Tissue-Engineered Skin Substitutes - Cigna

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Medical Coverage PolicyEffective Date . 5/15/2022Next Review Date. 3/15/2023Coverage Policy Number . 0068Tissue-Engineered Skin SubstitutesTable of ContentsRelated Coverage ResourcesOverview . 1Coverage Policy.1General Background .24Medicare Coverage Determinations .109Coding/Billing Information .109References .116Autologous Platelet Derived Growth Factors (PlateletRich Plasma [PRP])Bone, Cartilage, Ligament Graft SubstitutesBreast Reconstruction Following Mastectomy orLumpectomyElectrical Stimulation Therapy and Home DevicesHyperbaric & Topical Oxygen TherapiesInjectable FillersLumbar Fusion for Spinal Instability and DegenerativeDisc Conditions, Including Sacroiliac FusionNegative Pressure Wound Therapy/Vacuum-AssistedClosure (VAC) for Non-healing WoundsPlantar Fasciitis TreatmentsScar RevisionINSTRUCTIONS FOR USEThe following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines ofbusiness only provide utilization review services to clients and do not make coverage determinations. References to standard benefit planlanguage and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpretingcertain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document[Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] maydiffer significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plandocument may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefitplan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coveragemandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specificinstance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicablelaws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particularsituation. Each coverage request should be reviewed on its own merits. Medical directors are expected to exercise clinical judgment andhave discretion in making individual coverage determinations. Coverage Policies relate exclusively to the administration of health benefitplans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets,delegated vendor guidelines may be used to support medical necessity and other coverage determinations.OverviewThis Coverage Policy addresses tissue engineered skin substitutes and the various proposed indications for theiruse in multiple conditions.Coverage PolicyEach of the following skin grafts is considered medically necessary for wound closure: autologous skin graft (CPT Codes 15040-15261)Page 1 of 157Medical Coverage Policy: 0068

unprocessed allogeneic human, cadaver skin graft (CPT Codes 15271-15278; HCPCS Code Q4100)unprocessed allogeneic pig skin graft (CPT Codes 15271-15278; HCPCS Code Q4100)Each of the following products is considered medically necessary as indicated:SkinSubstituteIndicationCriteriaAlloDerm BreastreconstructionAlloMax BreastreconstructionAlloPatchPliable Diabetic footulcerConsidered medically necessary when usedin association with a covered, medicallynecessary breast reconstruction procedureConsidered medically necessary when usedin association with a covered, medicallynecessary breast reconstruction procedureConsidered medically necessary when ALL ofthe following criteria are met: full-thickness diabetic foot ulcer of greaterthan six weeks duration for whichstandard therapy has failed type I or type II diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70ApplicationCPT 78115275-15278Q412815275-15278Q4151Q4168When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications for up to amaximum of eight in 12 weeks whenthere is evidence of wound healing (e.g.,signs of epithelialization and reduction inulcer size)AmnioBand Diabetic footulcerAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound statusConsidered medically necessary when ALL ofthe following criteria are met: full-thickness diabetic foot ulcer of greaterthan six weeks duration for whichstandard therapy has failed type I or type II diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply:Page 2 of 157Medical Coverage Policy: 0068

SkinSubstituteIndicationCriteria Apligraf Diabetic footulcerApplicationCPT 15278Q4101treatment is limited to one initialapplicationadditional applications for up to amaximum of eight in 12 weeks whenthere is evidence of wound healing (e.g.,signs of epithelialization and reduction inulcer size)Additional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when ALL ofthe following criteria are met: full-thickness diabetic foot ulcer of greaterthan three weeks duration for whichstandard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof four in 12 weeks are consideredmedically necessary when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)Apligraf Venous stasisulcerPage 3 of 157Medical Coverage Policy: 0068Additional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when BOTHof the following criteria are met: partial- or full-thickness venous stasisulcer of greater than four weeks durationfor which standard wound therapy hasfailed treated lower extremity has adequateblood supply as evidenced by either thepresence of a palpable pedal pulse or anankle-brachial index (ABI) of 0.70

SkinSubstituteIndicationCriteriaApplicationCPT hen the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof four in 12 weeks when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)BiobraneBurn woundBiobrane-LBurn woundCortiva BreastreconstructionDermACELL BreastreconstructionDermACELL AWMDiabetic footulcerAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when usedfor temporary covering of a partial-thicknessfreshly debrided or excised burn woundConsidered medically necessary when BOTHof the following criteria are met: temporary covering of a partial-thicknessfreshly debrided or excised burn wound adjunct to meshed autograftConsidered medically necessary when usedin association with a covered, medicallynecessary breast reconstruction procedureConsidered medically necessary when usedin association with a covered, medicallynecessary breast reconstruction procedureConsidered medically necessary when ALL ofthe following criteria are met: partial or full-thickness diabetic foot ulcerof greater than four weeks duration forwhich standard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, treatment is limited to a total of twoapplications.Dermagraft Diabetic footulcerPage 4 of 157Medical Coverage Policy: 0068Additional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when ALL ofthe following criteria are met:

SkinSubstituteIndicationCriteria ApplicationCPT Q4100C939915275-15278Q4186full-thickness diabetic foot ulcer of greaterthan six weeks duration for whichstandard therapy has failedtype I or type II diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12%treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications for up to amaximum of eight in 12 weeks whenthere is evidence of wound healing (e.g.,signs of epithelialization and reduction inulcer size)EpicelBurn woundEpiFix AmnioticMembraneDiabetic footulcerAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when usedaccording to the U.S. Food and DrugAdministration (FDA)-approved HumanitarianDevice Exemption (HDE) for an individualwith deep dermal or full-thickness burnscomprising a total body surface area ofgreater than or equal to 30%Considered medically necessary when ALL ofthe following criteria are met: partial or full-thickness, diabetic foot ulcerof greater than four weeks duration forwhich standard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications may be applied ata minimum of one week intervals, for upto a maximum of four in 12 weeks areconsidered medically necessary whenPage 5 of 157Medical Coverage Policy: 0068

SkinSubstituteIndicationCriteriaApplicationCPT 412815275-15278Q4203evidence of wound healing is present(e.g., signs of epithelialization andreduction in ulcer size)EpiFix AmnioticMembraneVenous stasisulcerAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when BOTHof the following criteria are met: partial- or full-thickness venous stasisulcer of greater than four weeks durationfor which standard wound therapy hasfailed treated lower extremity has adequateblood supply as evidenced by either thepresence of a palpable pedal pulse or anankle-brachial index (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof four in 12 weeks when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)FlexHD AcellularHydratedDermisGeistlichDerma-Gide AdvancedWound MatrixBreastreconstructionDiabetic footulcerAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when usedin association with a covered, medicallynecessary breast reconstruction procedure.Considered medically necessary when ALL ofthe following criteria are met: full-thickness, diabetic foot ulcer ofgreater than four weeks duration forwhich standard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply:Page 6 of 157Medical Coverage Policy: 0068

SkinSubstituteIndicationCriteria Grafix Diabetic footulcerApplicationCPT 5271-15278Q4132Q4133treatment is limited to one initialapplicationadditional applications at a minimum ofone week intervals, for up to a maximumof eight in 12 weeks are consideredmedically necessary when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)Additional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound statusConsidered medically necessary when ALL ofthe following criteria are met: partial or full-thickness diabetic foot ulcerof greater than four weeks duration forwhich standard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof six in 12 weeks are consideredmedically necessary when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)Grafix Venous stasisulcerPage 7 of 157Medical Coverage Policy: 0068Additional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when BOTHof the following criteria are met: partial- or full-thickness venous stasisulcer of greater than four weeks durationfor which standard wound therapy hasfailed treated lower extremity has adequateblood supply as evidenced by either thepresence of a palpable pedal pulse or anankle-brachial index (ABI) of 0.70

SkinSubstituteIndicationCriteriaApplicationCPT 15278Q4105Q4104Q4108C936315275-15278Q4105When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof six in 12 weeks when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)GraftJacket RegenerativeTissue MatrixIntegra DermalRegenerationTemplateDiabetic footulcerBurn woundIntegra Bilayer MatrixWoundDressingAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when ALL ofthe following criteria are met: partial or full-thickness, diabetic foot ulcerof greater than four weeks duration forwhich standard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, one application is consideredmedically necessary.Considered medically necessary when BOTHof the following criteria are met: postexcisional treatment of a fullthickness or deep partial-thickness burn sufficient autograft is not available at timeof excision or is contraindicatedIntegra Matrix WoundDressingIntegra MeshedBilayerWound MatrixIntegra DermalRegenerationTemplate/Diabetic FootUlcerPage 8 of 157Medical Coverage Policy: 0068Considered medically necessary when ALL ofthe following criteria are met:

SkinSubstituteIndicationCriteria OmnigraftDermalRegenerationMatrix ApplicationCPT Q4102Q4124partial or full-thickness diabetic foot ulcerof greater than six weeks duration forwhich standard wound therapy has failedtype 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12%treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof four in 12 weeks are consideredmedically necessary when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)Oasis Wound MatrixDiabetic footulcerOasis UltraTri-LayerMatrixAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound statusConsidered medically necessary when ALL ofthe following criteria are met: partial or full-thickness, diabetic foot ulcerof greater than four weeks duration forwhich standard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof four in 12 weeks are consideredmedically necessary when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)Page 9 of 157Medical Coverage Policy: 0068

SkinSubstituteOasis WoundMatrixIndicationVenous stasisulcerOasis UltraTri-LayerMatrixCriteriaAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound statusConsidered medically necessary when BOTHof the following criteria are met: partial or full-thickness, lower extremityvenous stasis ulcer of four weeksduration for which standard woundtherapy has failed treated lower extremity has adequateblood supply as evidenced by either thepresence of a palpable pedal pulse or anankle-brachial index (ABI) of 0.70ApplicationCPT Q4102Q412415275-15278Q4110When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof four in 12 weeks are consideredmedically necessary when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)PriMatrix Diabetic FootUlcerAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound statusConsidered medically necessary when ALL ofthe following criteria are met: partial or full-thickness diabetic foot ulcerof greater than six weeks duration forwhich standard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof three in 12 weeks are consideredmedically necessary when evidence ofwound healing is present (e.g., signs ofPage 10 of 157Medical Coverage Policy: 0068

SkinSubstituteIndicationCriteriaApplicationCPT tion and reduction in ulcersize)PriMatrix Venous stasisulcerAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound statusConsidered medically necessary when BOTHof the following criteria are met: partial or full-thickness, lower extremityvenous stasis ulcer of four weeksduration for which standard woundtherapy has failed treated lower extremity has adequateblood supply as evidenced by either thepresence of a palpable pedal pulse or anankle-brachial index (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof three in 12 weeks are consideredmedically necessary when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)Suprathel BurnTheraSkin Diabetic footulcerAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound statusConsidered medically necessary when usedfor the treatment of first- and second-degreeburns.Considered medically necessary when ALL ofthe following criteria are met: partial or full-thickness, diabetic foot ulcerof greater than four weeks duration forwhich standard wound therapy has failed type 1 or type 2 diabetes mellitus with ahemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supplyas evidenced by either the presence of apalpable pedal pulse or an ankle-brachialindex (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply:Page 11 of 157Medical Coverage Policy: 0068

SkinSubstituteIndicationCriteria TheraSkin Venous stasisulcerApplicationCPT 15278Q4182treatment is limited to one initialapplicationadditional applications may be applied ata minimum of one week intervals, for upto a maximum of four in 12 weeks areconsidered medically necessary whenevidence of wound healing is present(e.g., signs of epithelialization andreduction in ulcer size)Additional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when BOTHof the following criteria are met: partial- or full-thickness venous stasisulcer of greater than four weeks durationfor which standard wound therapy hasfailed treated lower extremity has adequateblood supply as evidenced by either thepresence of a palpable pedal pulse or anankle-brachial index (ABI) of 0.70When the above medical necessity criteriaare met, the following conditions of coverageapply: treatment is limited to one initialapplication additional applications at a minimum ofone week intervals, for up to a maximumof four in 12 weeks when evidence ofwound healing is present (e.g., signs ofepithelialization and reduction in ulcersize)Transcyte Burn woundAdditional applications beyond 12 weeks areconsidered not medically necessaryregardless of wound status.Considered medically necessary when usedfor temporary covering of a surgically exciseddeep partial- or full-thickness burn wound asa covering prior to autografting.Each of the products listed above for ANY unlisted indication is considered experimental,investigational, or unproven.Each of the following products listed below is considered experimental, investigational, or unproven forANY indication:Page 12 of 157Medical Coverage Policy: 0068

Skin SubstituteReason(s) for Request(this list may not be all inclusive)Actigraft Wound healingActishield AmnioticBarrier MembraneActishield CF AmnioticBarrier MembraneActiveBarrier Soft and/or hard tissue repairActiveMatrix flowableConnective tissue repairAcuseal CardiovascularPatchAdherus Dural Sealant Cardiovascular reconstructionAffinityAlloGen Wound careSoft tissue repairAlloMend AcellularDermal MatrixAllopatch HD Soft tissue repairAlloSkin Wound careAlloSkin ACAlloSkin RTAllowrap DS and DryAmnioAMP-MP Wound careWound careWound careWound careAmnioArmorAmnioBand ParticulateAmniobind Wound careWound careWound careAmnioCare Tendon/nerve repairAmnioClear Wound careSurgical barrierKnee pain and inflammationAmnioClear LTCflowableAmnioCore Amniocyte FlowableMatrixAmniocyte PlusInjectableAmnioExCel/AmnioExcelPlus/BioDExCel Amniofix AmnioticMembraneAmniofix InjectableAmnioHeal PlusPage 13 of 157Medical Coverage Policy: 0068Soft and/or hard tissue repairWound careDural repairTendon augmentationWound careConnective tissue repairConnective tissue repairWound careSoft tissue repairTendon/nerve repairTendon repairSoft tissue repairWound -15278C5271-C5278No specificcodeNo specificcodeNo specificcode15271-15278No specificcodeNo specificcodeNo 1577715271-15278C5271-C5278No Q4100C9399Q4100C9399Q4100C9399Q4100C9399C1768No specificcode15271-15278No specificcodeNo specificcode15271-15278J3590No specificcodeNo 3590Q4100C9399

Skin SubstituteAmnio-MaxxAmnioMatrix Reason(s) for Request(this list may not be all inclusive)AmnioPro MembraneWound careWound careSoft tissue repairWound careSoft tissue repairWound careAmnioPro FlowWound careAmniorepair/AltiplyWound careAmniotext InjectableTissue defectAmniotext PatchWound careAmnio WoundAmnios /Amnios RTWound careWound careAmniovo Amniowrap2 Soft tissue repairTendon repairWound careAmniplyWound careAnu RHEO Connective tissue repairApis Wound careArchitect BiomatrixArtacent CordWound careWound CareArtacent WoundSurgical barrierArtacent ac, membraneArtacent ac, powderWound careWound careArthrex Amnion MatrixOrthopedic barrier or wrapArthrex Amnion ViscousArthroFlex (FlexGraft )Orthopedic barrier or wrapAmnioMTM InjectableARTIA ReconstructiveTissue MatrixAscent Avance Nerve GraftAvive Soft TissueMembraneAxoBioMembranePage 14 of 157Medical Coverage Policy: 0068Shoulder reconstructionAchilles tendon repairSoft tissue repairWound careJoint and tendon repairPeripheral nerve repairSoft tissue repairSoft tissue 278C5271-C5278No specificcode15271-15278No specificcode15271-15278C5271-C5278No specificcode15271-15278C5271-C527815271-15278No specificcodeNo -C5278No -15278C5271-C527No specificcode15271-15278No specificcodeNo specificcodeNo specificcodeNo specificcodeNo specificcodeNo specificcode6491264913No Q4100C9399Q4100C9399Q4211

Skin SubstituteAxoGuard NerveConnectorAxoGuard NerveProtectorAxolotl Ambient Peripheral nerve repairApplicationCPT/HCPCSCodes64999Peripheral nerve repair64999Axolotl Cryo Soft tissue repairAxolotl DualGraft Soft tissue repairAxolotl Graft Soft tissue repairBellaCell HDSoft tissue repairBellaDerm AcellularHydrated DermisBio-ConneKt BioDfactor BioDRestore flowableIntegumental tissue repairSoft tissue repairWound careWound careSoft tissue repairSurgical wrap/barrierTendon repairSurgical wrap/barrierTendon repairSoft tissue repairBiodesign Dural GraftDural repairBiodesign (Surgisis )AFP Anal Fistula PlugBiodesign (Surgisis )Hiatal Hernia MatrixBiodesign (Surgisis )Inguinal Hernia MatrixBiodesign OtologicRepair GraftBiodesign (Surgisis )RVP Recto-VaginalFistula PlugBiodesign Peyronie’sRepair GraftBiodesign SinonasalRepair GraftBioFix Anal and rectal fistula repairBioNextPatchBioVance BioWound Burn careWound careWound careWound careBioWound PlusWound careBioWound XPlusWound careBioDfence BioDfence DryFlexPage 15 of 157Medical Coverage Policy: 0068Reason(s) for Request(this list may not be all inclusive)Soft tissue repairNo specificcodeNo -C527815271-15278C5271-C5278No specificcode15271-1527815271-15278C5271-C5278No specificcodeNo specificcodeNo specificcodeNo specificcode46707Hernia repair49568Hernia repair49568Otologic repairRecto-vaginal fístula repairUrological deficitsWound careWound careNo specificcodeNo specificcodeNo specificcodeNo 4100C1763Q4100C9399Q4228Q4154Q4217Q4217Q4217

Skin SubstituteCardioCel CardioGRAFT MC DecellularizedPulmonary Artery PatchGraftcarePATCHCellerateRX Reason(s) for Request(this list may not be all inclusive)Pericardial closureCard

Closure (VAC) for Non-healing Wounds Plantar Fasciitis Treatments . Scar Revision . INSTRUCTIONS FOR USE . . (CPT Codes 15040-15261) Page 2 of 157 Medical Coverage Policy: 0068 unprocessed allogeneic human, cadaver skin graft (CPT Codes 15271-15278; HCPCS Code Q4100)