Upload
others
View
0
Download
0
Embed Size (px)
Citation preview
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com 1
What,WhenandWhy:Designinga340BSelf-Audit
Program
TonyZappa,Pharm.D.,MBAVicePresident,VisanteInc.
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Agenda
• 340BComplianceRequirements:WhatDoesHRSAExpect?
• ComponentsandBestPracJcesofSelf-AuditPrograms
• KeyTake-aways• Q&A
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Disclosures and Caveats
• OpinionsstatedarefromVisanteandmyselfandarenotofficial
• Iamnotalawyerandamnotofferinglegaladviceoropinion
• AlwayscheckwithyouraWorneys,ApexusorHRSAbeforemakinganychangesthatcouldimpactyourprograms’eligibility,complianceorperformance
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
340BComplianceRequirements:
WhatDoesHRSAExpect?
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
340B Compliance Requirements
• Every covered entity is responsible for program compliance – Cannot be outsourced to audit
firms or 340B administrators • HRSA looks for 3 things
– Eligibility • Registration • P&Ps • Contracts
– Diversion • Ineligible patients
– Duplicate Discounts • Medicaid exclusion
ProgramCompliance
DiversionEligibility
DuplicateDiscounts
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
What Does HRSA Expect?
• Keep340BdatabaseinformaJonaccurateanduptodate– RegisternewoutpaJentfaciliJesandcontractpharmaciesas
theyareadded• RecerJfyeligibilityeveryyear• Preventduplicatediscounts(MedicaidExclusionFile)• PreventdiversiontoineligiblepaJents• Prepareforprogramaudits.Maintainauditablerecords
documenJngcompliancewith340BProgramrequirements• StoppurchasingcoveredoutpaJentdrugsfromGPOs(DSHs,
CANs,andPEDs)• NoJfysuppliersthatoutpaJentdrugpurchaseswillnowbe
madeat340Bprices
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
What Does HRSA Expect?
• Independentauditsare“expected,”notrequired– SenJneleffectofHRSA’sauditshasmovedmostenJJestoimplementanauditprogram
• RouJneself-auditsarealsoexpected– Whatshouldthisinclude?– Whenshouldtasksbedone?Bywhom?– Whoshouldprovideoversight?– HowarecorrecJveacJonplanscreated,implementedandmanaged?• Andcommunicated!
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
What’s Coming in the Omnibus Guidance?
• Contractpharmacyoversight– “ThecoveredenJtyisexpectedtoconductquarterlyreviewsandannualindependentauditsofeachcontractpharmacylocaJon;theresultsofthesereviewsareincludedintherecords’requirementsofsecJon340B(a)(5)(C)ofthePHSA.Any340BProgramviolaJondetectedthroughquarterlyreviewsorannualauditsofacontractpharmacyshouldbedisclosedtoHHS.CoveredenJJesaresubjecttotheapplicablepenalJesforinstancesofduplicatediscountsanddiversion.”
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
What’s Coming in the Omnibus Guidance?
• MaintenanceofAuditableRecords– “AcoveredenJtymustmaintainauditablerecordsdemonstraJngcompliancewithall340BProgramrequirementsforitself,anychildsite,andanycontractpharmacyfor5yearsfromthedatethe340Bdrugwasorderedorprescribed,regardlessofwhethertheenJtyconJnuestoparJcipateinthe340BProgram...IfanenJty,anychildsite,oranycontractpharmacyterminatesits340BProgramparJcipaJon,anenJtymustmaintainapplicableauditablerecordsfor5yearsaeerthedateofterminaJon.”
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
What’s Coming in the Omnibus Guidance?
• AnnualRecerJficaJon– “InordertoconJnuetobelistedasaneligiblecoveredenJtyandpurchase340Bdrugs,acoveredenJtyannuallyrecerJfiesthatthecoveredenJty,itschildsites,anditscontractpharmacyarrangementsmeetall340BProgrameligibilityandcompliancerequirements.ThisrecerJficaJonshallbecarriedoutinamannerandJmeframespecifiedbyHHS.”
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
How is Compliance Enforced?
• AuditsbyHRSA/OPA– PermiWedintheoriginallegislaJon,implementedin2011
• Auditsbymanufacturers– MustdemonstratereasonablecauseandgetHRSA’spriorapproval– ManufacturerscanonlyauditforcompliancewithpaJentdefiniJonandthe
duplicatediscountprohibiJon• AnnualrecerJficaJonprocess
– AuthorizingofficialsmustaWesttofullcomplianceduringrecerJficaJon,includingcomplianceatcontractpharmacies
• PenalJes– Failuretocomplywiththeprogram’sanJ-diversionandduplicatediscount
provisions:forfeitureofdiscounts– IfknowingandintenJonal:interestonthediscountsthattheyrefund– IfsystemaJcandegregiousaswellasknowingandintenJonal:disqualifica9on
theprogram“forareasonable9me,”tobedeterminedbyHRSA
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
ComponentsandBestPracJces
ofSelf-AuditPrograms
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Components and Best Practices
• Createa340Bprogramgoverningcouncil– PharmacyoperaJons(represenJngin-clinicandretaildistribuJon)
– Finance– IT/IS– Reimbursement– Legal– Compliance– Seniorleadership
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Components and Best Practices
• Providecomprehensivetrainingtoall340Bprogramstaff,withatleastannualrefreshers(parJcularlyoncompliancetopics)– Considershortteststogaugecomprehension– Considersendingallkeystaffto340BUniversityannually• UpdatesandnetworkingopportuniJes
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Components and Best Practices
• DevelopanddocumentwriWenpoliciesandproceduresforall340B-relatedtopics– Programgovernance– PaJentdefiniJon– GPOprohibiJon– DuplicatediscountprevenJon(includingMedicaidcarve-
in/carve-out)– Inventorymanagement– Systemsmaintenance– Compliancereviewsandself-audittasks
• DefiniJonofamaterialbreach– Useof340Bsavings
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Components and Best Practices
• EnsurethatALLsystemsusedfor340BprogrammanagementareconJnuouslymaintained– Splimngsoeware,inventorymanagement,contractpharmacyadministraJon,billingsystems,EMRs,dispensingsystems
• EnsurethatALLrecordsneededforauditarereadilyavailable– Includingfromoutsidevendors
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
What are “Auditable Records?”
• Any documentation related to eligibility, registration and drug purchases of/by: – Covered entity – Child sites – Contract pharmacies
Examples• MedicareCostReportor
NoJceofGrantAward• Contractwithgovernmentto
provideservices• Contractpharmacy
agreements• Purchasingrecords(340B
andnon-340B)• P&Psregarding
procurement,GPOexclusion,contractpharmacy,compliance,etc.
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Components and Best Practices
• ReviewandupdateHRSAdatabaserecords– EnJtyinformaJon– Childsites– Authorizingofficialsandprimarycontacts– Contractpharmacies
• LocaJons• StartandterminaJondates• Confirmyouhaveactualcontracts!
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Components and Best Practices
• Developandimplementgoodmethodsforself-audit– EstablishcontrolsforallsystemsandoperaJons,withallowed
variances– RouJnereviewsof340BtransacJonsandprescripJonsusing
reasonablesamples– RouJneeligibilityreviewsofproviders,sites,pharmacies
• Includingpharmacyvolumes/uJlizaJon– PeriodicallyvisitcontractpharmacylocaJonstochecksignature
logs,inventoryanddispensingpracJces– Periodicallycheckcontractsandagreementsforvalidityand
completeness– Document,document,document
• Obtainanindependentauditatleastannually
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Components and Best Practices
• EstablishprocedurestodesignandimplementcorrecJveacJonplans– Whenthey’reneeded– Whowillmanagethem– Whooverseesthem
• ConJnuouslymonitorandreview340Bprogramchanges– HRSA/OPA– Apexus– Peer-to-peer
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Suggested Schedule: Hospitals
AtLeastAnnually AtLeastQuarterly AtLeastMonthly • Governance program • Policies and
procedures • Contract pharmacy
agreements
• Low income service provision
• Disproportionate share percentage
• Medicaid status and exclusion file
• HRSA database
entries
• Medicare cost report child site listing
• Orphan drug usage (if applicable)
• Provider file review • Transaction reviews
- Mixed-use - Contract Pharmacy - GPO exclusion
- Employee Rxs • Split-biller set-up
- NDC changes - Charge master
changes
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Suggested Schedule: Non-Hospitals
AtLeastAnnually AtLeastQuarterly AtLeastMonthly • Governance program • Policies and
procedures • Contract pharmacy
agreements
• Notice of Grant Award - Scope of grant
• Medicaid status and exclusion file
• HRSA database
entries
• Inventory reconciliation (if using physical inventory model)
• Provider file review • Transaction reviews
- Clinic-administered medications
- Contract Pharmacy
- Employee Rxs
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Self-Disclosure Process
• Establishanddocumentcriteriathatsignifywhenamaterialbreachofcompliancehasoccurred• ForsituaJonsthatareamaterialbreach,informHRSAwhilecorrecJngtheissue.Includethe
followinginformaJon:– 340BID– theviolaJonthatoccurredandscope– acorrecJveacJonplan(CAP)tofixtheproblemmovingforward– astrategytoinformaffectedmanufactures(ifapplicable)– aplanforfinancialremedyifrepaymentisowed
• Workoutanynecessaryfinancialremedywithmanufacturer(s)ingoodfaith
• HRSAreviewsself-disclosure,including:– violaJoninformaJon– CAP,ensuringthatitfullyaddressesissuescausingtheviolaJon– repaymentplanand/orcompleJonofplan– compleJonofcontacttoallaffectedmanufacturers
• HRSAclosesself-disclosure– Whenallcriteriaaremet,HRSAsendswriWencommunicaJonthatthemaWerisclosed
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Self-Disclosure Best Practices
• UseReporJngTool– The340BPrimeVendorProgramhasworkedwithHRSA,coveredenJJes,andmanufacturers
todevelopasuggestedtoolfortheself-disclosureprocess.• asampleleWertoHRSA,• alistofJpswhencontacJngmanufacturers,• aformatforsummarizingnon-compliance,• atemplateforaCorrecJveAcJonPlan(CAP),and• Jpsdirectlyfrommanufacturersonthebestwaystoresolveissuesquicklyandcompletely
• ProvideDetailedInformaJontoallStakeholders
• CoveredenJJesshouldprovideanimmediateremedytocorrectthematerialbreach,proposeaplanforperiodicassessmentandconJnuousmonitoring,andoutlineaclearmethodtodeterminewhentheCAPiscompleted.SuccessfulcoveredenJJeshavealsorouJnelyidenJfiedanimplementaJondate,enJtycontactperson,andclarifiedaninternal340BcommunicaJon/educaJonstrategy.
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
Key Takeaways
• BeconfidentinyourpaJentdefiniJon,340Busage,andabilitytopreventdiversionandduplicatediscounts
• BepreparedwithwriWen,comprehensive340Bprogrampoliciesandprocedures,including340Bprogramcompliance
• EnsurethatallrecordsnecessarytoauditcompliancearereadilyaccessibletoprogramleadersacrosstheorganizaJonandoutsideauditors
• Conductregularself-auditstoidenJfyareasofweaknessandimplementcorrecJonstoanyerrorsoroversights– Considertheuseofamock-audittoolandcentralizeddocumentaJon
system• Obtainanannualindependentaudit,andconsiderquarterlyaudit
assistance
© 2016 Pharmacy Stars, LLC All Rights Reserved www.pharmacystars.com
ForMoreInformaJon:
TonyZappa952-457-7174