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

1. REGISTER EARLY
5 annual
th AND SAVE!
Reserve your place by
CliniCal Billing &
January 14th for
Maximum Savings
PROUDLY 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, TENNEssEE
cONFErENcE Examine and discuss pressing issues Surrounding
chairPErsON 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 Impact
HEALTH RESEARCH ASSOCIATION • Gain a Greater Understanding of the Various Ethical Considerations
in Clinical Billing Compliance
HOSPITAL CORPORATION OF AMERICA
• Learn Effective Communication Tactics to Coordinate More
MEADE AND ROACH
Effectively with Research Administrators, Study Coordinators and
MEDSTAR HEALTH your IRB’s
OHIO STATE UNIVERSITY
• Develop a Framework for the Development & Implementation of
PIEDMONT HEALTHCARE, INC. Clinical Research Billing Workflows
SHARP HEALTHCARE • Identify the Common Areas of Risk and Issues that are Usually Cited
SHERIDAN CLINICAL RESEARCH in an Audit
SNR DENTON • Understand Requirements for Managing Conflicts of Interests
SYNERGISM between Research Physicians and Sponsors
UMDNJ • and much more!
UNIVERSITY OF MARYLAND MEDICAL SYSTEM
plUS!
UNIVERSITY OF UTAH SCHOOL OF MEDICINE CHOOSE FROM TWO SpECially SElECTEd
VANDERBILT UNIVERSITY MEDICAL CENTER pRE-COnFEREnCE WORKSHOpS On:
VIRGINIA COMMONWEALTH UNIVERSITY · The Risky Business of Clinical Research Billing
· Quirky Trials and Billing Compliance
SPONSORS:
TO REgiSTER Call 866-207-6528 OR ViSiT US aT WWW.ExlpHaRMa.COM/Billing

2. Welcome to the
5th CliniCal Billing & ReseaRCh ComplianCe
dear Colleague, RaVE REViEWS FROM paST CliniCal
RESEaRCH Billing & BUdgETS COMplianCE
I 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 the
ExL Pharma is pleased to announce the 5th Annual Clinical Research material covered and the group size for
Billing 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 CENTER
enhance operational effectiveness and increase compliance initiatives.
The program features perspectives from thought leaders, providing you “The event met my expectations and was
with 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 CENTER
Nashville, 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 to
Kelly Willenberg Bryon Main help your company forge new partnerships with potential
President Managing Director clients. To obtain more information about the accretive
SYNERGISM, LLC ExL PHARMA value in partnering with exl, please contact:
Lucas carrasco, Business develoPmenT mAnAgeR
pS- CCB CREdiTS Will BE OFFEREd! 212-400-6231, lcarrasco@exlpharma.com
WHO 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 Relations
VEnUE 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 meetings
HUTTOn 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. pRe-ConFeRenCe WoRKshops · sunday, march 6 th 2011
8:30 conference registration and continental Breakfast
pRE-COnFEREnCE WORKSHOp a:
9:00 The risky Business of clinical research Billing: The cTP, coverage analysis and Being Practical in Operations
This 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 protection
Ryan Meade, Partner, MEADE & ROACH - Kelly Willenberg, President, SYNERgiSM, LLC
12:00 Lunch for Wor ks h o p At t e n d e e s
pRE-COnFEREnCE WORKSHOp B:
1:00 Quirky Trials and Billing compliance
This 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 Areas
Kathleen R Hurtado, R.Ph, President and CEO, HEALTH RESEARCH ASSOCiATiON,
AN AffiLiATE Of THE UNivERSiTY Of SOUTHERN CALifORNiA
Deena Bernstein, Director of Clinical Research, SHERiDAN CLiNiCAL RESEARCH
4:00 cLose of pre-co n f e r e n c e Wo r ks h o p dAy
main ConFeRenCe · monday, march 7th 2011
8:00 conference registration and continental Breakfast 10:45 Panel Discussion on Physician issues and challenges
8:30 chairperson’s Welcome and Opening remarks in Billing compliance
Kelly Willenberg, President, SYNERgiSM, LLC
• Keeping abreast of the rapidly changing rules in billing compliance
8:45 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 perspective
Clinical 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 automation
Karen Mottola, M.A., C.C.R.C., C.P.C., Clinical Research Compliance Officer, • Impact of Billing Compliance on IRBs
UNivERSiTY Of UTAH SCHOOL Of MEDiCiNE • Federal Regulations
• Effective communcation between Research Administrators, Study
Coordinators and the IRB Administrator
10:15 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. main ConFeRenCe · monday, march 7th 2011
2:15 Effective communication, Training and Leadership 4:30 changes of scope: The clinical Trial study Budget and
amongst your research compliance Team Billing compliantly
Speaker 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 variances
3:30 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 Finance
Lisa Murtha, Partner, SNR DENTON US, LLP
main ConFeRenCe · tuesday, march 8th 2011
8:30 chairpersons recap of Day One
Kelly Willenberg, President, SYNERgiSM, LLC 11:30 CHOiCE OF TWO SESSiOnS
8:45 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, UMDNJ
9:30 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 SYSTEM
Kevin 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 k
10:15 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 Questions
10:45 CHOiCE OF TWO SESSiOnS on Billing compliance
The 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 SOUTHERN
Jennifer Lanter, BSN, RN, CCRC, MSPH; Associate Director of the
CALifORNiA
Research 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 CliniCal Billing &
th
ReseaRCh ComplianCe
Five Ways to Register:
Fees for attending the 5th Clinical Billing &
Fax: 888-221-6750
Research Compliance
Mail: 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 rates
Online: www.exlpharma.com main Conference only $995
main Conference, plus one Workshop $1195
Email: register@exlpharma.com 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. 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
register@exlpharma.com
HEALTH RESEARCH ASSOCIATION
I wish to receive email updates on ExL Pharma’s upcoming events
www.exlpharma.com
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
UMDNJ
TO 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