Skin Subistute Grafts Application

2/24/2015
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LocalCoverageDetermination(LCD):ApplicationofBioengineeredSkin
SubstitutestoLowerExtremityChronicNonHealingWounds(L27549)
ContractorInformation
ContractorName
NovitasSolutions,
Inc.
Contract
Type
AandB
MAC
Contract
Number
12402
LCDInformation
DocumentInformation
LCDID
L27549
Jurisdiction
LCDTitle
OriginalEffectiveDate
Forservicesperformedonorafter07/11/2008
NewJersey
ApplicationofBioengineeredSkinSubstitutestoLowerExtremity
ChronicNonHealingWounds
RevisionEffectiveDate
Forservicesperformedonorafter04/09/2015
RetirementDate
N/A
NoticePeriodStartDate
02/20/2015
NoticePeriodEndDate
04/08/2015
RevisionEndingDate
AMACPT/ADACDTCopyrightStatement
N/A
CPTonlycopyright20022015AmericanMedicalAssociation.AllRights
Reserved.CPTisaregisteredtrademarkoftheAmericanMedical
Association.ApplicableFARS/DFARSApplytoGovernmentUse.Fee
schedules,relativevalueunits,conversionfactorsand/orrelated
componentsarenotassignedbytheAMA,arenotpartofCPT,andthe
AMAisnotrecommendingtheiruse.TheAMAdoesnotdirectlyor
indirectlypracticemedicineordispensemedicalservices.TheAMA
assumesnoliabilityfordatacontainedornotcontainedherein.
TheCodeonDentalProceduresandNomenclature(Code)ispublished
inCurrentDentalTerminology(CDT).CopyrightAmericanDental
Association.Allrightsreserved.CDTandCDT2010aretrademarksof
theAmericanDentalAssociation.
UB04Manual.OFFICIALUB04DATASPECIFICATIONSMANUAL,2014,
iscopyrightedbyAmericanHospitalAssociation(AHA),Chicago,
Illinois.NoportionofOFFICIALUB04MANUALmaybereproduced,
sortedinaretrievalsystem,ortransmitted,inanyformorbyany
means,electronic,mechanical,photocopying,recordingorotherwise,
withoutpriorexpress,writtenconsentofAHA.HealthForumreserves
therighttochangethecopyrightnoticefromtimetotimeuponwritten
noticetoCompany.
CMSNationalCoveragePolicy
ThisLCDsupplementsbutdoesnotreplace,modifyorsupersedeexistingMedicareapplicableNationalCoverageDeterminations(NCDs)orpayment
policyrulesandregulationsforbioengineeredskinsubstitutes.FederalstatuteandsubsequentMedicareregulationsregardingprovisionand
paymentformedicalservicesarelengthy.TheyarenotrepeatedinthisLCD.NeitherMedicarepaymentpolicyrulesnorthisLCDreplace,modifyor
supersedeapplicablestatestatutesregardingmedicalpracticeorotherhealthpracticeprofessionsacts,definitionsand/orscopesofpractice.All
providerswhoreportservicesforMedicarepaymentmustfullyunderstandandfollowallexistinglaws,regulationsandrulesforMedicarepayment
forbioengineeredskinsubstitutesandmustproperlysubmitonlyvalidclaimsforthem.Pleasereviewandunderstandthemandapplythemedical
necessityprovisionsinthepolicywithinthecontextofthemanualrules.RelevantCMSmanualinstructionsandpoliciesregardingbioengineeredskin
substitutesarefoundinthefollowingInternetOnlyManuals(IOMs)publishedontheCMSWebsite:
CMSInternetOnlyManual(IOM),Pub.10004,MedicareClaimsProcessingManual,Chapter17,Section40.
CMSInternetOnlyManual(IOM).Pub.10003,MedicareNationalCoverageDeterminationsManual,Chapter1,Part4,Section270.13.
http://www.novitassolutions.com/LCDSearchResults/faces/spaces/search/page/lcd.jspx?_adf.ctrlstate=xkrchd16h_4
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CMSChangeRequest,CR8213AutologousPlateletRichPlasma(PRP)forChronicNonHealingWoundsissuedJune10,2013
SocialSecurityAct(XVIII)StandardReferences:
TitleXVIIIoftheSocialSecurityAct,1862(a)(1)(A)statesthatnoMedicarepaymentshallbemadeforitemsorserviceswhichare
notreasonableandnecessaryforthediagnosisortreatmentofillnessorinjury.
TitleXVIIIoftheSocialSecurityAct,Section1833(e)statesthatnopaymentshallbemadetoanyproviderforanyclaimthatlacks
thenecessaryinformationtoprocesstheclaim.
TitleXVIIIoftheSocialSecurityAct,Section1862(a)(7).Thissectionexcludesroutinephysicalexaminations.
CoverageGuidance
CoverageIndications,Limitations,and/orMedicalNecessity
Notice:ItisnotappropriatetobillMedicareforservicesthatarenotcovered(asdescribedbythisentireLCD)asiftheyarecovered.Whenbilling
fornoncoveredservices,usetheappropriatemodifier.
Compliancewiththeprovisionsinthispolicymaybemonitoredandaddressedthroughpostpaymentdataanalysisandsubsequentmedicalreview
audits.
TheadditionofSkinSubstitutesorCellularand/orTissueBasedProducts(CTPs)tocertainwoundsmayaffordahealingadvantageoverdressingsand
conservativetreatmentswhentheseoptionsappearinsufficienttoaffectcompletehealing.
Therearecurrentlyawidevarietyofbioengineeredproductsavailableforsofttissuecoveragetoaffectclosure.Theseproductsmaybederivedfrom
allogeneic,xenogeneic,syntheticsourcesoracombinationofanyorallofthesetypesofmaterials.However,withoutthecomponentofthe
recipientsowndistinctepitheliumandcellularskinelements,permanentskinreplacementorcoveragebythegraftcannotbeaccomplished.
Autologousskingrafts,alsoreferredtoasautografts,arepermanentcoversthatuseskinfromdifferentpartsoftheindividualsbody.These
graftsconsistoftheepidermisandadermalcomponentofvariablethickness.Asplitthicknessskingraft(STSG)includestheentireepidermisanda
portionofthedermis.Afullthicknessskingraft(FTSG)includesalllayersoftheskin.Althoughautograftsaretheoptimalchoiceforfullthickness
woundcoverage,areasforskinharvestingmaybelimited,particularlyincasesoflargeburnsorvenousstasisulceration.Harvestingproceduresare
painful,disfiguringandrequireadditionalwoundcare.
Allograftswhichuseskinfromanotherhuman(e.g.,cadaver)andXenograftswhichuseskinfromanotherspecies(e.g.,porcineorbovine)may
alsobeemployedastemporaryskinreplacements,buttheymustlaterbereplacedbyanautograftortheingrowthofthepatientsownskin.
BioengineeredSkin/CulturedEpidermalAutografts(CEA)areautograftsderivedfromthepatientsownskincellsgrownorculturedfrom
verysmallamountsofskinorhairfollicle.Productiontimeisprolonged.Onesuchproductisgrownonalayerofirradiatedmousecells,bestowing
someelementsofaxenograft.Widespreadusagehasnotbeenavailableduetolimitedavailabilityoraccesstothetechnology.
BioengineeredSkinSubstitutesorCellularandTissueBasedProducts(CTPs),referredtoasSkinSubstitutesbyCMS,TheCurrent
ProceduralTerminology(CPT)andTheHealthcareCommonProcedureCodingManualshavebeendevelopedinanattempttocircumvent
problemsinherentwithautografts,allograftsandxenografts.Theseconstitutebiologiccoversforrefractorywoundswithfullthicknessskinloss
secondaryto3rddegreeburnsorotherdiseaseprocessessuchasdiabeticneuropathiculcersandtheskinlossofchronicvenousstasisorvenous
hypertension.TheproductionofthesebiologicskinsubstitutesorCTPsvariesbycompanyandproduct,butgenerallyinvolvesthecreationof
immunologicallyinertbiologicalproductscontainingprotein,hormonesorenzymesseededintoamatrixwhichmayprovideproteinorgrowthfactors
proposedtostimulateorfacilitatehealingorpromoteepithelization.Avarietyofbiosyntheticandtissueengineeredskinsubstitutionproducts
marketedasHumanSkinEquivalents(HSE)orCellularand/orTissuebasedProducts(CTP)aremanufacturedunderanarrayoftrade
namesandmarketedforavarietyofindications.Allareprocured,produced,manufactured,processedandpromotedinsufficientlydifferentmanners
toprecludedirectproductcomparisonforequivalencyorsuperiorityinrandomizedcontrolledtrials.Sufficientdataisavailabletoestablishdistinct
inferioritytohumanskinautograftsandprecludetheirdesignationasskinequivalence.
BioengineeredskinsubstitutesorCTPsareclassifiedintothefollowingtypes:
Humanskinallograftsderivedfromdonatedhumanskin(cadavers)
Allogeneicmatricesderivedfromhumantissue(fibroblastsormembrane)
Compositematricesderivedfromhumankeratinocytes,fibroblastsandxenogeneiccollagen
Acellularmatricesderivedfromxenogeneiccollagenortissue
HumanSkinAllograftsarebioengineeredfromhumanskincomponentsandhumantissuewhichhavehadintactcellsremovedand/ortreatedto
avoidimmunologicrejection.Theyareavailableindifferentformspromotedtoallowscaffolding,softtissuefilling,growthfactorsandother
bioavailablehormonalorenzymaticactivity.
AllogeneicMatricesareusuallyderivedfromhumanneonatalfibroblastsoftheforeskinthatmaycontainmetabolicallyactiveorregenerative
componentsprimarilyusedforsofttissuesupport,thoughsomehavebeenapprovedforthetreatmentoffullthicknessskinandsofttissueloss.Most
arebiodegradableanddisappearafter34weeksimplantation.
CompositeMatricesarederivedfromhumankeratinocytesandfibroblastssupportedbyascaffoldofsyntheticmeshorxenogeneiccollagen.These
arealsoreferredtoashumanskinequivalentbutareunabletobeusedasautograftsduetoimmunologicrejectionordegradationoftheliving
componentsbythehost.Activecellularcomponentscontinuetogeneratebioactivecompoundsandproteinthatmayacceleratewoundhealingand
epithelialregrowth.
AcellularMatricesarederivedfromotherthanhumanskinandincludethemajorityofbioengineeredskinsubstitutes.Allarecomposedof
allogeneicorxenogeneicderivedcollagen,membrane,orcellularremnantsproposedtosimulateorexaggeratethecharacteristicsofhumanskin.All
proposetopromotehealingbythecreationoflocalizedintensificationofanarrayofhormonalandenzymaticactivitytoaccelerateclosureby
migrationofnativedermalandepithelialcomponents,ratherthanfunctionasdistinctlyincorporatedtissueclosingtheskindefect.
ForthepurposeofthisLCD,considerationisgiventotheuseofdermaland/orepidermalsubstitutetissueofhumanornonhumanorigin,withor
withoutbioengineeredorprocessedelements,withorwithoutmetabolicallyactiveelements,withadesignateduseascoverageforasuperficialskin
deficitthathaspersisted,despiteoptimalwoundcareforaperiodof4weeksorgreater.TheseproductsarethosereferredtoasHumanCellular
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and/orTissueBasedProducts(CTPs)orSkinSubstitutes.
Evaluationoftheclinicalliteratureindicatesthatstudiescomparingtheefficacyofbioengineeredskinsubstitutetoalternativewoundcare
approacheswithpatientsautologousskinarelimitedinnumber,applymainlytogenerallyhealthypatients,andexamineonlyasmallportionofthe
skinsubstituteproductsavailableintheUnitedStates.Therefore,allproductswithFDAclearance/approvalordesignated361HCT/P
exemptionusedinaccordancewiththatproductsindividualizedapplicationguidelineswillbeequallyconsideredforthepurpose
ofthisLCDandmaybeconsideredreasonableandnecessary.
RegulatoryStatus
USFoodandDrugAdministration(FDA)GoverningSkinSubstituteProducts
TheU.S.FoodandDrugAdministration(FDA)doesnotrefertoanyproductorclassofproductsasskinsubstitutes.However,productscommonly
describedasskinsubstitutesareregulatedbyFDAunderoneofthefourcategoriesdescribedbelowdependingontheoriginandcompositionofthe
productandlistedasaSkinSubstitutewithaHCPCScodeQ41XX.
1. HumanCells,Tissues,andCellularandTissueBasedProductsCellsandtissuestakenfromhumandonorsandtransplantedtoa
recipientareregulatedunderPHS361[21CFR1270&1271].ThisregulationdescribestherulesconcerningtheuseofHCT/Psforhuman
medicalpurposes.Thefinalrule,21CFRPart1271,becameeffectiveonApril4,2001,forhumantissuesintendedfortransplantationthat
areregulatedundersection361ofthePHSActand21CFRPart1270.HCT/PsareregulatedbytheCenterforBiologicsEvaluationand
Research(CBER).CBERisresponsibleforregulatingbiologicalandrelatedproductsincludingblood,vaccines,allergenics,tissues,and
cellularandgenetherapies.EstablishmentsproducingHCT/PsmustregisterwithFDAandlisttheirHCT/Ps.HCT/Psestablishmentsarenot
requiredtodemonstratethesafetyoreffectivenessoftheirproductsandFDAdoesnotevaluatethesafetyoreffectivenessofthese
products.
2. PremarketApprovalPremarketapproval(PMA)byFDAistherequiredprocessofscientificreviewtoensurethesafetyandeffectiveness
ofClassIIIdevices.BeforeClassIIIdevicescanbemarketed,theymusthaveanapprovedPMAapplication.Therefore,woundcareproducts
regulatedunderthePMAprocesswillrequireevidencethattheypromotewoundhealingbeforetheyareapprovedformarketing.
3. 510(k)SubmissionsAccordingtoFDAdocumentsa510(k)isapremarketsubmissionmadetoFDAtodemonstratethatthedevicetobe
marketedisatleastassafeandeffective,thatis,substantiallyequivalent(SE),toalegallymarketeddevice(21CFR807.92(a)(3))thatisnot
subjecttoPMA."Submittersmustcomparetheirdevicetooneormoresimilarlegallymarketeddevicesandmakeandsupporttheir
substantialequivalencyclaims.UnlikePMA,510(k)confersreasonableassuranceofsafetyandeffectivenessviademonstrationofsubstantial
equivalencetoalegallymarketeddevicethatdoesnotrequirepremarketapproval.Therefore,woundcareproductsregulatedunderthe
510(k)processwillnottypicallyrequireclinicalevidencetoestablisheffectivenessinwoundhealing,ascomparedwithproductsregulated
underthePMAprocessinwhichsubstantialclinicalevidenceisalwaysrequired.
4. HumanitarianDeviceExemptionAnHDEissimilarinbothformandcontenttoapremarketapproval(PMA)application,butisexempt
fromtheeffectivenessrequirementsofaPMA.AnHDEapplicationisnotrequiredtocontaintheresultsofscientificallyvalidclinical
investigationsdemonstratingthatthedeviceiseffectiveforitsintendedpurpose.Theapplicantmustdemonstratethatnocomparable
devicesareavailabletotreatordiagnosethediseaseorcondition,andthattheycouldnototherwisebringthedevicetomarket.HDE
approvalisbasedonevidenceofprobablebenefitinadiseasepopulationoccurringatafrequencyoflessthan4,000patientsperyearinthe
UnitedStates.
Updateddesignationandapprovedusagecriteriamaybefoundat
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances.
ExpandedclassificationcriteriaandexplanationisincludedintheHHS/AHRSFinalReport,December18,2012entitledSkinSubstitutesfor
TreatingChronicWounds
PertheAmericanMedicalAssociationandtheCPTManual,SkinReplacementSurgeryorSkinSubstituteGraftingisaconceptualmodelfocusingon
theworkandservicesprovidedregardlessoftheproductused.Thisremovestherequirementformaintenanceandeducationontheuseofsupply
codesthathavelittleimpactonthe"typicalpatient"ortheprovidereffortforapplicationoftheproduct.Theapplicationofskinsubstitute(orCTP)is
distinguishedaccordingtothewoundcharacteristicsandsurfacearearatherthanbyproductdescription.Currently,noproducthasdemonstrated
individualsuperiorityforthetreatmentofdiabeticfootulcers(DFU)andvenouslegulcers(VLU)ofthelowerextremity,and,frequentlysuchproducts
areutilizedinappropriately.
Nongraftwounddressingsaregenerallyincludedinstandardwoundcaremanagementsuchproductsmayprovidevalueand,infact,maypreclude
theneedforskinsubstituteapplication.
Standardtreatmentofchroniclowerextremityulcersorskinloss(e.g.,DFUand/orVLU)primarilyincludesinfectionandedemacontrol,mechanical
offloading,mechanicalcompressionorlimbelevation,debridementofnecroticorinfectedtissue,andmanagementofconcomitantandinciting
medicalissues(bloodglucosecontrol,tobaccouse).Maintenanceofatherapeuticenvironmentwithappropriatedressingstoprecludefurthertrauma
facilitatesdevelopmentofhealthygranulationtissueandencouragesreepithelialization.Awoundthatfailstoshowevidenceofhealingby
contractionandadvancementofepithelialmarginsfollowing4weeksofoptimization,includingallaspectsofstandardtherapy,isconsidereda
chronicnonhealingwoundandfallsintotheauspicesofthisLCD.Thefundamentalbasisfornonhealingofawoundisofparamountimportanceand
mustbecorrectedpriortoconsiderationofadditionaltherapy.
Thedepthofskinlossisthedeterminantofitsabilitytoreturn..Fullthicknessskinloss,implyingthelossofallelementsoftheepidermisanddermis,
willrequirereepithelizationofthesurfaceonceacleangranularbaseisestablished.Bothfullandpartialthicknessskinlossmaybenefitfrom
enhancedproductsreferredtoasSkinSubstitutes.Thoughnoskinsubstitutesarecapableofreplacingthepatientsownskin,theyhavebeen
demonstratedtoallowscaffoldingforthegrowthofepithelium,enzymaticcleansingandprovisionofgrowthfactorsbeneficialtodeficitreduction
andreepithelization.
Thisdocumentaddressesthemanagementofchronicnonhealingwoundsorskindeficitsofthelowerextremitieswiththegoalofwoundandskin
closurewhenstandardorconservativemeasureshavefailed.Whilelowerextremityulcershavenumerouscausessuchasburns,trauma,immobility,
ischemiaorotherneurologicimpairment,over90%ofthelesionsarerelatedtovenousstasisdiseaseanddiabeticneuropathy.Therefore,thefocus
ofthispolicyistheapplicationofbioengineeredskinsubstitutematerialtodiabeticfootulcersandvenouslegulcersofthelowerextremitiesandthe
reasonableandnecessary(R&N)thresholdforutilizationofskinsubstitutes.Particularemphasisisplacedontheindicationsforapplicationof
bioengineeredskinsubstitutematerialforDFUandVLU.
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Patientsreceivingaskinsubstitutegraftmustbeunderthecareofaphysicianlicensedbythestatewithfullscopeofpracticeforthetreatmentof
thesystemicdiseaseprocess(s)etiologicforthecondition(e.g.,venousinsufficiency,diabetes,neuropathy).Thisconcurrentmedicalmanagement
andtheidentityofthemanagingmedicalphysicianshallbeclearlydiscernableinthemedicalrecordandavailableuponrequest.
Medicarecoverageforwoundcareonacontinuingbasis,forasinglewound,inanindividualpatientiscontingentuponevidencedocumentedinthe
patientsmedicalrecordthatthewoundisimprovinginresponsetothewoundcarebeingprovided.Sinceitisneitherreasonablenormedically
necessarytocontinueagiventypeofwoundcareintheabsenceofwoundimprovement,itisexpectedthatthewoundsresponsetotreatmentwillbe
documentedinthemedicalrecordatleastonceevery30daysforeachepisodeofwoundtreatmentandmadeavailabletothecontractorupon
request.
Documentationofresponserequiresmeasurementsoftheinitialulcer,measurementsatthecompletionofatleastfourweeksofappropriate
woundcareandmeasurementsimmediatelypriortoplacementandwitheachsubsequentplacementofthebioengineeredskinsubstituteorCTP.
DefinitionsperCPT:
Autografts/tissueculturedautografts:Includetheharvestand/orapplicationofanautologousskingraft.
Skinsubstitutegrafts:Includenonautologoushumancellularandtissueproducts(e.g.,dermalorepidermal,cellularandacellular,homograftor
allograft),nonhumancellularortissueproducts(i.e.,xenograft),andbiologicalproducts(syntheticorxenogeneic)thatareappliedinasheetoveran
openwoundtoaugmentwoundclosureand/orskingrowth.
Indications:
ChronicWoundsaredefinedaswoundsthatdonotrespondtostandardwoundtreatmentforatleasta30dayperiodduringorganized
comprehensiveconservativetherapy.
Forallwounds,documentation(asoutlinedinthedocumentationrequirementsofthepolicy)andacomprehensivetreatmentplan,beforeinitiation
ofaspecializedwoundtherapyproductisrequired.
FailedResponseappliestoulcersorskindeficitsthathavefailedtorespondtodocumentedappropriatewoundcaremeasures,haveincreasedin
sizeordepth,orhasnochangeinbaselinesizeordepthornoindicationthatimprovementislikely(suchasgranulation,epithelializationorprogress
towardsclosing).
UlcersorWoundswithFailedResponsetoappropriatetherapyare:
Partialand/orfullthicknessulcers,notinvolvingtendon,muscle,jointcapsuleorexhibitingexposedboneorsinustracts,withaclean
granularbase
Skindeficitatleast1.0cminsize
Cleanandfreeofnecroticdebrisorexudate
Haveadequatecirculation/oxygenationtosupporttissuegrowth/woundhealingasevidencedbyphysicalexamination(e.g.,AnkleBrachial
Index(ABI)ofnolessthan0.60,toepressure>30mmHg)
Patientisanonsmoker,orhasrefrainedfromsystemictobaccointakeforatleast4weeksduringconservativewoundcareandpriorto
plannedbioengineeredskinreplacementtherapy
Fordiabeticfootulcers,thepatientsmedicalrecordreflectsadiagnosisofType1orType2Diabetesandalsoreflectsmedicalmanagement
forthiscondition
Documentation(inthepreservicerecord)specificallyaddressingcircumstancesastowhythewoundhasfailedtorespondtostandardwound
caretreatmentofgreaterthan4weeksandmustreferencespecificinterventionsthathavefailed.Suchrecordshouldincludeupdated
medicationhistory,reviewofpertinentmedicalproblemsthatmayhaveoccurredsincethepreviouswoundevaluation,andexplanationofthe
plannedskinreplacementsurgerywithchoiceofskinsubstitutegraftproduct.Theprocedurerisksandcomplicationsshouldalsobereviewed
anddocumented.
Applicationofaskinsubstitutegraftforlowerextremitychronicwound(DFUandVLU)willbecoveredwhenthefollowingconditionsaremetforthe
individualpatient:
Presenceofneuropathicdiabeticfootulcer(s)havingfailedtorespondtodocumentedconservativewoundcaremeasuresofgreaterthan
fourweeks,duringwhichthepatientiscompliantwithrecommendations,andwithoutevidenceofunderlyingosteomyelitisornidusof
infection.
Presenceofavenousstasisulcerlongerthan3monthsdurationwithfailuretorespondtodocumentedappropriatetherapyforgreaterthan
1monthwithdocumentedcompliance.
Presenceofafullthicknessskinlossulcerthatistheresultofabscess,injuryortraumathathasfailedtorespondtoappropriatecontrolof
infection,foreignbody,tumorresection,orotherdiseaseprocessforaperiodof4weeksorlonger.
Inallwoundmanagementtheulcermustbefreeofinfectionandunderlyingosteomyelitiswithdocumentationoftheconditionsthathave
beentreatedandresolvedpriortotheinstitutionofskinsubstitutetherapy.ForpurposesofthisLCD,appropriatetherapyincludes,butisnot
limitedto:
Controlofedema,venoushypertensionorlymphedema
Controlofanynidusofinfectionorcolonizationwithbacterialorfungalelements
Eliminationofunderlyingcellulitis,osteomyelitis,foreignbody,ormalignantprocess
Appropriatedebridementofnecrotictissueorforeignbody(exposedboneortendon)
Fordiabeticfootulcers,appropriatenonweightbearingand/oroffloadingpressure
Forvenousstasisulcers,compressiontherapyprovidedwithdocumenteddiligentuseofmultilayerdressings,compressionstockings
of>20mmHgpressure,orpneumaticcompression
Provisionofwoundenvironmenttopromotehealing(protectionfromtraumaandcontaminants,eliminationofincitingoraggravating
processes)
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Limitations:
Duetothepropensityformisuseofskinsubstituteandbiologicaldressingproducts,reimbursementmaybemadeonlywhenthemedicalrecord
clearlydocumentsthattheseproductshavebeenusedinacomprehensive,organizedwoundmanagementprogram.Alllistedproducts,unless
theyarespecificallyFDAlabeledorclearedforuseinthetypesofwoundsbeingtreated,willbeconsideredtobebiologic
dressingsandpartoftherelevantEvaluationandManagement(E/M)serviceprovidedandnotseparatelyreimbursed.
Partialthicknesslosswiththeretentionofepithelialappendagesisnotacandidateforgraftingorreplacement,asepitheliumwillrepopulate
thedeficitfromtheappendages,negatingthebenefitofovergrafting
OnespecificskinsubstitutegraftwillbeallowedfortheepisodeofwoundcareincompliancewithFDAguidelinesforthatspecificproduct
(seeutilizationguidelines)nottoexceed10applicationsortreatments.
Treatmentofanychronicskinwoundwilltypicallylastnomorethantwelve(12)weeks.
Repeatoralternativeapplicationsofskinsubstitutegraftsarenotconsideredmedicallyreasonableandnecessarywhenapreviousfull
courseofapplicationswasunsuccessful.Unsuccessfultreatmentisdefinedasincreaseinsizeordepthofanulcerornochangeinbaseline
sizeordepthandnosignofimprovementorindicationthatimprovementislikely(suchasgranulation,epithelializationorprogresstowards
closing)foraperiodof4weekspaststartoftherapy.
Retreatmentofhealedulcers,thoseshowinggreaterthan75%sizereductionandsmallerthan.5sq.cm,isnotconsideredmedically
reasonableandnecessary.
Skinsubstitutegraftsarecontraindicatedandnotconsideredreasonableandnecessaryinpatientswithinadequatecontrolofunderlying
conditionsorexacerbatingfactors(e.g.,uncontrolleddiabetes,activeinfection,andactiveCharcotarthropathyoftheulcerextremity,
vasculitisorcontinuedtobaccosmoking.)
Skinsubstitutegraftsarecontraindicatedinpatientswithknownhypersensitivitytoanycomponentofthespecificskinsubstitutegraft(e.g.,
allergytoavian,bovine,porcine,equineproducts).
Repeatuseofsurgicalpreparationservices(CPTcodes15002,15003,15004,and15005)inconjunctionwithskinsubstituteapplicationcodes
willbeconsiderednotreasonableandnecessary.Itisexpectedthateachwoundwillrequiretheuseofappropriatewoundpreparationcode
atleastonceatinitiationofcarepriortoplacementoftheskinsubstitutegraft.
Retreatmentwithinone(1)yearofanygivencourseofskinsubstitutetreatmentforavenousstasisulceror(diabetic)neuropathicfootulcer
isconsideredtreatmentfailureanddoesnotmeetreasonableandnecessarycriteriaforretreatmentofthatulcerwithaskinsubstitute
procedure.
CMShasguidanceregardingotherspecializedwoundtreatmenttechnologyandspecificallyaddressesplateletrichplasmasystems(e.g.,Autologet,
Magellan)negativepressurewoundtherapydevicesandelectromagnetic/ultrasound/misttherapies.TheyarenotaddressedinthisLCDastheirrole
inthetreatmentofthetwomajortypesoflowerextremitywoundsdiscussedhereislimited.Utilizationremainsattheprovidersdiscretionandmust
bereasonableandnecessary.Notethatcombinationtherapywithanybioengineeredskinsubstitute(CTP)willbeconsiderednotreasonableand
necessary.
PleaseNote:AutologousPlateletRichPlasma(PRP)systemsusedinthetreatmentofChronicNonHealingWoundsisnot
consideredreasonableandnecessaryexceptasdescribedinNationalCoverageDetermination(NCD)forBloodDerivedProducts
forChronicNonHealingWounds(270.3).PleaserefertotheNCDforcoveragedetails.
AspublishedinCMSIOM10008,Chapter13,Section13.5.1,inordertobecoveredunderMedicare,aserviceshallbereasonableandnecessary.
Whenappropriate,contractorsshalldescribethecircumstancesunderwhichtheproposedLCDfortheserviceisconsideredreasonableandnecessary
underSection1862(a)(1)(A).Contractorsshallconsideraservicetobereasonableandnecessaryifthecontractordeterminesthattheserviceis:
Safeandeffective.
Notexperimentalorinvestigational(exception:routinecostsofqualifyingclinicaltrialserviceswithdatesofserviceonorafterSeptember
19,2000,thatmeettherequirementsoftheClinicalTrialsNCDareconsideredreasonableandnecessary).
Appropriate,includingthedurationandfrequencythatisconsideredappropriatefortheservice,intermsofwhetheritis:
Furnishedinaccordancewithacceptedstandardsofmedicalpracticeforthediagnosisortreatmentofthepatientsconditionorto
improvethefunctionofamalformedbodymember.
Furnishedinasettingappropriatetothepatientsmedicalneedsandcondition.
Orderedandfurnishedbyqualifiedpersonnel.
Onethatmeets,butdoesnotexceed,thepatientsmedicalneeds.
Atleastasbeneficialasanexistingandavailablemedicallyappropriatealternative.
Italicizedand/orquotedmaterialisexcerptedfromtheAmericanMedicalAssociation,CurrentProceduralTerminology(CPT)codes.
CodingInformation
BillTypeCodes
ContractorsmayspecifyBillTypestohelpprovidersidentifythoseBillTypestypicallyusedtoreportthisservice.AbsenceofaBillTypedoesnot
guaranteethatthepolicydoesnotapplytothatBillType.CompleteabsenceofallBillTypesindicatesthatcoverageisnotinfluencedbyBillTypeand
thepolicyshouldbeassumedtoapplyequallytoallclaims.
999x
NotApplicable
RevenueCodes
ContractorsmayspecifyRevenueCodestohelpprovidersidentifythoseRevenueCodestypicallyusedtoreportthisservice.InmostinstancesRevenue
CodesarepurelyadvisoryunlessspecifiedinthepolicyservicesreportedunderotherRevenueCodesareequallysubjecttothiscoverage
determination.CompleteabsenceofallRevenueCodesindicatesthatcoverageisnotinfluencedbyRevenueCodeandthepolicyshouldbeassumed
toapplyequallytoallRevenueCodes.
99999
NotApplicable
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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
C5272
C5273
C5274
C5275
C5276
C5277
C5278
Group2Paragraph
HCPCScodesincludedinthislistareinclusiveofknownFDAapprovedbioengineeredwounddressings,skinsubstitutes,matrixesorscaffoldingforchroniculcertreatmentasof
publication.EachproducthasspecificFDAdesignatedapprovedusage.Therefore,anyHCPCScodethatisnotincludedinthislistwillnotbeseparatelyreimbursed.(Pleasereferto
thelimitationssection)
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
6/12
2/24/2015
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:ItistheprovidersresponsibilitytoselectcodescarriedouttothehighestlevelofspecificityandselectedfromtheICD9CMcodebookappropriatetothe
yearinwhichtheserviceisrenderedfortheclaim(s)submitted.
Group1Codes
XX000
NotApplicable
ICD9CodesthatDONOTSupportMedicalNecessity
AllthosenotlistedundertheICD9CodesthatSupportMedicalNecessitysectionofthispolicy.
XX000
NotApplicable
GeneralInformation
AssociatedInformation
DocumentationRequirements
1. Alldocumentationmustbemaintainedinthepatientsmedicalrecordandmadeavailabletothecontractoruponrequest.
2. Everypageoftherecordmustbelegibleandincludeappropriatepatientidentificationinformation(e.g.,completename,datesof
service(s)).Thedocumentationmustincludethelegiblesignatureofthephysicianornonphysicianpractitionerresponsibleforand
providingthecaretothepatient.
3. ThesubmittedmedicalrecordmustsupporttheuseoftheselectedICD9CMcode(s).ThesubmittedCPT/HCPCScodemustdescribethe
serviceperformed.
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.
Apatientthatcontinuestousetobaccoproductsonaregularbasisthrua4weektrialofappropriatewoundcarepriortoplacement
ofskingraftorbioengineeredskinsubstitutewillbeconsiderednoncoveredfortreatmentwithanyformofgraftorskinsubstitute
graft.
10. Theamountofutilizedandwastedskinsubstitutemustbeclearlydocumentedintheprocedurenotewiththefollowingminimum
information:
Date,timeandlocationofulcertreated
Nameofskinsubstituteandhowproductsupplied
Amountofproductunitused
Amountofproductunitdiscarded
Reasonforthewastage
Manufacturersserial/lot/batchorotherunitidentificationnumberofgraftmaterial.Whenmanufacturerdoesnotsupplyunit
identification,recordmustdocumentsuch.
Note:Novitasexpectsthatwheremultiplesizesofaspecificproductareavailable,thesizethatbestfitsthewoundwiththeleastamount
ofwastagewillbeutilized.
UtilizationGuidelines
InaccordancewithCMSRuling951(V),utilizationoftheseservicesshouldbeconsistentwithlocallyacceptablestandardsofpractice.
Itistheexpectationthataspecificskinsubstituteproductwillbeusedfortheepisodeofeachdocumentedwound,andincompliancewithFDA
7/12
2/24/2015
assessmentsandsubmittedguidelinesforthespecificproduct.Greaterthanten(10)applicationsforthetreatmentofasinglewoundwithina12
weekperiodoftime,willbeconsideredNotReasonableandNecessaryandwillbesubjecttoreview.
Separatelybilledrepeateduseoftheskinsubstituteafter12weeksforasinglewoundorepisodeisnoncovered.Alternativeoradditionalskin
substituteproductsusedwithinthe12weekinitialwoundepisodearesimilarlynoncoveredwhenthesumofapplicationsofallSkinSubstitutesis
greaterthanten(10)forasinglewound.
Theutilizationofbioengineeredskinsubstitutenoncompliantwithmedicalnecessityordesignatedguidelinesforthatspecificproductmay
necessitatereviewornoncoverageasnotmedicallynecessary.
Labelingformostskinsubstitutegraftsincludelanguagesuggestingmultipleapplicationshowever,Medicaredoesnotexpectthateveryulcerin
everypatientwillrequirethemaximumnumberofapplicationslistedontheproductlabelorallowedforreimbursement.
Utilizationrates,thatexceedpeernorms,identifiedthroughdataanalysismaypromptprepaymentorpostpaymentmedicalreview.
SourcesofInformationandBasisforDecision
Note:SomereferencessourcesarelistedbyrequestofSkinSubstituteproductstakeholdersandshouldnotbeinterpretedasNovitasendorsementofany
specificproduct.
Contractorisnotresponsibleforthecontinuedviabilityofwebsiteslisted.
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WintersCL,BrigidoSA,LidenBA,SimmonsM,HartmanJF,WrightML.Amulticenterstudyinvolvingtheuseofahumanacellulardermalregenerativetissue
matrixforthetreatmentofdiabeticlowerextremitywounds.AdvSkinWoundCare.200821(8):375381.
WolcottRD,CoxS,Moreeffectivecellbasedtherapythroughbiofilmsuppression.JournalofWoundCare.January201322(1):16
WollinaU,SchmidtWD,KrnertC,NelskampC,ScheibeA,FasslerD.Someeffectsofatopicalcollagenbasedmatrixonthemicrocirculationandwound
healinginpatientswithchronicvenouslegulcers:preliminaryobservations.IntJLowExtremWounds.20054(4):214224.
ZelenCM,GouldL,SerenaTE,etal.AProspective,Randomised,Controlled,MultiCentreComparativeEffectivenessStudyofHealingUsingDehydrated
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InternationalWoundJournal.2014:17.
ZimnyS,SchatzH,PfohlM.Determinantsandestimationofhealingtimesindiabeticfootulcers.JDiabetesandItsComplications,200216:327332.
ContractorMedicalDirectors
OriginalJHLCD,L32622,BioengineeredSkinSubstitutes.
RevisionHistoryInformation
RevisionHistory
RevisionNumber
R5
EffectiveDate
04/09/2015
Explanation
ReasonforChange
LCDpostedfornoticeon02/20/2015tobecomeeffective
04/09/2015.
09/18/2014DraftLCDpostedforcomment.
LinktothisLCDontheMCD:
Lookingformoredetail?ViewthispolicyattheCMSMedicareCoverageDatabase(MCD)foryourstatebychoosingtheappropriatelink:
Pennsylvania|Maryland|Delaware|DistrictofColumbia|NewJersey
AssociatedDocuments
Attachments
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RelatedLocalCoverageDocuments
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Keywords
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Skin Subistute Grafts Application

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Skin Subistute Grafts Application

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2/24/2015

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