1. REGISTER EARLY 5 annual th AND SAVE! Reserve your place by CliniCal Billing & January 14th forMaximum SavingsPROUDLY PRESENTS ReseaRCh ComplianCe Bringing together Research Sites, Hospitals, and Trial Sponsors to Discuss Billing and Research Compliance Best PracticesMarch 6-8, 2011 hUTTON hOTEL NashviLLE, TENNEssEEcONFErENcEExamine and discuss pressing issues SurroundingchairPErsON Clinical Billing & Research Compliance such as: KELLY WiLLENBErG HowtoWorkClinicalTrialPolicy,theNCDandthedevelopmentofacoverageanalysisintoyourbusinessprocesses President SYNERGISM, LLC DiscernwhethertoBillforItemsandServicesUnderCurrentGuidancesthroughCaseExamples UtilizeanElectronicClinicalTrialManagementSystemandFlowforsPEaKEr ParTiciPaTiON FrOMBillingComplianceThE FOLLOWiNG OrGaNiZaTiONs: LearnRecentDevelopmentsinBillingforResearchRelatedServicesCOVENANT HEALTHandUnderstandHealthCareReformsImpactHEALTH RESEARCH ASSOCIATION GainaGreaterUnderstandingoftheVariousEthicalConsiderationsinClinicalBillingComplianceHOSPITAL CORPORATION OF AMERICA LearnEffectiveCommunicationTacticstoCoordinateMoreMEADE AND ROACHEffectivelywithResearchAdministrators,StudyCoordinatorsandMEDSTAR HEALTHyourIRBsOHIO STATE UNIVERSITY DevelopaFrameworkfortheDevelopment&ImplementationofPIEDMONT HEALTHCARE, INC. ClinicalResearchBillingWorkflowsSHARP HEALTHCARE IdentifytheCommonAreasofRiskandIssuesthatareUsuallyCitedSHERIDAN CLINICAL RESEARCHinanAuditSNR DENTON UnderstandRequirementsforManagingConflictsofInterestsSYNERGISM betweenResearchPhysiciansandSponsorsUMDNJ andmuchmore!UNIVERSITY OF MARYLAND MEDICAL SYSTEMplUS!UNIVERSITY OF UTAH SCHOOL OF MEDICINE CHOOSE FROM TWO SpECially SElECTEdVANDERBILT UNIVERSITY MEDICAL CENTERpRE-COnFEREnCE WORKSHOpS On:VIRGINIA COMMONWEALTH UNIVERSITY The Risky Business of Clinical Research Billing Quirky Trials and Billing ComplianceSPONSORS: TO REgiSTER Call 866-207-6528 OR ViSiT US aT WWW.ExlpHaRMa.COM/Billing

2. Welcome to the5th CliniCal Billing & ReseaRCh ComplianCedear Colleague,RaVE REViEWS FROM paST CliniCal RESEaRCH Billing & BUdgETS COMplianCEIamonceagainthrilledtobeabletoofferyoutheopportunitytoattendThe meeting exceeded my expectations!anallbillingcomplianceconference.AssomeonewhohasworkedinCompliance Officer, Corporate Integrity,billing compliance, I know its ever changing while exciting! You needOCHSNER HEALTH SYSTEMbestpracticesfromotherswhohavedoneitandareconsideredexperts. Great event and speaker line-up! I liked theExLPharmaispleasedtoannouncethe5thAnnualClinicalResearchmaterial covered and the group size forBillingComplianceConference.Thisuniqueeventisaoneofkindeventnetworking and discussionsforthebillingcomplianceforyourinstitutionorofficepractice.ExpertResearch Compliance Coordinator,speakerswillshowyouhowtheyhaveimprovedthebillingprocesstoPROviDENCE AK MEDiCAL CENTERenhanceoperationaleffectivenessandincreasecomplianceinitiatives.Theprogramfeaturesperspectivesfromthoughtleaders,providingyouThe event met my expectations and waswiththeopportunitytolearnandimplementcurrentstrategiestoim-very well conducted! Program Manager, Finance/Research Operations,proveyourclinicalresearchbillingefforts.JoinusMarch6-8th,2011in JAMES CANCER HOPSiTAL, OSU MEDiCAL CENTERNashville,Tennesseeforthisstimulatingevent! SpOnSORSHip and ExHiBiT OppORTUniTiES:Sincerely, Maximize your Marketing Efforts increase your companys direct exposure to targeted audi- ences by partnering with exl. We provide unique, valuable forums that display your products, highlight your services and illustrate your expertise. exl events are designed toKelly Willenberg Bryon Mainhelp your company forge new partnerships with potentialPresidentManaging Director clients. To obtain more information about the accretiveSYNERGISM,LLC ExLPHARMAvalue in partnering with exl, please contact: Lucas carrasco, Business develoPmenT mAnAgeRpS- CCB CREdiTS Will BE OFFEREd! 212-400-6231, lcarrasco@exlpharma.comWHO SHOUld aTTEnd? audience Breakdown at the 2010 Clinical Research Billing & Budgets Compliance:Thiseventisdesignedforprofessionalsemployedbyacademichealthcen-ters,hospitals,universitymedicalcenters,pharmaceutical&medicalde-vicecompanieswithinthefollowingareas:6% ClinicalBilling Thisprogramisalsoofinterestto: 21% ClinicalTrialsManagement18% goveRnmenT ClinicalFinance InvestigatorSites32%seRviCe PRovideRPhARmACeuTiCAl Contracts&Budgeting IRBsRseARCh siTesConsulTAnT & ResearchCompliance CROs23% QualityManagement&Control DataManagementProvidershosPiTAlsACAdemiC ResearchCoverageAnalysis SiteManagementConsultants Grants ResearchAdministration ComplianceOperations SiteRelationsVEnUE inFORMaTiOn:ExperienceasophisticatedandcomfortableNashville,Tennesseelodgingdestination-wherefour-starluxuryadoptsastylishandaccommodatingnewspirit.HuttonHoteloffersastrikingcontrasttotheconventionalclusterofWestEndanddowntownNashvillehotels,pairingatten-tiveservicewithelegant,contemporarydesign.TreatyourselftowelcomingNashvilleluxuryhotellodging,wherewarmhospitalityfindsanewperspective. LocatedintheheartofNashville,Tennessee Convenienttothecitysrenownedmusicsceneandlandmarkattractions High-speedwiredandwirelessInternetaccessforallguests State-of-the-artfitnesscenterwithPre-Corequipment,LCDpanels,andmore ComplimentaryBusinessCenterserviceswith24-houraccess 13,600squarefeetofelegantly-appointedspaceformeetingsHUTTOn HOTEl. 1808 WesT end Avenue, Pleasecall866-894-4609forreservationsandmentionyouarepartoftheExLPharmaRoomnAshville, Tn, 37203 Phone: 615-340-9333Block.Roomblockcut-offisFebruary20,2011. 3. pRe-ConFeRenCe WoRKshops sunday, march 6 th 20118:30 conference registration and continental BreakfastpRE-COnFEREnCE WORKSHOp a:9:00 The risky Business of clinical research Billing: The cTP, coverage analysis and Being Practical in OperationsThissessionwillprovidethedefinitionoftheClinicalTrialPolicy,theNCD,thedevelopmentofacoverageanalysisandhowtoworkthisintoyournormalworkflow.Wewillprovideexamplesoftoolsandtemplatesandhowtoactuallyperformacoverageanalysis.TheClinicalTrialPolicy,ReferenceSheets BreakingdownLocalCoverageDetermination(LCDs)byprocedureCreatingaMedicareCoverageAnalysisandbillingplan BillingGuidesDiscusstheregulationofclinicalresearchincludingoversight Implementaprocessforcoordinationandcommunicationofinformationto regulatoryagencies,thescopeoflawsandregulations,and ensureresearchservicesarecorrectlyidentifiedandnotbilledtopayor humansubjectprotectionRyan Meade, Partner, MEADE & ROACH - Kelly Willenberg, President, SYNERgiSM, LLC12:00 Lunch for Wor ks h o p At t e n d e e spRE-COnFEREnCE WORKSHOp B:1:00 Quirky Trials and Billing complianceThissessionwilldiscussallofthevaryingissueswiththecomplextypesofstudiesthatareincreasinglymoredifficulttobill.Wewillworkthroughthestudytypeslistedanddiscusshowtodiscernwhetheryoucanbillforitemsandservicesundertheguidelines.Wewillprovidesamplesandusecaseswheretherehavebeenissuesinregardstobillingcompliance.DeviceTrials PhaseITrialsInvestigatorInitiated HUDsOfflabelUse CompassionateUseInpatientTrials ComplicatedStudiesDoneAcrossDifferentHospitalAreasKathleen R Hurtado, R.Ph, President and CEO, HEALTH RESEARCH ASSOCiATiON,AN AffiLiATE Of THE UNivERSiTY Of SOUTHERN CALifORNiADeena Bernstein, Director of Clinical Research, SHERiDAN CLiNiCAL RESEARCH4:00 cLose of pre-co n f e r e n c e Wo r ks h o p dAymain ConFeRenCe monday, march 7th 20118:00 conference registration and continental Breakfast 10:45 Panel Discussion on Physician issues and challenges8:30 chairpersons Welcome and Opening remarksin Billing complianceKelly Willenberg, President, SYNERgiSM, LLC Keepingabreastoftherapidlychangingrulesinbillingcompliance8:45 recent Developments in Billing For research related EducatingPhysiciansonnewguidancesservices Overseethecomplianceofphysiciansandhealthcarepractitioners UnderstandcarereformandhowitwillimpactthebillingofPANEL MODERATOR: Ryan Meade, Partner, MEADE & ROACHservicesforclinicalresearchPANELiSTS: Local Physicians to be determined RecallnewdirectivesinbillingMedicareforresearchrelatedservices 11:30Ethical considerations in Billing compliance Understandyourresponsibilitiesforliabilityreporting ReviewethicalconsiderationsinclinicaltrialbillingfromanDavid vulcano, Assistant Vice President & Responsible Executive, historicalperspectiveClinical Research, HOSPiTAL CORPORATiON Of AMERiCA Identifyparticularareasofclinicaltrialbillingthatpresentethicalissuesforinvestigators,researchstaff,andresearchsubjects9:30 CaSE STUdy Usingcaseanalyses,applyacombinationofethicalconsiderationsUse of an Electronic clinical Trial Management inclinicaltrialbillingandregulatoryrequirementstoarriveatsystem and Flow of Billing complianceeffectivecompliancestrategies Quincy J. Byrdsong, EdD, CiM, CiP, CCRP Historicalbackground,researchbillingcompliancepriorto Executive Director of Research Administration, Virginia Commonwealthpurchaseofelectronicclinicaltrialmanagement(CTM)system UNivERSiTY MEDiCAL CENTER EnhancementofpurchasedCTMsystemandintegrationwithEPICbillingsystemforrobustbillingcompliance 12 : 30 Lu n c h fo r co n f e r e n c e At t e n d e e s Resultingbillingcomplianceprocess:fromprotocolbillingplantoelectronicjournalentry1:30Billing compliance and the irB ContinuedchallengesforbillingcomplianceautomationKaren Mottola, M.A., C.C.R.C., C.P.C., Clinical Research Compliance Officer, ImpactofBillingComplianceonIRBsUNivERSiTY Of UTAH SCHOOL Of MEDiCiNE FederalRegulations EffectivecommuncationbetweenResearchAdministrators,Study CoordinatorsandtheIRBAdministrator10:15 net Working & r e f r e s h m e n t B r eA k ImportanceofthesampleInformedConsentpriortoIRBreview Contract/BillingchangesafterIRBapproval Becky West, MS, CIP, IRB Administrator, COvENANT HEALTH 4. main ConFeRenCe monday, march 7th 20112:15 Effective communication, Training and Leadership 4:30 changes of scope: The clinical Trial study Budget and amongst your research compliance TeamBilling compliantlySpeaker to be announced Monitoringtheprocessofamendmentsandprotocolchanges3:00net Working B r eA k & r e f r e s h m e n t Br e A k Deliveringamethodologyforeditingcoverageanalysis Maintainingcontroloverbudgetvariances3:30 The significance of a Billing compliance Program at an Collaboratingwithsponsorsforawin-winsituationacademic Medical center The Growth and Growing PainsWarren E. Beck, Associate Vice Chancellor for Health AffairsSr. VP of Finance vANDERBiLT UNivERSiTY, MEDiCAL CENTER Creationofabillingcomplianceprogram Systemsandprocessesforthemethodologyoftheprogram5 : 15 dAy o n e co n c Lu d e s ConclusionastowhyitwasestablishedintheDepartmentofFinanceandhasremainedinFinanceLisa Murtha, Partner, SNR DENTON US, LLP main ConFeRenCe tuesday, march 8th 20118:30 chairpersons recap of Day OneKelly Willenberg, President, SYNERgiSM, LLC 11:30CHOiCE OF TWO SESSiOnS8:45 Best Practices and Lessons Learned in Development &conflict of interest and Physician Billing implementation of clinical research Billing Workflows RequirementsformanagingofconflictsofinterestsbetweenresearchphysiciansandsponsorsGaininsightsintohowcolleaguesdevelop&runtheirclinical Anti-KickbackStatuteandtheoftenunseenconflicts researchbillingoperations SurveyofapproachestomitigatingconflictsLearnaboutsharedpitfallsandcommonchallengesandhowtheyAngelique Dorsey, JD, CHRC, Research Compliance Director, aremanagedbyyourpeerinstitutions MEDSTAR HEALTHCompareworkflows,policiesanddocumentsandcontributetoa formslibraryhostedontheSynergismwebsiteforyear-roundinTERaCTiVE ROUndTaBlE diSCUSSiOn accesstoresourcesthatmayhelpyoufurtherdevelopyourclinical Living and Breathing Billing compliance in Practice researchoperationshow coordinators Deal with the issues ?Sonia Kleiner-Arje, CHRC, Executive Director,OffiCE Of CLiNiCAL RESEARCH ADMiNiSTRATiON, UMDNJ9:30 Tactical Framework for a clinical Trial Billing audit 12 : 30Lu n c h fo r co n f e r e n c e At t e n d e e sElementsofaneffectiveauditprogramIdentifythecommonareasofriskandissuesthatareusually 1:30 Nih/Grant requirements, Patient & sponsor Billing citedinanauditcompliance and Other responsibilitiesSummarizewhatsomeofthestrategicoptionsareforreducing risk NIHGrantRequirements;StrategiesforCompliantGrantActivitiesChallengesinbillingaudits Settingupandmanaginganeffectivebillingcompliancesystem;Targetedauditsbypatientenrollment,thirdpartypayer, CaseStudy orstudysponsor OtherResponsibilitiesoftheClinicalTrialAdministrativeOfficeAuditScopeandObjectivesRobert Di vito, JD, CHRC, PiEDMONT HEALTHCARE, iNC.fred Herman, Research Compliance Manager,UNivERSiTY Of MARYLAND MEDiCAL SYSTEMKevin Eskew, Managing Director, Healthcare, SNR DENTON US LLP 2 : 15 n e tWo r k i n g & r e f r e s h m e n t B r eA k10:15 net Working & r e f r e s h m e n t B r eA k2:45 Puzzled: ask the Proficient Professional Your Questions10:45 CHOiCE OF TWO SESSiOnS on Billing complianceThe Billing of Device Trials and Pre-DeterminationCHAiR:ReviewtheMedicareBillingRulesforInvestigationalDevices Kelly Willenberg, President, SYNERgiSM, LLCReviewCommercialPayerpositionsonpayingfor InvestigationalDevices PANELiSTS:UnderstandtheroleofPre-DeterminationinInvestigationalDeena Bernstein, Director of Clinical Research, DeviceStudiesSHERiDAN CLiNiCAL RESEARCHLearnaboutpeerprocessesandworkflowsfor pre-determinationofclinicaltrials.Kathleen R Hurtado, R.Ph, President and CEO, HEALTH RESEARCHASSOCiATiON, AN AffiLiATE Of THE UNivERSiTY Of SOUTHERNJennifer Lanter, BSN, RN, CCRC, MSPH; Associate Director of theCALifORNiAResearch Billing Office, OHiO STATE UNivERSiTY (tENtAtIVE)coding and Billing The secrets of the Trade 4 : 0 0 co n f e r e n c e co n c Lu d e sBillingMedicareforanythingonaclinicaltrialpatientBillingMedicareforanythingonaIDEDevicetrial;samerules?HowdoMedicareAdvantagepatientsfitin?Aretheyincluded?Terry Ann Cox, Clinical trials Financial Analyst, SHARP HEALTHCARE 5. 5 CliniCal Billing &th ReseaRCh ComplianCeFive Ways to Register:Fees for attending the 5th Clinical Billing &Fax:888-221-6750Research ComplianceMail: ExL Events, inc.555 8th avenue, suite 310 rEGisTEr BY JaNUarY 21sT, 2010 TO TaKE aDvaNTaGE OF OUrNew York, NY 10018EarLY PricE DiscOUNTs:Phone: 866-207-6528 academic, Non-Profit, Government ratesOnline: www.exlpharma.com main Conference only$995main Conference, plus one Workshop$1195Email: register@exlpharma.com main Conference, plus both Workshops$1395corporate rates:main Conference only$1695main Conference, plus one Workshop$1895 MEdia paRTnERS main Conference, plus both Workshops$1995aFTEr JaNUarY 21sT, PriciNG is as FOLLOWs:academic, Non-Profit, Government ratesmain Conference only$1195main Conference, plus one Workshop$1395main Conference, plus both Workshops$1595corporate rates:main Conference only$1895main Conference, plus one Workshop$2095main Conference, plus both Workshops$2295GrOUP DiscOUNT PrOGraM:For every three simultaneous registrations from your company, you willreceive a fourth complimentary registration to the program. To take advan-tage, please register online or call 888-207-6528.make checks payable to exl events, inc. and write code P244 on yourcheck. You may also use visa, masterCard, discover or American express.Payments must be received by February 22, 2010CANCELLATiONS: if you need to cancel your registration for an upcoming ExL con-ference, please note the following policies derived from the Start Date of the event:four weeks or more: A full refund (minus a $95 processing fee), or a voucher toanother ExL event valid for two years from the voucher issue date.ONE TO fOUR WEEKS: A 50% refund, or a voucher to another ExL event valid fortwo years from the voucher issue date.WiTHiN THE LAST WEEK: A voucher to another ExL event valid for two years fromthe voucher issue date.To receive a refund or voucher, please fax your request to 888-221-6750.Please Note: Speakers and agenda are subject to change without notice. In the event of aspeaker cancellation, every effort to find a suitable replacement will be made. 6. 5th annual PROUDLY PRESENTSCliniCal Billing &ReseaRCh ComplianCeExp. Date:PLEASE MENTION PRIORITY CODE: P244Bringing together Research Sites and Trial555 8th Avenue, Suite 310Sponsors to Discuss Billing and ResearchCompliance Best PracticesNew York, NY 10018REGISTER EARLYMarch 6-8, 2011 AND SAVE!hUTTON hOTELReserve your place by NashviLLE, TENNEssEEJanuary 14th for Maximum SavingsiNTrODUciNG OUrName on CardCard NumberchairPErsON FOr Signature2010:SpEaKER paRTiCipaTiOnFROM THE FOllOWingKELLY WiLLENBErG,ORganiZaTiOnS:President,SYNERGISM, LLCPlease contact me: Im interested in marketing opportunities at this eventCOVENANT HEALTHregister@exlpharma.comHEALTH RESEARCH ASSOCIATION I wish to receive email updates on ExL Pharmas upcoming events www.exlpharma.comYes! Register me for the Conference and Workshop: ZipHOSPITAL CORPORATION OF AMERICAMEADE AND ROACH 888-221-6750SPONSORS:MEDSTAR HEALTHOHIO STATE UNIVERSITY State Title FaxPIEDMONT HEALTHCARE, INC.SHARP HEALTHCARESHERIDAN CLINICAL RESEARCHRegister me for the conference onlySNR DENTONSYNERGISMNew York, NY 10018UMDNJTO R E G I S T E R555 8th Avenue,UNIVERSITY OF MARYLAND MEDICAL SYSTEMExL Events, Inc. 866-207-6528UNIVERSITY OF UTAH SCHOOL OF MEDICINESuite 310VANDERBILT UNIVERSITY MEDICAL CENTERVIRGINIA COMMONWEALTH UNIVERSITY Telephone Company Address Name Email Dept. City TO REgiSTER Call 866-207-6528 OR ViSiT US aT WWW.ExlpHaRMa.COM/Billing