Humana Skin and Tissue Substitutes Form

. Bioengineered 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. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 2 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 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. For information regarding anatomic 3D bioprinting, please refer to Code Compendium (Miscellaneous) Medical Coverage Policy. For information regarding bone graft materials/bone graft substitute products, please refer to Bone Graft Substitutes Medical Coverage Policy. For information regarding ocular defects, please refer to Ocular Surface Disease Diagnosis and Treatments Medical Coverage Policy. For information regarding plantar fasciitis, please refer to Plantar Fasciitis Treatments Medical Coverage Policy. Coverage Determination Any state mandates for skin and tissue substitutes take precedence over this medical coverage policy. Humana members may be eligible under the Plan for skin and tissue substitutes when the following criteria are met: Skin / Tissue Substitute Indication(s) / Criteria 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 • 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 Associated HCPCS Code(s) Q4116 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 3 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Indication(s) / Criteria Associated HCPCS Code(s) natural biological components, ready to enable the body to mount its own tissue regeneration process. 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. 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. Cortiva and Cortiva 1 mm Allograft Dermis Non-crosslinked acellular dermal matrix. Reconstruction Medical Coverage Policy) • Use with standard therapeutic Q4101 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 standard wound therapy; OR • 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, capsule, muscle or tendon exposure • Full-thickness (third-degree) burns; OR • Partial-thickness (second-degree) burns Q4100 • For use in association with a covered, medically necessary breast reconstruction procedure Q4100, C1763 (For information regarding coverage determination/limitations for breast See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 4 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Indication(s) / Criteria Associated HCPCS Code(s) Q4122 Q4106 reconstruction, please refer to Breast Reconstruction Medical Coverage Policy) • 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 Medical Coverage Policy) • 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 • Used in conjunction with standard wound therapy • Full-thickness diabetic foot ulcers Q4186 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 • For use in association with a Q4128 covered, medically necessary breast reconstruction procedure DermACELL Acellular human dermis. Dermagraft Manufactured from human fibroblast cells derived from newborn foreskin tissue. The fibroblasts are cultured on a bioarbsorbable polyglactin mesh. Proteins and growth factors are secreted during the culture period and generate a three dimensional (3D) human dermis. Epifix Biologic human amniotic membrane. FlexHD Human allograft skin minimally processed to See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 5 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Indication(s) / Criteria remove epidermal and dermal cells and preserve the ECM of the dermis. (excluding implant-based breast reconstruction) Grafix Core/Grafix Prime ECM containing growth factors. (For information regarding coverage determination/limitations for breast reconstruction, please refer to Breast Reconstruction Medical Coverage Policy) • 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 wound therapy Associated HCPCS Code(s) Q4132, Q4133 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. 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 • Full-thickness diabetic foot ulcers Q4107 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 • Treatment of chronic venous or Q4104 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 6 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Indication(s) / Criteria Associated HCPCS Code(s) biodegradable matrix provides a scaffold for cellular invasion and capillary growth. 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. Integra Meshed Bilayer Wound Matrix Porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The collagen-glycosaminoglycan biodegradable matrix • Partial-thickness (second-degree) burns • Postexcisional treatment of life- Q4105 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 individual; OR • 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 wound therapy • 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, Q4104, C9363 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 7 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Indication(s) / Criteria Associated HCPCS Code(s) provides a scaffold for cellular invasion and capillary growth. The meshed bilayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. Oasis Ultra Tri-Layer Matrix and Oasis Wound Matrix A naturally derived, ECM created from the submucosal layer of porcine small intestine. Transcyte Combines a synthetic epidermis with a bioengineered human dermal layer that contains fibronectin growth factors and collagen capsule, muscle or tendon exposure; OR • Partial-thickness (second-degree) burns • 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 • For use as a temporary wound Q4182 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 Coverage Limitations Humana members may NOT be eligible under the Plan for any of the following skin and tissue substitutes 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 8 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. • Biobrane/Biobrane-L; OR • Cortiva and Cortiva 1 mm Allograft Dermis; OR • DermACELL; OR • Dermagraft; OR • Epifix; OR • FlexHD; OR • Grafix Core/Grafix Prime; OR • GraftJacket 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 • Transcyte These are considered experimental/investigational as they are not identified as widely used and generally accepted for any other proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. Humana members may NOT be eligible under the Plan for any of the following for ANY indications: Associated HCPCS/ CPT® Code(s) A2020 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) AC5 Advanced Wound System Lyophilized peptide in sterile water for injection. Biocompatible and resorbable peptides that self-assemble into a nanofiber network which resembles the construct of the extracellular matrix. • Topical dressing for the management of wounds including: o Diabetic ulcers o Partial- and full-thickness wounds o Pressure ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 9 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4293 Q4300 o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence) o Venous ulcers • Wound covering or barrier membrane, over acute and chronic wounds • Wound covering or barrier membrane, over acute and chronic wounds • Homologous use to cover and Q4100 protect tissue • Wound covering or barrier Q4301 membrane • Surgical use to supplement or Q4100 replace damaged or inadequate connective tissue • Onlay graft for: Q4159 o Acute and chronic wounds including neuropathic ulcers, pressure ulcers and venous stasis ulcers o Burns Acesso DL Dehydrated dual layer human amniotic membrane allograft. Acesso TL Dehydrated triple layer human amniotic membrane allograft. ACTISHIELD, ACTISHIELD CF Allografts derived from dehydrated human amniotic tissue. Activate Matrix Triple layer human amnion and chorionic membrane allograft. ActiveBarrier, ActiveMatrix, CryoMatrix Placental connective tissue matrix. Affinity Minimally processed amniotic fluid membrane allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 10 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4212 Q4100 Q4128 Q4115, Q4141, Q4123 Q4150 Q4235 o Postsurgical wounds o Posttraumatic wounds • Burns • Chronic, nonhealing wounds • Soft tissue repair including: o Breast reconstruction o Chest wall defect o Hernia repair • Provision of ECM scaffold for tendon augmentation • Acute and chronic wound therapy • Onlay and/or wrapping tissue applications following surgical repair • Acute and chronic wound therapy Allogen Liquid Human liquid amnion. AlloMax A sterile regenerative human collagen matrix. 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 Quad-Core Four layer human amniotic membrane allograft. • Wound covering or barrier Q4294 membrane See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 11 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4295 Amnio Tri-Core Triple layer human amniotic membrane allograft. 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. Amnio-Maxx Dual layered, dehydrated, amniotic tissue membrane graft. Amnio-Maxx Lite Single layer, dehydrated, amniotic tissue membrane graft. AmnioAMP-MP Decellularized dehydrated human amniotic membrane (DDHAM) which is derived from the placental amnion. • Wound covering or barrier membrane • Intended for the following Q4181 conditions: 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 • Chronic wound covering for: o Diabetic ulcers o Soft tissue defects o Venous stasis ulcers Q4239 • Partial- or full-thickness skin Q4250 wounds such as: o Burns o Diabetic ulcers o Pressure ulcers o Venous ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 12 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4188 Q4151, Q4168 Q4225 • Repair of skin over any wound including those with exposed bone, muscle or tendon • Acute and chronic wound therapy • Soft tissue defects • Surgical sites • Ulcers • Wounds • Acute and chronic wound therapy • Connective tissue matrix to Q4100 replace or supplement damaged or inadequate integumental tissue • Surgical wrap or barrier • Acute and chronic wound therapy Q4227 • Wound covering or barrier Q4298 membrane • Wound covering or barrier Q4299 membrane 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 or DermaBind TL 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. AmnioCore Dual layer amniotic tissue allograft. AmnioCore Pro Dual layer human amnion and chorionic membrane allograft. AmnioCore Pro+ Triple layer human amnion and chorionic membrane allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 13 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4242 • Replace or supplement damaged or inadequate tissue AmnioCyte Minimally manipulated human tissue allograft derived from the extracellular matrix of the amniotic membrane. AmnioFill Cellular tissue matrix allograft that contains multiple ECM proteins, growth factors, cytokines, and other specialty proteins. AmnioFix Human amniotic membrane comprises the innermost layer of the placenta and lines the amniotic cavity. AmnioFLEX, ASG Barrier, ASG Fluid Human tissue, chorion free allograft, comprised of minimally manipulated amniotic membrane derived from placental tissue. AmnioGraft Minimally manipulated, cryopreserved amniotic membrane. • Modulate inflammation in the Q4100 surgical site • Reduce scar tissue formation • Replace or supplement damaged or inadequate integumental tissue for acute and chronic wounds • Modulate inflammation in the Q4100 surgical site • Reduce scar tissue formation • Surgical wrap or barrier • Aid in the healing and repair of Q4100 wounds • Construct a natural scaffold for new tissue growth • Any indication other than ocular use (eg, diabetic ulcer) Q4100, V2790 (For information regarding coverage determination/ limitations for ocular indications, please refer See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 14 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4100 Q4139 Q4211 to Ocular Surface Disease Diagnosis and Treatments Medical Coverage Policy) • Chronic wound covering for: o Burns o Diabetic ulcers o Pressure ulcers o Venous stasis ulcers • Anti-inflammatory wound dressing • Hollow regions of bone • Soft tissue injuries • Acute and chronic wounds • Partial- or full-thickness skin wounds • Wounds and soft tissue defects Q4163 • Wounds and soft tissue defects Q4162 • Provides a barrier and support function to aid in healing of defect Q4245 AmnioHeal Plus Amniotic membrane graft AmnioMatrix Cryopreserved (frozen) complex of amniotic tissue, liquid human allograft. Amnion Bio, AxoBioMembrane Human amnion allograft. Amniopro, Amniogen-45, Amniogen-200, BioRenew, BioSkin, WoundEx Human ECM placental tissue allografts. Amniopro Flow, Amniogen-a, Amniogen-c, BioRenew Flo, BioSkin Flo, WoundEx Flo Human ECM placental tissue injectable allografts. Amniotext Minimally manipulated, amniotic membrane derived human tissue allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 15 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Associated HCPCS/ CPT® Code(s) Q4247 Q4221 Q4249 A2010 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Amniotext patch Minimally manipulated amniotic membrane derived human tissue allograft. AmnioWrap2 Amniotic/chorionic tissue allograft. Amniply Collagenous membrane derived from the submucosa of the placenta. Apis Biodegradable and absorbable gelatin, a porcine collagen derivative, is the primary material. The two other materials are Manuka honey and hydroxyapatite. • Management of chronic wounds including: o Diabetic foot ulcers o Venous ulcers • Management of wounds including: o Acute and chronic wounds o Chronic vascular ulcers o Diabetic ulcers o Venous ulcers • Chronic wound covering for: o Diabetic foot ulcers o Pressure ulcers o Venous leg ulcers • Management of wounds including: o Diabetic ulcers o Partial- and full-thickness wounds o Pressure ulcers o Surgical wounds (eg, donor sites/grafts) o Trauma wounds (eg, abrasions, healing by secondary intention) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 16 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Architect, Architect PX, Architect FX ECM Stabilized collagen matrix. Artacent AC Human amnion/chorion membrane graft. Artacent Cord Umbilical cord allograft. Associated HCPCS/ CPT® Code(s) Q4147 Q4189, Q4190 o Venous ulcers • Partial- or full-thickness skin wounds such as: o Diabetic foot ulcers o Second-degree burns o Venous leg ulcers • Acute and chronic wounds such as: o Burns o Diabetic ulcers o Pressure ulcers o Venous stasis ulcers o Wounds that are refractory to more conservative care • Acute and chronic wounds such Q4216 as: o Burns o Diabetic ulcers o Venous stasis ulcers o Wounds that are refractory to more conservative care See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 17 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Artacent – Flex, Wound Amniotic tissue graft with an epithelial layer of native membrane facing out on both sides. ArthroFlex Decellularized dermis patch. Ascent Dehydrated cell and protein concentrate (dCPC) injectable derived from human amniotic fluid. Avance Nerve Graft Processed, decellularized nerve allograft. Axograft Dual layer amniotic membrane. AxoGuard – Nerve Connector, Nerve Protector Porcine submucosa ECM. Associated HCPCS/ CPT® Code(s) Q4169 Q4125 Q4213 • Surgical barrier for these types of surgeries: o Extremity o Orthopedic o Plastics o Spinal o Urological o Vascular • Achilles tendon repair and shoulder reconstruction • Burns • Chronic, nonhealing wounds • Alternative to nerve conduits for nerve repair procedures 64912, 64913 • Promote bone healing, spinal Q4100 fusion and wound treatment in spinal arthrodesis procedures • Coaptation aid for close approximation and reinforcement of severed nerve ends • Isolate nerve tissue during the C1763 Q4215 Q4210 healing process • Soft tissue injuries Axolotl Ambient, Axolotl Cryo Human amniotic flowable allografts. Axolotl DualGraft, Axolotl Graft • Wound barrier See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 18 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Human amniotic allograft, decellularized, dehydrated placental membrane. Barrera SL, Barrera DL Dehydrated human amniotic membrane allograft. BellaCell HD Human acellular dehydrated dermis regenerative tissue matrix. Bio-ConneKt Conformable and porous wound dressing made of reconstituted collagen derived from equine tendon. Associated HCPCS/ CPT® Code(s) Q4281 • Nerve wrap • Barrier or cover for wounds including surgically created wounds • Abdominal wall and hiatal hernia Q4220 repair • Breast reconstruction • Burns • Skin ulcers • Management of moderately to Q4161 heavily exuding wounds including: 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 19 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) C1763 o Trauma wounds (eg, abrasions, lacerations, second- degree burns, skin tears) o Tunneled wounds o Venous ulcers • Repair of soft tissue defects including: o Dura mater o Sinonasal o Tympanic membrane • The plug is absorbed into the body in 6 – 8 weeks C1763, 46707 • 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 • Abdominal wall reconstruction and hernia repair C1763 • Support weakened soft tissue during nipple reconstruction C1763 Biodesign – Dural Graft, Duraplasty Graft, ENT Repair Graft, Otologic Repair Graft Nonporous, absorbable multi- layer sheet of extracellular collagen matrix derived from porcine SIS. Biodesign – Enterocutaneous Fistula Plug and Fistula Plug Cone-shaped plug made of connective tissue from porcine small intestine submucosa (SIS). Biodesign – Hernia, Hiatal Hernia, Incision Graft Multilayered sheet of extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). Biodesign Nipple Reconstruction Cylinder See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 20 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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) 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. BioFix, BioFix Plus, BioFix Flow Amniotic allografts are derived from human placental tissue. Biovance Dehydrated, decellularized human amniotic membrane. Biovance Tri-layer, Biovance 3L Triple-layer decellularized, dehydrated human amniotic membrane. • Reinforcement of soft tissue C1763 • Scaffold for tissue repair and Q4137 regeneration • Localized areas of inflammation • Supports soft tissue regeneration • Tissue voids and defects Q4140, Q4138 • Wound covering for: Q4100 o Surgical sites o Tissue defects o Tissue voids • Treatment or replacement of damaged or lost soft tissue Q4154 • Cover or protect, from the Q4283 surrounding environment, in wound, surgical repair and reconstruction procedures See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 21 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Associated HCPCS/ CPT® Code(s) Q4217 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) BioWound, BioWound Plus, BioWound XPlus, WoundFix, WoundFix Plus, WoundFix XPlus Human amnion-based membranes. • Repair of acute and chronic wounds including, but may not be limited to: o Burns 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 • Repair of skin over any wound including those with exposed bone, capsule, muscle or tendon • Barrier or cover for wounds including surgically created wounds Q4236 carePATCH Dehydrated amniotic membrane allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 22 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4259 • Wound covering or barrier membrane Celera Dual Membrane, Celera Dual Layer Amniotic and/or chorionic allograft derived from placental tissue. Cellesta Minimally manipulated amniotic membrane allograft. Cellesta Cord Umbilical cord allograft product. Cellesta Flowable Amnion Minimally manipulated, chorion-free human amniotic membrane. Cocoon Membrane Human amnionic membrane allograft. Cogenex Amniotic Membrane Minimally manipulated, amniotic membrane allograft. • Burns Q4184 • Chronic wound repair • Urologic and gynecological surgeries • Acute and chronic wound Q4214 therapy • Surgical wounds • Application in difficult to access wound sites, deep dermal wounds, irregularly shaped crevassing and tunneling wounds Q4185 • Acute and chronic wounds Q4264 • Partial- or full-thickness skin wounds • Burns • Chronic, nonhealing wounds • Urologic and gynecological surgeries Q4229 Cogenex Flowable Amnion Minimally manipulated, amniotic membrane allograft. • Application in difficult to access Q4230 wound sites, deep dermal wounds, irregularly shaped crevassing and tunneling wounds See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 23 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Coll-e-derm Allograft derived from human dermal tissue. Complete AA Dual layer human amnion membrane allograft. Complete ACA Triple layer human amnion and chorionic membrane allograft. Complete FT Resorbable full-thickness amnion/chorion allograft. Complete SL Resorbable single layer amniotic allograft. CopiOs Pericardium Membrane Bovine pericardium-based, noncross-linked collagen matrix. CoreCyte Wharton’s jelly allograft. CoreText, ProText Wharton’s jelly allograft. CorMatrix ECM Acellular biomaterial (porcine small intestine submucosa processed to remove cells) the remaining ECM is composed of structural proteins such as collagen, elastin, etc. Corplex Associated HCPCS/ CPT® Code(s) Q4193 Q4303 Q4302 Q4271 Q4270 C1763 • Regenerative support to wounds and burns • Wound covering or barrier membrane, over acute and chronic wounds • Wound covering or barrier membrane, over acute and chronic wounds • Wound covering or barrier membrane, over acute and chronic wounds • Wound covering or barrier membrane, over acute and chronic wounds • Guided tissue and bone regeneration in oral surgery procedures • Aid in the healing and repair of Q4240 wounds • Cartilage tears • Muscle tears • Soft tissue defects • Wounds • Support cardiac repairs and gradually replace tissue as it is remodeled, leaving no foreign material behind Q4246 C1763 • Acute and chronic wound Q4232 therapy See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 24 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Human umbilical cord allograft composed of the epithelial layer and the Wharton’s jelly. Corplex P Wharton’s jelly allograft. Cryo-Cord Minimally manipulated umbilical cord allograft. Cygnus Dual Amniotic tissue matrix. Cygnus Matrix Amniotic tissue matrix. Cygnus – Max, Solo Amniotic tissue matrix. Cymetra Micronized Alloderm Tissue Matrix Micronized particulate form of AlloDerm, delivered by injection containing collagens, elastin, proteins and proteoglycans. • Wound covering for connective Q4231 tissue voids • Chronic, nonhealing wounds Q4237 • Barrier or cover for wounds • 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 care • Correction of soft tissue defects requiring minimally invasive techniques Q4282 Q4199 Q4170 Q4112 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 25 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Associated HCPCS/ CPT® Code(s) Q4166 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Cytal – Burn Matrix, Micro Matrix and Wound Matrix (formerly MatriStem Wound Matrix and Multilayer Wound Matrix) • Management of topical wounds including, but may not be limited to: o Chronic vascular ulcers Noncross-linked urinary bladder matrix (UBM) that maintains an epithelial basement membrane and numerous collagens. 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 • Repair or replacement of damaged or inadequate integumental tissue Q4238 Derm-Maxx Freeze-dried decellularized dermal matrix allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 26 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Derma-Gide Comprised of a porcine derived, porous, purified collagen matrix. • Management of wounds including, but may not be limited to: Associated HCPCS/ CPT® Code(s) Q4203 o Diabetic ulcers 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) DermaBind CH Dehydrated human ECM chorion derived membrane allograft. DermaBind DL Dehydrated human ECM allograft. DermaBind SL Dehydrated human amniotic membrane allograft. o Venous ulcers • Wound covering or barrier membrane Q4288 • Wound covering or barrier Q4287 membrane • Acute and chronic wounds Q4284 including, but may not be limited to: o Chronic vascular ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 27 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated 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) Dermacyte Amniotic membrane allograft. DermaMatrix Allograft derived from donated human skin. DermaPure Derived from split-thickness grafts harvested from human cadaver tissue donors. o Venous ulcers • Diabetic foot ulcers • Partial-thickness wounds • Venous stasis ulcers • Repair, replacement or Q4248 Q4100 reinforcement of soft tissue for grafting purposes • Acute and chronic wounds such Q4152 as: o Diabetic foot ulcers o Venous stasis ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 28 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) DermaSpan ACD ADM derived from allograft human skin. o Wounds that are refractory to more conservative care • Covering, protection, Q4126 reinforcement or supplemental support of tendon • Homologous uses of human integument • Repair or replacement of damaged or inadequate integumental tissue • Skin replacement or supplement for damaged or inadequate integumental tissue such as surgical sites, ulcers or wounds • Implantation to reinforce soft tissues in gastroenterological, gynecological and urological anatomy Q4153 Q4100 • Treatment of hernias where the connective tissue has ruptured • Wound covering or barrier Q4262 membrane • Absorbable implant for the repair Q4100 of dura mater Dermavest, Plurivest Amnion/chorion, umbilical cord and placental disk tissue preserved with attachment proteins, growth factors and cytokines. DermMatrix (formerly InteXen) Porcine Dermal Matrix Pyrogen free, porcine dermis. Dual Layer Impax Membrane Dehydrated dual layered human amniotic membrane allograft. DuraGen Onlay graft comprised of a porous, purified collagen matrix. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 29 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) E-Z Derm Porcine derived xenograft in which the collagen has been chemically cross-linked with aldehyde (a chemical compound). Emerge Matrix Dual layer human amniotic and chorionic membranes. EndoForm Dermal Template, Myriad ECM derived from ovine forestomach. • Alternative to allografts in the treatment of burn wounds, especially for partial-thickness skin losses • Protection for meshed autografts • Temporary coverage prior to autograft • Wound covering or barrier membrane, over acute and chronic wounds, including full- thickness ulcers • Management of wounds including, but may not be limited to: Associated HCPCS/ CPT® Code(s) Q4136 Q4297 A6021, A6022 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 30 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 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 • Wound covering or barrier membrane, over acute and chronic wounds, including dermal ulcers or defects • Replace the epidermis on a severely burned individual • Burns • Plastic surgery • Wound care • Barrier or cover for acute and chronic wounds Q4258 Q4100 Q4145, Q4187 Q4278 • Barrier or cover for acute and Q4272 chronic wounds • Barrier or cover for acute and Q4273 chronic wounds Enverse Dehydrated human amniotic membrane. Epicel Skin cells are grown or cultured from a postage stamp sized sample of the individual’s own healthy skin. Epicord, Epifix Biologic human amniotic membrane. Epieffect Human amniotic membrane allograft. Esano A Single-layer, decellularized, dehydrated human amniotic membrane allograft. Esano AAA Tri-layer, decellularized, dehydrated human amniotic membrane allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 31 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4274 Esano AC Dual-layer, decellularized, dehydrated human amniotic membrane allograft. Esano ACA Tri-layer, decellularized, dehydrated human amniotic membrane allograft. Excellagen Pharmaceutically formulated fibrillar Type I bovine collagen gel. FloGraft Cryopreserved, injectable, liquid amniotic fluid derived allograft. Floweramnioflo Premixed, ambient temperature placental tissue matrix allograft. Floweramniopatch Dehydrated amniotic membrane allograft. Flowerderm Acellular dermal allograft ECM composed of proteoglycans, • Barrier or cover for acute and chronic wounds • Barrier or cover for acute and Q4275 chronic wounds • Applied immediately following Q4149 wound debridement • Purported to promote: o Cellular adhesion o Chemotaxis o Migration and proliferation to stimulate granulation tissue formation • Soft tissue repair Q4100 • Replace or supplement damaged Q4177 or integumental tissue • Wound covering Q4178 • Reinforcement of tendons and Q4179 supplemental support • Wound covering See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 32 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) hyaluronic acid, collagen, fibronectin and elastin. Fluid Flow, Fluid GF Human amniotic flowable allograft. Fortify Flowable Extracellular matrix (ECM) derived from porcine small intestinal submucosa. • Acute and chronic wound Q4206 therapy • Soft tissue injuries • Management of wounds including, but may not be limited to: A4100, Q4100 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 33 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4100 o Venous ulcers • Soft tissue repair procedures such as hernia repair Fortiva Porcine Dermis Noncross-linked porcine dermis, designed to act as a scaffold that allows for neovascularization and reincorporation with the individual’s own tissue. GalaFLEX, GalaFLEX 3D and GalaFLEX 3DR Bioresorbable surgical scaffold made of monofilament fibers of the biopolymer, poly-4- hydroxybutarate (P4HB). • Reinforcing scaffold in soft tissue repair procedures such as: A4100, Q4100 o General soft tissue reconstruction o Plastic and reconstructive surgery GammaGraft Irradiated human skin allograft acquired from cadaveric donors. Genesis Amniotic Membrane Dehydrated, collagenous human tissue allograft. Gentrix Surgical Matrix (formerly MatriStem Surgical Matrix) Composed of a porcine derived ECM, also known as UBM and • Temporary graft for treating: Q4111 o Burns o Chronic wounds o Full-thickness wounds o Partial-thickness wounds • Acute and chronic wound therapy • Soft tissue injuries • Reinforcement of soft tissue within gastroenterological, plastic, reconstructive or urological surgery including, but Q4198 C1763, C1781 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 34 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) supplied in multilayer sheet configurations. may not be limited to, the following procedures: Grafix PLUS Human chorionic membrane allograft. GraftJacket Xpress Injectable allograft treatment that is mixed with sterile saline. Helicoll Helicoll is an ADM derived from bovine Type-1 collagen. o Colon and rectal prolapse repair o Esophageal repair o Hernia and body wall repair o Tissue repair • Wound covering or barrier membrane, over acute and chronic wounds • Facilitate the rapid formation of granulation tissue and reduce infection risk Q4304 Q4113 • Full- and partial-thickness Q4164 wounds • Second-degree burns • Skin donor sites • Skin ulcers hMatrix Acellular, dermal scaffold processed from donated human skin. • Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears) • Replace damaged or inadequate integumental tissue such as: o Abdominal wall repair Q4134 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 35 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4224 o Breast reconstruction o Wound covering • Wound covering or barrier membrane Human Health Factor 10 Amniotic Patch (hhf10-p) Single-layer amniotic allograft derived from full-term human birth tissue, specifically the immunoprivileged amnion layer. Hyalomatrix Bioresorbable, dermal substitute made of HYAFF, a long-acting derivative of hyaluronic acid providing a microenvironment. InnovaBurn, InnovaMatrix XL Decellularized extracellular matrix (ECM) derived from porcine placental tissue. • Full-thickness wounds and burns Q4117 • Provides a wound preparation to support the implantation of autologous skin grafts • Management of wounds A2022 including, but 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 36 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) InnovaMatrix AC Decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. 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: A2001 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 37 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) InnovaMatrix FS Decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. 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: A2013 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 38 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) o Tunneled wounds o Undermined wounds InnovaMatrix PD Decellularized extracellular matrix (ECM) derived from porcine placental tissue. o Venous ulcers • Management of wounds including, but may not be limited to: A2023 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 39 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4114 o Venous ulcers • Difficult to access wound sites, as well as tunneled wounds. 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. Integra Matrix Wound Dressing Biodegradable, porous matrix of cross-linked bovine tendon and glycosaminoglycan. Interfyl – Flowable, Particulate Decellularized, connective ECM derived from human placental tissue. Keramatrix Absorbable matrix made from a combination of keratin technology that dissolves into wounds. Kerecis Omega3 Acellular intact fish skin that contains proteins, lipids (including omega3) and other • Reinforcing scaffold in soft tissue Q4100 repair procedures such as: o Abdominal wall reconstruction o Breast reconstruction • Tendon protection • Scaffold for cellular invasion and Q4108 capillary growth • Correct defects and fill voids and Q4171 in soft tissue, providing mechanical and structural support to facilitate the tissue repair process • Full- and partial-thickness Q4165 wounds with low to high exudate • Reconstruction of: Q4158 o Breast o Burns o Chronic wounds See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 40 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) skin elements and bioactive lipid content. o Dura mater o Hernia repair o Oral wounds Kerecis Omega3 MariGen Shield Acellular intact fish skin that contains proteins, lipids (including omega3) and other skin elements and bioactive lipid content. • Management of wounds A2019 including: 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) Keroxx Flowable matrix made from a combination of keratin technology that dissolves into wounds. o Venous ulcers • Chronic wounds such as: Q4202 o Diabetic ulcers o Donor sites/grafts o Pressure ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 41 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Lamellas Dehydrated human resorbable allograft derived from placental tissue. Lamellas XT Dehydrated human resorbable allograft derived from placental tissue. Leneva Allograft adipose extracellular matrix (ECM). MatriDerm Acellular dermal substitute composed of bovine collagen and elastin. Associated HCPCS/ CPT® Code(s) Q4292 Q4291 • Wound covering or barrier membrane, over acute and chronic wounds • Wound covering or barrier membrane, over acute and chronic wounds • Soft tissue reconstruction Q4100 • Management of wounds Q4100 including, but 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 42 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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 Trauma wounds (eg, abrasions, lacerations, second- degree burns, skin tears) o Venous ulcers • Chronic wounds Q4201 • Management of wounds Q4118 including, but 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) o Trauma wounds (eg, abrasions, lacerations, second- degree burns, skin tears) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 43 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Matrix HD Acellular human dermis allograft retains the three- dimensional intertwined multidirectional fibers and mechanical properties of the native tissue architecture. Mediskin Frozen irradiated porcine xenograft with a dermal and epidermal layer. o Tunneled wounds o Undermined wounds o Venous ulcers • Protect, reinforce or cover soft tissue and provide a scaffold to support regenerative processes Q4128 • Meshed autograft protection Q4135 • Partial-thickness skin ulcerations and abrasions • Temporary covering for full- thickness skin loss Membrane Graft, Membrane Wrap Human amniotic allograft. • Toxic epidermal necrolysis (TEN) • Management of wounds including, but may not be limited to: Q4205 o Burns o Chronic vascular ulcers o Diabetic ulcers o Pressure ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 44 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Membrane Wrap-Hydro Human amnion membrane allograft. MemoDerm ADM derived from human allograft skin tissue. Microlyte Matrix Synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver. o Surgical wounds (eg, donor sites/grafts, podiatric, post laser surgery, post-Mohs surgery, wound dehiscence) o Ulcers caused by mixed vascular etiologies o Venous ulcers • Wound covering or barrier membrane, over acute and chronic wounds • Repairs (eg, rotator cuff) and wounds (eg, chronic diabetic ulcer) • Management of wounds including, but may not be limited to: Q4290 Q4126 A2005 o Diabetic ulcers o First and second-degree burns o Partial- and full-thickness wounds o Pressure ulcers o Surgical wounds (eg, donor sites/grafts) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 45 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) o Trauma wounds (eg, abrasions, lacerations, skin tears) o Venous ulcers • Management of wounds including, but may not be limited to: A2025 Miro3D Decellularized extracellular matrix (ECM) derived from porcine liver tissue. 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 46 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Associated HCPCS/ CPT® Code(s) Q4175 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Miroderm, Miromesh Noncross-linked acellular wound matrix derived from porcine liver and is processed and stored in a phosphate buffered aqueous solution. o Venous ulcers • Management of wounds including, but 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) o Trauma wounds (eg, abrasions, lacerations, second- degree burns, skin tears) o Tunneled wounds o Undermined wounds Mirragen Advanced Wound Matrix o Venous ulcers • Management of wounds including, but may not be limited to: A2002 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 47 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Biocompatible and resorbable borate glass fibers and particulate. 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 MLG-Complete Full thickness amnion-chorion derived allograft. o Venous ulcers • Management of wounds including, but may not be limited to: Q4256 o Chronic vascular ulcers o Diabetic ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 48 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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 • Chronic wounds • Postsurgical wounds Q4226 • Management of wounds A2021 including: o Chronic vascular ulcers o Diabetic ulcers o Draining wounds MyOwn Skin Autologous, homologous human skin product. NeoMatriX Wound Matrix Acellular axolotl dermal extracellular matrix. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 49 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated 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/undermined wounds o Venous ulcers • External wound covering for dermal ulcerations including: o Chronic venous ulcers o Diabetic ulcers • Acute and chronic wounds including, but may not be limited to: o Chronic vascular ulcers o Diabetic ulcers Q4176 Q4267 Neopatch Terminally sterilized, dehydrated human placental membrane tissue comprised of both amnion and chorion. Neostim DL Double layer dehydrated amniotic membrane allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 50 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated 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/undermined wounds Neostim Membrane Single layer dehydrated amniotic membrane allograft. o Venous ulcers • Acute and chronic wounds including, but may not be limited to: Q4266 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 51 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) laser surgery, post-Mohs surgery, wound dehiscence) o Trauma wounds (eg, abrasions, lacerations, second- degree burns, skin tears) o Tunneled/undermined wounds Neostim TL Triple layer dehydrated amniotic membrane allograft. o Venous ulcers • Acute and chronic wounds including, but may not be limited to: Q4265 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 52 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) o Tunneled/undermined wounds o Venous ulcers • Surgical wrap or barrier, quick- Q4156 peel matrix • Wound covering for dermal ulcers and defects, quick-peel matrix • Surgical wrap or barrier, 1 mm Q4148 thick form • Wound covering for dermal ulcers and defects, 1 mm thick form • Replace or supplement damaged or inadequate integumental tissue Q4155 • Repair of peripheral nerve C1763 discontinuities where gap closure can be achieved by flexion of the extremity • Peripheral nerve repair C9361 • Onlay graft for: Q4194 Neox 100; OR Cryopreserved human amniotic membrane and umbilical cord. Clarix 100 Cryopreserved human amniotic membrane, umbilical cord and additional proteins. Neox Cord 1K; OR Cryopreserved human amniotic membrane and umbilical cord. Clarix Cord 1K Cryopreserved human amniotic membrane, umbilical cord and additional proteins. Neox Flo or Clarix Flo Particulate products of the above-mentioned matrices. NeuraGen Nerve Guide, NeuraWrap Nerve Protector Bovine derived collagen conduit. NeuroMend Nerve Wrap Resorbable, semipermeable, type I collagen nerve wrap. Novachor Chorion layer of the placental membranes. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 53 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) o Acute and chronic wounds including neuropathic ulcers, pressure ulcers and venous stasis ulcers o Burns o Postsurgical wounds Novafix Dehydrated human amniotic membrane allograft. o Posttraumatic wounds • Management of wounds including, but may not be limited to: Q4208 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 54 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) o Tunneled wounds o Undermined wounds Novafix DL Dehydrated human amnion chorion membrane allograft. o Venous ulcers • Management of wounds including, but may not be limited to: Q4254 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 55 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Associated HCPCS/ CPT® Code(s) A2006 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) NovoSorb Matrix Acellular, synthetic dermal matrix of biodegradable polyurethane foam bonded with a polyurethane adhesive layer. o Venous ulcers • Management of wounds including, but 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) o Trauma wounds (eg, abrasions, lacerations, second- degree burns, skin tears) o Venous ulcers • Provides an environment for tissue growth, repair and healing • Acute and chronic wounds • Burns • Soft tissue injuries Q4100 Q4233 NuCel Allograft derived from human amnion and amniotic fluid. NuDyn, SurFactor Acellular, flowable human amniotic membrane allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 56 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) NuDYN DL, NuDYN DL MESH Human amnion/chorion membrane allografts. • Surgical wounds • Barrier or cover for acute and chronic wounds including, but may not be limited to: Associated HCPCS/ CPT® Code(s) Q4285 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 NuDYN SL, NuDYN SLW Human amnion membrane allografts. o Venous ulcers • Barrier or cover for acute and chronic wounds including, but may not be limited to: Q4286 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 57 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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 NuShield Allograft derived from amniotic and chorionic membranes. o Venous ulcers • Assist in healing of soft tissue Q4160 injuries • Barrier protection of dura, nerves and tendons • Burns See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 58 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Oasis Burn Matrix Naturally derived, ECM created from the submucosal layer of porcine small intestine. ologen Collagen Matrix Biodegradable porcine-derived collagen matrix. Associated HCPCS/ CPT® Code(s) Q4103 • Wound covering • Acellular scaffold that accommodates remodeling of host tissue • Management of wounds Q4100 including, but may not be limited to: o Chronic vascular ulcers o Diabetic ulcers o Draining wounds o Oral wounds/sores o Partial- and full-thickness wounds o Pressure ulcers o Surgical wounds o Trauma wounds (eg, second- degree burns) Omeza Collagen Matrix Hydrolyzed fish collagen infused with cod liver oil. o Venous ulcers • Management of wounds including, but may not be limited to: A2014 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 59 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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 Orion Dual-layer, dehydrated human amniotic membrane allograft. OrthoFlo Allograft derived from amniotic fluid. o Venous ulcers • Barrier or cover for acute and chronic wounds • For use in joints to: Q4276 Q4100 o Modulate inflammation o Protect and cushion See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 60 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4100 Q4173, Q4174 o Provide lubrication for enhanced mobility • Reinforce and/or repair soft tissue where weakness exists • Repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material • Aid in healing and repair of wounds • Wound covering and support for native tissue • Patch to reinforce soft tissue where weakness occurs C9364 • Surgical repair of damaged or ruptured soft tissue • Partial-thickness burns • Skin donor sites A2016 OviTex Bio scaffold composed of ovine (sheep) derived ECM and polyglycolic acid (PGA). 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. Permacol A porcine dermal collagen implant. 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. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 61 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Associated HCPCS/ CPT® Code(s) A2018 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) 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: o Chronic vascular ulcers o Diabetic ulcers o Draining wounds o 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 Venous ulcers • Debrided partial-thickness hand A2017 burns 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. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 62 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Associated HCPCS/ CPT® Code(s) A2015 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Phoenix Wound Matrix Bioabsorbable, conformable, non-woven, fibrous, three- dimensional matrix. Composed of poly(lactide-co-caprolactone) and polyglycolic acid. • Management of wounds including, but 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 • Replace or supplement damaged Q4241 or inadequate tissue PolyCyte Minimally manipulated human tissue allograft derived from the Wharton's jelly of the umbilical cord. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 63 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4100 • Cover for vessels following anterior vertebral surgery, providing a plane of dissection PRECLUDE Vessel Guard Three-layer construction with two outer layers consisting of a tight expanded polytetrafluoroethylene (ePTFE) microstructure. PriMatrix ADM derived from fetal bovine skin. Procenta Acellular, sterile human placental derived allograft. ProgenaMatrix Human keratin matrix derived from human hair. • Scaffold capable of being Q4110 integrated, remodeled and eventually replaced by functional host tissue • Chronic wound covering for: Q4244 o Diabetic foot ulcers o Venous stasis ulcers • Management of wounds including, but may not be limited to: Q4222 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 64 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) o Trauma wounds (eg, abrasions, lacerations, skin tears) ProLayer Human acellular dermal matrix. o Venous ulcers • Reinforcement of soft tissue including: Q4100 Promogran Matrix Freeze-dried composite prepared from bone collagen and oxidized regenerated cellulose. PuraPly, PuraPly AM, PuraPly XT Purified Type 1 native collagen matrix creates a durable biocompatible scaffold. Puros Dermis A natural biological matrix. Rebound Matrix Dehydrated human allograft derived from placental tissue. REGUaRD Hydrated acellular human dermal allograft matrix. o Breast reconstruction • Bind and protect the functionality Q4100 of growth factors, such as platelet-derived growth factors (PDGF) in hostile proteolytic environments • Barrier against a wide array of microorganisms Q4195, Q4196, Q4197 • Inhibit formation of biofilm on the wound surface • Periodontal/peri-implant soft Q4100 tissue management • Soft tissue enhancement • Wound covering or barrier membrane, over acute and chronic wounds, including full- thickness ulcers and other skin defects • Burns • Chronic, nonhealing wounds Q4296 Q4255 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 65 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Relese Dehydrated human amniotic membrane obtained from donated placental tissue. Repliform Acellular human dermis. Repriza Pre hydrated, ready to use, ADM prepared from human skin allograft. • Acute and chronic wounds including dermal ulcers and other defects • Pelvic floor repair • 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 Associated HCPCS/ CPT® Code(s) Q4257 Q4100 Q4143 Resolve Matrix Non-crosslinked acellular wound dressing derived from porcine peritoneum membrane. o Breast reconstruction • Management of topical wounds including, but may not be limited to: A2024 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 66 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) laser surgery, post-Mohs surgery, wound dehiscence) o Trauma wounds (eg, abrasions, lacerations, second-degree burns, skin tears) o Tunneled wounds o Undermined wounds Restorigin Amnion umbilical cord tissue. Restrata Resorbable nanofiber wound matrix. o Venous ulcers • Burns • Chronic, nonhealing wounds • Management of wounds including, but may not be limited to: Q4191, Q4192 A2007 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 67 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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 • Acute and chronic wounds, including defects and dermal ulcers • Wound covering or barrier membrane • Damaged membranes • Dressing for burns • Full-thickness wounds • Wound covering or barrier membrane, over acute and chronic wounds Q4180 Q4157 Q4289 • Surgical use to supplement or Q4100 replace damaged or inadequate connective tissue • Repair of acute and chronic Q4260 wounds including, but may not be limited to: o Burns Revita Dehydrated, sterile human amniotic membrane and chorionic membrane. Revitalon Composed of native human amnion and chorion in addition to collagen and growth factors. RevoShield + Amniotic Barrier Dual layer amniotic membrane. RX Flow, RX Membrane Placental connective tissue matrix. Signature APatch Amniotic membrane allograft. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 68 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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 Q4100 inadequate integumental tissue SkinTE Autologous, homologous, full – thickness skin product composed of viable skin cells and an organized extracellular matrix. StrataGraft Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen- dsat. Strattice Reconstructive Tissue Matrix Derived from porcine dermis, which undergoes nondamaging processing that removes cells and reduces the key component • Soft tissue defects • Burns • Chronic wounds • Homologous uses of human integument • Adults with thermal burns containing intact dermal elements (eg, deep partial- thickness burns) Q4200 Q4100 • Surgical repair of damaged or Q4130 ruptured soft tissue • Surgically implanted patch to reinforce where weakness exists See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 69 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) in the xenogeneic rejection response. Stravix Cryopreserved human placental tissue composed of umbilical amnion and Wharton’s jelly. Supra SDRM Biodegradable matrix wound dressing fabricated from a tri- polymer of polylactide, trimethylene carbonate, ε- caprolactone and polyvinyl alcohol. • Wrap to aid in surgical Q4100 procedures and wound repair • Acute and chronic wounds such A2011 as: o Burns 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) Suprathel o Venous ulcers • Dermal wounds such as: A2012 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 70 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Bioresorbable dermal covering, composed entirely of synthetic materials, including a tripolymer of polylactide, s- caprolactone and trimethylene carbonate. o Abrasions o Burns o Split-thickness skin graft donor sites SureDerm Human acellular dermal matrix. • Burns • Periodontal soft tissue management SurgiCORD Umbilical tissue membrane allograft. • Skin ulcers • Management of wounds including, but may not be limited to: Surgigraft Human amnion-only regenerative extracellular tissue matrix. o Neuropathic ulcers o Post-traumatic wounds o Pressure injuries o Venous stasis ulcers • 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 Q4220 Q4218 Q4183 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 71 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) SurgiGRAFT-DUAL Minimally processed bilayer allograft. o Venous stasis ulcers • Management of wounds including, but may not be limited to: Associated HCPCS/ CPT® Code(s) Q4219 SurgiMend Collagen Matrix Acellular tissue matrix of either fetal or neonatal bovine origin. SurGraft Dehydrated amniotic membrane sheet. o Neuropathic ulcers o Post-traumatic wounds o Pressure injuries • Breast reconstruction • Reinforcement for weak or damaged soft tissues • Management of wounds including, but may not be limited to: C9358, C9360 Q4209 o Burns o Diabetic ulcers o Full- and partial-thickness wounds o Pressure wounds o Surgical wounds SurGraft FT Full-thickness amnion/chorion tissue allograft. o Venous ulcers • Acute and chronic wounds including, but may not be limited to: Q4268 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. o Chronic vascular ulcers Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 72 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated 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/undermined wounds SurGraft TL Triple layer amniotic tissue allograft. o Venous ulcers • Repair of acute and chronic wounds including, but may not be limited to: Q4263 o Chronic vascular ulcers o Diabetic ulcers o Draining wounds See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 73 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated 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 SurGraft XT Dual layer amniotic tissue allograft. o Venous ulcers • Acute and chronic wounds including, but may not be limited to: Q4269 o Chronic vascular ulcers o Diabetic ulcers o Draining wounds o Partial- and full-thickness wounds o Pressure ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 74 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 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/undermined wounds Symphony Extracellular matrix (ECM) derived from ovine forestomach tissue. o Venous ulcers • Management of wounds including, but may not be limited to: A2009 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) See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 75 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 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 TAG Triple layer amniotic allograft derived from placental tissue. Talymed Advanced matrix composed of shortened fibers isolated from microalgae. o Venous ulcers • Wound covering or barrier membrane, over acute and chronic wounds • Management of wounds including, but may not be limited to: Q4261 Q4127 o Abrasions o Chronic vascular ulcers o Dehisced surgical wounds o Diabetic ulcers o Donor sites/grafts o Full- and partial-thickness wounds o Lacerations o Post-laser surgery and other bleeding surface wounds See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 76 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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 • Tendon and wound coverage Q4146 • Management of wounds A2008 including, but may not be limited to: o Chronic vascular ulcers o Diabetic ulcers o Draining wounds o Partial- and full-thickness wounds o Pressure ulcers TenSIX Acellular Dermal Matrix Acellular matrix with natural histomorphology preserved. TheraGenesis Bilayered wound matrix comprised of a porcine tendon- derived atelocollagen layer and a silicone film layer. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 77 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 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 Venous ulcers • Management of wounds including, but may not be limited to: Q4121 o Dehisced surgical wounds o Diabetic foot ulcers o Necrotizing fasciitis o Pressure ulcers o Radiation burns o Venous leg ulcers • Repair of skin over any wound including those with exposed bone, capsule, muscle or tendon • Reinforcement of soft tissue that is repaired using sutures or anchors during tendon repair surgery • Replace or supplement damaged or inadequate integumental tissue for acute and chronic Q4100 Q4126 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. TissueMend Remodeled collagen matrix created from bovine skin. TranZgraft AC (InteguPly) Acellular collagen matrix derived from human allograft skin tissue. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 78 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Associated HCPCS/ CPT® Code(s) Q4167 Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Truskin Split-thickness, cryopreserved skin allograft extracellular matrix with growth factors and endogenous living skin cells. wounds including, but may not be limited to: o Diabetic foot ulcers o Pressure ulcers o Venous leg ulcers • Repair of acute and chronic wounds including, but may not be limited to: o Diabetic foot ulcers o Pressure ulcers o Surgical wounds o Venous leg ulcers Tutomesh, Tutopatch Noncross-linked acellular collagen matrices derived from bovine pericardium. Vendaje Dehydrated human amniotic membrane composed of the amnion layer. Vendaje AC Decellularized amniotic and chorionic allograft derived from placental tissue. Veritas Collagen Matrix o Wounds with exposed bone and tendon • Pericardial repair • Soft tissue reconstruction C1763 • Support and serve as a barrier for Q4252 integumental tissue • Protective covering for soft tissue Q4279 wounds • Hernia repair C9354 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 79 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Acellular tissue matrix derived from bovine pericardium. • Pelvic floor procedures Viaflow, Viaflow C Flowable placental tissue matrices. VIM Allograft sheet of human amnion. • Plastic and reconstructive procedures • Breast reconstruction • Tissue voids and defects • Barrier for the following types of Q4251 surgeries: o Ophthalmic o Orthopedic Associated HCPCS/ CPT® Code(s) Q4100 WoundPlus Membrane, E-graft Single-layer, dehydrated and devitalized human amniotic membrane allograft. Xcell Amnio Matrix Lyophilized amniotic membrane allograft. • Wound covering • Barrier or cover for acute and chronic wounds Q4277 • Acute and chronic wounds Q4280 including, but may not be limited to: o Chronic vascular ulcers o Diabetic ulcers o Partial- and full-thickness wounds o Pressure ulcers See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 80 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 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/undermined wounds XCellerate Lyophilized human amniotic membrane allograft. XCelliStem Extracellular matrix (ECM) composed of porcine collagen. o Venous ulcers • Burns • Chronic, nonhealing wounds Q4234 • Management of wounds A2004 including, but 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 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 81 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) 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 • 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 XCM Biologic Tissue Matrix Noncross-linked 3-D matrix derived from porcine dermis. Xelma ECM protein XenMatrix Acellular noncross-linked porcine collagen scaffold with open collagen structure. • Hard to heal wounds such as Q4100 venous leg ulcers • Surgical repair of damaged or ruptured soft tissue, including, but may not be limited to: C1763 o Abdominal plastic and reconstructive surgery o Hernia repair including abdominal, diaphragmatic, See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 82 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Skin / Tissue Substitute Purported Indications (Not covered for ANY indication) Associated HCPCS/ CPT® Code(s) Q4204, Q4100 femoral, incisional, inguinal, scrotal and umbilical hernias o Muscle flap reinforcement • Soft tissue defects and wounds • Repair of a body wall defect or Q4100 hernia requiring the addition of a reinforcing or bridging material • Acute and chronic wound Q4253 therapy • Application in difficult to access wound sites, deep dermal wounds and irregularly shaped wounds XWrap Dry or Hydro Plus Resorbable, chorion-free, human amnion allograft. Zenapro Combination of ultra- lightweight polypropylene and small intestinal submucosa (SIS). Zenith Amniotic Membrane Dehydrated amniotic membrane allograft. Humana members may NOT be eligible under the Plan for any other skin or tissue substitutes not addressed in the Coverage Determination section. These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. Background Additional information about burns and chronic wounds may be found from the following website: • National Library of Medicine See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 83 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Medical Alternatives Alternatives to skin and tissue substitutes include, but may not be limited to, the following: • Hyperbaric oxygen treatment (please refer to Hyperbaric Oxygen Therapy, Topical Oxygen Therapy Medical Coverage Policy) • Negative pressure wound therapy (please refer to Negative Pressure Wound Therapy Medical Coverage Policy) • Prescription drug therapy • Standard wound care Physician consultation is advised to make an informed decision based on an individual’s health needs. Humana may offer a disease management program for this condition. The individual may call the number on his/her identification card to ask about our programs to help manage his/her care. Provider Claims Codes Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. CPT® Code(s) 15271 Description Comments Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 84 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 15272 15273 15274 15275 15276 15277 Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure) Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 85 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 15278 Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (List separately in addition to code for primary procedure) 15777 Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (ie, breast, trunk) (List separately in addition to code for primary procedure) 15778 Implantation of absorbable mesh or other prosthesis for delayed closure of defect(s) (ie, external genitalia, perineum, abdominal wall) due to soft tissue infection or trauma Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section New Code Effective 01/01/2023 46707 64912 64913 Repair of anorectal fistula with plug (eg, porcine small intestine submucosa [SIS]) Nerve repair; with nerve allograft, each nerve, first strand (cable) Nerve repair; with nerve allograft, each additional strand (List separately in addition to code for primary procedure) Not Covered Not Covered Not Covered 64999 Unlisted procedure, nervous system Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section CPT® Category III Code(s) Description Comments See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 86 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 0437T HCPCS Code(s) A2001 A2002 A2004 A2005 A2006 A2007 A2008 A2009 A2010 A2011 A2012 A2013 A2014 A2015 A2016 A2017 A2018 Implantation of non-biologic or synthetic implant (eg, polypropylene) for fascial reinforcement of the abdominal wall (List separately in addition to code for primary procedure) Description InnovaMatrix AC, per sq cm Mirragen Advanced Wound Matrix, per sq cm XCelliStem, per sq cm Microlyte Matrix, per sq cm NovoSorb SynPath dermal matrix, per sq cm Restrata, per sq cm TheraGenesis, per sq cm Symphony, per sq cm Apis, per sq cm Supra sdrm, per square centimeter Suprathel, per square centimeter Innovamatrix fs, per square centimeter Omeza collagen matrix, per 100 mg Phoenix wound matrix, per square centimeter Permeaderm b, per square centimeter Permeaderm glove, each Permeaderm c, per square centimeter A2019 Kerecis omega3 marigen shield, per square centimeter A2020 Ac5 advanced wound system (ac5) A2021 Neomatrix, per square centimeter Not Covered Comments Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 04/01/2023 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 87 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. A2022 Innovaburn or innovamatrix xl, per square centimeter A2023 Innovamatrix pd, 1 mg A2024 Resolve matrix, per square centimeter A2025 Miro3d, per cubic centimeter A4100 Skin substitute, fda cleared as a device, not otherwise specified A6021 Collagen dressing, sterile, size 16 sq in or less, each A6022 Collagen dressing, sterile, size more than 16 sq in but less than or equal to 48 sq in, each Not Covered New Code Effective 10/01/2023 Not Covered New Code Effective 10/01/2023 Not Covered New Code Effective 10/01/2023 Not Covered New Code Effective 10/01/2023 Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 88 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. C1763 Connective tissue, nonhuman (includes synthetic) C1781 Mesh (implantable) Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section C1832 Autograft suspension, including cell processing and application, and all system components Not Covered C1849 Skin substitute, synthetic, resorbable, per sq cm C5271 Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area C5272 C5273 Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure) Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 89 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Application of low cost skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (list separately in addition to code for primary procedure) Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (list separately in addition to code for primary procedure) Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children Application of low cost skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; each additional 100 sq cm wound surface area, or part thereof, or each additional 1% of body area of infants and children, or part thereof (list separately in addition to code for primary procedure) Acellular pericardial tissue matrix of nonhuman origin (Veritas), per sq cm Dermal substitute, native, nondenatured collagen, fetal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm Dermal substitute, native, nondenatured collagen, neonatal bovine origin (SurgiMend Collagen Matrix), per 0.5 sq cm Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used in conjunction with any skin or tissue substitute outlined in Coverage Limitations section Not Covered Not Covered Not Covered C5274 C5275 C5276 C5277 C5278 C9354 C9358 C9360 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 90 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. C9361 C9363 C9364 Collagen matrix nerve wrap (NeuroMend Collagen Nerve Wrap), per 0.5 cm length Skin substitute (Integra Meshed Bilayer Wound Matrix), per sq cm Porcine implant, Permacol, per sq cm C9399 Unclassified drugs or biologicals Q4100 Skin substitute, not otherwise specified Q4101 Q4102 Q4103 Q4104 Q4105 Apligraf, per sq cm Oasis wound matrix, per sq cm Oasis burn matrix, per sq cm Integra bilayer matrix wound dressing (BMWD), per sq cm Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per sq cm Dermagraft, per sq cm GRAFTJACKET, per sq cm Integra matrix, per sq cm PriMatrix, per sq cm GammaGraft, per sq cm Cymetra, injectable, 1 cc GRAFTJACKET XPRESS, injectable, 1 cc Integra flowable wound matrix, injectable, 1 cc AlloSkin, per sq cm AlloDerm, per sq cm HYALOMATRIX, per sq cm Q4106 Q4107 Q4108 Q4110 Q4111 Q4112 Q4113 Q4114 Q4115 Q4116 Q4117 Q4118 MatriStem micromatrix, 1 mg Q4121 TheraSkin, per sq cm Not Covered Not Covered Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 91 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Q4122 DermACELL, DermACELL AWM or DermACELL AWM Porous, per sq cm AlloSkin RT, per sq cm OASIS ultra tri-layer wound matrix, per sq cm ArthroFlex, per sq cm Q4123 Q4124 Q4125 Q4126 MemoDerm, DermaSpan, TranZgraft or InteguPly, per sq cm Talymed, per sq cm Q4127 FlexHD, AllopatchHD, or Matrix HD, per sq cm Q4128 Strattice TM, per sq cm Q4130 Grafix Core and GrafixPL Core, per sq cm Q4132 Grafix PRIME, GrafixPL PRIME, Stravix and StravixPL, per sq cm Q4133 Q4134 HMatrix, per sq cm Q4135 Mediskin, per sq cm E-Z Derm, per sq cm Q4136 AmnioExcel, AmnioExcel Plus or BioDExcel, per sq cm Q4137 BioDFence DryFlex, per sq cm Q4138 AmnioMatrix or BioDMatrix, injectable, 1 cc Q4139 BioDFence, per sq cm Q4140 AlloSkin AC, per sq cm Q4141 XCM biologic tissue matrix, per sq cm Q4142 Repriza, per sq cm Q4143 EpiFix, injectable, 1 mg Q4145 Tensix, per sq cm Q4146 Architect, Architect PX, or Architect FX, extracellular matrix, per sq cm Neox Cord 1K, Neox Cord RT, or Clarix Cord 1K, per sq cm Excellagen, 0.1 cc AlloWrap DS or dry, per sq cm AmnioBand or Guardian, per sq cm DermaPure, per sq cm Dermavest and Plurivest, per sq cm Q4148 Q4149 Q4150 Q4151 Q4152 Q4153 Q4147 Not Covered if used to report any skin or tissue substitute outlined in Coverage Limitations section Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 92 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Biovance, per sq cm Neox Flo or Clarix Flo 1 mg Neox 100 or Clarix 100, per sq cm Revitalon, per sq cm Kerecis Omega3, per sq cm Affinity, per sq cm Nushield, per sq cm bio-ConneKt wound matrix, per sq cm Q4154 Q4155 Q4156 Q4157 Q4158 Q4159 Q4160 Q4161 Q4162 WoundEx Flow, BioSkin Flow, 0.5 cc Q4163 WoundEx, BioSkin, per sq cm Helicoll, per sq cm Q4164 Keramatrix or Kerasorb, per sq cm Q4165 Cytal, per sq cm Q4166 Truskin, per sq cm Q4167 AmnioBand, 1 mg Q4168 Artacent wound, per sq cm Q4169 Cygnus, per sq cm Q4170 Interfyl, 1 mg Q4171 PalinGen or PalinGen XPlus, per sq cm Q4173 Q4174 PalinGen or ProMatrX, 0.36 mg per 0.25 cc Q4175 Miroderm, per sq cm Q4176 Q4177 Q4178 Q4179 Q4180 Q4181 Q4182 Q4183 Q4184 Q4185 Q4186 Q4187 Q4188 Neopatch or therion, per square centimeter FlowerAmnioFlo, 0.1 cc FlowerAmnioPatch, per sq cm FlowerDerm, per sq cm Revita, per sq cm Amnio Wound, per sq cm Transcyte, per sq cm Surgigraft, per sq cm Cellesta or Cellesta Duo, per sq cm Cellesta Flowable Amnion (25 mg per cc); per 0.5 cc Epifix, per sq cm Epicord, per sq cm AmnioArmor, per sq cm Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 93 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Keroxx (2.5 g/cc), 1 cc Derma-Gide, per sq cm XWRAP, per sq cm Artacent AC, 1 mg Artacent AC, per sq cm Restorigin, per sq cm Restorigin, 1 cc Coll-e-Derm, per sq cm Novachor, per sq cm PuraPly, per sq cm PuraPly AM, per sq cm PuraPly XT, per sq cm Genesis Amniotic Membrane, per sq cm Cygnus matrix, per sq cm SkinTE, per sq cm Q4189 Q4190 Q4191 Q4192 Q4193 Q4194 Q4195 Q4196 Q4197 Q4198 Q4199 Q4200 Q4201 Matrion, per sq cm Q4202 Q4203 Q4204 Q4205 Membrane Graft or Membrane Wrap, per sq cm Q4206 Q4208 Q4209 Q4210 Q4211 Q4212 Q4213 Q4214 Q4215 Q4216 Fluid Flow or Fluid GF, 1 cc Novafix, per sq cm SurGraft, per sq cm Axolotl Graft or Axolotl DualGraft, per sq cm Amnion Bio or AxoBioMembrane, per sq cm AlloGen, per cc Ascent, 0.5 mg Cellesta Cord, per sq cm Axolotl Ambient or Axolotl Cryo, 0.1 mg Artacent Cord, per sq cm WoundFix, BioWound, WoundFix Plus, BioWound Plus, WoundFix Xplus or BioWound Xplus, per sq cm SurgiCORD, per sq cm SurgiGRAFT-DUAL, per sq cm BellaCell HD or Surederm, per sq cm Amnio Wrap2, per sq cm ProgenaMatrix, per sq cm Q4217 Q4218 Q4219 Q4220 Q4221 Q4222 Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 94 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Q4224 Q4225 Q4226 Human health factor 10 amniotic patch (hhf10-p), per square centimeter Amniobind, per square centimeter MyOwn Skin, includes harvesting and preparation procedures, per sq cm AmnioCoreTM, per sq cm Cogenex Amniotic Membrane, per sq cm Cogenex Flowable Amnion, per 0.5 cc Corplex P, per cc Corplex, per sq cm SurFactor or NuDyn, per 0.5 cc XCellerate, per sq cm AMNIOREPAIR or AltiPly, per sq cm Carepatch, per square centimeter Cryo-Cord, per sq cm Derm-Maxx, per sq cm Amnio-Maxx or Amnio-Maxx Lite, per sq cm CoreCyte, for topical use only, per 0.5 cc PolyCyte, for topical use only, per 0.5 cc AmnioCyte Plus, per 0.5 cc Procenta, per 200 mg AmnioText, per cc CoreText or ProText, per cc Amniotext patch, per sq cm Dermacyte Amniotic Membrane Allograft, per sq cm AMNIPLY, for topical use only, per sq cm AmnioAmp-MP, per sq cm Vim, per sq cm Vendaje, per sq cm Zenith Amniotic Membrane, per sq cm Novafix DL, per sq cm REGUaRD, for topical use only, per sq cm Q4227 Q4229 Q4230 Q4231 Q4232 Q4233 Q4234 Q4235 Q4236 Q4237 Q4238 Q4239 Q4240 Q4241 Q4242 Q4244 Q4245 Q4246 Q4247 Q4248 Q4249 Q4250 Q4251 Q4252 Q4253 Q4254 Q4255 Q4256 Mlg-complete, per square centimeter Q4257 Relese, per square centimeter Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered Not Covered See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 95 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Q4258 Q4259 Q4260 Q4261 Enverse, per square centimeter Celera dual layer or celera dual membrane, per square centimeter Signature apatch, per square centimeter Tag, per square centimeter Q4262 Dual layer impax membrane, per square centimeter Q4263 Surgraft tl, per square centimeter Q4264 Cocoon membrane, per square centimeter Q4265 Neostim tl, per square centimeter Q4266 Neostim membrane, per square centimeter Q4267 Neostim dl, per square centimeter Q4268 Surgraft ft, per square centimeter Not Covered Not Covered Not Covered Not Covered Not Covered New Code Effective 01/01/2023 Not Covered New Code Effective 01/01/2023 Not Covered New Code Effective 01/01/2023 Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 04/01/2023 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 96 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Q4269 Surgraft xt, per square centimeter Q4270 Complete sl, per square centimeter Q4271 Complete ft, per square centimeter Q4272 Esano a, per square centimeter Q4273 Esano aaa, per square centimeter Q4274 Esano ac, per square centimeter Q4275 Esano aca, per square centimeter Q4276 Orion, per square centimeter Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 04/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 97 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Q4277 Woundplus membrane or e-graft, per square centimeter Q4278 Epieffect, per square centimeter Q4279 Vendaje ac, per square centimeter Q4280 Xcell amnio matrix, per square centimeter Q4281 Barrera sl or barrera dl, per square centimeter Q4282 Cygnus dual, per square centimeter Q4283 Biovance tri-layer or biovance 3l, per square centimeter Q4284 Dermabind sl, per square centimeter Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 Not Covered New Code Effective 07/01/2023 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 98 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Q4285 Nudyn dl or nudyn dl mesh, per square centimeter Q4286 Nudyn sl or nudyn slw, per square centimeter Q4287 Dermabind dl, per square centimeter Q4288 Dermabind ch, per square centimeter Q4289 Revoshield + amniotic barrier, per square centimeter Q4290 Membrane wrap-hydro, per square centimeter Q4291 Lamellas xt, per square centimeter Q4292 Lamellas, per square centimeter Not Covered New Code Effective 10/01/2023 Not Covered New Code Effective 10/01/2023 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 99 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Q4293 Acesso dl, per square centimeter Q4294 Amnio quad-core, per square centimeter Q4295 Amnio tri-core amniotic, per square centimeter Q4296 Rebound matrix, per square centimeter Q4297 Emerge matrix, per square centimeter Q4298 Amniocore pro, per square centimeter Q4299 Amnicore pro+, per square centimeter Q4300 Acesso tl, per square centimeter Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 100 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Q4301 Activate matrix, per square centimeter Q4302 Complete aca, per square centimeter Q4303 Complete aa, per square centimeter Q4304 Grafix plus, per square centimeter V2790 Amniotic membrane for surgical reconstruction, per procedure Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered New Code Effective 01/01/2024 Not Covered if used for any indication outlined in Coverage Limitations section References 1. 2. 3. Agency for Healthcare Research and Quality (AHRQ). Technical Brief. Skin substitutes for treating chronic wounds. https://www.ahrq.gov. Published February 2, 2020. Accessed December 14, 2022. ECRI Institute. Clinical Evidence Assessment. AlloDerm regenerative tissue matrix (AbbVie, Inc.) for reconstructing breast tissue. https://www.ecri.org. Published December 18, 2018. Updated November 30, 2020. Accessed December 9, 2022. ECRI Institute. Clinical Evidence Assessment. Amnioband allograft placental matrix (MTF Biologics) for treating chronic wounds. https://www.ecri.org. Published June 20, 2016. Updated September 23, 2020. Accessed December 6, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 101 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 4. 5. 6. 7. 8. 9. ECRI Institute. Clinical Evidence Assessment. Arthroflex acellular dermal matrix (LifeNet Health and Arthrex, Inc.) for repairing large to massive rotator cuff tears. https://www.ecri.org. Published October 23, 2017. Updated June 16, 2022. Accessed December 12, 2022. ECRI Institute. Clinical Evidence Assessment. Biodesign sinonasal repair graft (Cook Medical, Inc.) for repairing sinus and nasal cavity defects. https://www.ecri.org. Published December 9, 2021. Accessed December 9, 2022. ECRI Institute. Clinical Evidence Assessment. Biovance amniotic membrane allograft (Celularity, Inc.) for treating chronic wounds. https://www.ecri.org. Published January 3, 2017. Updated July 24, 2020. Accessed December 9, 2022. ECRI Institute. Clinical Evidence Assessment. Cortiva and Cortiva 1 mm allograft dermis (RTI Surgical, Inc.) for breast reconstruction. https://www.ecri.org. Published November 13, 2018. Updated November 30, 2020. Accessed December 9, 2022. ECRI Institute. Clinical Evidence Assessment. Cygnus amniotic allografts (Vivex Medical, Inc.) for treating chronic wounds. https://www.ecri.org. Published April 29, 2022. Accessed December 6, 2022. ECRI Institute. Clinical Evidence Assessment. Dermacell advanced decellularized dermis (LifeNet Health Bio-Implants Division) for breast reconstruction. https://www.ecri.org. Published August 15, 2016. Updated December 2, 2020. Accessed December 9, 2022. 10. ECRI Institute. Clinical Evidence Assessment. Dermacell AWM (LifeNet Health Bio-Implants Division) for chronic wounds. https://www.ecri.org. Published March 8, 2018. Updated December 18, 2020. Accessed December 6, 2022. 11. ECRI Institute. Clinical Evidence Assessment. Fortify Flowable extracellular matrix (Sanara Medtech, Inc.) for treating wounds. https://www.ecri.org. Published October 3, 2022. Accessed December 9, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 102 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 12. ECRI Institute. Clinical Evidence Assessment. GalaFlex surgical scaffold (Galatea Surgical, Inc.) for soft-tissue reinforcement in breast reconstruction Surgery. https://www.ecri.org. Published October 7, 2022. Accessed December 6, 2022. 13. ECRI Institute. Clinical Evidence Assessment. Grafix cellular repair matrix (Osiris Therapeutics, Inc.) for treating chronic wounds. https://www.ecri.org. Published November 9, 2012. Updated July 14, 2021. Accessed December 9, 2022. 14. ECRI Institute. Clinical Evidence Assessment. Hyalomatrix tissue reconstruction matrix (Anika Therapeutics, Inc.) for treating chronic wounds. https://www.ecri.org. Published June 7, 2018. Updated April 13, 2021. Accessed December 6, 2022. 15. ECRI Institute. Clinical Evidence Assessment. Integra bilayer matrix (Integra LifeSciences Corp.) for treating diabetic foot ulcers. https://www.ecri.org. Published April 8, 2021. Accessed December 6, 2022. 16. ECRI Institute. Clinical Evidence Assessment. Leneva allograft adipose matrix (MTF Biologics) for treating wounds. https://www.ecri.org. Published October 3, 2022. Accessed December 9, 2022. 17. ECRI Institute. Clinical Evidence Assessment. Matriderm (MedSkin Solutions) for managing wounds following otorhinolaryngology surgery. https://www.ecri.org. Published April 11, 2022. Accessed December 6, 2022. 18. ECRI Institute. Clinical Evidence Assessment. Myriad soft-tissue matrix (Aroa Biosurgery Ltd.) for treating chronic wounds. https://www.ecri.org. Published September 21, 2020. Accessed December 9, 2022. 19. ECRI Institute. Clinical Evidence Assessment. NEOX Flo wound matrix (Amniox Medical, Inc.) for treating chronic wounds. https://www.ecri.org. Published December 4, 2015. Updated August 27, 2021. Accessed December 9, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 103 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 20. ECRI Institute. Clinical Evidence Assessment. NeuraGen 3D nerve guide (Integra LifeSciences) for repairing nerve gap injuries. https://www.ecri.org. Published April 28, 2022. Accessed December 9, 2022. 21. ECRI Institute. Clinical Evidence Assessment. NovoSorb biodegradable temporizing matrix (PolyNovo Ltd.) for managing wounds. https://www.ecri.org. Published September 1, 2019. Updated November 2, 2021. Accessed December 30, 2022. 22. ECRI Institute. Clinical Evidence Assessment. NuShield placental allograft (Organogenesis, Inc.) for treating burns. https://www.ecri.org. Published November 29, 2021. Accessed December 6, 2022. 23. ECRI Institute. Clinical Evidence Assessment. Omega3 wound matrix (Kerecis) for treating chronic wounds. https://www.ecri.org. Published June 1, 2019. Updated March 8, 2022. Accessed December 6, 2022. 24. ECRI Institute. Clinical Evidence Assessment. Overview of flowable matrices for treating chronic and acute wounds. https://www.ecri.org. Published September 1, 2022. Accessed December 12, 2022. 25. ECRI Institute. Clinical Evidence Assessment. Overview of selected human amniotic membranes for treating chronic wounds. https://www.ecri.org. Published May 1, 2022. Accessed December 9, 2022. 26. ECRI Institute. Clinical Evidence Assessment. OviTex PRS reinforced tissue matrix (TELA Bio) for breast reconstruction. https://www.ecri.org. Published December 13, 2021. Accessed December 9, 2022. 27. ECRI Institute. Clinical Evidence Assessment. OviTex reinforced bioscaffolds (Tela Bio, Inc.) for hernia repair. https://www.ecri.org. Published December 16, 2021. Accessed December 9, 2022. 28. ECRI Institute. Clinical Evidence Assessment. ProLayer acellular dermal matrix (Stryker Corp.) for breast reconstruction. https://www.ecri.org. Published March 4, 2022. Accessed December 9, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 104 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 29. ECRI Institute. Clinical Evidence Assessment. PuraPly AM antimicrobial wound matrix (Organogenesis, Inc.) for treating chronic wounds. https://www.ecri.org. Published November 7, 2018. Updated April 29, 2022. Accessed December 6, 2022. 30. ECRI Institute. Clinical Evidence Assessment. Revita placental allograft (StimLabs, LLC) for treating diabetic foot ulcers. https://www.ecri.org. Published March 1, 2022. Accessed December 6, 2022. 31. ECRI Institute. Clinical Evidence Assessment. Skin substitutes for treating diabetic foot ulcers in patients aged 65 years or older. https://www.ecri.org. Published January 25, 2021. Accessed December 6, 2022. 32. ECRI Institute. Clinical Evidence Assessment. Standard-of-care practices for managing diabetic foot ulcers. https://www.ecri.org. Published January 28, 2020. Updated December 31, 2021. Accessed December 6, 2022. 33. ECRI Institute. Clinical Evidence Assessment. StrataGraft allogeneic cellularized scaffold (Mallinckrodt Pharmaceuticals) for treating thermal burns. https://www.ecri.org. Published February 6, 2022. Accessed December 6, 2022. 34. ECRI Institute. Clinical Evidence Assessment. Stravix cryopreserved placental tissue (Osiris Therapeutics, Inc.) for treating surgical wounds. https://www.ecri.org. Published July 8, 2021. Accessed December 6, 2022. 35. ECRI Institute. Clinical Evidence Assessment. Suprathel skin substitute (PolyMedics Innovations GmbH) for treating donor site wounds. https://www.ecri.org. Published February 22, 2021. Accessed December 6, 2022. 36. ECRI Institute. Clinical Evidence Assessment. SurgiMend collagen matrix (Integra LifeSciences Corp.) for breast reconstruction. https://www.ecri.org. Published November 14, 2019. Updated May 4, 2021. Accessed December 9, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 105 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 37. ECRI Institute. Clinical Evidence Assessment. Synthetic versus biologic mesh for breast reconstructive surgery. https://www.ecri.org. Published October 30, 2015. Updated February 1, 2022. Accessed December 12, 2022. 38. ECRI Institute. Hotline Response. Skin substitutes for managing pilonidal disease excision wounds. https://www.ecri.org. Published March 31, 2020. Accessed December 6, 2022. 39. ECRI Institute. Hotline Response. Synthetic versus biologic mesh for abdominal wall reconstructive surgery. https://www.ecri.org. Published October 15, 2015. Updated November 13, 2019. Accessed December 12, 2022. 40. ECRI Institute. Product Brief. AmnioExcel amniotic allograft membrane (Integra LifeSciences Corp.) for treating chronic wounds. https://www.ecri.org. Published November 20, 2019. Accessed December 9, 2022. 41. ECRI Institute. Product Brief. AmnioFix amnion/chorion membrane allograft (MiMedx) for treating surgical wounds. https://www.ecri.org. Published April 14, 2015. Updated May 10, 2019. Accessed December 6, 2022. 42. ECRI Institute. Product Brief. Avance nerve graft (AxoGen, Inc.) for repairing nerve gap injuries. https://www.ecri.org. Published March 14, 2012. Updated January 27, 2020. Accessed December 12, 2022. 43. ECRI Institute. Product Brief. AxoGuard nerve connector (AxoGen, Inc.) for repairing peripheral nerve injuries. https://www.ecri.org. Published April 30, 2019. Accessed December 9, 2022. 44. ECRI Institute. Product Brief. Cortiva Allograft Dermis (RTI Surgical, Inc.) for hernia repair. https://www.ecri.org. Published October 1, 2018. Accessed December 12, 2022. 45. ECRI Institute. Product Brief. Epicord umbilical cord allograft (MiMedx) for treating diabetic foot ulcers. https://www.ecri.org. Published February 6, 2020. Accessed January 12, 2023. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 106 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 46. ECRI Institute. Product Brief. EpiFix amnion/chorion membrane allograft (MiMedx) for treating chronic wounds. https://www.ecri.org. Published September 10, 2018. Updated December 2, 2019. Accessed December 9, 2022. 47. ECRI Institute. Product Brief. FlexHD pliable acellular hydrated dermis (Musculoskeletal Transplant Foundation) for breast reconstructive surgery. https://www.ecri.org. Published October 30, 2015. Updated January 17, 2020. Accessed December 9, 2022. 48. ECRI Institute. Product Brief. Hyalomatrix tissue reconstruction matrix (Anika Therapeutics, Inc.) for treating burns. https://www.ecri.org. Published July 29, 2016. Updated June 10, 2018. Accessed December 9, 2022. 49. ECRI Institute. Product Brief. Integra flowable wound matrix (Integra LifeSciences Corp.) for treating diabetic foot ulcers. https://www.ecri.org. Published October 2, 2019. Accessed December 12, 2022. 50. ECRI Institute. Product Brief. NuCel human amniotic allograft (Organogenesis, Inc.) for use in orthopedic procedures. https://www.ecri.org. Published June 1, 2019. Updated February 1, 2020. Accessed December 12, 2022. 51. ECRI Institute. Product Brief. Omega3 wound matrix (Kerecis) for treating acute wounds. https://www.ecri.org. Published April 21, 2020. Accessed December 6, 2022. 52. ECRI Institute. Product Brief. PriMatrix dermal repair scaffold (Integra LifeSciences Corp.) for treating chronic wounds. https://www.ecri.org. Published July 25, 2016. Updated October 31, 2019. Accessed December 6, 2022. 53. ECRI Institute. Product Brief. Restrata resorbable wound matrix (Acera Surgical) for treating chronic wounds. https://www.ecri.org. Published July 1, 2019. Accessed December 6, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 107 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 54. ECRI Institute. Product Brief. Strattice reconstructive tissue matrix (Allergan plc) for breast reconstruction. https://www.ecri.org. Published February 3, 2012. Updated November 25, 2019. Accessed December 9, 2022. 55. ECRI Institute. Product Brief. TheraSkin human skin allograft (Solsys Medical, LLC) for treating surgical and chronic wounds. https://www.ecri.org. Published October 5, 2018. Updated April 1, 2019. Accessed December 6, 2022. 56. ECRI Institute. Product Brief. XenMatrix surgical grafts (C.R. Bard, Inc.) for hernia repair. https://www.ecri.org. Published December 5, 2019. Accessed December 13, 2022. 57. ECRI Institute. Product Brief (ARCHIVED). Affinity human amniotic allograft (Nutech Medical) for use in chronic and surgical wounds. https://www.ecri.org. Published September 15, 2015. Accessed December 6, 2022. 58. ECRI Institute. Product Brief (ARCHIVED). AlloMax surgical graft (C.R. Bard, Inc./Davol, Inc.) for reconstructive surgery. https://www.ecri.org. Published October 9, 2015. Updated July 25, 2016. Accessed December 13, 2022. 59. ECRI Institute. Product Brief (ARCHIVED). AlloPatch HD acellular dermal matrix (Musculoskeletal Transplant Foundation) for repairing rotator cuff tears. https://www.ecri.org. Published October 23, 2017. Accessed December 9, 2022. 60. ECRI Institute. Product Brief (ARCHIVED). Biodesign dural graft (Cook Medical) for repairing dural tears. https://www.ecri.org. Published August 26, 2015. Accessed December 13, 2022. 61. ECRI Institute. Product Brief (ARCHIVED). Biodesign hernia graft (Cook Biotech, Inc.) for reconstructive surgery. https://www.ecri.org. Published July 20, 2016. Accessed December 13, 2022. 62. ECRI Institute. Product Brief (ARCHIVED). Biodesign nipple reconstruction cylinder (Cook Medical) for plastic surgery. https://www.ecri.org. Published April 5, 2018. Accessed December 13, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 108 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 63. ECRI Institute. Product Brief (ARCHIVED). Biodesign otologic repair graft (Cook Medical) for tympanic reconstruction. https://www.ecri.org. Published January 22, 2018. Accessed December 9, 2022. 64. ECRI Institute. Product Brief (ARCHIVED). BioDFactor viable tissue matrix (Integra LifeSciences) for treating surgical and chronic wounds. https://www.ecri.org. Published September 24, 2018. Accessed December 12, 2022. 65. ECRI Institute. Product Brief (ARCHIVED). CopiOs pericardium membrane (Zimmer Dental, Inc.) for use during oral surgery. https://www.ecri.org. Published February 6, 2017. Accessed December 6, 2022. 66. ECRI Institute. Product Brief (ARCHIVED). Cytal wound matrix (ACell, Inc.) for treating acute and chronic wounds. https://www.ecri.org. Published October 23, 2017. Updated March 15, 2019. Accessed December 6, 2022. 67. ECRI Institute. Product Brief (ARCHIVED). Gentrix surgical matrix (ACell, Inc.) for reinforcing soft tissue. https://www.ecri.org. Published June 30, 2018. Accessed December 9, 2022. 68. ECRI Institute. Product Brief (ARCHIVED). GraftJacket Regenerative Tissue Matrix (Wright Medical Technology) to augment tendon and ligament repair. https://www.ecri.org. Published April 7, 2004. Updated February 12, 2018. Accessed December 13, 2022. 69. ECRI Institute. Product Brief (ARCHIVED). Helicoll (EnColl, Corp.) type-1 collagen-based sterile dressing for treating burns and wounds. https://www.ecri.org. Published August 1, 2014. Accessed December 6, 2022. 70. ECRI Institute. Product Brief (ARCHIVED). Integra flowable wound matrix (Integra LifeSciences Corp.) for treating deep soft-tissue or tunneling wounds. https://www.ecri.org. Published February 20, 2017. Accessed December 6, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 109 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 71. ECRI Institute. Product Brief (ARCHIVED). Integra template and matrix wound skin substitutes (Integra LifeSciences Corp.) for treating chronic wounds. https://www.ecri.org. Published May 1, 2018. Accessed December 6, 2022. 72. ECRI Institute. Product Brief (ARCHIVED). MatriStem MicroMatrix (ACell, Inc.) for treating surgical and chronic wounds. https://www.ecri.org. Published August 28, 2018. Accessed December 6, 2022. 73. ECRI Institute. Product Brief (ARCHIVED). NuShield placental allograft (Nutech Medical) for use in chronic and surgical wounds. https://www.ecri.org. Published September 15, 2015. Accessed December 6, 2022. 74. ECRI Institute. Product Brief (ARCHIVED). Oasis wound matrix (Smith & Nephew, Inc.) for treating surgical and chronic wounds. https://www.ecri.org. Published April 7, 2004. Updated July 25, 2016. Accessed December 9, 2022. 75. ECRI Institute. Product Brief (ARCHIVED). Permacol surgical implant (Medtronic plc) for repairing hernias and abdominal wall defects. https://www.ecri.org. Published July 25, 2016. Accessed December 13, 2022. 76. ECRI Institute. Product Brief (ARCHIVED). Promogran Prisma Matrix (Acelity L.P., Inc.) for promoting surgical wound healing. https://www.ecri.org. Published August 22, 2018. Accessed December 6, 2022. 77. ECRI Institute. Product Brief (ARCHIVED). Surgimend collagen matrix (Integra LifeSciences Corp.) for reconstructive surgery. https://www.ecri.org. Published July 5, 2016. Accessed December 13, 2022. 78. ECRI Institute. Product Brief (ARCHIVED). Surgisis Biodesign fistula plug (Cook Medical, Inc.) for repairing anal and rectovaginal fistulas. https://www.ecri.org. Published May 17, 2010. Updated June 8, 2012. Accessed December 13, 2022. 79. ECRI Institute. Product Brief (ARCHIVED). Veritas collagen matrix (Synovis Surgical Innovations) for surgically repairing soft-tissue deficiencies. https://www.ecri.org. Published March 6, 2013. Accessed December 9, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 110 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 80. ECRI Institute. Product Brief (ARCHIVED). XCM biologic tissue matrix (Ethicon US, LLC/DePuy Synthes) for reconstructive surgery. https://www.ecri.org. Published November 4, 2015. Updated July 25, 2016. Accessed December 12, 2022. 81. ECRI Institute. Product Brief (ARCHIVED). XenMatrix Surgical Grafts (C.R. Bard, Inc./Davol, Inc.) for reconstructive surgery. https://www.ecri.org. Published October 30, 2015. Updated July 25, 2016. Accessed December 13, 2022. 82. Hayes, Inc. Evidence Analysis Research Brief. MicroMatrix (ACell Inc.) for treatment of wounds. https://evidence.hayesinc.com. Published March 25, 2022. Accessed December 13, 2022. 83. Hayes, Inc. Evidence Analysis Research Brief. Mirragen Advanced Wound Matrix (ETS Wound Care) for management of diabetic foot ulcers. https://evidence.hayesinc.com. Published May 2, 2022. Accessed December 13, 2022. 84. Hayes, Inc. Evidence Analysis Research Brief. NuShield placental allograft for the management of diabetic foot ulcers. https://evidence.hayesinc.com. Published March 17, 2022. Accessed December 13, 2022. 85. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Amniotic allografts to promote postoperative healing of abdominopelvic wounds. https://evidence.hayesinc.com. Published June 11, 2020. Accessed December 13, 2022. 86. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Amniotic membrane allografts for vaginal indications. https://evidence.hayesinc.com. Published August 23, 2021. Accessed December 13, 2022. 87. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). ArthroFLEX decellularized dermal allograft augmentation in arthroscopic superior capsule reconstruction. https://evidence.hayesinc.com. Published January 11, 2021. Accessed December 13, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 111 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 88. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). EpiCord dehydrated human umbilical cord (MiMedx) for treatment of chronic wounds. https://evidence.hayesinc.com. Published April 13, 2020. Accessed December 13, 2022. 89. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Two-stage Integra wound reconstruction following skin cancer surgery. https://evidence.hayesinc.com. Published August 25, 2020. Accessed December 13, 2022. 90. Hayes, Inc. Evolving Evidence Review. Kerecis Omega3 wound (Kerecis Limited) for the management of chronic lower extremity wounds. https://evidence.hayesinc.com. Published February 1, 2022. Accessed December 13, 2022. 91. Hayes, Inc. Evolving Evidence Review. PuraPly AM antimicrobial wound matrix (Organogenesis) for treatment of wounds. https://evidence.hayesinc.com. Published December 12, 2022. Accessed December 13, 2022. 92. Hayes, Inc. Health Technology Assessment. Acellular skin substitutes for chronic foot ulcers in adults with diabetes mellitus. https://evidence.hayesinc.com. Published May 6, 2020. Updated April 25, 2022. Accessed December 13, 2022. 93. Hayes, Inc. Health Technology Assessment. Amniotic allografts for tendon and ligament injuries. https://evidence.hayesinc.com. Published September 16, 2020. Updated September 9, 2022. Accessed December 13, 2022. 94. Hayes, Inc. Health Technology Assessment. Cellular skin substitutes for chronic foot ulcers in adults with diabetes mellitus. https://evidence.hayesinc.com. Published March 26, 2020. Updated March 9, 2022. Accessed December 13, 2022. 95. Hayes, Inc. Health Technology Assessment. Grafix cryopreserved placental membrane (Osiris Technologies Inc.) for treatment of chronic foot ulcers in patients with diabetes mellitus. https://evidence.hayesinc.com. Published September 3, 2019. Updated October 25, 2022. Accessed December 13, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 112 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 96. Hayes, Inc. Health Technology Assessment. Processed nerve allografts with the Avance Nerve Graft (Axogen Corporation) for peripheral nerve discontinuities. https://evidence.hayesinc.com. Published March 2, 2020. Updated February 4, 2022. Accessed December 13, 2022. 97. Hayes, Inc. Health Technology Assessment. Skin substitutes for venous leg ulcers in adults. https://evidence.hayesinc.com. Published July 23, 2020. Updated August 16, 2022. Accessed December 13, 2022. 98. Hayes, Inc. Health Technology Brief (ARCHIVED). FlexHD acellular dermis (Musculoskeletal Transplant Foundation) for hernia repair. https://evidence.hayesinc.com. Published August 8, 2012. Updated June 30, 2014. Accessed December 13, 2022. 99. Hayes, Inc. Health Technology Brief (ARCHIVED). Oasis wound matrix (Cook Biotech Inc.) for lower extremity ulcers. https://evidence.hayesinc.com. Published December 31, 2012. Updated December 12, 2014. Accessed December 13, 2022. 100. Hayes, Inc. Health Technology Brief (ARCHIVED). SurgiMend (Integra Life Sciences) for postmastectomy breast reconstruction. https://evidence.hayesinc.com. Published April 27, 2017. Updated May 2, 2019. Accessed December 13, 2022. 101. Hayes, Inc. Health Technology Brief (ARCHIVED). Surgisis AFP anal fistula plug (a.k.a. SIS Fistula Plug) (Cook Biotech Inc.) for repair of anal fistulas. https://evidence.hayesinc.com. Published April 7, 2008. Updated April 9, 2010. Accessed December 13, 2022. 102. Hayes, Inc. Medical Technology Directory. Comparative effectiveness review of biologic mesh for hernia repair: a review of reviews. https://evidence.hayesinc.com. Published March 16, 2018. Updated March 1, 2022. Accessed December 13, 2022. 103. Hayes, Inc. Medical Technology Directory. Comparative effectiveness review of human acellular dermal matrix for breast reconstruction. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 113 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. https://evidence.hayesinc.com. Published January 28, 2019. Updated February 28, 2022. Accessed December 13, 2022. 104. Hayes, Inc. Medical Technology Directory (ARCHIVED). Biological tissue- engineered skin substitutes for wound healing. https://evidence.hayesinc.com. Published January 28, 2010. Updated February 11, 2014. Accessed December 13, 2022. 105. Hayes, Inc. Medical Technology Directory (ARCHIVED). Biosynthetic tissue- engineered skin substitutes for wound healing. https://evidence.hayesinc.com. Published January 14, 2010. Updated February 14, 2014. Accessed December 13, 2022. 106. Hayes, Inc. Medical Technology Directory (ARCHIVED). Synthetic tissue for dural repair. https://evidence.hayesinc.com. Published May 14, 2015. Updated June 11, 2019. Accessed December 13, 2022. 107. MCG Health. Skin substitute, tissue-engineered (human cellular), for diabetic foot ulcer and venous ulcer. 26th edition. https://www.mcg.com. Accessed August 2, 2022. 108. National Pressure Injury Advisory Panel (NPIAP). Clinical Practice Guideline. Prevention and treatment of pressure ulcers/injuries: quick reference guide. https://www.npiap.com. Published 2009. Updated 2019. Accessed December 14, 2022. 109. Society for Vascular Surgery (SVS). Clinical Practice Guidelines (ARCHIVED) of the Society for Vascular Surgery and the American Venous Forum. Management of venous leg ulcers. https://www.jvascsurg.org. Published August 2014. Accessed December 14, 2022. 110. UpToDate, Inc. Basic principles of wound management. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 114 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 111. UpToDate, Inc. Implant-based breast reconstruction and augmentation. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 112. UpToDate, Inc. Management of diabetic foot ulcers. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 113. UpToDate, Inc. Management of ventral hernias. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 114. UpToDate, Inc. Medical management of lower extremity chronic venous disease. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 115. UpToDate, Inc. Operative management of anorectal fistulas. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 116. UpToDate, Inc. Overview of surgical procedures used in the management of burn injuries. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 117. UpToDate, Inc. Overview of treatment of chronic wounds. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 118. UpToDate, Inc. Primary operative management of hand burns. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 119. UpToDate, Inc. Skin substitutes. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 120. UpToDate, Inc. Topical agents and dressings for local burn wound care. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 115 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 121. UpToDate, Inc. Treatment of superficial burns requiring hospital admission. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. 122. US Food & Drug Administration (FDA). 510(k) summary. Bilayer Matrix Wound Dressing. https://www.fda.gov. Published May 23, 2002. Accessed January 14, 2022. 123. US Food & Drug Administration (FDA). 510(k) summary. Biobrane. https://www.fda.gov. Published November 28, 1989. Accessed January 14, 2022. 124. US Food & Drug Administration (FDA). 510(k) summary. Integra Meshed Bilayer Wound Matrix. https://www.fda.gov. Published December 4, 2008. Accessed January 14, 2022. 125. US Food & Drug Administration (FDA). 510(k) summary. Oasis Wound Matrix. https://www.fda.gov. Published July 19, 2006. Accessed January 14, 2022. 126. US Food & Drug Administration (FDA). Premarket approval (PMA) summary. Transcyte. https://www.fda.gov. Published March 18, 1997. Accessed January 14, 2022. 127. US Food & Drug Administration (FDA). Safety Communication. Acellular dermal matrix (ADM) products used in implant-based breast reconstruction differ in complication rates. https://www.fda.gov. Published March 31, 2021. Accessed April 8, 2021. 128. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Apligraf (Graftskin). https://www.fda.gov. Published May 22, 1998. Accessed January 14, 2022. 129. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Dermagraft. https://www.fda.gov. Published September 28, 2001. Accessed January 14, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 116 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 130. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Integra Dermal Regeneration Template and Integra Omnigraft Dermal Regeneration Matrix. https://www.fda.gov. Published January 7, 2016. Accessed January 14, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Skin and Tissue Substitutes Effective Date: 12/14/2023 Revision Date: 12/14/2023 Review Date: 02/02/2023 Policy Number: HUM-0370-051 Page: 117 of 117 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Appendix A Standard wound therapy based on the specific type of wound includes: • Appropriate offloading; AND • Assessment of an individual’s vascular status and correction of any amenable vascular problems for arterial and/or venous ulcers; AND • Compression garments/dressings have been consistently applied for venous ulcers; AND • Frequent repositioning of an individual with pressure injuries (usually every 2 hours); AND • Improvement of glucose control with documented (within the past 90 days) glycosylated hemoglobin level (HbA1c) less than 9.0% or blood glucose records demonstrating efforts to sustain blood sugar less than 200 mg/dL; AND • Maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings (eg, alginate, films, foams, hydrocolloid, hydrogels that provide a moist wound environment); AND • Necessary treatment to resolve any infection that may be present (eg, antibiotics, debridement of devitalized tissue, surgical management of osteomyelitis); AND • Optimization of nutritional status with documented prealbumin level greater than 20 mg/dL or albumin level greater than 3.4 g/dL See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.