REGISTER EARLY                   5 annual                     th                                                          ...
Welcome to the5th CliniCal Billing & ReseaRCh ComplianCedear Colleague,                                                   ...
pRe-ConFeRenCe WoRKshops · sunday, march 6 th 20118:30 conference registration and continental BreakfastpRE-COnFEREnCE WOR...
main ConFeRenCe · monday, march 7th 20112:15 Effective communication, Training and Leadership                             ...
5 CliniCal Billing &        th ReseaRCh ComplianCeFive Ways to Register:                                    Fees for atten...
5th annual                                                                                                                ...
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5th Annual Clinical Billing & Research Compliance, March 2011, Nashville


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Bringing Together Research Sites, Hospitals, and Trial Sponsors to Discuss Billing and Research Compliance Best Practices

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5th Annual Clinical Billing & Research Compliance, March 2011, Nashville

  1. 1. REGISTER EARLY 5 annual th AND SAVE! Reserve your place by CliniCal Billing & January 14th for Maximum SavingsPROUDLY PRESENTS ReseaRCh ComplianCe Bringing together Research Sites, Hospitals, and Trial Sponsors to Discuss Billing and Research Compliance Best Practices March 6-8, 2011 · hUTTON hOTEL · NashviLLE, TENNEssEEcONFErENcE Examine and discuss pressing issues SurroundingchairPErsON Clinical Billing & Research Compliance such as: KELLY WiLLENBErG • How to Work Clinical Trial Policy, the NCD and the development of a coverage analysis into your business processes President SYNERGISM, LLC • Discern whether to Bill for Items and Services Under Current Guidance’s through Case Examples • Utilize an Electronic Clinical Trial Management System and Flow for sPEaKEr ParTiciPaTiON FrOM Billing Compliance ThE FOLLOWiNG OrGaNiZaTiONs: • Learn Recent Developments in Billing for Research Related Services COVENANT HEALTH and Understand Health Care Reforms ImpactHEALTH RESEARCH ASSOCIATION • Gain a Greater Understanding of the Various Ethical Considerations in Clinical Billing ComplianceHOSPITAL CORPORATION OF AMERICA • Learn Effective Communication Tactics to Coordinate More MEADE AND ROACH Effectively with Research Administrators, Study Coordinators and MEDSTAR HEALTH your IRB’sOHIO STATE UNIVERSITY • Develop a Framework for the Development & Implementation of PIEDMONT HEALTHCARE, INC. Clinical Research Billing WorkflowsSHARP HEALTHCARE • Identify the Common Areas of Risk and Issues that are Usually Cited SHERIDAN CLINICAL RESEARCH in an AuditSNR DENTON • Understand Requirements for Managing Conflicts of Interests SYNERGISM between Research Physicians and SponsorsUMDNJ • and much more!UNIVERSITY OF MARYLAND MEDICAL SYSTEM plUS!UNIVERSITY OF UTAH SCHOOL OF MEDICINE CHOOSE FROM TWO SpECially SElECTEdVANDERBILT UNIVERSITY MEDICAL CENTER pRE-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. 2. Welcome to the5th CliniCal Billing & ReseaRCh ComplianCedear Colleague, RaVE REViEWS FROM paST CliniCal RESEaRCH Billing & BUdgETS COMplianCEI am once again thrilled to be able to offer you the opportunity to attend “The meeting exceeded my expectations!”an all “billing compliance” conference. As someone who has worked in Compliance Officer, Corporate Integrity,billing compliance, I know it’s ever changing while exciting! You need OCHSNER HEALTH SYSTEM“best practices” from others who have done it and are considered experts. “Great event and speaker line-up! I liked theExL Pharma is pleased to announce the 5th Annual Clinical Research material covered and the group size forBilling Compliance Conference. This unique event is a one of kind event networking and discussions”for the billing compliance for your institution or office practice. Expert Research Compliance Coordinator,speakers will show you how they have improved the billing process to PROviDENCE AK MEDiCAL CENTERenhance operational effectiveness and increase compliance initiatives. The program features perspectives from thought leaders, providing you “The event met my expectations and waswith the opportunity to learn and implement current strategies to im- very well conducted!” Program Manager, Finance/Research Operations,prove your clinical research billing efforts. Join us March 6-8th, 2011 in JAMES CANCER HOPSiTAL, OSU MEDiCAL CENTERNashville, Tennessee for this stimulating event! SpOnSORSHip and ExHiBiT OppORTUniTiES:Sincerely, Maximize your Marketing Efforts increase your company’s 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 Main help your company forge new partnerships with potentialPresident Managing Director clients. To obtain more information about the accretiveSYNERGISM, LLC ExL PHARMA value 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:This event is designed for professionals employed by academic health cen-ters, hospitals, university medical centers, pharmaceutical & medical de-vice companies within the following areas: 6%• Clinical Billing This program is also of interest to: 21%• Clinical Trials Management 18% goveRnmenT• Clinical Finance • Investigator Sites 32% seRviCe PRovideR PhARmACeuTiCAl• Contracts & Budgeting • IRB’s RseARCh siTes ConsulTAnT &• Research Compliance • CRO’s 23%• Quality Management & Control • Data Management Providers hosPiTAls ACAdemiC• Research Coverage Analysis • Site Management Consultants• Grants• Research Administration• Compliance Operations• Site RelationsVEnUE inFORMaTiOn: Experience a sophisticated and comfortable Nashville, Tennessee lodging destination - where four-star luxury adopts a stylish and accommodating new spirit. Hutton Hotel offers a striking contrast to the conventional cluster of West End and downtown Nashville hotels, pairing atten- tive service with elegant, contemporary design. Treat yourself to welcoming Nashville luxury hotel lodging, where warm hospitality finds a new perspective. • Located in the heart of Nashville, Tennessee • Convenient to the city’s renowned music scene and landmark attractions • High-speed wired and wireless Internet access for all guests • State-of-the-art fitness center with Pre-Cor equipment, LCD panels, and more • Complimentary Business Center services with 24-hour access • 13,600 square feet of elegantly-appointed space for meetingsHUTTOn HOTEl. 1808 WesT end Avenue, Please call 866-894-4609 for reservations and mention you are part of the ExL Pharma Room nAshville, Tn, 37203 · Phone: 615-340-9333 Block. Room block cut-off is February 20, 2011.
  3. 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 OperationsThis session will provide the definition of the Clinical Trial Policy, the NCD, the development of a coverage analysis and how to work this into your normal workflow. We will provide examples of tools and templates and how to actually perform a coverage analysis. • The Clinical Trial Policy, Reference Sheets • Breaking down Local Coverage Determination (LCD’s) by procedure • Creating a Medicare Coverage Analysis and billing plan • Billing Guides• Discuss the regulation of clinical research including oversight • Implement a process for coordination and communication of information to regulatory agencies, the scope of laws and regulations, and ensure research services are correctly identified and not billed to payor human subject protectionRyan 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 complianceThis session will discuss all of the varying issues with the complex types of studies that are increasingly more difficult to bill. We will work through the study types listed and discuss how to discern whether you can bill for items and services under the guidelines. We will provide samples and use cases where there have been issues in regards to billing compliance.• Device Trials • Phase I Trials• Investigator Initiated • HUD’s • Off label Use • Compassionate Use• Inpatient Trials • Complicated Studies Done Across Different Hospital AreasKathleen 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 dAy main ConFeRenCe · monday, march 7th 20118:00 conference registration and continental Breakfast 10:45 Panel Discussion on Physician issues and challenges8:30 chairperson’s Welcome and Opening remarks in Billing complianceKelly Willenberg, President, SYNERgiSM, LLC • Keeping abreast of the rapidly changing rules in billing compliance8:45 recent Developments in Billing For research related • Educating Physicians on new guidances services • Oversee the compliance of physicians and health care practitioners • Understand care reform and how it will impact the billing of PANEL MODERATOR: Ryan Meade, Partner, MEADE & ROACH services for clinical research PANELiSTS: Local Physicians to be determined • Recall new directives in billing Medicare for research related services 11:30 Ethical considerations in Billing compliance • Understand your responsibilities for liability reporting • Review ethical considerations in clinical trial billing from an David vulcano, Assistant Vice President & Responsible Executive, historical perspectiveClinical Research, HOSPiTAL CORPORATiON Of AMERiCA • Identify particular areas of clinical trial billing that present ethical issues for investigators, research staff, and research subjects 9:30 CaSE STUdy • Using case analyses, apply a combination of ethical considerations Use of an Electronic clinical Trial Management in clinical trial billing and regulatory requirements to arrive at system and Flow of Billing compliance effective compliance strategies Quincy J. Byrdsong, EdD, CiM, CiP, CCRP • Historical background, research billing compliance prior to Executive Director of Research Administration, Virginia Commonwealth purchase of electronic clinical trial management (CTM) system UNivERSiTY MEDiCAL CENTER • Enhancement of purchased CTM system and integration with EPIC billing system for robust billing compliance 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 • Resulting billing compliance process:  from protocol billing plan to electronic journal entry 1:30 Billing compliance and the irB • Continued challenges for billing compliance automationKaren Mottola, M.A., C.C.R.C., C.P.C., Clinical Research Compliance Officer, • Impact of Billing Compliance on IRBsUNivERSiTY Of UTAH SCHOOL Of MEDiCiNE • Federal Regulations • Effective communcation between Research Administrators, Study Coordinators and the IRB Administrator10:15 net Working & r e f r e s h m e n t B r eA k • Importance of the sample Informed Consent prior to IRB review • Contract / Billing changes after IRB approval Becky West, MS, CIP, IRB Administrator, COvENANT HEALTH
  4. 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 Team Billing compliantlySpeaker to be announced • Monitoring the process of amendments and protocol changes 3:00 net Working B r eA k & r e f r e s h m e n t Br e A k • Delivering a methodology for editing coverage analysis • Maintaining control over budget variances3:30 The significance of a Billing compliance Program at an • Collaborating with sponsors for a win-win situation academic Medical center – The Growth and Growing Pains Warren E. Beck, Associate Vice Chancellor for Health Affairs Sr. VP of Finance – vANDERBiLT UNivERSiTY, MEDiCAL CENTER • Creation of a billing compliance program • Systems and processes for the methodology of the program 5 : 15 dAy o n e co n c Lu d e s • Conclusion as to why it was established in the Department of Finance and has remained in FinanceLisa Murtha, Partner, SNR DENTON US, LLP main ConFeRenCe · tuesday, march 8th 20118:30 chairpersons recap of Day OneKelly Willenberg, President, SYNERgiSM, LLC 11:30 CHOiCE OF TWO SESSiOnS8:45 Best Practices and Lessons Learned in Development & conflict of interest and Physician Billing implementation of clinical research Billing Workflows • Requirements for managing of conflicts of interests between research physicians and sponsors • Gain insights into how colleagues develop & run their clinical • Anti-Kickback Statute and the often unseen conflicts research billing operations • Survey of approaches to mitigating conflicts • Learn about shared pitfalls and common challenges and how they Angelique Dorsey, JD, CHRC, Research Compliance Director, are managed by your peer institutions MEDSTAR HEALTH • Compare workflows, policies and documents and contribute to a forms library hosted on the Synergism website for year-round inTERaCTiVE ROUndTaBlE diSCUSSiOn access to resources that may help you further develop your clinical Living and Breathing Billing compliance in Practice – research operations how 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 : 30 Lu n c h fo r co n f e r e n c e At t e n d e e s • Elements of an effective audit program • Identify the common areas of risk and issues that are usually 1:30 Nih/Grant requirements, Patient & sponsor Billing cited in an audit compliance and Other responsibilities • Summarize what some of the strategic options are for reducing risk • NIH Grant Requirements; Strategies for Compliant GrantActivities • Challenges in billing audits • Setting up and managing an effective billing compliance system; • Targeted audits by patient enrollment, third party payer, Case Study or study sponsor • Other Responsibilities of the Clinical Trial Administrative Office • Audit Scope and Objectives Robert 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 k 2:45 Puzzled: ask the Proficient Professional Your Questions10:45 CHOiCE OF TWO SESSiOnS on Billing complianceThe Billing of Device Trials and Pre-Determination CHAiR: • Review the Medicare Billing Rules for Investigational Devices Kelly Willenberg, President, SYNERgiSM, LLC • Review Commercial Payer positions on paying for Investigational Devices PANELiSTS: • Understand the role of Pre-Determination in Investigational Deena Bernstein, Director of Clinical Research, Device Studies SHERiDAN CLiNiCAL RESEARCH • Learn about peer processes and workflows for pre-determination of clinical trials. Kathleen R Hurtado, R.Ph, President and CEO, HEALTH RESEARCH ASSOCiATiON, AN AffiLiATE Of THE UNivERSiTY Of SOUTHERNJennifer Lanter, BSN, RN, CCRC, MSPH; Associate Director of the CALifORNiAResearch 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 s • Billing Medicare for anything on a clinical trial patient • Billing Medicare for anything on a IDE Device trial; same rules? • How do Medicare Advantage patients fit in? Are they included?Terry Ann Cox, Clinical trials Financial Analyst, SHARP HEALTHCARE
  5. 5. 5 CliniCal Billing & th ReseaRCh ComplianCeFive Ways to Register: Fees for attending the 5th Clinical Billing &Fax: 888-221-6750 Research ComplianceMail: ExL Events, inc. 555 8th avenue, suite 310 rEGisTEr BY JaNUarY 21sT, 2010 TO TaKE aDvaNTaGE OF OUr New York, NY 10018 EarLY PricE DiscOUNTs:Phone: 866-207-6528 academic, Non-Profit, Government ratesOnline: main Conference only $995 main Conference, plus one Workshop $1195Email: main Conference, plus both Workshops $1395 corporate rates: main Conference only $1695 main Conference, plus one Workshop $1895 MEdia paRTnERS main Conference, plus both Workshops $1995 aFTEr JaNUarY 21sT, PriciNG is as FOLLOWs: academic, Non-Profit, Government rates main Conference only $1195 main Conference, plus one Workshop $1395 main Conference, plus both Workshops $1595 corporate rates: main Conference only $1895 main Conference, plus one Workshop $2095 main Conference, plus both Workshops $2295 GrOUP DiscOUNT PrOGraM: For every three simultaneous registrations from your company, you will receive 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 your check. You may also use visa, masterCard, discover or American express. Payments must be received by February 22, 2010 CANCELLATiONS: 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 to another 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 for two years from the voucher issue date. WiTHiN THE LAST WEEK: A voucher to another ExL event valid for two years from the 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 a speaker cancellation, every effort to find a suitable replacement will be made.
  6. 6. 5th annual PROUDLY PRESENTS CliniCal Billing & ReseaRCh ComplianCe Exp. Date: PLEASE MENTION PRIORITY CODE: P244 Bringing together Research Sites and Trial 555 8th Avenue, Suite 310 Sponsors to Discuss Billing and Research Compliance Best Practices New York, NY 10018 REGISTER EARLY March 6-8, 2011 AND SAVE! hUTTON hOTEL Reserve your place by NashviLLE, TENNEssEE January 14th for Maximum Savings iNTrODUciNG OUr Name on Card Card Number chairPErsON FOr Signature 2010: SpEaKER paRTiCipaTiOn FROM THE FOllOWing KELLY WiLLENBErG, ORganiZaTiOnS: President, SYNERGISM, LLC Please contact me: I’m interested in marketing opportunities at this event COVENANT HEALTH HEALTH RESEARCH ASSOCIATION I wish to receive email updates on ExL Pharma’s upcoming events Yes! Register me for the Conference and Workshop: Zip HOSPITAL CORPORATION OF AMERICA MEADE AND ROACH 888-221-6750 SPONSORS: MEDSTAR HEALTH OHIO STATE UNIVERSITY State Title Fax PIEDMONT HEALTHCARE, INC. SHARP HEALTHCARE SHERIDAN CLINICAL RESEARCH Register me for the conference only SNR DENTON SYNERGISM New York, NY 10018 UMDNJTO R E G I S T E R 555 8th Avenue, UNIVERSITY OF MARYLAND MEDICAL SYSTEM ExL Events, Inc. 866-207-6528 UNIVERSITY OF UTAH SCHOOL OF MEDICINE Suite 310 VANDERBILT UNIVERSITY MEDICAL CENTER VIRGINIA COMMONWEALTH UNIVERSITY Telephone Company Address Name Email Dept. City TO REgiSTER Call 866-207-6528 OR ViSiT US aT WWW.ExlpHaRMa.COM/Billing