Skin Subistute Grafts Application

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LocalCoverageDetermination(LCD):ApplicationofBioengineeredSkinSubstitutestoLowerExtremityChronicNonHealingWounds(L27549)ContractorInformation

ContractorNameNovitasSolutions,Inc.

ContractNumber12402

ContractTypeAandBMAC

LCDInformationDocumentInformation

LCDIDL27549

JurisdictionNewJersey

LCDTitleApplicationofBioengineeredSkinSubstitutestoLowerExtremityChronicNonHealingWounds

OriginalEffectiveDateForservicesperformedonorafter07/11/2008

RevisionEffectiveDateForservicesperformedonorafter04/09/2015

RetirementDateN/A

NoticePeriodStartDate02/20/2015

NoticePeriodEndDate04/08/2015

RevisionEndingDateN/A

AMACPT/ADACDTCopyrightStatementCPTonlycopyright20022015AmericanMedicalAssociation.AllRightsReserved.CPTisaregisteredtrademarkoftheAmericanMedicalAssociation.ApplicableFARS/DFARSApplytoGovernmentUse.Feeschedules,relativevalueunits,conversionfactorsand/orrelatedcomponentsarenotassignedbytheAMA,arenotpartofCPT,andtheAMAisnotrecommendingtheiruse.TheAMAdoesnotdirectlyorindirectlypracticemedicineordispensemedicalservices.TheAMAassumesnoliabilityfordatacontainedornotcontainedherein.

TheCodeonDentalProceduresandNomenclature(Code)ispublishedinCurrentDentalTerminology(CDT).CopyrightAmericanDentalAssociation.Allrightsreserved.CDTandCDT2010aretrademarksoftheAmericanDentalAssociation.

UB04Manual.OFFICIALUB04DATASPECIFICATIONSMANUAL,2014,iscopyrightedbyAmericanHospitalAssociation(AHA),Chicago,Illinois.NoportionofOFFICIALUB04MANUALmaybereproduced,sortedinaretrievalsystem,ortransmitted,inanyformorbyanymeans,electronic,mechanical,photocopying,recordingorotherwise,withoutpriorexpress,writtenconsentofAHA.HealthForumreservestherighttochangethecopyrightnoticefromtimetotimeuponwrittennoticetoCompany.

CMSNationalCoveragePolicy

ThisLCDsupplementsbutdoesnotreplace,modifyorsupersedeexistingMedicareapplicableNationalCoverageDeterminations(NCDs)orpaymentpolicyrulesandregulationsforbioengineeredskinsubstitutes.FederalstatuteandsubsequentMedicareregulationsregardingprovisionandpaymentformedicalservicesarelengthy.TheyarenotrepeatedinthisLCD.NeitherMedicarepaymentpolicyrulesnorthisLCDreplace,modifyorsupersedeapplicablestatestatutesregardingmedicalpracticeorotherhealthpracticeprofessionsacts,definitionsand/orscopesofpractice.AllproviderswhoreportservicesforMedicarepaymentmustfullyunderstandandfollowallexistinglaws,regulationsandrulesforMedicarepaymentforbioengineeredskinsubstitutesandmustproperlysubmitonlyvalidclaimsforthem.Pleasereviewandunderstandthemandapplythemedicalnecessityprovisionsinthepolicywithinthecontextofthemanualrules.RelevantCMSmanualinstructionsandpoliciesregardingbioengineeredskinsubstitutesarefoundinthefollowingInternetOnlyManuals(IOMs)publishedontheCMSWebsite:

CMSInternetOnlyManual(IOM),Pub.10004,MedicareClaimsProcessingManual,Chapter17,Section40.CMSInternetOnlyManual(IOM).Pub.10003,MedicareNationalCoverageDeterminationsManual,Chapter1,Part4,Section270.13.



CMSChangeRequest,CR8213AutologousPlateletRichPlasma(PRP)forChronicNonHealingWoundsissuedJune10,2013SocialSecurityAct(XVIII)StandardReferences:

TitleXVIIIoftheSocialSecurityAct,1862(a)(1)(A)statesthatnoMedicarepaymentshallbemadeforitemsorserviceswhicharenotreasonableandnecessaryforthediagnosisortreatmentofillnessorinjury.TitleXVIIIoftheSocialSecurityAct,Section1833(e)statesthatnopaymentshallbemadetoanyproviderforanyclaimthatlacksthenecessaryinformationtoprocesstheclaim.TitleXVIIIoftheSocialSecurityAct,Section1862(a)(7).Thissectionexcludesroutinephysicalexaminations.

CoverageGuidance

CoverageIndications,Limitations,and/orMedicalNecessityNotice:ItisnotappropriatetobillMedicareforservicesthatarenotcovered(asdescribedbythisentireLCD)asiftheyarecovered.Whenbillingfornoncoveredservices,usetheappropriatemodifier.

Compliancewiththeprovisionsinthispolicymaybemonitoredandaddressedthroughpostpaymentdataanalysisandsubsequentmedicalreviewaudits.

TheadditionofSkinSubstitutesorCellularand/orTissueBasedProducts(CTPs)tocertainwoundsmayaffordahealingadvantageoverdressingsandconservativetreatmentswhentheseoptionsappearinsufficienttoaffectcompletehealing.

Therearecurrentlyawidevarietyofbioengineeredproductsavailableforsofttissuecoveragetoaffectclosure.Theseproductsmaybederivedfromallogeneic,xenogeneic,syntheticsourcesoracombinationofanyorallofthesetypesofmaterials.However,withoutthecomponentoftherecipientsowndistinctepitheliumandcellularskinelements,permanentskinreplacementorcoveragebythegraftcannotbeaccomplished.

Autologousskingrafts,alsoreferredtoasautografts,arepermanentcoversthatuseskinfromdifferentpartsoftheindividualsbody.Thesegraftsconsistoftheepidermisandadermalcomponentofvariablethickness.Asplitthicknessskingraft(STSG)includestheentireepidermisandaportionofthedermis.Afullthicknessskingraft(FTSG)includesalllayersoftheskin.Althoughautograftsaretheoptimalchoiceforfullthicknesswoundcoverage,areasforskinharvestingmaybelimited,particularlyincasesoflargeburnsorvenousstasisulceration.Harvestingproceduresarepainful,disfiguringandrequireadditionalwoundcare.

Allograftswhichuseskinfromanotherhuman(e.g.,cadaver)andXenograftswhichuseskinfromanotherspecies(e.g.,porcineorbovine)mayalsobeemployedastemporaryskinreplacements,buttheymustlaterbereplacedbyanautograftortheingrowthofthepatientsownskin.

BioengineeredSkin/CulturedEpidermalAutografts(CEA)areautograftsderivedfromthepatientsownskincellsgrownorculturedfromverysmallamountsofskinorhairfollicle.Productiontimeisprolonged.Onesuchproductisgrownonalayerofirradiatedmousecells,bestowingsomeelementsofaxenograft.Widespreadusagehasnotbeenavailableduetolimitedavailabilityoraccesstothetechnology.

BioengineeredSkinSubstitutesorCellularandTissueBasedProducts(CTPs),referredtoasSkinSubstitutesbyCMS,TheCurrentProceduralTerminology(CPT)andTheHealthcareCommonProcedureCodingManualshavebeendevelopedinanattempttocircumventproblemsinherentwithautografts,allograftsandxenografts.Theseconstitutebiologiccoversforrefractorywoundswithfullthicknessskinlosssecondaryto3rddegreeburnsorotherdiseaseprocessessuchasdiabeticneuropathiculcersandtheskinlossofchronicvenousstasisorvenoushypertension.TheproductionofthesebiologicskinsubstitutesorCTPsvariesbycompanyandproduct,butgenerallyinvolvesthecreationofimmunologicallyinertbiologicalproductscontainingprotein,hormonesorenzymesseededintoamatrixwhichmayprovideproteinorgrowthfactorsproposedtostimulateorfacilitatehealingorpromoteepithelization.AvarietyofbiosyntheticandtissueengineeredskinsubstitutionproductsmarketedasHumanSkinEquivalents(HSE)orCellularand/orTissuebasedProducts(CTP)aremanufacturedunderanarrayoftradenamesandmarketedforavarietyofindications.Allareprocured,produced,manufactured,processedandpromotedinsufficientlydifferentmannerstoprecludedirectproductcomparisonforequivalencyorsuperiorityinrandomizedcontrolledtrials.Sufficientdataisavailabletoestablishdistinctinferioritytohumanskinautograftsandprecludetheirdesignationasskinequivalence.

BioengineeredskinsubstitutesorCTPsareclassifiedintothefollowingtypes:

Humanskinallograftsderivedfromdonatedhumanskin(cadavers)Allogeneicmatricesderivedfromhumantissue(fibroblastsormembrane)Compositematricesderivedfromhumankeratinocytes,fibroblastsandxenogeneiccollagenAcellularmatricesderivedfromxenogeneiccollagenortissue

HumanSkinAllograftsarebioengineeredfromhumanskincomponentsandhumantissuewhichhavehadintactcellsremovedand/ortreatedtoavoidimmunologicrejection.Theyareavailableindifferentformspromotedtoallowscaffolding,softtissuefilling,growthfactorsandotherbioavailablehormonalorenzymaticactivity.

AllogeneicMatricesareusuallyderivedfromhumanneonatalfibroblastsoftheforeskinthatmaycontainmetabolicallyactiveorregenerativecomponentsprimarilyusedforsofttissuesupport,thoughsomehavebeenapprovedforthetreatmentoffullthicknessskinandsofttissueloss.Mostarebiodegradableanddisappearafter34weeksimplantation.

CompositeMatricesarederivedfromhumankeratinocytesandfibroblastssupportedbyascaffoldofsyntheticmeshorxenogeneiccollagen.Thesearealsoreferredtoashumanskinequivalentbutareunabletobeusedasautograftsduetoimmunologicrejectionordegradationofthelivingcomponentsbythehost.Activecellularcomponentscontinuetogeneratebioactivecompoundsandproteinthatmayacceleratewoundhealingandepithelialregrowth.

AcellularMatricesarederivedfromotherthanhumanskinandincludethemajorityofbioengineeredskinsubstitutes.Allarecomposedofallogeneicorxenogeneicderivedcollagen,membrane,orcellularremnantsproposedtosimulateorexaggeratethecharacteristicsofhumanskin.Allproposetopromotehealingbythecreationoflocalizedintensificationofanarrayofhormonalandenzymaticactivitytoaccelerateclosurebymigrationofnativedermalandepithelialcomponents,ratherthanfunctionasdistinctlyincorporatedtissueclosingtheskindefect.

ForthepurposeofthisLCD,considerationisgiventotheuseofdermaland/orepidermalsubstitutetissueofhumanornonhumanorigin,withorwithoutbioengineeredorprocessedelements,withorwithoutmetabolicallyactiveelements,withadesignateduseascoverageforasuperficialskindeficitthathaspersisted,despiteoptimalwoundcareforaperiodof4weeksorgreater.TheseproductsarethosereferredtoasHumanCellular



and/orTissueBasedProducts(CTPs)orSkinSubstitutes.

Evaluationoftheclinicalliteratureindicatesthatstudiescomparingtheefficacyofbioengineeredskinsubstitutetoalternativewoundcareapproacheswithpatientsautologousskinarelimitedinnumber,applymainlytogenerallyhealthypatients,andexamineonlyasmallportionoftheskinsubstituteproductsavailableintheUnitedStates.Therefore,allproductswithFDAclearance/approvalordesignated361HCT/PexemptionusedinaccordancewiththatproductsindividualizedapplicationguidelineswillbeequallyconsideredforthepurposeofthisLCDandmaybeconsideredreasonableandnecessary.

RegulatoryStatus

USFoodandDrugAdministration(FDA)GoverningSkinSubstituteProducts

TheU.S.FoodandDrugAdministration(FDA)doesnotrefertoanyproductorclassofproductsasskinsubstitutes.However,productscommonlydescribedasskinsubstitutesareregulatedbyFDAunderoneofthefourcategoriesdescribedbelowdependingontheoriginandcompositionoftheproductandlistedasaSkinSubstitutewithaHCPCScodeQ41XX.

1. HumanCells,Tissues,andCellularandTissueBasedProductsCellsandtissuestakenfromhumandonorsandtransplantedtoarecipientareregulatedunderPHS361[21CFR1270&1271].ThisregulationdescribestherulesconcerningtheuseofHCT/Psforhumanmedicalpurposes.Thefinalrule,21CFRPart1271,becameeffectiveonApril4,2001,forhumantissuesintendedfortransplantationthatareregulatedundersection361ofthePHSActand21CFRPart1270.HCT/PsareregulatedbytheCenterforBiologicsEvaluationandResearch(CBER).CBERisresponsibleforregulatingbiologicalandrelatedproductsincludingblood,vaccines,allergenics,tissues,andcellularandgenetherapies.EstablishmentsproducingHCT/PsmustregisterwithFDAandlisttheirHCT/Ps.HCT/PsestablishmentsarenotrequiredtodemonstratethesafetyoreffectivenessoftheirproductsandFDAdoesnotevaluatethesafetyoreffectivenessoftheseproducts.

2. PremarketApprovalPremarketapproval(PMA)byFDAistherequiredprocessofscientificreviewtoensurethesafetyandeffectivenessofClassIIIdevices.BeforeClassIIIdevicescanbemarketed,theymusthaveanapprovedPMAapplication.Therefore,woundcareproductsregulatedunderthePMAprocesswillrequireevidencethattheypromotewoundhealingbeforetheyareapprovedformarketing.

3. 510(k)SubmissionsAccordingtoFDAdocumentsa510(k)isapremarketsubmissionmadetoFDAtodemonstratethatthedevicetobemarketedisatleastassafeandeffective,thatis,substantiallyequivalent(SE),toalegallymarketeddevice(21CFR807.92(a)(3))thatisnotsubjecttoPMA."Submittersmustcomparetheirdevicetooneormoresimilarlegallymarketeddevicesandmakeandsupporttheirsubstantialequivalencyclaims.UnlikePMA,510(k)confersreasonableassuranceofsafetyandeffectivenessviademonstrationofsubstantialequivalencetoalegallymarketeddevicethatdoesnotrequirepremarketapproval.Therefore,woundcareproductsregulatedunderthe510(k)processwillnottypicallyrequireclinicalevidencetoestablisheffectivenessinwoundhealing,ascomparedwithproductsregulatedunderthePMAprocessinwhichsubstantialclinicalevidenceisalwaysrequired.

4. HumanitarianDeviceExemptionAnHDEissimilarinbothformandcontenttoapremarketapproval(PMA)application,butisexemptfromtheeffectivenessrequirementsofaPMA.AnHDEapplicationisnotrequiredtocontaintheresultsofscientificallyvalidclinicalinvestigationsdemonstratingthatthedeviceiseffectiveforitsintendedpurpose.Theapplicantmustdemonstratethatnocomparabledevicesareavailabletotreatordiagnosethediseaseorcondition,andthattheycouldnototherwisebringthedevicetomarket.HDEapprovalisbasedonevidenceofprobablebenefitinadiseasepopulationoccurringatafrequencyoflessthan4,000patientsperyearintheUnitedStates.

Updateddesignationandapprovedusagecriteriamaybefoundathttp://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances.

ExpandedclassificationcriteriaandexplanationisincludedintheHHS/AHRSFinalReport,December18,2012entitledSkinSubstitutesforTreatingChronicWounds

PertheAmericanMedicalAssociationandtheCPTManual,SkinReplacementSurgeryorSkinSubstituteGraftingisaconceptualmodelfocusingontheworkandservicesprovidedregardlessoftheproductused.Thisremovestherequirementformaintenanceandeducationontheuseofsupplycodesthathavelittleimpactonthe"typicalpatient"ortheprovidereffortforapplicationoftheproduct.Theapplicationofskinsubstitute(orCTP)isdistinguishedaccordingtothewoundcharacteristicsandsurfacearearatherthanbyproductdescription.Currently,noproducthasdemonstratedindividualsuperiorityforthetreatmentofdiabeticfootulcers(DFU)andvenouslegulcers(VLU)ofthelowerextremity,and,frequentlysuchproductsareutilizedinappropriately.

Nongraftwounddressingsaregenerallyincludedinstandardwoundcaremanagementsuchproductsmayprovidevalueand,infact,mayprecludetheneedforskinsubstituteapplication.

Standardtreatmentofchroniclowerextremityulcersorskinloss(e.g.,DFUand/orVLU)primarilyincludesinfectionandedemacontrol,mechanicaloffloading,mechanicalcompressionorlimbelevation,debridementofnecroticorinfectedtissue,andmanagementofconcomitantandincitingmedicalissues(bloodglucosecontrol,tobaccouse).Maintenanceofatherapeuticenvironmentwithappropriatedressingstoprecludefurthertraumafacilitatesdevelopmentofhealthygranulationtissueandencouragesreepithelialization.Awoundthatfailstoshowevidenceofhealingbycontractionandadvancementofepithelialmarginsfollowing4weeksofoptimization,includingallaspectsofstandardtherapy,isconsideredachronicnonhealingwoundandfallsintotheauspicesofthisLCD.Thefundamentalbasisfornonhealingofawoundisofparamountimportanceandmustbecorrectedpriortoconsiderationofadditionaltherapy.

Thedepthofskinlossisthedeterminantofitsabilitytoreturn..Fullthicknessskinloss,implyingthelossofallelementsoftheepidermisanddermis,willrequirereepithelizationofthesurfaceonceacleangranularbaseisestablished.BothfullandpartialthicknessskinlossmaybenefitfromenhancedproductsreferredtoasSkinSubstitutes.Thoughnoskinsubstitutesarecapableofreplacingthepatientsownskin,theyhavebeendemonstratedtoallowscaffoldingforthegrowthofepithelium,enzymaticcleansingandprovisionofgrowthfactorsbeneficialtodeficitreductionandreepithelization.

Thisdocumentaddressesthemanagementofchronicnonhealingwoundsorskindeficitsofthelowerextremitieswiththegoalofwoundandskinclosurewhenstandardorconservativemeasureshavefailed.Whilelowerextremityulcershavenumerouscausessuchasburns,trauma,immobility,ischemiaorotherneurologicimpairment,over90%ofthelesionsarerelatedtovenousstasisdiseaseanddiabeticneuropathy.Therefore,thefocusofthispolicyistheapplicationofbioengineeredskinsubstitutematerialtodiabeticfootulcersandvenouslegulcersofthelowerextremitiesandthereasonableandnecessary(R&N)thresholdforutilizationofskinsubstitutes.ParticularemphasisisplacedontheindicationsforapplicationofbioengineeredskinsubstitutematerialforDFUandVLU.



Patientsreceivingaskinsubstitutegraftmustbeunderthecareofaphysicianlicensedbythestatewithfullscopeofpracticeforthetreatmentofthesystemicdiseaseprocess(s)etiologicforthecondition(e.g.,venousinsufficiency,diabetes,neuropathy).Thisconcurrentmedicalmanagementandtheidentityofthemanagingmedicalphysicianshallbeclearlydiscernableinthemedicalrecordandavailableuponrequest.

Medicarecoverageforwoundcareonacontinuingbasis,forasinglewound,inanindividualpatientiscontingentuponevidencedocumentedinthepatientsmedicalrecordthatthewoundisimprovinginresponsetothewoundcarebeingprovided.Sinceitisneitherreasonablenormedicallynecessarytocontinueagiventypeofwoundcareintheabsenceofwoundimprovement,itisexpectedthatthewoundsresponsetotreatmentwillbedocumentedinthemedicalrecordatleastonceevery30daysforeachepisodeofwoundtreatmentandmadeavailabletothecontractoruponrequest.

Documentationofresponserequiresmeasurementsoftheinitialulcer,measurementsatthecompletionofatleastfourweeksofappropriatewoundcareandmeasurementsimmediatelypriortoplacementandwitheachsubsequentplacementofthebioengineeredskinsubstituteorCTP.

DefinitionsperCPT:

Autografts/tissueculturedautografts:Includetheharvestand/orapplicationofanautologousskingraft.

Skinsubstitutegrafts:Includenonautologoushumancellularandtissueproducts(e.g.,dermalorepidermal,cellularandacellular,homograftorallograft),nonhumancellularortissueproducts(i.e.,xenograft),andbiologicalproducts(syntheticorxenogeneic)thatareappliedinasheetoveranopenwoundtoaugmentwoundclosureand/orskingrowth.

Indications:

ChronicWoundsaredefinedaswoundsthatdonotrespondtostandardwoundtreatmentforatleasta30dayperiodduringorganizedcomprehensiveconservativetherapy.

Forallwounds,documentation(asoutlinedinthedocumentationrequirementsofthepolicy)andacomprehensivetreatmentplan,beforeinitiationofaspecializedwoundtherapyproductisrequired.

FailedResponseappliestoulcersorskindeficitsthathavefailedtorespondtodocumentedappropriatewoundcaremeasures,haveincreasedinsizeordepth,orhasnochangeinbaselinesizeordepthornoindicationthatimprovementislikely(suchasgranulation,epithelializationorprogresstowardsclosing).

UlcersorWoundswithFailedResponsetoappropriatetherapyare:

Partialand/orfullthicknessulcers,notinvolvingtendon,muscle,jointcapsuleorexhibitingexposedboneorsinustracts,withacleangranularbaseSkindeficitatleast1.0cminsizeCleanandfreeofnecroticdebrisorexudateHaveadequatecirculation/oxygenationtosupporttissuegrowth/woundhealingasevidencedbyphysicalexamination(e.g.,AnkleBrachialIndex(ABI)ofnolessthan0.60,toepressure>30mmHg)Patientisanonsmoker,orhasrefrainedfromsystemictobaccointakeforatleast4weeksduringconservativewoundcareandpriortoplannedbioengineeredskinreplacementtherapyFordiabeticfootulcers,thepatientsmedicalrecordreflectsadiagnosisofType1orType2DiabetesandalsoreflectsmedicalmanagementforthisconditionDocumentation(inthepreservicerecord)specificallyaddressingcircumstancesastowhythewoundhasfailedtorespondtostandardwoundcaretreatmentofgreaterthan4weeksandmustreferencespecificinterventionsthathavefailed.Suchrecordshouldincludeupdatedmedicationhistory,reviewofpertinentmedicalproblemsthatmayhaveoccurredsincethepreviouswoundevaluation,andexplanationoftheplannedskinreplacementsurgerywithchoiceofskinsubstitutegraftproduct.Theprocedurerisksandcomplicationsshouldalsobereviewedanddocumented.

Applicationofaskinsubstitutegraftforlowerextremitychronicwound(DFUandVLU)willbecoveredwhenthefollowingconditionsaremetfortheindividualpatient:

Presenceofneuropathicdiabeticfootulcer(s)havingfailedtorespondtodocumentedconservativewoundcaremeasuresofgreaterthanfourweeks,duringwhichthepatientiscompliantwithrecommendations,andwithoutevidenceofunderlyingosteomyelitisornidusofinfection.Presenceofavenousstasisulcerlongerthan3monthsdurationwithfailuretorespondtodocumentedappropriatetherapyforgreaterthan1monthwithdocumentedcompliance.Presenceofafullthicknessskinlossulcerthatistheresultofabscess,injuryortraumathathasfailedtorespondtoappropriatecontrolofinfection,foreignbody,tumorresection,orotherdiseaseprocessforaperiodof4weeksorlonger.

Inallwoundmanagementtheulcermustbefreeofinfectionandunderlyingosteomyelitiswithdocumentationoftheconditionsthathavebeentreatedandresolvedpriortotheinstitutionofskinsubstitutetherapy.ForpurposesofthisLCD,appropriatetherapyincludes,butisnotlimitedto:

Controlofedema,venoushypertensionorlymphedemaControlofanynidusofinfectionorcolonizationwithbacterialorfungalelementsEliminationofunderlyingcellulitis,osteomyelitis,foreignbody,ormalignantprocessAppropriatedebridementofnecrotictissueorforeignbody(exposedboneortendon)Fordiabeticfootulcers,appropriatenonweightbearingand/oroffloadingpressureForvenousstasisulcers,compressiontherapyprovidedwithdocumenteddiligentuseofmultilayerdressings,compressionstockingsof>20mmHgpressure,orpneumaticcompressionProvisionofwoundenvironmenttopromotehealing(protectionfromtraumaandcontaminants,eliminationofincitingoraggravatingprocesses)



Limitations:

Duetothepropensityformisuseofskinsubstituteandbiologicaldressingproducts,reimbursementmaybemadeonlywhenthemedicalrecordclearlydocumentsthattheseproductshavebeenusedinacomprehensive,organizedwoundmanagementprogram.Alllistedproducts,unlesstheyarespecificallyFDAlabeledorclearedforuseinthetypesofwoundsbeingtreated,willbeconsideredtobebiologicdressingsandpartoftherelevantEvaluationandManagement(E/M)serviceprovidedandnotseparatelyreimbursed.

Partialthicknesslosswiththeretentionofepithelialappendagesisnotacandidateforgraftingorreplacement,asepitheliumwillrepopulatethedeficitfromtheappendages,negatingthebenefitofovergraftingOnespecificskinsubstitutegraftwillbeallowedfortheepisodeofwoundcareincompliancewithFDAguidelinesforthatspecificproduct(seeutilizationguidelines)nottoexceed10applicationsortreatments.Treatmentofanychronicskinwoundwilltypicallylastnomorethantwelve(12)weeks.Repeatoralternativeapplicationsofskinsubstitutegraftsarenotconsideredmedicallyreasonableandnecessarywhenapreviousfullcourseofapplicationswasunsuccessful.Unsuccessfultreatmentisdefinedasincreaseinsizeordepthofanulcerornochangeinbaselinesizeordepthandnosignofimprovementorindicationthatimprovementislikely(suchasgranulation,epithelializationorprogresstowardsclosing)foraperiodof4weekspaststartoftherapy.Retreatmentofhealedulcers,thoseshowinggreaterthan75%sizereductionandsmallerthan.5sq.cm,isnotconsideredmedicallyreasonableandnecessary.Skinsubstitutegraftsarecontraindicatedandnotconsideredreasonableandnecessaryinpatientswithinadequatecontrolofunderlyingconditionsorexacerbatingfactors(e.g.,uncontrolleddiabetes,activeinfection,andactiveCharcotarthropathyoftheulcerextremity,vasculitisorcontinuedtobaccosmoking.)Skinsubstitutegraftsarecontraindicatedinpatientswithknownhypersensitivitytoanycomponentofthespecificskinsubstitutegraft(e.g.,allergytoavian,bovine,porcine,equineproducts).Repeatuseofsurgicalpreparationservices(CPTcodes15002,15003,15004,and15005)inconjunctionwithskinsubstituteapplicationcodeswillbeconsiderednotreasonableandnecessary.Itisexpectedthateachwoundwillrequiretheuseofappropriatewoundpreparationcodeatleastonceatinitiationofcarepriortoplacementoftheskinsubstitutegraft.Retreatmentwithinone(1)yearofanygivencourseofskinsubstitutetreatmentforavenousstasisulceror(diabetic)neuropathicfootulcerisconsideredtreatmentfailureanddoesnotmeetreasonableandnecessarycriteriaforretreatmentofthatulcerwithaskinsubstituteprocedure.

CMShasguidanceregardingotherspecializedwoundtreatmenttechnologyandspecificallyaddressesplateletrichplasmasystems(e.g.,Autologet,Magellan)negativepressurewoundtherapydevicesandelectromagnetic/ultrasound/misttherapies.TheyarenotaddressedinthisLCDastheirroleinthetreatmentofthetwomajortypesoflowerextremitywoundsdiscussedhereislimited.Utilizationremainsattheprovidersdiscretionandmustbereasonableandnecessary.Notethatcombinationtherapywithanybioengineeredskinsubstitute(CTP)willbeconsiderednotreasonableandnecessary.

PleaseNote:AutologousPlateletRichPlasma(PRP)systemsusedinthetreatmentofChronicNonHealingWoundsisnotconsideredreasonableandnecessaryexceptasdescribedinNationalCoverageDetermination(NCD)forBloodDerivedProductsforChronicNonHealingWounds(270.3).PleaserefertotheNCDforcoveragedetails.

AspublishedinCMSIOM10008,Chapter13,Section13.5.1,inordertobecoveredunderMedicare,aserviceshallbereasonableandnecessary.Whenappropriate,contractorsshalldescribethecircumstancesunderwhichtheproposedLCDfortheserviceisconsideredreasonableandnecessaryunderSection1862(a)(1)(A).Contractorsshallconsideraservicetobereasonableandnecessaryifthecontractordeterminesthattheserviceis:

Safeandeffective.Notexperimentalorinvestigational(exception:routinecostsofqualifyingclinicaltrialserviceswithdatesofserviceonorafterSeptember19,2000,thatmeettherequirementsoftheClinicalTrialsNCDareconsideredreasonableandnecessary).Appropriate,includingthedurationandfrequencythatisconsideredappropriatefortheservice,intermsofwhetheritis:

Furnishedinaccordancewithacceptedstandardsofmedicalpracticeforthediagnosisortreatmentofthepatientsconditionortoimprovethefunctionofamalformedbodymember.Furnishedinasettingappropriatetothepatientsmedicalneedsandcondition.Orderedandfurnishedbyqualifiedpersonnel.Onethatmeets,butdoesnotexceed,thepatientsmedicalneeds.Atleastasbeneficialasanexistingandavailablemedicallyappropriatealternative.

Italicizedand/orquotedmaterialisexcerptedfromtheAmericanMedicalAssociation,CurrentProceduralTerminology(CPT)codes.

CodingInformation

BillTypeCodes

ContractorsmayspecifyBillTypestohelpprovidersidentifythoseBillTypestypicallyusedtoreportthisservice.AbsenceofaBillTypedoesnotguaranteethatthepolicydoesnotapplytothatBillType.CompleteabsenceofallBillTypesindicatesthatcoverageisnotinfluencedbyBillTypeandthepolicyshouldbeassumedtoapplyequallytoallclaims.

999x NotApplicable

RevenueCodes

ContractorsmayspecifyRevenueCodestohelpprovidersidentifythoseRevenueCodestypicallyusedtoreportthisservice.InmostinstancesRevenueCodesarepurelyadvisoryunlessspecifiedinthepolicyservicesreportedunderotherRevenueCodesareequallysubjecttothiscoveragedetermination.CompleteabsenceofallRevenueCodesindicatesthatcoverageisnotinfluencedbyRevenueCodeandthepolicyshouldbeassumedtoapplyequallytoallRevenueCodes.

99999 NotApplicable



CPT/HCPCSCodes

Group1Paragraph

Note:ProvidersareremindedtorefertothelongdescriptorsoftheCPTcodesintheirCPTbook.

Group1Codes

15002 Woundpreptrk/arm/leg

15003 Woundprepaddl100cm

15004 Woundprepf/n/hf/g

15005 Wndprepf/n/hf/gaddlcm

15040 Harvestculturedskingraft

15050 Skinpinchgraft

15271 Skinsubgrafttrnk/arm/leg

15272 Skinsubgraftt/a/laddon

15273 Skinsubgrftt/arm/lgchild

15274 Sknsubgrftt/a/lchildadd

15275 Skinsubgraftface/nk/hf/g

15276 Skinsubgraftf/n/hf/gaddl

15277 Sknsubgrftf/n/hf/gchild

15278 Sknsubgrftf/n/hf/gchadd

C5271 Lowcostskinsubstituteapp








Group2Paragraph

HCPCScodesincludedinthislistareinclusiveofknownFDAapprovedbioengineeredwounddressings,skinsubstitutes,matrixesorscaffoldingforchroniculcertreatmentasofpublication.EachproducthasspecificFDAdesignatedapprovedusage.Therefore,anyHCPCScodethatisnotincludedinthislistwillnotbeseparatelyreimbursed.(Pleaserefertothelimitationssection)

Group2Codes

Q4100 Skinsubstitute,NOS

Q4101 Apligraf

Q4102 Oasiswoundmatrix

Q4103 Oasisburnmatrix

Q4104 IntegraBMWD

Q4105 IntegraDRT

Q4106 Dermagraft

Q4107 Graftjacket

Q4108 Integramatrix

Q4110 Primatrix

Q4111 Gammagraft

Q4115 Alloskin

Q4117 Hyalomatrix

Q4118 Matristemmicromatrix

Q4119 Matristemwoundmatrix

Q4120 Matristemburnmatrix

Q4121 Theraskin

Q4122 Dermacell

Q4123 Alloskin

Q4124 Oasistrilayerwoundmatrix

Q4126 Memoderm/derma/tranz/integup

Q4127 Talymed

Q4129 Unitebiomatrix



Q4131 Epifix

Q4132 Grafixcore

Q4133 Grafixprime

Q4134 hMatrix

Q4135 Mediskin

Q4136 EZderm

Q4137 Amnioexcelorbiodexcel,1cm

Q4140 Biodfence1cm

Q4141 Alloskinac,1cm

Q4148 Neox1k,1cm

Q4152 Dermapure1squarecm

Q4156 Neox1001squarecm

ICD9CodesthatSupportMedicalNecessity

Group1Paragraph:ItistheprovidersresponsibilitytoselectcodescarriedouttothehighestlevelofspecificityandselectedfromtheICD9CMcodebookappropriatetotheyearinwhichtheserviceisrenderedfortheclaim(s)submitted.

Group1Codes

XX000 NotApplicable

ICD9CodesthatDONOTSupportMedicalNecessityAllthosenotlistedundertheICD9CodesthatSupportMedicalNecessitysectionofthispolicy.

XX000 NotApplicable

GeneralInformation

AssociatedInformationDocumentationRequirements

1. Alldocumentationmustbemaintainedinthepatientsmedicalrecordandmadeavailabletothecontractoruponrequest.2. Everypageoftherecordmustbelegibleandincludeappropriatepatientidentificationinformation(e.g.,completename,datesof

service(s)).Thedocumentationmustincludethelegiblesignatureofthephysicianornonphysicianpractitionerresponsibleforandprovidingthecaretothepatient.

3. ThesubmittedmedicalrecordmustsupporttheuseoftheselectedICD9CMcode(s).ThesubmittedCPT/HCPCScodemustdescribetheserviceperformed.

4. Medicalrecorddocumentationmustsupportthemedicalnecessityoftheservicesasdirectedinthispolicy.5. Thedocumentationmustsupportthattheservicewasperformedandmustbeincludedinthepatientsmedicalrecord.Thisinformationis

normallyfoundinthehistoryandphysical,office/progressnotes,hospitalnotes,and/orprocedurereport.6. ThemedicalrecordmustclearlyshowthatthecriterialistedundertheIndicationsandLimitationsofCoverageand/orMedicalNecessity

sectionshavebeenmet,aswellas,theappropriatediagnosisandresponsetotreatment.7. Thedocumentationmustsupporttheneedforskinsubstituteapplicationandtheproductused.8. Adescriptionofthewound(s)mustbedocumentedatbaseline(priortobeginningconservativetreatment)relativetosize,location,stage,

duration,andpresenceofinfection,inadditiontotypeoftreatmentgivenandresponse.a. Thisinformationmustbeupdatedinthemedicalrecordthroughouttreatment.b. Wounddescriptionmustalsobedocumentedpreandposttreatmentwiththeskinsubstitutegraftbeingused.c. Ifobvioussignsofworseningorlackoftreatmentresponseisnoted,continuingtreatmentwiththeskinsubstitutewouldnotbe

consideredmedicallyreasonableandnecessarywithoutdocumentationofareasonablerationalefordoingso.9. Documentationofsmokinghistory,andthatthepatienthasreceivedcounselingontheeffectsofsmokingonsurgicaloutcomesand

treatmentforsmokingcessation(ifapplicable)aswellasoutcomeofcounsellingmustbeinthemedicalrecord.Apatientthatcontinuestousetobaccoproductsonaregularbasisthrua4weektrialofappropriatewoundcarepriortoplacementofskingraftorbioengineeredskinsubstitutewillbeconsiderednoncoveredfortreatmentwithanyformofgraftorskinsubstitutegraft.

10. Theamountofutilizedandwastedskinsubstitutemustbeclearlydocumentedintheprocedurenotewiththefollowingminimuminformation:

Date,timeandlocationofulcertreatedNameofskinsubstituteandhowproductsuppliedAmountofproductunitusedAmountofproductunitdiscardedReasonforthewastageManufacturersserial/lot/batchorotherunitidentificationnumberofgraftmaterial.Whenmanufacturerdoesnotsupplyunitidentification,recordmustdocumentsuch.

Note:Novitasexpectsthatwheremultiplesizesofaspecificproductareavailable,thesizethatbestfitsthewoundwiththeleastamountofwastagewillbeutilized.

UtilizationGuidelines

InaccordancewithCMSRuling951(V),utilizationoftheseservicesshouldbeconsistentwithlocallyacceptablestandardsofpractice.

Itistheexpectationthataspecificskinsubstituteproductwillbeusedfortheepisodeofeachdocumentedwound,andincompliancewithFDA



assessmentsandsubmittedguidelinesforthespecificproduct.Greaterthanten(10)applicationsforthetreatmentofasinglewoundwithina12weekperiodoftime,willbeconsideredNotReasonableandNecessaryandwillbesubjecttoreview.

Separatelybilledrepeateduseoftheskinsubstituteafter12weeksforasinglewoundorepisodeisnoncovered.Alternativeoradditionalskinsubstituteproductsusedwithinthe12weekinitialwoundepisodearesimilarlynoncoveredwhenthesumofapplicationsofallSkinSubstitutesisgreaterthanten(10)forasinglewound.

Theutilizationofbioengineeredskinsubstitutenoncompliantwithmedicalnecessityordesignatedguidelinesforthatspecificproductmaynecessitatereviewornoncoverageasnotmedicallynecessary.

Labelingformostskinsubstitutegraftsincludelanguagesuggestingmultipleapplicationshowever,Medicaredoesnotexpectthateveryulcerineverypatientwillrequirethemaximumnumberofapplicationslistedontheproductlabelorallowedforreimbursement.

Utilizationrates,thatexceedpeernorms,identifiedthroughdataanalysismaypromptprepaymentorpostpaymentmedicalreview.

SourcesofInformationandBasisforDecisionNote:SomereferencessourcesarelistedbyrequestofSkinSubstituteproductstakeholdersandshouldnotbeinterpretedasNovitasendorsementofanyspecificproduct.

Contractorisnotresponsibleforthecontinuedviabilityofwebsiteslisted.

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FoodandDrugAdministration(FDA)[website].CenterforDevicesandRadiologicalHealth(CDRH).510(k)PremarketNotificationDatabase[search:K061711].OasisWoundMatrix.July19,2006b.Availableathttp://www.accessdata.fda.gov/cdrh_docs/pdf6/K061711.pdf.

FoodandDrugAdministration(FDA)[website].CenterforDevicesandRadiologicalHealth(CDRH).PremarketApproval(PMA)Database[search:H990002].Epicel(culturedepidermalautografts)H990002.October25,2007.Availableat:http://www.accessdata.fda.gov/cdrh_docs/pdf/H990002a.pdf.

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FotiC,BonamonteD,ConservaA,AngeliniG.Allergiccontactdermatitistoregeneratedoxidizedcellulosecontainedinamatrixemployedforwoundtherapy.ContactDermatitis.200757(1):4748.

FranzMG,RobsonMC,SteedDL,BarbulA,BremH,CooperDM,etal.Guidelinestoaidhealingofacutewoundsbydecreasingimpedimentsofhealing.WoundRepairRegen.200816(6):723748.

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GelfandJM,HoffstadO,MargolisDJ,SurrogateEndpointsfortheTreatmentofVenousLegUlcers.TheJournalofInvestigativeDermatology.December2002119(6):14201425.

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HanftJ,SurprenantMS.HealingofChronicFootUlcersinDiabeticPatientsTreatedwithaHumanFibroblastDerivedDermis.JFoot&AnkleSurgery,200241(5):291299.

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Hayes,WinifredS.DirectoryReport.Biologicaltissueengineeredskinsubstitutesforwoundhealing.January17,2013.Availableat:http://www.hayesinc.com.

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JonesI,CurrieL,MartinR.Aguidetobiologicalskinsubstitutes.BrJPlastSurg.200255(3):185193.

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LCDsandpoliciesfromotherMedicarecontractorsandprivateinsurers

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ContractorMedicalDirectors

OriginalJHLCD,L32622,BioengineeredSkinSubstitutes.

RevisionHistoryInformation

RevisionHistoryRevisionNumber EffectiveDate Explanation ReasonforChange

R5 04/09/2015 LCDpostedfornoticeon02/20/2015tobecomeeffective04/09/2015.

09/18/2014DraftLCDpostedforcomment.

LinktothisLCDontheMCD:

Lookingformoredetail?ViewthispolicyattheCMSMedicareCoverageDatabase(MCD)foryourstatebychoosingtheappropriatelink:

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Keywords

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