MEDICAL POLICY: Skin Substitutes and Wound Repair Procedures

Transcription

1 POLICY: PG0203 ORIGINAL EFFECTIVE: 01/15/09 LAST REVIEW: 03/13/18 MEDICAL POLICY: Skin Substitutes and Wound Repair Procedures GUIDELINES This policy does not certify benefits or authorization of benefits, which is designated by each individual policyholder contract. Paramount applies coding edits to all medical claims through coding logic software to evaluate the accuracy and adherence to accepted national standards. This guideline is solely for explaining correct procedure reporting and does not imply coverage and reimbursement. DESCRIPTION The addition of skin substitutes or cellular or tissue based products (CTPs) to certain wounds may afford a healing advantage over dressings and conservative treatments when these options appear insufficient to affect complete healing. There are currently a wide variety of bioengineered products available for soft tissue coverage to affect closure. These products may be derived from allogeneic, xenogeneic, synthetic sources or a combination of any or all of these types of materials. However, without the component of the recipient s own distinct epithelium and cellular skin elements, permanent skin replacement or coverage by the graft cannot be accomplished. As a clinical practice guideline and checklist to wound care, the concept of DOMINATE is an effective and efficient standard of care in improving wound care. DOMINATE guidelines include Debridement of necrotic tissue and biofilm, Offloading (especially diabetic) wound, Moisture balance (also rule out Malignancy and adjust Medications which may be impairing healing), Infection and Inflammation control, Nutrition to assist healing, Arterial assessment to insure adequate perfusion for healing, Technical Advances, Edema control and Education (offloading, abstinence from tobacco, blood sugar control, swelling control). For diabetic foot s and venous stasis s, it is generally felt that if after one month of good wound care (which employs DOMINATE), there has not been a significant reduction in wound measurements (40 50%), then it is unlikely the wound will heal by 3 months and it is reasonable and even recommended that a different approach be taken. At that time, considering Technical Advances (T) can improve healing outcomes. It is then that cellular and tissue based products (skin substitutes) may be appropriate. It should be noted that the DOMINATE category Technical Advances also includes consideration for negative pressure wound therapy as well as hyperbaric oxygen therapy both of which can improve the wound bed in preparation for CTPs. Future advances in wound care may positively affect the timing for using these substitute skin products and this should be kept in mind (WOUNDS 2014;26(1):1-12). POLICY HMO, PPO, Individual Marketplace, Elite Cellular or tissue based products (CTPs) Q4101, Q4102, Q4106, Q4107, Q4121, Q4127, Q4131, Q4132, Q4133, Q4158, Q4182 do not require prior authorization. All other skin substitutes are considered to be "biologic wound dressings" which are part of the relevant service provided and not separately payable. Advantage Cellular or tissue based products (CTPs) Q4101, Q4102, Q4103, Q4104, Q4105, Q4106, Q4107, Q4108, Q4110, Q4111, Q4112, Q4113, Q4114, Q4115, Q4116, Q9117, Q4121, Q4123, Q4131, Q4132, & Q4133, Q4176- Q4182 do not require prior authorization for Advantage. All other skin substitutes are considered non-covered. HMO, PPO, Individual Marketplace, Elite, Advantage Application of CTPs for the treatment of lower extremity disease will be covered when the following conditions are met and documented as appropriate for the individual patient: 1. Presence of neuropathic diabetic foot s for greater than four weeks duration 2. Presence of venous stasis s of greater than one month duration that have failed to respond to documented conservative measures for greater than one month duration 3. Presence of neuropathic diabetic foot s that have failed to respond to documented conservative measures for greater than one month duration. These measures must include appropriate steps to offload pressure during treatment. 4. Presence of partial or full-thickness s

2 5. Measurements of the initial size, the size following cessation of any conservative management and the size at the beginning of skin substitute treatment. In all cases, the must be free of infection and underlying osteomyelitis. Documentation must support that these conditions have been successfully treated, resolved, prior to instituting skin substitute treatment. CTPs are covered only if they meet FDA approval for that intended usage and patient type (i.e., pediatric or adult), and have sufficient scientific evidence to support their application. The supply of CTP graft(s) should be reported separately in conjunction with the application Select the appropriate from based upon location and size of the defect. For biological implant for soft tissue reinforcement, use in conjunction with primary procedure. CTPs may be used on burns when skin grafting is not the appropriate option. These covered bioengineered skin substitutes are expected to function as a permanent replacement for lost or damaged skin. They may be used for temporary wound coverage or wound closure as appropriate and medically necessary. A single application of CTP for any particular is usually all that is required to affect wound healing in those wounds that are likely to be helped by this therapy. More than three applications to a single wound are usually not expected. If CTP applications and re-applications show no significant improvement after three separate treatments, additional re-applications are inappropriate and other treatment modalities should be considered. CTP treatments should not last more than twelve weeks. Improvement of fifty per cent or greater must be documented in the medical records for the reimbursement of additional re-applications after twelve weeks of treatment. If after twelve weeks the medical records do not support the significant improvement of the wound using the CTP treatments, Paramount may recoup any inappropriate reimbursement. Since application of CTP is considered a physician service, it must be applied by either a physician or a nonphysician practitioner (NPP), and NOT by non-advanced practice nurses, therapists or medical assistants. CTPs are not separately reimbursable in any institutional setting, including long-term care facility, hospital inpatient, outpatient, or emergency room place of service. Wound preparation is considered part of the procedure. All products, including dressings, are included in the evaluation and management service and are not separately reimbursable. Claims submitted with unlisted will be denied if the product is a non-covered treatment. An invoice is required for unlisted for covered treatments. Reimbursement is based on review of the product reported per an individual claim basis. The following treatments for wound care are considered experimental and investigational because there is inadequate evidence in the peer-reviewed medical literature to support their clinical effectiveness (this list may not be all-inclusive): Adherus Dural Sealant AlloMax for indications other than breast reconstruction AlloSource cryopreserved human cadaver skin AmnioCare AmnioExCel AmnioFix AmnioGenix AmnioHeal amniotic membrane Amniomatrix AmnioMTM AmnioShield AmnioStrip

3 Amniotic fluid injection for corneal wound healing and for prevention of adhesions after orthopedic surgery Amniox (human embryonic membrane) for tarsel tunnel repair and all other indications Architect ECM Architect PX Artacent Wound Artelon (poly[urethane urea] elastomer) for anterior cruciate ligament reconstruction, rotator cuff repair, trapezio-metacarpal joint osteoarthritis and all other indications Arthres GraftRope for acromio-clavicular joint separation reconstruction Avotermin for improvement of skin scarring BioDexcel BioDfactor/BioDfence human amniotic allograft BioDfence Dryflex BioDmatrix BioDRestore Elemental Tissue Matrix Biostat Biologx fibrin sealant for wound healing and all other indications Biotape reinforcement matrix for soft tissue augmentation and all other indications CellerateRX Clarix 100 Clarix Cord 1K CollaFix Conexa reconstructive tissue matrix CorMatrix ECM Patch for cardiac tissue repair and all other indications Cortiva Allograft Dermis C-QUR biosynthetic mesh CRXa CYGNUS Cymetra injectable allograft for wound healing Cytal Burn Matrix Cytal Multilayer Wound Matrix Cytal Wound Matrix Dehydrated human amniotic membrane allograft (e.g., AmnioPro, BioFix and FlowerPatch) DermaClose continuous external tissue expander for facilitation of wound closure and all other indications DermaMatrix (formerly InteXen) Porcine Dermal Matrix for wound healing and other indications other than breast reconstruction DryFlex (human amnion allograft) for shoulder repair and all other indications DuraGen Plus dural regeneration matrix for surgical repair of soft tissue deficiencies and all other indications DuraMatrix DuraSeal Durepair Regeneration Matrix Endoform Dermal Template ENDURAGen Epicord Epidex EPIFLO transdermal continuous oxygen therapy for wound healing Equine-derived decellularized collagen products (e.g., OrthADAPT, Unite, and Unite Biomatrix) E-Z Derm for wound healing and all other indications Evicel fibrin sealant for repair of cerebrospinal fluid leakage and all other indications Excellagen FloGraft Fortaderm Fortaderm Antimicrobial Fortiva Porcine Dermis; GORE BIO-A Fistula Plug Guardian HydroFix Inforce

4 Interfyl LiquidGen MariGen Matriderm MediHoney Medeor Menaflex Collagen Meniscus Implant Meso BioMatrix MIRODERM Neoform Dermis for wound healing; for NeoForm for breast reconstruction Neox Cord 1K Neuragen Neuroflex NuCel liquid wound covering OrthADAPT Bioimplant (type I collagen scaffold) for tendon repair and all other indications OrthoFlo OsseoGuard Ovation PalinGen Flow PalinGen Hydromembrane PalinGen Membrane Palingen SportFlow PalinGen XPlus Hydromembrane PalinGen XPlus Membrane Parietex Composite (PCO) Mesh for the treatment of genito-urinary (e.g., uterine or vaginal vault) prolapse Peri-Guard Repair Patch Peri-Strips Dry, and Peri-Strips Dry with Veritas Collagen Matrix Permacol Biologic Implant for soft tissue surgical repairs, including hernia repair, muscle flap reinforcement, rectal prolapse (including intussusception), rectocele repair, abdominal wall defects, plastic and reconstructive surgery, complex abdominal wall repair and all other indications; Porcine-derived decellularized collagen products (e.g., Collamend, Cuffpatch, Pelvicol, and Pelvisoft) Porcine-derived polypropylene composite wound dressing (e.g., Avaulta Plus) ProMatrX ACF Promogran Matrix PTFE felt Puracol PuraPly Antimicrobial Wound Matrix (PuraPly AM) PuraPly Wound Matrix (PuraPly) Puros Dermis Repliform Repriza Seamguard Silver-coated wound dressings (e.g., Acticoat, Actisorb, and Silversorb) for wound healing and all other indications Solana allograft Sonafine wound dressing SportMatrix SportMesh SteriShield II dual layer amnion patch Strattice Reconstructive Tissue Matrix for wound healing; for Strattice for breast reconstruction Stravix Suprathel Surgisis (including Surgisis AFP Anal Fistula Plug, Surgisis Gold Hernia Repair Grafts, and Surgisis Biodesign) TenoGlide tendon protector sheet (Tendon WrapTM tendon protector) for the management and protection of tendon injuries and all other indications TenSIX Acellular Dermal Matrix for tendon repair and all other indications

5 Tornier BioFiber Absorbable Biological Scaffold, and Tornier Collagen Coated BioFiber Scaffold Truskin Unite Biomatrix Vaso Shield Veritas Collagen Matrix for use as an implant in the surgical repair of soft tissue deficiencies and all other indications Viaflow / Viaflow C flowable placental tissue matrices Vitagel surgical hemostat for wound healing and all other indications X-Repair XCM Biologic Tissue Matrix Xelma XenMatrix XWrap Dry or Hydro Plus Skin Substitute/ Platelet Derived Growth Factor & Indication Adherus Dural Sealant Dural repair Criteria Surgical Procedure Codes No specific DME Item Affinity Q4159 AlloDerm Breast reconstruction AlloMax Covered as medically necessary when used in association with a covered, medically necessary breast reconstruction procedure Q4116 Covered as medically necessary when used in association with a covered, medically necessary breast reconstruction procedure Breast reconstruction Allopatch HD Tendon augmentation No specific Q4128 AlloSkin Q4115 Diabetic foot Covered as medically necessary when ALL of the following partial or full-thickness, diabetic foot of greater than four weeks duration for which standard wound therapy has failed type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by AlloSkin RT Q4123 Allowrap Q4150 AmnioBand/Guardian Q4151 AmnioCare Tendon/nerve repair No specific AmnioExCel Soft tissue repair Amniofix Tendon/nerve repair No specific AmnioMatrix Soft tissue repair AmnioMTM Soft tissue repair Apligraf Covered as medically necessary when ALL of the following Q4101

6 Diabetic foot, s Venous stasis full-thickness diabetic foot of greater than three weeks duration for which standard wound therapy has failed type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by Covered as medically necessary when BOTH of the following partial- or full-thickness venous stasis of greater than four weeks duration for which standard wound therapy has failed treated foot has adequate blood supply as evidenced by Coverage is limited to up to five applications per. ArthroFlex Shoulder reconstruction No specific Q4125 (FlexGraft ) Achilles tendon repair Biobrane Covered as medically necessary when used for temporary covering of a partial-thickness freshly debrided or excised burn Burn wound wound Biobrane-L Covered as medically necessary when BOTH of the following Burn wound temporary covering of a partial-thickness freshly debrided or excised burn wound adjunct to meshed autograft BioDfence/BioDfactor Dura Repair No specific Biodesign Anal and rectal fistula repair (Surgisis ) AFP Anal Fistula Plug Biodesign (Surgisis ) Hiatal Hernia Matrix Hernia repair No specific Biodesign (Surgisis ) Inguinal Hernia Matrix Biodesign (Surgisis ) RVP Recto-Vaginal Fistula Plug Hernia repair Recto-vaginal fístula repair No specific No specific BioVance Wound Care Q4154 Clarix Flo Integumental tissue repair NA Q4155 Conexa Tendon repair No specific CorMatrix ECM for Intracardiac patch No specific Cardiac Tissue Repair CorMatrix ECM for Carotid artery repair No specific Carotid Repair CorMatrix ECM for Pericardial repair No specific Pericardial Closure CryoSkin

7 Cymetra Integumental tissue repair Dermacell Dermagraft Diabetic foot, s Covered as medically necessary for repair or replacement of damaged or inadequate integumental tissue. Breast reconstruction Covered as medically necessary when ALL of the following full-thickness diabetic foot of greater than six weeks duration for which standard therapy has failed type I or type II diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by Q Q Q4106 Frequency is limited to eight applications per. Paramount does not cover continued reapplication of Dermagraft for the same if satisfactory and reasonable healing progress is not noted after 12 weeks of therapy. DermaMatrix Facial soft tissue defects Acellular Dermis Breast reconstruction DermaPure Q4152 DermaSpan Wound covering Q4126 Tendon repair Dermavest Q4153 Duraform Dural repair No specific Duragen Dural repair No specific DuraMatrix Dural repair No specific DuraSeal Dural Dural repair No specific Sealant System DuraSeal Spine Dural repair No specific Sealant System Durepair Dural repair No specific Regeneration Matrix Endoform Dermal Template Covered as medically necessary with documentation of ANY of the following conditions: C Chronic vascular s 2. Diabetic s 3. Pressure s 4. Venous s 5. Draining wounds 6. Partial or full thickness wounds 7. Tunneled, undermined wounds 8. Surgical wounds (i.e., donor sites/grafts, post-mohs surgery, post-laser surgery, podiatric, wound dehiscence) 9. Trauma wounds (i.e., abrasions, lacerations, second-degree burns, skin tears) Epicel Burn wound Covered as medically necessary when used according to the U.S. Food and Drug Administration (FDA)-approved Humanitarian Device Exemption (HDE) for an individual with

8 Epifix Diabetic foot, s deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30% Epifix is an amniotic membrane allograft used in the treatment of chronic and acute wounds. Epifix is indicated for neuropathic diabetic foot and venous stasis that have failed to respond to conservative measures Q4131 Venous stasis Coverage is limited to five applications per. Continued reapplication when the treatment is unsuccessful after 30 days of treatment, retreatment of an following an unsuccessful course of treatment or retreatment of a successfully treated healed will not be considered medically necessary. EZ Derm Q4136 FlexHD Acellular Hydrated Dermis Integumental/soft tissue repair Breast reconstruction Hernia repair Q4128 FloGraft Tendonitis Fortaderm C9349 GammaGraft Indicated in various types of wounds as a temporary dressing that may require multiple applications Q4111 GORE BIO-A Anorectal fistulas Fistula Plug Grafix Core Wound Care Q4132 Diabetic foot, Venous stasis Coverage is limited to five applications per. Grafix Prime Wound Care Q4133 Diabetic foot, Venous stasis Coverage is limited to five applications per. GraftJacket Regenerative Tissue Matrix Diabetic foot, s Covered as medically necessary when ALL of the following full-thickness diabetic foot of greater than six weeks duration for which standard therapy has failed type I or type II diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by Coverage limited to 1 application per Q4107

9 GraftJacket Xpress Covered as medically necessary when ALL of the following Q4113 Diabetic foot full-thickness diabetic foot of greater than six weeks duration for which standard therapy has failed type I or type II diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by hmatrix Integumental tissue repair Q4134 Hyalomatrix PA Q4117 HydroFix Vaso Shield Integra Dermal Regeneration Template Integra Bilayer Matrix Wound Dressing Integra Matrix Wound Dressing Integra Meshed Bilayer Wound Matrix Burn wound Integra Flowable Wound Matrix Kerecis Omega3 Wound Diabetic foot, s Vessel guard Management of wounds including: partial and full-thickness wounds, pressure s, venous s, diabetic s, chronic vascular s, surgical wounds (donor sites/grafts, post-mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. Covered as medically necessary for tunneled or undermined wounds. Coverage is limited to twelve applications per. No specific Q4105 Q4104 Q4108 C Q Q4158 Venous stasis MatriStem Q4118 Q4119 Q4120 Matrix HD Tendon repair Mediskin Q4135 MemoDerm NeoForm Dermis Breast reconstruction Tendon repair Covered as medically necessary when used in association with a covered, medically necessary breast reconstruction procedure Q Neox Wound Matrix Q4148

10 Q4156 Neox 1K Q4148 Neox Q4156 Neox Flo Wound Care NA Q4155 NeuraGen Nerve Peripheral nerve repair No specific C9352 Guide NeuraWrap Nerve Peripheral nerve repair No specific C9353 Protector NuCel Tendon repair No specific NuShield Tendon repair No specific Q4160 Orthopaedics NuShield Spine Dura repair No specific Q4160 Oasis Burn Matrix Covered as medically necessary when BOTH of the following Q4103 Burn wound post excisional treatment of a full-thickness or deep partialthickness burn sufficient autograft is not available at time of excision or is contraindicated Oasis Wound Matrix Covered as medically necessary when ALL of the following Q4102 Oasis Ultra Tri- Layer Matrix partial or full-thickness, diabetic foot of greater than four weeks duration for which standard wound therapy has Q4124 Diabetic foot, s failed type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by Venous stasis Covered as medically necessary when BOTH of the following partial or full-thickness, lower extremity venous stasis of four weeks duration for which standard wound therapy has failed treated foot has adequate blood supply as evidenced by Orcel Burn wounds Coverage is limited to 12 weeks of therapy and up to twelve applications of Oasis (Q4102) per. Covered as medically necessary for either of the following uses: Dystrophic epidermolysis bullosa in children who are undergoing reconstructive hand surgery. Full-thickness (3rd degree) and partial-thickness (2nd degree) thermal burns. Healing donor site wounds in burn victims OrthADAPT Soft tissue reinforcement Bioimplant OsseoGuard Oral defects Ovation Wound healing Peri-Guard Repair Soft tissue repair

11 Patch Pericardial and intracardiac repair Peri-Strips Dry Staple line reinforcement No specific Peri-Strips Dry with Staple line reinforcement No specific Veritas Collagen Matrix. Permacol Soft tissue reinforcement/repair PriMatrix Dermal Repair Scaffold Covered as medically necessary with documentation of ANY of the following: 1. Diabetic s 2. Pressure s 3. Venous s 4. Draining wounds 5. Partial or full thickness wounds 6. Tunneled, undermined wounds 7. Surgical wounds (i.e., donor sites/grafts, post-mohs surgery, post-laser surgery, podiatric, wound dehiscence) 8. Trauma wounds (i.e., abrasions, lacerations, second-degree burns, skin tears) Q4110; C Q4110 Restore Soft tissue reinforcement Orthobiologic Soft Tissue Implant Revitalon Q4157 SportMesh Soft tissue reinforcement Strattice Reconstructive Tissue Matrix SurgiMend Collagen Matrix Talymed Soft tissue reinforcement/repair Q4130 Soft tissue reinforcement/repair C9358; C9360 Coverage is limited to five applications per Q4127 Diabetic foot, s TenoGlide Tendon Protector Sheet TheraSkin Diabetic foot, s Tendon repair When used with standard diabetic foot care for neuropathic Diabetic Foot Ulcer (DFU)s: Only if the patient has the current medical diagnosis of either Type I or Type II diabetes mellitus; Only if the patient does not have a current HbA1C reading exceeding 12%; Only for full thickness s of greater than three weeks in duration, which extend through the dermis, with or without tendon, muscle, capsule or bone exposure; Only when adequate treatment of the underlying disease process(es) contributing to the, e.g., diabetes is provided and documented in conjunction with treatment; and Only for s located on the foot or toes that are free of infection, redness, drainage, underlying osteomyelitis, surrounding cellulitis, tunnels and tracts, eschar or any necrotic material. No specific C Q4121 Venous stasis Covered as medically necessary when the following criteria are met for venous stasis (VSU):

12 Only for s that have failed to respond to documented conservative measures of greater than six (6) weeks in duration, that have at minimum included regular dressing changes, debridement of necrotic tissue and standard therapeutic compression. A "failed response" is defined as an that has increased in size or depth, or for which there has been no change in baseline size or depth and no sign of improvement or indication that improvement is likely, such as granulation, epithelialization, or progress towards closing. Documentation of response or lack thereof, requires measurement of the at baseline, following cessation of conservative or conventional management. Documentation should also include measurement of the immediately prior to the placement of TheraSkin. Only when adequate treatment of the underlying disease process(es) contributing to the, e.g. hypertension, is provided and documented in conjunction with the treatment; and Only for s that are free of infection, redness, drainage, underlying osteomyelitis, surround cellulitis, sinus tracts or tunnels, eschar or any necrotic material. TissueMend Tornier BioFiber Absorbable Biological Scaffold Tornier Collagen Coated BioFiber Scaffold Transcyte Coverage is limited to five applications per. Soft tissue repair Tendon repair Soft tissue reinforcement/repair Soft tissue reinforcement/repair Covered as medically necessary when used for temporary covering of a surgically excised deep partial- or full-thickness Q4182 Burn wound burn wound as a covering prior to autografting. Unite Biomatrix Q4129 XCM Biologic Soft tissue reinforcement/repair XenMatrix Surgical Graft Soft tissue reinforcement/repair C1781 CODING/BILLING INFORMATION The appearance of a in this section does not necessarily indicate coverage. Codes that are covered may have selection criteria that must be met. Payment for supplies may be included in payment for other services rendered. CPT CODES Tissue cultured skin autograft, trunk, arms, legs; first 25 sq cm or less Tissue cultured skin autograft, trunk, arms, legs; additional 1 sq cm to 75 sq cm Tissue cultured skin autograft, trunk, arms, legs; each additional 100 sq cm, or each additional 1% of body area of infants and children, or part thereof Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 25 sq cm or less Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; additional 1 sq cm to 75 sq cm Tissue cultured skin autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; each additional 100 sq cm, or each additional 1% of body area of infants and children, or part thereof 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 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 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

13 100 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 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 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 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 Implantation of biologic implant (eg, acellular dermal matrix) for soft tissue reinforcement (eg, breast, trunk) (List separately in addition to for primary procedure) Repair of anorectal fistula with plug (eg: porcine small intestine submucosa [SIS]) HCPCS CODES C1781 Mesh (implantable) C9349 Fortaderm, and fortaderm antimicrobial, any type, per square centimeter C9352 Microporous collagen implantable tube (neuragen nerve guide), per centimeter C9353 Microporous collagen implantable slit tube (neurawrap nerve protector), per centimeter length C9356 Tendon, porous matrix of cross-linked collagen and glycosaminoglycan matrix (tenoglide tendon protector sheet), per square centimeter C9358 Dermal substitute, native, non-denatured collagen, fetal bovine origin (surgimend collagen matrix), per 0.5 square centimeters C9360 Dermal substitute, native, non-denatured collagen, neonatal bovine origin (surgimend collagen matrix), per 0.5 square centimeters C9363 Skin substitute, integra meshed bilayer wound matrix, per square centimeter C9364 Porcine implant, permacol, per square centimeter C9367 Skin substitute, endoform dermal template, per square centimeter Skin substitute, not otherwise classified Q4101 Apligraf, per square centimeter Q4102 Oasis wound matrix, per square centimeter Q4103 Oasis burn matrix, per square centimeter Q4104 Integra bilayer matrix wound dressing (BMWD), per square centimeter Q4105 Integra dermal regeneration template (DRT) or Integra Omnigraft dermal regeneration matrix, per square centimeter Q4106 Dermagraft, per square centimeter Q4107 Graftjacket, per square centimeter Q4108 Integra matrix, per square centimeter Q4110 PriMatrix, per square centimeter Q4111 GammaGraft, per square centimeter Q4112 Cymetra injectable, 1cc Q4113 Graftjacket Express injectable 1cc Q4114 Integra flowable wound matrix, injectable, 1cc Q4115 AlloSkin per square centimeter Q4116 AlloDerm, per square centimeter Q4117 Hyalomatrix, per square centimeter Q4118 MatriStem micromatrix, 1mg Q4119 MatriStem wound matrix, per square centimeter (Deleted effective 01/01/17) Q4120 MatriStem burn matrix, per square centimeter (Deleted effective 01/01/17) Q4121 TheraSkin, per square centimeter Q4122 Dermacell, per square centimeter Q4123 Alloskin RT, per square centimeter Q4124 Oasis ultra tri-layer wound matrix, per square centimeter Q4125 Arthroflex, per square centimeter Q4126 Memoderm, per square centimeter Q4127 Talymed, per square centimeter Q4128 Flexhd or allopatch HD, per square centimeter Q4129 Unite biomatrix, per square centimeter (Deleted effective 01/01/17) Q4130 Strattice TM, per square centimeter

14 Q4131 Q4132 Q4133 Q4134 Q4135 Q4136 Q4137 Q4138 Q4139 Q4140 Q4141 Q4142 Q4143 Q4145 Q4146 Q4147 Q4148 Q4149 Q4150 Q4151 Q4152 Q4153 Q4154 Q4155 Q4156 Q4157 Q4158 Q4159 Q4160 Q4161 Q4162 Q4163 Q4164 Q4165 Q4166 Q4167 Q4168 Q4169 Q4170 Q4171 Q4172 Q4173 Q4174 Q4175 Q4176 Q4177 Q4178 Q4179 Q4180 Q4181 Q4182 EpiFix or Epicord, per square centimeter Grafix CORE and GrafixPL CORE, per square centimeter Grafix prime and GrafixPL prime, per square centimeter hmatrix, per square centimeter Mediskin, per square centimeter EZ-derm, per square centimeter AmnioExCel or BioDExCel, per square centimeter BioDfence Dryflex, per square centimeter AmnioMatrix or BioDMatrix, injectable, 1 cc BioDfence, per square centimeter Alloskin AC, per square centimeter XCM Biologic Tissue Matrix, per square centimeter Repriza, per square centimeter Epifix, injectable, 1 mg TenSIX, per square centimeter Architect, Architect PX, or Architect FX, extracellular matrix, per square centimeter NEOX Cord 1k, NEOX Cord RT, or Clarix Cord 1k, per square centimeter Excellagen, 0.1 cc Allowrap DS or Dry, per square centimeter AmnioBand or Guardian, per square centimeter DermaPure, per square centimeter Dermavest, per square centimeter Biovance, per square centimeter NeoxFlo or ClarixFlo, 1 mg NEOX 100 or Clarix 100, per square centimeter Revitalon, per square centimeter Kerecis Omega3, per square centimeter Affinity, per square centimeter NuShield, per square centimeter Bio-connekt wound matrix, per square centimeter WoundEx Flow, BioSkin Flow, 0.5 cc WoundEx, BioSkin, per square centimeter Helicoll, per square centimeter Keramatrix, per square centimeter Cytal, per square centimeter Truskin, per square centimeter Amnioband, 1 mg Artacent wound, per square cm Cygnus, per square cm Interfyl, 1 mg PuraPly, PuraPly antimic Palingen or palingen xplus, per sq cm Palingen/Promatrix 0.36mg/0.25 CC Miroderm, per square cm Neopatch, per square centimeter Floweramnioflo, 0.1 cc Floweramniopatch, per square centimeter Flowerderm, per square centimeter Revita, per square centimeter Amnio wound, per square centimeter Transcyte, per square centimeter REVISION HISTORY EXPLANATION 07/01/09: Added s 08/15/10: Updated 01/01/11: Added/deleted s 01/01/12: Deleted Codes Q4109, 15170, 15171, 15175, 15176, 15330, 15331, 15335, 15336, 15340, 15341, 15360, 15361, 15365, 15366, 15400, 15401, 15420, 15421, 15430, Added Codes 15271, 15272, 15273, 15374, 15275, 15276, 15277, 15278, C9366, Q4117, Q4118, Q4119, Q4120, and Q4121.

15 03/11/14: C9359 & C9362 s removed from this policy as they are bone graft substitute s. Removed s , C9354, C9355, & C9361. Added s Q4131-Q4149, C1781,. Policy reviewed and updated to reflect most current clinical evidence. Approved by Medical Policy Steering Committee as revised. 04/14/15: Added new s effective 1/1/15 Q4150-Q4160 and C9349. Q4150-Q4160 will require prior authorization for Advantage per ODM guidelines. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 10/13/15: Changes in coverage made due to ODM & Medicare guideline changes. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 10/11/16: Added effective 01/01/16 new s Q4161-Q4165. Changes in coverage made due to ODM & Medicare guideline updates. These s are also now covered for Advantage: Q9117, Q4132, & Q4133. These s are also now covered for HMO, PPO, Individual Marketplace, Elite: Q4103, Q4104, Q4105, Q4108, Q4111, Q4115, Q4117, Q4118, Q4119, Q4120, Q4122, Q4123, Q4124, Q4126, Q4127, Q4129, Q4132, Q4133, Q4134, Q4135, Q4136, Q4137, Q4140, Q4141, Q4146, Q 4147, Q4148, Q4151, Q4152, Q4153, Q4154, Q4156, Q4157, Q4158, Q4159, Q4160, Q4161, Q4163, Q4164, Q4165. Added wound care as criteria for Integra. Added term Cellular or Tissue Based Products (CTPs) to policy. Incorporated the elements of DOMINATE into policy with a citation to the published site. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 01/10/17: Added effective 01/01/17 new s Q4166-Q4175 as non-covered for all product lines. Cellular or tissue based products (CTPs) Q4101, Q4102, Q4106, Q4107, Q4121, Q4127, Q4131, Q4132, Q4133, Q4158 will be separately reimbursed, and all other skin substitutes are considered to be "biologic wound dressings" which are part of the relevant service provided and not separately payable for HMO, PPO, Individual Marketplace, & Elite per CMS guidelines. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 06/13/17: Deleted effective 01/01/17 s Q4119, Q4120, & Q4129. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 01/09/18: Added effective 01/01/18 new s Q4176-Q4181 as non-covered HMO, PPO, Individual Marketplace, Elite and covered for Advantage per ODM guidelines. Added effective 01/01/18 new Q4182 as covered for all product lines. Revised effective 01/01/18 s Q4132, Q4133, Q4148, Q4156, Q4158, Q4162, Q4163. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. 03/13/18: Added list of treatments for wound care that are non-covered as considered experimental and investigational. Policy reviewed and updated to reflect most current clinical evidence per Medical Policy Steering Committee. REFERENCES/RESOURCES Centers for Medicare and Medicaid Services, CMS Manual System and other CMS publications and services Ohio Department of Medicaid American Medical Association, Current Procedural Terminology (CPT ) and associated publications and services Centers for Medicare and Medicaid Services, Healthcare Common Procedure Coding System, HCPCS Release and Code Sets Industry Standard Review