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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ForMoreInforma&on…

TonyZappa952-457-7174

tzappa@visanteinc.com

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