YaleCenterforClinicalInvestigationYaleCenterforClinicalInvestigation

ResearchBillingComplianceQualityAssurance

TrainingKellySantamauro

AssociateDirector,ResearchBillingComplianceQualityAssurance

YaleCenterforClinicalInvestigation

• Navigatingandcomplyingwiththenumerousfederalregulationsaroundclinicaltrialsbillingisperhapsoneofthemostcomplexoperationalandregulatorychallengesfacedbyacademicmedicalcentersandhealthcaresystems

• Accuratelybillingforclinicaltrialservicesrequiresatremendousamountofefforttocoordinateoperationsandprovideoversighttoappropriatelymitigatecompliancerisks

• Alackofadequatecontrolscanincreasetheriskforfalseclaimsandinsurancefraudallegations,bothofwhichcanresultinstiffpenalties.

Whyistrainingsoimportant?

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• Inanefforttoincreaseparticipationinclinicaltrials,formerPresidentBillClintonissuedanexecutivememorandumdirectingtheSecretaryofHealthandHumanServicesto:“Explicitlyauthorize[Medicare]paymentforroutinepatientcarecosts…andcostsduetomedicalcomplicationsassociatedwithparticipationinclinicaltrials”

• In responsetothememorandum,theCenterforMedicareandMedicaidServices(CMS),issuedtheClinicalTrialPolicyNationalCoverageDetermination(NCD).

HistoricalPerspective

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• EffectiveJuly9,2007,Medicarecoverstheroutinecostsofqualifyingclinicaltrials,aswellasreasonableandnecessaryitemsandservicesusedtodiagnoseandtreatcomplicationsarisingfromparticipationinallclinicaltrials

• TheNCDforRoutineCostsinClinicalTrials(310.1)isnowthestandardbywhichcommercialpayersbaseclinicalresearchcoveragedecisions

Historical Perspective

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• StandardMedicarebillingrulesapplytoitemsdeemedroutinecostsundertheNCD

• Routineclinicaltrialcostsincludeallitemsandservicesthatwouldnormallyoccuraspartofthepatient’scareoutsideofaclinicaltrial

• Costsassociatedwiththeprevention,diagnosisand/ortreatmentofcomplicationsarisingfromparticipationinclinicaltrialsarealsocovered

• AclinicaltrialmustmeetspecificrequirementsundertheNCDtoreceiveMedicarecoverageforroutinecosts

RoutineCosts

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MedicareQualifyingTrials(MQT)

Beforebilling'routinecosts'associatedwithaclinicaltrialtoMedicareorotherinsurancecarriers,YCCIdeterminesifthetrialmeetstheCMSqualifyingcriteria.Thereare4criteriatomeetinordertobeconsideredaMedicare“qualifying”trial:1. Thetrialmusthavetherapeuticintent.Itcannotbedesignedto

exclusivelytesttoxicityordiseasepathology.2. Trialsoftherapeuticinterventionmustenrollpeoplewithdiagnosed

disease;andifhealthycontrolsareenrolled,theymustbeassignedtoapropercontrolgroup.

3. ThepurposeofthetrialmustbeevaluationofanitemorservicethatfallswithinaMedicareBenefitcategoryandisnotstatutorilyexcludedfromcoverage(i.e.Medicaredoesnotcovercosmeticsurgery).

4. Theclinicaltrialmustbedeterminedtomeetthe7desirablecharacteristicsor“deemed”tomeetthecharacteristics.

• Pleasenote:Thetrialmustmeetall4ofthesecriteriatobeconsidered“qualifying”.

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MedicareQualifyingTrials(MQT)

The7desirablecharacteristicsneededtobeconsideredMedicare“qualifying”trial:

1. Theprincipalpurposeofthetrialistotestwhethertheinterventionpotentiallyimprovestheparticipants’healthoutcomes.

2. Thetrialiswell-supportedbyavailablescientificandmedicalinformationoritisintendedtoclarifyorestablishthehealthoutcomesofinterventionsalreadyincommonclinicaluse;

3. Thetrialdoesnotunjustifiablyduplicateexistingstudies;4. Thetrialdesignisappropriatetoanswertheresearchquestionbeing

askedinthetrial;5. Thetrialissponsoredbyacredibleorganizationorindividual

capableofexecutingtheproposedtrialsuccessfully;6. ThetrialisincompliancewithFederalregulationsrelatingtothe

protectionofhumansubjects;and7. Allaspectsofthetrialareconductedaccordingtotheappropriate

standardsofscientificintegrity.

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MedicareQualifyingTrials(MQT)

Atrialisconsidered“deemed”tomeetthe7desirablecharacteristicsbyMedicareifitmeetsatleastoneofthefollowingcriteria:

1. FundedbyNIH,CDC,AHRQ,CMS,DOD,ortheVA.

2. SupportedbycentersorcooperativegroupsthatarefundedbytheNIH, CDC,AHRQ,CMS,DOD,ortheVA.(Ifthetrialisnotfundedbyoneoftheseagencies,butisconductedbyacenterthatispartofacooperativegrouporreceivesfundingfromoneoftheseagenciestoconductresearch,itstillmaybeconsideredtobe‘deemed’.CMSassumesthesecenterswillholdtheirnon-fundedtrialstothesamequalitiesastrialsfundedbyoneoftheseagencies.)

3. AninvestigationaldrugtrialconductedunderanIND.

4. AdrugtrialexemptfromanINDunder21CFR312.2(b)(1).

• Ifyouareconductingatrialthatisnotdeemedtomeetthe7desirablecharacteristics,thelocalMedicarecontractormayneedtobecontactedpriortobillingthemfortheroutinecostsassociatedwiththetrial.

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MedicareQualifyingTrials(MQT)

WhatisNOTcoveredbytheMedicareClinicalTrialpolicy?

1. Investigationalitemorserviceitself(examples:manyinvestigationaldrugs,devicesanddiagnostictests),unlessotherwisecoveredoutsideoftheclinicaltrial.

2. Itemsandservicesprovidedsolelyforthepurposesofdeterminingeligibilityandnotrelatedtomedicallynecessaryclinicalcare.

3. ItemsandservicesstatutorilyexcludedunderMedicare(example:cosmeticsurgery).

4. ItemsandServicesprovidedsolelytosatisfydatacollectionandanalysisneedsandnotnecessaryforclinicalmanagement(example:MonthlyCTscansforaconditionusuallyrequiringonlyasinglescan).

5. Itemsandservicesprovidedbytheresearchsponsorsfreeofcharge.

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MedicareQualifyingTrial(MQT)Process

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ClinicalResearchBillingTaskforce

Duetothecomplexityofclinicalresearchbillingandmanagement,aClinicalResearchBillingTaskforcewasformedin2018andchargedwiththedevelopmentandimplementationofaresearchpolicywhichwouldaddressallresearchstudiesidentifiedwithbillableservicesaswellastoidentifythecriticalcomponentsinvolvedwithresearchbillingcompliance.

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ResearchBillingCompliancePolicy

• EffectiveApril1,2019,allMedicareQualifyingTrials(MQT)willberequiredtoadheretotheYaleResearchBillingCompliancePolicywhichaddressesallresearchstudieswithbillableservices.

• YaleSchoolofMedicineiscommittedtoensuringtheappropriatebillingofclinicalproceduresandservicesassociatedwithitsresearchstudies.ThiscommitmentappliestoallresearchstudiesregardlessofthesourceoffundsorYaleSchoolofMedicinedepartmentperformingtheresearchstudy.

• LinkforPolicy:YaleSchoolofMedicineResearchBillingCompliancePolicy

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OnceastudyisidentifiedasanMQTandpriortobudgetdetermination,YCCI’scentralizedcoverageanalysisunitwillconductaMedicareCoverageAnalysis(MCA).TheanalysiswillbecompletedbyYCCI’scentralunitregardlessofwhoisresponsibleforthedraftingandnegotiationofthebudget.Asaresult,anybudgetsperformedoutsideofYCCIwillundergoaQAprocesstoconfirmthatthenegotiationsalignwiththeanalysis(whichisrepresentedintheOnCorecalendar):

• Medicarecoverageanalysis(MCA)istheprocessofreviewingandmappingcostsaccordingtothestudyprotocolaseitherroutinecostsorascostsbillabletothestudysponsorsand/orathird-partypayer

• Itisdependentuponasystematicreviewofresearchrelateddocumentstodeterminethebillingstatusofboththestudyitselfandtheitems/servicesprovidedtotheresearchparticipantsthatareoutlinedintheresearchdocumentsoverthecourseofthestudy

• Basedonthoroughresearch,supportedbynationalandlocalguidelineswhichmeetthestandardandcompliantgovernmentregulations

• SourcestobeusedandCited:NIH,NCCN,ACC,JAMA,NEJM,CMSNCDandLCD,specialtysocieties,etc

CoverageAnalysis,AKA“SOCvs.RS”Designations:

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CAfindingsarebasisforBudgetdevelopment

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ResearchBillingComplianceManual

InadditiontotheYaleSchoolofMedicineResearchBillingCompliancePolicy,anonlinemanualwascreatedinordertoeducatefacultyandstaffontheresearchbillingcomplianceworkflowandthecriticalcomponentsthatencompassclinicaltrialbillingandmanagement.

Link:ResearchBillingComplianceManual

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ResearchBillingComplianceWorkflow

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OncearesearchstudyisidentifiedasaMQT,theBillingComplianceQualityAssuranceTeamcompletesariskassessmentdeterminationastowhetheraclinicaltrialishigh,moderate,orlowriskforresearchbillingcompliancepurposes.

BillingRiskAssessment

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ClinicalTrialBillingQAProcessandWorkflow

BillingReviewProcess:

• Oncetheassessmentiscompleteandtheriskleveldetermined,aprospectivereviewwilltakeplacebyaQAresearchanalyst.Ifthereareanyfindingsidentified,theresearchanalystwilldeterminethesourceoftheoversightaswellasaddressanypossiblepreemptiveactionstomitigateanyfuturerisk.

• FindingswillbereviewedwiththePI;willaddressbillingopportunitiesanddocumentationrecommendationsinaproactive,educationalmanner

• Allfindingswillbeaccompaniedwithacorrectiveactionplanandexecutionduedates

• Follow-upontheCAPaswellascontinuingeducation,asneeded,willbescheduledatthetimeofreviewmeeting

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Source(s)ofBillingData:

• CoverageAnalysis• BudgetandContract• ICF• Protocol• HCFAs,UBs(PBvsHBclaims)• OnCore• EpicWQ,MedicalRecordDocumentation• SponsorInvoices(internallyinitiated,Auto-generated)

ClinicalTrialBillingQAProcessandWorkflow

YaleCenterforClinicalInvestigation

Identifysource(s)ofError:

• Budgetpreparationandnegotiation:Whopaysforadverseevents?Whatisthelanguagerelatedtosubjectinjury?

• Informedconsentlanguage;Arethereitems/servicespromisedfreeofchargeand/orco-paymentsanddeductibles?

• SchedulingProcess:Arevisitsbeinglinkingandidentifiedasresearchvisits?

• UntimelySubjectManagement:whatcanwedotobemoreproactiveandoccurringvisitsinatimelymanner?

• Documentation:isthedocumentationclearthatthevisit or procedure isclinicaltrialrelated?

ClinicalTrialBillingQAProcessandWorkflow

YaleCenterforClinicalInvestigation

• RushUniversityMedicalCenteragreedtoa$1millionsettlementafterself-disclosureofimproperlybillingMedicareforphysicianandhospitalservicesandasroutinecostsincancercare.

• TenetUSCNorrisCancerHospitalsettledfor$1.9millionafterself-disclosureofoverbillingwithoncologytrials.

• TheUniversityofAlabamaatBirminghamaccepteda$3.39millionsettlementforfalselybillingMedicareforresearchertimespentonpatientcarewhennopatientshadbeenseen.

• EmoryUniversityagreedtoa$1.5millionsettlementforfalselybillingMedicareandMedicaidforclinicaltrialservicesthatwerenotpermittedbytheMedicareandMedicaidrulesinawhistleblowercase.

The Consequences….

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1. Thereare4criteriatomeetinordertobeconsideredaMedicare“qualifying”trial.Thetrialdoesnotneedtomeetall4ofthesecriteriatobeconsidered“qualifying”.

TrueorFalse?

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1. Thereare4criteriatomeetinordertobeconsideredaMedicare“qualifying”trial.Thetrialdoesnotneedtomeetall4ofthesecriteriatobeconsidered“qualifying”.

TrueorFalse?

TheanswerisFalse…Thetrialmustmeetall4ofthesecriteriatobeconsidered“qualifying”.

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2. Atrialisconsidered“deemed”tomeetthe7desirablecharacteristicsbyMedicareifitmeetsatleastoneofthefollowingcriteria:

1. FundedbyNIH,CDC,AHRQ,CMS,DOD,ortheVA.2. Supportedbycentersorcooperativegroupsthatarefundedbythe

NIH, CDC,AHRQ,CMS,DOD,ortheVA.(Ifthetrialisnotfundedbyoneoftheseagencies,butisconductedbyacenterthatispartofacooperativegrouporreceivesfundingfromoneoftheseagenciestoconductresearch,itstillmaybeconsideredtobe‘deemed’.CMSassumesthesecenterswillholdtheirnon-fundedtrialstothesamequalitiesastrialsfundedbyoneoftheseagencies.)

3. AninvestigationaldrugtrialconductedunderanIND.4. AdrugtrialexemptfromanINDunder21CFR312.2(b)(1).

TrueorFalse?

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2. Atrialisconsidered“deemed”tomeetthe7desirablecharacteristicsbyMedicareifitmeetsatleastoneofthefollowingcriteria:

1. FundedbyNIH,CDC,AHRQ,CMS,DOD,ortheVA.

2. SupportedbycentersorcooperativegroupsthatarefundedbytheNIH,3. CDC,AHRQ,CMS,DOD,ortheVA.(Ifthetrialisnotfundedbyoneofthese

agencies,butisconductedbyacenterthatispartofacooperativegrouporreceivesfundingfromoneoftheseagenciestoconductresearch,itstillmaybeconsideredtobe‘deemed’.CMSassumesthesecenterswillholdtheirnon-fundedtrialstothesamequalitiesastrialsfundedbyoneoftheseagencies.)

4. AninvestigationaldrugtrialconductedunderanIND.5. AdrugtrialexemptfromanINDunder21CFR312.2(b)(1).

TrueorFalse?

TheanswerisTrue.Rememberifyouareconductingatrialthatisnotdeemedtomeetthe7desirablecharacteristics,thelocalMedicarecontractormayneedtobecontactedpriortobillingthemfortheroutinecostsassociatedwiththetrial.

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3. OnceastudyisidentifiedasanMQTandpriortobudgetdetermination,thePrincipalInvestigatorisresponsibleforconductingaMedicareCoverageAnalysis(MCA).

TrueorFalse?

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3. OnceastudyisidentifiedasanMQTandpriortobudgetdetermination,thePrincipalInvestigatorisresponsibleforconductingaMedicareCoverageAnalysis(MCA).

TrueorFalse?

TheanswerisFalse.

OnceastudyisidentifiedasanMQTandpriortobudgetdetermination,YCCI’scentralizedcoverageanalysisunitwillconductaMedicareCoverageAnalysis(MCA).

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4. Oneofthesourcesusedforresearchbillingqualityassuranceauditsincludewhichofthefollowing?

a) CoverageAnalysisb) BudgetandContractc) ICFd) Alloftheabove.

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4. Oneofthesourcesusedforresearchbillingqualityassuranceauditsincludewhichofthefollowing?

a) CoverageAnalysisb) BudgetandContractc) ICFd) Alloftheabove.

ThecorrectanswerisD.Additionalsourceswouldinclude:

• Protocol• HCFAs,UBs(PBvsHBclaims)• OnCore

• EpicWQ,MedicalRecordDocumentation• SponsorInvoices(internallyinitiated,Auto-generated)

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ThatconcludesourpresentationofYCCI’sResearchBilling

ComplianceTraining.Questionscanbedirectedto:

KellySantamauro

kelly.santamauro@yale.edu

(203) 785-5218

Toreceivecreditforthistrainingmodulepleaseclickonthe

linkbelow,completetheattachedformandclickonsubmit.

https://medicine.yale.edu/ycci/researchservices/compliance/rbc/attestation/