HCCA Compliance InstituteHCCA Compliance Institute

Compliance Education and Compliance Education and Auditing & Monitoring in Life Auditing & Monitoring in Life

SciencesSciences

April 23, 2006April 23, 2006

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AgendaAgenda9:009:00--9:30 9:30 -- Introductions, background on organization Introductions, background on organization 9:309:30--10:1510:15 -- TrainingTraining

Process (types of training, frequency, # of hrs per year) Process (types of training, frequency, # of hrs per year) Delivery methodsDelivery methodsMeasuring effectiveness of trainingMeasuring effectiveness of trainingEli Lilly DVD DemoEli Lilly DVD Demo

10:1510:15--10:3010:30 -- BreakBreak10:3010:30--11:4511:45 -- Auditing & MonitoringAuditing & Monitoring

Panel Discussion and TipsPanel Discussion and TipsDeveloping the Audit PlanDeveloping the Audit PlanDeveloping the Audit (scope, sample, attributes)Developing the Audit (scope, sample, attributes)Sample Audit ToolsSample Audit Tools

11:4511:45--12:00 12:00 -- Close and final Q&AClose and final Q&A

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Seven Elements of a Compliance Seven Elements of a Compliance ProgramProgram

ComplianceProgram

Policy & Procedures

Training

CommunicationMonitor &Auditing

Owner

Discipline Process

CorrectiveActions

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WorldWorld’’s Largest Retailers Largest Retailer3800+ Pharmacies in US & Puerto Rico3800+ Pharmacies in US & Puerto Rico

WalWal--Mart & SAMMart & SAM’’S CLUBS CLUBHospitals & ClinicsHospitals & ClinicsSpecialty PharmacySpecialty PharmacyMail Order PharmacyMail Order Pharmacy

WalWal--Mart Stores Inc.Mart Stores Inc.

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WalWal--MartMartCorporate Integrity AgreementCorporate Integrity Agreement

Entered into a 4Entered into a 4--year CIA in March 2004year CIA in March 2004Established Compliance Program Established Compliance Program

Compliance OfficerCompliance OfficerAuditing & MonitoringAuditing & MonitoringTraining & EducationTraining & EducationConfidential Disclosure ProgramConfidential Disclosure Program

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WalWal--Mart Pharmacy Compliance Mart Pharmacy Compliance StaffStaff

Field Support Field Support StaffStaff

Regional Regional Compliance Compliance ManagersManagersDivisional, Divisional, Regional, District Regional, District & Pharmacy & Pharmacy ManagersManagersInternal Audit Internal Audit

Home Office StaffHome Office StaffCompliance OfficerCompliance Officer2 Compliance Mgrs 2 Compliance Mgrs

(Billing & HIPAA Compliance)(Billing & HIPAA Compliance)

Assistant Assistant

Compliance BudgetCompliance BudgetTraining & SeminarsTraining & SeminarsPublicationsPublicationsTravelTravel

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Eli Lilly and CompanyEli Lilly and Company

InnovationInnovation--driven Pharmaceutical Manufacturerdriven Pharmaceutical ManufacturerLilly products treat depression, schizophrenia, Lilly products treat depression, schizophrenia, attentionattention--deficit hyperactivity disorder, diabetes, deficit hyperactivity disorder, diabetes, osteoporosis and many other conditions osteoporosis and many other conditions 43,000 employees worldwide43,000 employees worldwideProducts marketed in 143 countriesProducts marketed in 143 countries

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Eli Lilly and Company Compliance Eli Lilly and Company Compliance OrganizationOrganization

Chief Compliance OfficerChief Compliance OfficerCorporate Compliance CommitteeCorporate Compliance CommitteeUS Affiliate Compliance OrganizationUS Affiliate Compliance Organization

2 Directors2 Directors5 Managers5 Managers17 Associates and Assistants17 Associates and Assistants

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Lilly Consent DecreeLilly Consent Decree

Agreed to settle with FDA Office of Agreed to settle with FDA Office of Consumer Litigation Consumer Litigation 5 year consent decree beginning 5 year consent decree beginning February 2006February 2006Requirements for Compliance Program, Requirements for Compliance Program, Training, Disclosure Program, Monitoring, Training, Disclosure Program, Monitoring, and Independent Review Organizationand Independent Review Organization

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AstellasAstellas

Merger of Yamanouchi and Fujisawa Merger of Yamanouchi and Fujisawa Healthcare Inc. (April 2005)Healthcare Inc. (April 2005)Among top 20 pharmaceutical companies Among top 20 pharmaceutical companies worldwideworldwide1750 employees in North America1750 employees in North America

879 Marketing and Sales employees879 Marketing and Sales employees

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Astellas Compliance StaffAstellas Compliance Staff

Independent DepartmentIndependent DepartmentVP of Corporate ComplianceVP of Corporate ComplianceAssistant Director, Manager, Exec. AssistantAssistant Director, Manager, Exec. AssistantCrossCross--functional teams/issuesfunctional teams/issuesSales and Marketing primary focusSales and Marketing primary focus

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Eli Lilly Eli Lilly -- Compliance Training Compliance Training DevelopmentDevelopment

Use adult learning principlesUse adult learning principlesTell themTell themTell them why, WIFMTell them why, WIFMLet them practiceLet them practice

Content developmentContent developmentInclude people with sales experience as Include people with sales experience as well as compliance, legal and regulatory well as compliance, legal and regulatory Translate policy and legalTranslate policy and legal--ese ese Use Sales Trainers or Field Personnel to Use Sales Trainers or Field Personnel to review and validate trainingreview and validate trainingWhen selecting When selecting ““Off the shelf solutionsOff the shelf solutions““ --consider the Learnerconsider the Learner

Testing Testing Aligned to training objectives and desired Aligned to training objectives and desired behaviorsbehaviorsValidated testsValidated tests

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Eli Lilly Eli Lilly -- Compliance Training Compliance Training DeliveryDelivery

Incorporate into existing sales training processIncorporate into existing sales training processNew rep sales schoolsNew rep sales schoolsOngoing training Ongoing training -- sales meetings, selfsales meetings, self--studystudy

Spread out over the year Spread out over the year -- not just one day once a year not just one day once a year Tracking of completionTracking of completion

Presented by Directors, Managers and TrainersPresented by Directors, Managers and TrainersCreating a culture of compliance Creating a culture of compliance

Model appropriate responses to the toughest situationsModel appropriate responses to the toughest situationsPractice Practice -- just like message practicejust like message practiceCreate realisticCreate realistic scenarios to assist with understandingscenarios to assist with understanding

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Eli Lilly Eli Lilly -- PhRMA Code ExamplePhRMA Code ExampleIssue: Issue: Spouses or guests attending Spouses or guests attending meals or presentations by a meals or presentations by a pharmaceutical company pharmaceutical company

Question:Under the code may a Healthcare Professional’s (HCP) spouse or other guest be included in a meal, if the HCP pays?

Answer:No, A spouse or guest is not appropriate regardless of who pays unless they are an HCP for whom the information is appropriate.

Voluntary PhRMA Code became law in California 7/1/05

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Inappropriate attendeesInappropriate attendeesSpouses, family, or friends not practicing medicine in a field Spouses, family, or friends not practicing medicine in a field relevantrelevant to the to the information presented information presented Inappropriate guests must not attend Lilly business meals or FDAInappropriate guests must not attend Lilly business meals or FDA ––Regulated programsRegulated programs

Rep can prevent a situation before it happens by: Rep can prevent a situation before it happens by: Discuss with HCP in advanceDiscuss with HCP in advanceRefer to statement on invitationRefer to statement on invitationPlan alternatives to evening programs (breakfast, lunch, immediaPlan alternatives to evening programs (breakfast, lunch, immediately tely after office hours)after office hours)Confirm attendees with a phone call the day before the programConfirm attendees with a phone call the day before the program

Or you will have to ask inappropriate attendees to leaveOr you will have to ask inappropriate attendees to leave

PhRMA Code:Q: “Under the code, may HCP’s spouse or other guest be included in a

meal…if the HCP pays for the spouse or guest?”A: “No. The code provides that it is not appropriate to include a spouse or

guest at a meal…regardless of who pays for the meal, unless the spouse or guest would independently qualify as a HCP for whom the informational presentation is appropriate.”

Eli Lilly Example of Sales Force Training

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Computer Based TrainingComputer Based TrainingSelfSelf--study tools work well for study tools work well for administrative topicsadministrative topics

Sample AccountabilitySample AccountabilityExpense ReportingExpense ReportingAdverse Event / Product Adverse Event / Product Complaint ReportingComplaint Reporting

Quick Checks and Scenario ChallengesQuick Checks and Scenario ChallengesKnowledge of policiesKnowledge of policiesApplication of policiesApplication of policies

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WalWal--Mart Compliance TrainingMart Compliance TrainingGeneral Compliance Program , Annual TrainingGeneral Compliance Program , Annual Training

Pharmacy Associates, Directors, ExecutivesPharmacy Associates, Directors, ExecutivesComputer Based TrainingComputer Based TrainingDistrict Manager Orientation TrainingDistrict Manager Orientation Training

Specialized Annual TrainingSpecialized Annual TrainingTargeted GroupsTargeted GroupsComputer Based Training & Computer Based Training & OnOn--Site TrainingSite Training

Pharmacists & TechniciansPharmacists & TechniciansReconciliation DepartmentReconciliation DepartmentSpecialty & Mail Order PharmaciesSpecialty & Mail Order Pharmacies

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WalWal--Mart Compliance TrainingMart Compliance TrainingPharmacist Directed TrainingPharmacist Directed Training

Monthly updates reviewed by Pharmacy Managers Monthly updates reviewed by Pharmacy Managers with Staff. with Staff. Updates educate on FAQUpdates educate on FAQ’’s & commonly identified s & commonly identified exceptions. exceptions.

ReRe--trainingtrainingAdditional ResourcesAdditional Resources

Compliance Hotlines (Pharmacy, Ethics, and HIPAA)Compliance Hotlines (Pharmacy, Ethics, and HIPAA)Email questions to Compliance Email questions to Compliance –– ConfidentialConfidential

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WalWal--Mart Compliance Training Mart Compliance Training ––Additional ResourcesAdditional Resources

Compliance Hotlines (Pharmacy, Ethics, Compliance Hotlines (Pharmacy, Ethics, and HIPAA)and HIPAA)Email questions to Compliance Email questions to Compliance ––ConfidentialConfidential

2020

Astellas Astellas –– Compliance TrainingCompliance Training

Current activitiesCurrent activities--Orientation overviewOrientation overview--Online training programOnline training program--In person presentationsIn person presentations

Company meetingsCompany meetingsSales and Marketing meetingsSales and Marketing meetings

--Corrective action plansCorrective action plans

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Astellas Astellas –– Compliance TrainingCompliance Training

In development: training tools and In development: training tools and processesprocesses

Written guideWritten guideScenario based Scenario based ““tool kittool kit””Custom online modules, shortsCustom online modules, shortsIntegration with already existing programs Integration with already existing programs and processesand processes

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Play Eli Lilly DVDPlay Eli Lilly DVD

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Eli Lilly Eli Lilly -- Monitoring & Assessment Monitoring & Assessment Develop a monitoring plan to assess effectiveness of Develop a monitoring plan to assess effectiveness of training and assure compliance with policiestraining and assure compliance with policies

Rep rideRep ride--alongs alongs Speaker TrainingSpeaker TrainingSpeaker Programs Speaker Programs Sales Meetings Sales Meetings District reviewsDistrict reviewsExhibitsExhibits

Determine the appropriate sample size through a statistical Determine the appropriate sample size through a statistical analysisanalysis

Annual target based on volume of business activitiesAnnual target based on volume of business activities

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Eli Lilly Eli Lilly -- Monitoring & AssessmentMonitoring & Assessment

The The ““open book testopen book test””Protocols and checklists based directly Protocols and checklists based directly from your policiesfrom your policies

Document what is going wellDocument what is going wellInvestigate any findings and followInvestigate any findings and follow--up up with corrective actionswith corrective actions

Is this an isolated finding or an indicator of broader Is this an isolated finding or an indicator of broader issues?issues?Make adjustments in policy or training for clarity and Make adjustments in policy or training for clarity and consistencyconsistency

Take disciplinary actions if necessaryTake disciplinary actions if necessary

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Eli Lilly Eli Lilly -- Good Business Practice Good Business Practice Review (GBP)Review (GBP)

InIn--depth review of a sales district depth review of a sales district -- One per Area per YearOne per Area per YearPrePre--work Review work Review

Expense reports, sample accountability, performance Expense reports, sample accountability, performance management documents, field visit or call notes, action management documents, field visit or call notes, action plans, district expenses, speaker program database, plans, district expenses, speaker program database, compliance training records, violation logcompliance training records, violation log

OnOn--site site Ride with one representativeRide with one representativeMeet with district manager and review informationMeet with district manager and review information

PostPost--workworkDM investigation and corrective action on any findingsDM investigation and corrective action on any findingsFinal report issued to Area Director and Business Unit Final report issued to Area Director and Business Unit leaderleader

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Eli Lilly Eli Lilly -- Monitoring & AssessmentMonitoring & AssessmentUse the Monitoring Program to Use the Monitoring Program to integrate integrate Accountability into the BusinessAccountability into the BusinessProvide onProvide on--going Dashboard going Dashboard metrics metrics for business unitsfor business unitsCompile annual monitoring Compile annual monitoring results results for Senior Management Reviewsfor Senior Management ReviewsLook for trends and patterns Look for trends and patterns Set expectations for linkages to Set expectations for linkages to performance evaluationsperformance evaluations

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WalWal--Mart Auditing & MonitoringMart Auditing & MonitoringPharmacy OnPharmacy On--Site ReviewsSite Reviews

Pharmacies randomly selectedPharmacies randomly selectedReview Partial Fill Prescription Review Partial Fill Prescription & Return to Stock processes& Return to Stock processesInterview Associates to ensure Interview Associates to ensure understanding of compliance understanding of compliance directed processesdirected processesObserve Pharmacy AssociatesObserve Pharmacy Associates

Manager Requested ReviewsManager Requested ReviewsAllow for a more targeted Allow for a more targeted review of proceduresreview of proceduresBuild an audit plan that Build an audit plan that reviews areas of concern.reviews areas of concern.

Reg. Compliance Mgr ReviewsReg. Compliance Mgr ReviewsRegional Compliance Mgr / per Regional Compliance Mgr / per StateStateConduct a high level review of Conduct a high level review of pharmacy procedurespharmacy procedures

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WalWal--Mart Auditing & MonitoringMart Auditing & MonitoringPharmacy Home Office ReviewsPharmacy Home Office Reviews

Targeted and Random claims reviewsTargeted and Random claims reviewsOverpaymentsOverpaymentsUnderpaymentsUnderpaymentsDocumentationDocumentation

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WalWal--Mart Auditing & MonitoringMart Auditing & MonitoringFollowFollow--up reviews (Monitoring)up reviews (Monitoring)

Conduct reviews of pharmacies Conduct reviews of pharmacies previously audited.previously audited.Use to monitor compliance & ensure Use to monitor compliance & ensure previous audit findings have been previous audit findings have been addressed.addressed.

Draft Audit ReportsDraft Audit ReportsProvided to Pharmacy, District, & Provided to Pharmacy, District, & Regional MgrRegional Mgr

Mgmt Responses for each ExceptionMgmt Responses for each ExceptionSpecific Corrective ActionSpecific Corrective ActionCorrective Action Going ForwardCorrective Action Going Forward

Finalized Audit ReportsFinalized Audit ReportsSent to Pharmacy Exec Mgmt & Sent to Pharmacy Exec Mgmt & Compliance Officer Compliance Officer

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Astellas Compliance ProcessAstellas Compliance ProcessRisk Assessment

Gap Analysis

Corrective ActionTraining andCommunication

Auditing, Monitoring,Data collection Compliance Process

Astellas Auditing & MonitoringAstellas Auditing & Monitoring

Travel & Entertainment Policy and PhRMA Travel & Entertainment Policy and PhRMA Code intersectionsCode intersections

Expense reporting systemExpense reporting systemSpending levels/person; types of Spending levels/person; types of expenditures; frequency of events; attendee expenditures; frequency of events; attendee informationinformationReporting issues and processReporting issues and processCorrective actionCorrective action

Astellas Auditing & MonitoringAstellas Auditing & Monitoring

Advisory Board Process AuditAdvisory Board Process AuditGuidelines and rulesGuidelines and rulesTraining for employees involved in functionTraining for employees involved in functionForms and remindersForms and remindersTraining for reviewersTraining for reviewersTools and methodologyTools and methodology

Astellas Auditing & MonitoringAstellas Auditing & Monitoring

FindingsFindingsNow what?Now what?Reporting issuesReporting issues--who, what, when, howwho, what, when, howCorrective action, process improvementsCorrective action, process improvementsDocumentationDocumentationDoing it all over againDoing it all over again

Deloitte & Touche Deloitte & Touche –– Auditing & Auditing & Monitoring from an IRO PerspectiveMonitoring from an IRO Perspective

What is the company currently doing What is the company currently doing around auditing and monitoring?around auditing and monitoring?Do the P&P address regulatory Do the P&P address regulatory requirements and legal risks?requirements and legal risks?Are the employees following the P&P?Are the employees following the P&P?Do systems/processes exist to do efficient Do systems/processes exist to do efficient auditing and monitoring?auditing and monitoring?

All All -- Developing the Audit PlanDeveloping the Audit Plan

dentificationdentificationCorporate Integrity AgreementCorporate Integrity AgreementOIG Work PlanOIG Work PlanCompliance CommitteeCompliance CommitteeRisk AssessmentRisk Assessment

All All -- Developing the Audit Developing the Audit

ScopeScopeSampleSampleAttributesAttributes

All All –– Sharing of Audit ToolsSharing of Audit Tools

AstellasAstellasEli LillyEli LillyWalWal--MartMartDeloitte & ToucheDeloitte & Touche

Still a little cloudy?Still a little cloudy?