Surfactor or nudyn E&I Q4234 Xcellerate E&I Q4235 Amniorepair or altiply E&I Q4236 Carepatch E&I Q4238 Derm-maxx E&I Q4239 Amnio-maxx or amnio-maxx lite E&I Q4240 Corecyte, for topical use only E&I Q4241 Polycyte, for topical use only E&I Q4242 Amniocyte plus E&I Q4245 Amniotext E&I Q4246 Coretext or protext E&I Q4247 Amniotext patch E&I Q4248 Dermacyte amniotic membrane allograft E&I Q4249 Amniply, for topical use only E&I Q4250 Amnioamp-mp E&I Q4251 Vim, per square centimeter E&I Q4252 Vendaje, per square centimeter E&I Q5253 Zenith amniotic membrane E&I Q4255 Reguard, for topical use only E&I Q4256 Mlg-complete E&I Q4257 Relese E&I Q4258 Enverse E&I Q4259 Celera dual layer or celera dual membrane E&I Q4260 Signature apatch E&I Q4261 Tag E&I Q4262 Dual layer impax membrane E&I

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Q4263 Surgraft tl E&I Q4264 Cocoon membrane E&I Q4265 Neostim tl E&I Q4266 Neostim membrane E&I Q4267 Neostim dl E&I Q4269 Surgraft xt E&I Q4270 Complete sl E&I Q4271 Complete ft E&I Q4272 Esano a E&I Q4273 Esano aaa E&I Q4274 Esano ac E&I Q4275 Esano aca E&I Q4276 Orion E&I Q4278 Epieffect E&I Q4279 Vendaje ac E&I Q4280 Xcell amnio matrix E&I Q4281 Barrera sl or barrera dl E&I Q4282 Cygnus dual E&I Q4283 Biovance tri-layer or biovance 3l E&I Q4284 Dermabind sl E&I Q4285 Nudyn dl or nudyn dl mesh E&I Q4286 Nudyn sl or nudyn slw E&I Q4287 Dermabind dl E&I Q4288 Dermabind ch E&I Q4289 Revoshield+ amnio E&I Q4290 Membrane wrap hydro E&I Q4291 Lamellas xt E&I Q4292 Lamellas E&I Q4393 Acesso dl E&I

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Q4294 Amnio quad-core E&I Q4295 Amnio tri-core E&I Q4296 Rebound matrix E&I Q4297 Emerge matrix E&I Q4298 Amnicore pro E&I Q4299 Amnicore pro+ E&I Q4300 Acesso tl E&I Q4301 Activate matrix E&I Q4302 Complete aca E&I Q4303 Complete aa E&I Q4304 Grafix plus E&I Q4305 American Amnion AC Tri-Layer, per sq cm E&I Q4306 American Amnion AC, per sq cm E&I Q4307 American Amnion, per sq cm E&I Q4308 Sanopellis, per sq cm E&I Q4309 VIA Matrix, per sq cm E&I Q4310 Procenta, per 100 mg E&I Q4311 Acesso, per sq cm E&I Q4312 Acesso AC, per sq cm E&I Q4313 DermaBind FM, per sq cm E&I Q4314 Reeva FT, per sq cm E&I Q4315 RegeneLink Amniotic Membrane Allograft, per sq cm E&I Q4316 AmchoPlast, per sq cm E&I Q4317 VitoGraft, per sq cm E&I Q4318 E-Graft, per sq cm E&I Q4319 SanoGraft, per sq cm E&I Q4320 PelloGraft, per sq cm E&I Q4321 RenoGraft, per sq cm E&I Q4322 CaregraFT, per sq cm E&I

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Q4323 alloPLY, per sq cm E&I Q4324 AmnioTX, per sq cm E&I Q4325 ACApatch, per sq cm E&I Q4326 WoundPlus, per sq cm E&I Q4327 DuoAmnion, per sq cm E&I Q4328 MOST, per sq cm E&I Q4329 Singlay, per sq cm E&I Q4330 TOTAL, per sq cm E&I Q4331 Axolotl Graft, per sq cm E&I Q4332 Axolotl DualGraft, per sq cm E&I Q4333 ArdeoGraft, per sq cm E&I Q4334 Amnioplast 1, per square centimeter E&I Q4335 Amnioplast 2, per square centimeter E&I Q4336 Artacent C, per square centimeter E&I Q4337 Artacent trident, per square centimeter E&I Q4338 Artacent velos, per square centimeter E&I Q4339 Artacent vericlen, per square centimeter E&I Q4340 Simpligraft, per square centimeter E&I Q4341 Simplimax, per square centimeter E&I Q4342 Theramend, per square centimeter E&I Q4343 Dermacyte ac matrix amniotic membrane allograft, per square centimeter E&I Q4344 Tri-membrane wrap, per square centimeter E&I Q4345 Matrix hd allograft dermis, per square centimeter E&I Q4346 Shelter dm matrix, per square centimeter E&I Q4347 Rampart dl matrix, per square centimeter E&I Q4348 Sentry sl matrix, per square centimeter E&I Q4349 Mantle dl matrix, per square centimeter E&I Q4350 Palisade dm matrix, per square centimeter E&I Q4351 Enclose tl matrix, per square centimeter E&I

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Q4352 Overlay sl matrix, per square centimeter E&I Q4353 Xceed tl matrix, per square centimeter E&I Q4354 Palingen dual-layer membrane, per square centimeter E&I Q4355 Abiomend xplus membrane and abiomend xplus hydromembrane, per square centimeter E&I Q4356 Abiomend membrane and abiomend hydromembrane, per square centimeter E&I Q4357 Xwrap plus, per square centimeter E&I Q4358 Xwrap dual, per square centimeter E&I Q4359 Choriply, per square centimeter E&I Q4360 Amchoplast fd, per square centimeter E&I Q4361 Epixpress, per square centimeter E&I Q4362 Cygnus disk, per square centimeter E&I Q4363 Amnio burgeon membrane and hydromembrane, per square centimeter E&I Q4364 Amnio burgeon xplus membrane and xplus hydromembrane, per square centimeter E&I Q4365 Amnio burgeon dual-layer membrane, per square centimeter E&I Q4367 Amniocore sl, per square centimeter E&I Q4368 AmchoThick, per sq cm E&I Q4369 AmnioPlast 3, per sq cm E&I Q4370 AeroGuard, per sq cm E&I Q4371 NeoGuard, per sq cm E&I Q4372 AmchoPlast EXCEL, per sq cm E&I Q4373 Membrane Wrap-Lite, per sq cm E&I Q4375 duoGRAFT AC, per sq cm E&I Q4376 Duograft AA, per sq cm E&I Q4377 triGRAFT FT, per sq cm E&I Q4378 Renew FT Matrix, per sq cm E&I Q4379 AmnioDefend FT Matrix, per sq cm E&I E&I= Experimental and Investigational

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Note: CPT/HCPCS codes are included for informational purposes and may not be all inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

Amniotic Allografts for Tendon and Ligament Injuries. (Sept. 16, 2020).
https://evidence.hayesinc.com/report/hss.amniotic4521

Comparative effectiveness review of biologic mesh for hernia repairs: A review of reviews (Annual review June 19, 2020).
https://www.hayesinc.com

Grafix Cryopreserved Placental Membrane (Osiris Technologies Inc.) For Treatment of Chronic Foot Ulcers in Patients with Diabetes Mellitus (Annual review Dec. 4, 2020).
https://www.hayesinc.com

Hingorani, A., LaMuraglia, G.M., Henke, P., Meissner, M.H., Loretz, L., Zinszer, K.M., …Murad, M.H. (2016, February). The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. Journal of Vascular Surgery, 63(2) 3S-21S. https://doi.org/10.1016/j.jvs.2015.10.003

Lavery L., Fulmer J., Shebetka, K.A., Regulski, M., Vayser, D., Fried, D., … Hesp, Z. (2018, September) Open label Extension Phase of a Chronic Diabetic Foot Ulcer. Multicenter, Controlled, Randomized Clinical Trail Using Cyropreserved Placental Membrane. Wounds, 30(9), 275-278.
https://pubmed.ncbi.nlm.nih.gov/30256747/

Lazic T., & Falanga, V. (2011, January). Bioengineered skin constructs and their use in wound healing. Plastic and Reconstructive Surgery, 127,(p), 75S-90S. https://journals.lww.com/plasreconsurg/Abstract/2011/01001/Bioengineered_Skin_Constructs_and_Their_Use _in.13.aspx

MassHealth Guidelines for Medical Necessity Determination for Skin Substitutes https://www.mass.gov/lists/masshealth-guidelines-for-medical-necessity-determination

National Institute for Health and Care Excellence (NICE). (2019). Diabetic Foot Problems: Prevention and Management [NG19].
https://www.nice.org.uk/guidance/ng19/evidence.

Nahabedian, M. (2019). Implant-based breast reconstruction and augmentation.
https://www.uptodate.com/contents/implant-based-breast-reconstruction-and- augmentation?search=implant%20based%20breast%20reconstruction%20and%20augmentation&source=se archresult&selectedTitle=1~150&usagetype=default&display_rank=1

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Shahrokhi, S, Skin substitutes.
https://www.uptodate.com/contents/skin- substitutes?search=skin%20substitutes&source=searchresult&selectedTitle=1~150&usagetype=default&d isplay_rank=1

Skin substitutes for venous leg ulcers in adults (July 23, 2020). https://evidence.hayesinc.com/report/dir.cerskinvenous4210

Van Zuijlen, P.P.M., Gardien, K., Ernst, J.B., Jaspers, M.E.H.. (2016 February). Tissue engineering in burn scar reconstruction, International Journal of Burns and Trauma, 9(18), 1-11. https://www.researchgate.net/publication/294891610_Tissue_engineering_in_burn_scar_reconstruction

Shahriar S, Arno A, Jeschke M. The Use of Dermal Substitutes in Burn Surgery: Acute Phase. (2014, January).
Wound Repair Regen, 22(1). https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3884830/

Zaulynov, L., & Kirsner, R. (2007, March) A review of bi-layered living cell treatment (Apligraf) in the treatment of venous leg ulcers and diabetic foot ulcers. Clinical Interventions in Aging 2(1), 93-98.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2684073/

Przekora, A. A Concise Review on Tissue Engineered Artificial Skin Grafts for Chronic Wound Treatment: Can We Reconstruct Functional Skin Tissue In Vitro? (Jul 9, 2020).
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7407512/

Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 11/2019 Initial policy date 11/2023 • Minor Title Change. • Coding table updated. 1/2024 Line of Business section added 4/2024 Q4144 removed, updated criteria for MassHealth, added codes effective 4/1/2024

Q4210, Q4277 deleted effective 6/30/2024. 12/2024 • Annual Review with updates • Added LCD 39828 and LCA A59712, effective 2/12/2025 to policy.
• Codes added to Diabetic Foot Ulcer as covered: A2019, Q4110, Q4121, Q4158, Q4159, Q4160, Q4187, Q4203. • Codes removed from Diabetic Foot Ulcer as covered: Q4101, Q4102, Q4104, Q4106 Q4114, Q4132, Q4168, Q4186, Q4196.

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Date Update • Updated Applicable diagnosis codes to Diabetic Foot Ulcer section. • Lower Extremity Skin Ulcer section renamed Diabetic Foot Ulcer (DFU) or Venous Leg Ulcers (VLU). • Added Q4151 to Diabetic Foot Ulcer (DFU) or Venous Leg Ulcers (VLU) as covered • Removed Q4104, Q4100, Q4124 from Diabetic Foot Ulcer (DFU) or Venous Leg Ulcers (VLU). • Updated Applicable diagnosis codes to Diabetic Foot Ulcer (DFU) or Venous Leg Ulcers (VLU).
• Codes added to Experimental Investigational list: Q4114, Q4132, Q4168, Q4311- Q4353. • Codes removed from Experimental and Investigational list: A2019, Q4121, Q4158, Q4159, Q4160, Q4187, Q4203. • References Updated. 3/2025 • Added A2030, A2031, A2034, A2033, A2034, A2035, Q4354, Q4355, Q4356, Q4357, Q4358, Q4359, Q4360, Q4351, Q4362, Q4363, Q4364, Q4365, Q4366, Q4367 added to Experimental/Investigational list effective 4/1/25.
• Removed Q4231 due to code discontinued 4/1/25. • Updated effective date for LCD 39828 and LCA A59712 to 4/13/25. 4/2025 • Removed reference to LCD L39828 and LCA A59712 due to CMS delay of implementation.
6/2025 • Q4368, Q4369, Q4370, Q4371, Q4372, Q4373, Q4375, Q4376, Q4377, Q4378, Q4379, Q4380, Q4382 added to Experimental/Investigational list effective 7/1/2025 • Q4132, Q4137, Q4154, Q4168 removed from the Experimental/Investigational list.
• Added Ophthalmic Indications to list of covered conditions.
• Added Human amniotic membrane graft definition.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer- reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government, or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at the time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.

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