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Evalua&ngtheRight340BTools
TonyZappa,Pharm.D.,MBAVicePresident,VisanteInc.
11/9/2016 (c)2016PharmacyStarsLLCAllRightsReserved 1
Agenda
• Whattoolsareneeded?• Howaretheseevaluated?• Keytake-aways• Q&A
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DisclosuresandCaveats
• OpinionsstatedarefromVisanteandmyselfandarenotofficial• Iamnotalawyerandamnotofferinglegaladviceoropinion• AlwayscheckwithyouraXorneys,ApexusorHRSAbeforemakinganychangesthatcouldimpactyourprograms’eligibility,complianceorperformance
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WhatToolsareNeededfor340BPrograms?
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340BComplianceRequirements
• Everycovereden_tyisresponsibleforprogramcompliance• Cannotbeoutsourcedtoauditfirmsor340Badministrators
• HRSAlooksfor3things• Eligibility
• Registra_on• P&Ps• Contracts
• Diversion• Ineligiblepa_ents
• DuplicateDiscounts• Medicaidexclusion
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ProgramCompliance
DiversionEligibility
DuplicateDiscounts
11/9/2016 (c)2016PharmacyStarsLLCAllRightsReserved
What340BToolsDo
• Streamlinethequalifica_onandinventorymanagementprocesses• Provideandmaintainauditabledata• Helpwithprogramop_miza_on• Keepprogramsincompliance• Provideoversight
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WhataretheAvailableTools?
• Direct• Split-billingsystem• Contractpharmacyadministra_onsystem• Audit/compliancemanagementsystem
• Bothself-auditandexternalaudit• Indirect• EMR• E-prescribingsystem• Billingsystem• Purchasingsystem• Training
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HowDoIEvaluateTheseTools?
Split-billersandContractPharmacyAdministrators
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Split-BillingandContractPharmacyAdministra&on
• Apexushasseveralcheckliststohelpwithevalua_ons• Split-billingsofwareevalua_on• Contractpharmacyvendorassessment• Audit/Compliancechecklists
• Toconfirmprogramconfigura_on,maintenance• hXps://www.apexus.com/solu_ons/educa_on/pvp-educa_on/340b-tools
• Considerini_alRFPandmarketassessmentsevery2-3years
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RFP:GainingKnowledge
• Data,interfacesandformatsrequired• EMR,inventory,wholesaler,ADT,billing• Real-_meorbatch
• En_tyresourcesrequired• Implementa_on(IT,Pharmacy,Finance,Purchasing,Billing,Creden_aling,ProjectManagement)• Maintenance
• Implementa_on_meandconversionprocess
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RFP:GainingKnowledge
• Qualifica_onprocedures• Whosetstherules:En_tyorVendor?• Mixed-use(outpa_entstatusiden_fica_on)• ContractPharmacy(encounter-based,provider-basedorboth)• All-in,brand-onlyorwinners-only?• Whenareclaims“captured”?• Howaredispensingfeescalculated?
• Flat-dollar?Percentage?Referencepricing?• LinkbetweenencounterandRxwriXendate?• Medicaidexclusionprocess?MedicaidManagedCare?
• Providerfileupdateschedule(namesandloca_ons)• Orphandrugexclusions?• Productexclusions?
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RFP:GainingKnowledge
• Inventorymanagementandorderingprocedures• Unitsreconcilia_on
• NDC-11only?• Wasteaccoun_ng• True-ups
• Howaretrue-upcostscalculated?• Accountsmanaged
• Non-GPO/WAC• 340B• GPO
• SupportforfreeorsubsidizedRxprograms• Built-inorviathird-partyPBM?
• Repor_ngcapabili_es• Completeaudittrailofsystemaccess,changes?
• Userinterface• Web-basedorproprietary?
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RFP:GainKnowledge
• Down_me,disasterrecoveryandbusinesscon_nuity• Customerserviceandresponse_mes
• Includingpost-implementa_onsupport• Ini_alandon-goingtraining
• Systemmaintenance• Repor_ngandanaly_cs
• Contractterms• Lengthandtermina_onrights• Wholesalerselec_on(En_ty,pharmacyorother)
• Fees(implementa_on,maintenance,customerservice)• Includingpenal_esandincen_ves• Perprocessedclaim,pereligibleclaimorpercapturedclaim?• Flat-dollar,percentageorcombina_on?
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HowDoIEvaluateTheseTools?
AuditandComplianceManagement
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AuditandComplianceManagement
• StartwithApexuschecklistsandprocedures• Addanindependentauditatleastannually• Considerquarterlycontractpharmacyassessmentsinlinewithproposedruleschanges
• Consideranautomatedcompliancemanagementsystemtoaidwithworkflowanddocumenta_on
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ApexusChecklists
• BrokenoutforDSH,non-DShospitalsandnon-hospitals• Covergeneralself-audit,Medicaid,P&Ps,contractpharmacy,duplicatediscount,diversionandothers• AlsoprovidetemplateP&Psifneeded• Besuretocustomizethemtoyourprogram!
• Advantage:TheycomefromtheHRSA-approvedprimevendor
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IndependentAuditor
• StartwithareferraloranRFP• Companyoverviewandexperience
• Dotheyknow340B?• HavetheybeenthroughaHRSAaudit?• Dotheyhavereferences?
• Auditteamqualifica_ons• Experience• Training• Levelofengagement(i.e.,seniority)
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IndependentAuditor
• StartwithanRFP• Methodology
• Whatdotheyreview,andhowextensively?• Howdotheychoosetransac_onstoreview?• Howmanytransac_onsarereviewed?• Whatresourcesdoyouhavetoprovide?• Whatkindsofdata/documentsdotheyneed
• Findingsandrecommenda_ons• Whatkindofreportdotheyprovide?• Howextensivearetheirrecommenda_ons?• Dotheyprovideorsupportcorrec_veac_onplans?• Dotheyhelpwithimplementa_on?
• Whatdotheycharge?• Arethereadd-onfees,suchasforHRSAauditsupport?
• CheckreferencesandPeer-to-Peerexperience11/9/2016 (c)2016PharmacyStarsLLCAllRightsReserved 18
ComplianceManagementSystem
• MostEn__esusemanualsystems• P&Ps:Paperchecklists• Eligibilityverifica_on:Excelspreadsheets• Tasktracking:?
• Considersofwaretomanagetheprocess• Standardizedprocesses• Centraldocumenta_onwithhistoryandassociatedworkfiles• Riskandgapiden_fica_on
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KeyTake-Aways
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KeyTakeaways
• Apexusoffersabroadrangeofpublic-domaintoolsforallEn_tytypes• Performanini_alRFPandfollowwithmarketchecksevery2-3years• Split-biller,contractpharmacyadministratorandindependentauditor
• Considerself-auditmanagementsystemstostandardizeanddocumentwork
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Ques&onsandDiscussion
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