c858-agenda

Ryan Meade, J.D.,Director Regulatory Compliance Studies,LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW

Debra L. Patterson, M.D., FACP, Vice President, Clinical Affairs and Chief Medical Officer, NOVITAS SOLUTIONS, INC.

Olatokunbo Awodele, M.D., Contractor Medical Director, WPS

Carolyn Cunningham, M.D., Contractor Medical Director, NATIONAL GOVERNMENT SERVICES

ALL-NEW PRE-CONFERENCE WORKSHOP AND POST-CONFERENCE MASTER CLASS SESSIONS

RESEARCH 101: THE FUNDAMENTALS OF STARTING A BILLING COMPLIANCE PROGRAM

A LEAN APPROACH TO INCREASING EFFICIENCIES IN RESEARCH REGISTRATION AND BILLING

BUDGET NEGOTIATIONS, CONTRACTS, AND ACCOUNTS PAYABLE AND ACCOUNTS RECEIVABLE MANAGEMENT: WHAT WORKS?

FINANCIAL COUNSELORS AND PRE-AUTHORIZATIONS: THE MYSTERY UNRAVELED

WALKING THE TIGHTROPE IN CLINICAL RESEARCH: IMPLEMENTING ELECTRONIC SYSTEMS WITHIN YOUR EMR

Thomas R. Mitchell, M.D., FACEP, FACP,Senior Contractor Medical Director, CAHABA GBA, LLC

VISIONARY LEADERS WEIGH IN ON FACING CHALLENGES WITHIN THE CHANGING LANDSCAPE OF CLINICAL TRIAL BILLING

FEATURED SESSIONS

Sponsored By:

Rosemarie Hakim, Ph.D., Senior Research Technical Advisor, Coverage and Analysis Group, CENTER FOR CLINICAL STANDARDS AND QUALITY, CENTERS FOR MEDICARE & MEDICAID SERVICES

CLINICAL TRIAL BILLING & RESEARCH COMPLIANCE

March 5 - 8, 2017 // The Woodlands Waterway Marriott Hotel & Convention Center // The Woodlands, TX

Bringing Together Sites, Payers and Sponsors to Address and Discuss Clinical Billing Challenges and Best Practices to Achieve Compliance Assurance

CONFERENCE

“Great conference for research billing compliance. I’ve been in attendance for seven years and always continue to learn how to make our program better.” —Research Finance Compliance Analyst, ST. VINCENT INDIANAPOLIS

11TH

NAVIGATING THE CLINICAL TRIAL BILLING PROCESS: “I DON’T KNOW WHAT I DON’T KNOW” Dr. Victor M. Santana, Vice President Clinical Trials Administration, Associate Director for Clinical Research at St. Jude Comprehensive Cancer Center, ST. JUDE CHILDREN’S RESEARCH HOSPITAL

ELI LILLY AND THE IMPLEMENTATION PROCESS OF A BILLING COMPLIANCE PROGRAM Scott P. Jensen, Strategy and Transformation Leader, Global Clinical Budgeting and Contracting, ELI LILLY AND COMPANY

A 360-DEGREE VIEW OF THE PAPERLESS CLINICAL TRIAL OFFICE Rick Arlow, Founder and CEO, COMPLION

Candida Barlow, MSN, RN, Director of Clinical Research, ST. JOHN CLINICAL RESEARCH INSTITUTE

Kelly Willenberg, DBA, RN, CHRC, CCRP, CHC, President,

KELLY WILLENBERG & ASSOCIATES

CHAIRPERSON

EXPERT PANEL DISCUSSIONS

ü CTMS and EMR — Interface or About Face

ü The Clinical Trial Business Process

üWorking with CMS and Your CMS Contractor

To Register Contact: Joel Nunez at 917-258-5157 or [email protected]

CLINICAL TRIAL BILLING & RESEARCH COMPLIANCE

CONFERENCE

11TH

Dear C ol league, The Clinical Trial Billing & Research Compliance Conference continues to be the top billing compliance event in the country, and you must join us in 2017! Our illustrious speaker list includes representatives from CMS, sponsors, community hospitals, physician practices, NCI, CTSU and academic medical centers, as well as Medicare contractors! This conference series has made significant strides in helping billing compliance sophistication throughout the years by bringing all stakeholders to the table. We are proud of your participation in that mission. Join us as we challenge ourselves in making this process more efficient! We can make it better each year with YOU in attendance!

Our 2017 event will feature six workshops. We will also have small breakout discussion groups that are after interactive sessions so you can network with your peers. Attendees will be able to choose from a multitude of new speakers and topics based on where they are in their career.

Houston is one of the largest cities in the United States, and Bush Intercontinental Airport is one of the top 10 airports in the country. The Woodlands Waterway Marriott Hotel & Convention Center is only 22 miles from Bush Intercontinental and is across the street from The Woodlands Mall, so there is a lot to do during your evenings or leisure time while you are attending the conference!

Who knows what 2017 can bring? Let us find out together and become one united voice in billing compliance assurance!

I look forward to welcoming you to Houston next March!

Sincerely,

Kel ly Wil lenberg Kelly Willenberg, DBA, RN, CHRC, CCRP, CHC, President, KELLY WILLENBERG & ASSOCIATES

WHO SHOULD ATTEND:This conference is designed for professionals from sites, payers, CROs and sponsors with roles and responsibilities involving:

_ Clinical Research Billing _ Clinical Trial Management _ Compliance Operations _ Consulting _ Contracts and Budgeting _ Coverage Analysis _ Grants Management _ Healthcare Provider Relationships _ Site Management _ Investigator Sites _ IRBs _ Managed Care, Medicaid and Commercial Health

Plans _ Quality Assurance _ Research Administration _ Research Compliance _ Research Finance _ Regulatory and Quality Assurance Services _ Internal Audits

This conference is also of interest to:

_ Advocacy Groups _ Agency and Capitol Hill Staff _ Brokers and Agents _ Health Services Researchers _ Legal Counsel _ Private Exchanges _ Software and Technology Providers _ Healthcare Providers _ Managed Care Organizations, Medicaid and

Commercial Health Plans _ Medicaid Officers _ IRBs _ SMOs _ Sponsors _ CROs _ EHR and Hospital Billing Systems _ Clinical Trial Management Systems

Venue Information: THE WOODLANDS WATERWAY MARRIOTT HOTEL & CONVENTION CENTER1601 Lake Robbins Drive

The Woodlands, TX 77380

The Woodlands Waterway Marriott Hotel & Convention Center welcomes you to our luxurious hotel located in the heart of The Woodlands, Texas near fine dining and shopping. The Woodlands hotel offers easy access to entertainment venues and 30-minute access to downtown Houston. Connected via Sky-bridge to The Cynthia Woods Mitchell Pavilion, concert-going guests are just minutes from the Pavilion stage.

To make reservations guests can call 1-800-228-9290 and request the group rate for ExL’s 11th Clinical Billing Meeting. To make reservations online please visit: http://bit.ly/2c4bIaj. The group rate is available until Monday, February 13, 2017. Please book your room early as rooms available at this rate are limited. Please note that the hotel is 22 miles from George Bush Intercontinental Airport - IAH and 40.4 miles from William P Hobby Airport - HOU. Parking is free at the hotel.

*ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at [email protected]. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

SPONSORSHIP AND EXHIBITION OPPORTUNITIESDo you want to spread the word about your organization’s solu-tions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact Andrew Sinetar, Managing Director, Business Development, at 212-400-6237 or [email protected].

CCB APPROVED FOR

CCB CREDIT(s)Compliance Certi�cation Board

36.3 CCB CONTINUING EDUCATION CREDITS

This conference program has been approved for 35 Compliance Certification Board (CCB) Continuing Education credits in compliance training, education, and auditing and monitoring for compliance. Granting of prior approval in no way constitutes endorsement by CCB of the program's content or sponsors. A one-hour session translates into 1.2 CCB CEUs for CHC, CHRC, CHPC and CCEP. Please visit www.exlevents.com/Billing for more information.


“Very valuable presentations, I enjoyed the different perspectives!” —Grants and Research, COOK CHILDREN’S HOSPITAL

7:30 CONTINENTAL BREAKFAST AND REGISTRATION FOR WORKSHOP ATTENDEES

8:00 WORKSHOP A RESEARCH 101: THE FUNDAMENTALS OF STARTING A BILLING COMPLIANCE PROGRAM The group will discuss the key organizational drivers leading to the creation of a billing compliance program and evaluation steps taken to gain buy-in from leadership. The panel will outline the research billing program key infrastructure requirements, core policies and procedures of focus, goals and core areas of focus, and common roadblocks encountered and tactical responses to start-up efforts.

g Discuss how to start a program g Create the infrastructure g Identify top needs g Work to develop goals g Establish must-have policies and procedures for the launch of a program

Melissa Kadar, Director, Clinical Operations - Industry Studies, OHIOHEALTH RESEARCH & INNOVATION INSTITUTERebecca Ohta, Manager, Research Regulatory Office, THE QUEEN’S MEDICAL CENTERCheryl L. Rice, Vice President and Chief Corporate Responsibility Officer, MERCY HEALTH – SYSTEM CORPORATE OFFICE

WORKSHOP B A LEAN APPROACH TO INCREASING EFFICIENCIES IN RESEARCH REGISTRATION AND BILLINGResearch registration and billing is a cumbersome, complex process, full of errors that necessitate redoing work, which causes frustration among staff, administrators and patients — and that opens the door for potential financial and compliance risks. A LEAN project was put forth to work on the compliance issues. The project included research, registration and patient financial services to look at the process and workflow. Project owners asked a number of questions: Was the subject registered properly? Were the initial bills dropped within 1-5 days of the patient visit? Did the clinical staff review them within 7-14 days after the visit occurred? Was the final bill issued within 21 days of the patient visit? Baseline data showed only a 1% accuracy rate. The session will show how AHS went to a 77% accuracy rate.

g Understand the pre- and post-awards process g Coordinate and work with Patient Financial Services g Analyze the LEAN project g Work through the auditing/compliance process g Participate in a Q&A panel discussion

Molly Maurer, MSN, RN, OCN, CCRC, Nurse Educator, Oncology Research, ATLANTIC HEALTH SYSTEMRosemary Stefiniw, Manager, Oncology, Pulmonary, Urology and Sports Health Research Data and Outcomes for the Oncology Service Line, ATLANTIC HEALTH SYSTEM Kelly Colucci, Manager, Grants and Contracts, ATLANTIC CENTER FOR RESEARCHAnna Kowal, President Research Compliance, Corporate Compliance and Internal Audit, ATLANTIC HEALTH SYSTEM

*There will be a 30-minute break during these sessions.

12:00 WORKSHOP LUNCHEON

1:00 WORKSHOP C FINANCIAL COUNSELORS AND PRE-AUTHORIZATIONS: THE MYSTERY UNRAVELEDHave you ever considered what it is like for patients as they sit in a waiting room prior to an appointment? Their minds are flooded by questions about their future: What will the doctor tell me? Am I going to be all right? Who is going to take care of things when I am gone? Just as troubling are the financial questions: Will my insurance cover this? How much am I going to have to pay? Should I be in a clinical trial? What does that mean? Is it FREE or am I responsible for something? These are the questions patients think about every day. This workshop will teach you what a patient needs to know about a clinical trial from the financial side. We will do a case study and show what information we provide the patient when they are considering enrolling in a clinical trial.

g Address the roles and responsibilities of a financial counselor g Review lessons learned g Highlight case study findings g Delve into the nuances of authorizations — what’s needed and why

Tracie Bistany, Post-Award Financial Specialist, CAROLINAS MEDICAL CENTER Maria Soliman, Director of Research Administration, CAROLINAS MEDICAL CENTER Wendy Portier, MSN, RN, CCM, CHRC, CHC, Consultant, KELLY WILLENBERG & ASSOCIATES

WORKSHOP D BUDGET NEGOTIATIONS, CONTRACTS, AND ACCOUNTS PAYABLE AND ACCOUNTS RECEIVABLE MANAGEMENT: WHAT WORKS? For each clinical trial, a clinical trial agreement (CTA) and budget are negotiated between the investigator and the sponsoring company to ensure the proper reimbursement of trial costs. The budget is a key component of the clinical trial process that stems from a coverage analysis. Hear examples of how a CTMS can aid in accounts receivable and payables.

Using real-life situations and examples, this workshop will help delegates understand how to create and negotiate budgets and contracts.

g Understand fair market value g Pay physicians for research time and effort g Outline research discount rates g Discuss accounts receivable, accounts payable and receivable management g Master budget lingo, contract terms, and contract language and meanings

Kathleen Hurtado, RPh, Consultant, KELLY WILLENBERG & ASSOCIATES Leigh Burgess, MHA, MEd, M.A., Chief Research Operations Officer, DUKE CANCER INSTITUTEMarilyn Windschiegl, J.D., Manager, Contracts and Compliance,PFS CLINICAL


5:00 END OF WORKSHOP DAY

SUNDAY, MARCH 5, 2017 PRE-CONFERENCE WORKSHOPS


MONDAY, MARCH 6, 2017 MAIN CONFERENCE, DAY ONE

7:00 REGISTRATION AND CONTINENTAL BREAKFAST

8:00 WELCOME BY CONFERENCE CHAIR AND OPENING PLENARY REMARKS: CURRENT ISSUES IN CLINICAL TRIAL BILLING COMPLIANCE

Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President,KELLY WILLENBERG & ASSOCIATES

8:15 PANEL DISCUSSION: HOW TO WORK WITH CMS AND YOUR CONTRACTOR

Join Dr. Rosemarie Hakim of the CMS and other panelists as they discuss how one site worked with a contractor to achieve success.At the end of this session, attendees will understand how to work with the CMS.

g Recognize the challenges between Medicare Contractor regions and CMS g Explore how making decisions together can result in success

Moderator: Ryan Meade, J.D., Director Regulatory Compliance Studies, LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW Panelists:Rosemarie Hakim, Ph.D., Senior Research Technical Advisor Coverage and Analysis Group, CENTER FOR CLINICAL STANDARDS AND QUALITY, CENTERS FOR MEDICARE & MEDICAID SERVICESKelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President, KELLY WILLENBERG & ASSOCIATES Fred Herman, CHRC, Director, Corporate Research Compliance, UMMS Finance, UNIVERSITY OF MARYLAND MEDICAL SYSTEM

9:15 PANEL DISCUSSION: THE REAL ISSUES WITH MEDICARE CONTRACTORS

Join us as we bring the Medicare Contracting regions together to have a frank discussion about how to work with them on a daily basis. This will be a collaborative session on the challenges we face daily with the Medical Directors. Moderator: Kelly Willenberg, DBA, RN, CCRP, CHRC, CHC, President, KELLY WILLENBERG & ASSOCIATES Panelists:Thomas R. Mitchell, M.D., FACEP, FACP, Senior Contractor Medical Director, CAHABA GBA, LLC Olatokunbo Awodele, M.D., Contractor Medical Director, WPS Debra L. Patterson, M.D., FACP, Vice President, Clinical Affairs and Chief Medical Officer, NOVITAS SOLUTIONS, INC. Carolyn Cunningham, M.D., Contractor Medical Director, NATIONAL GOVERNMENT SERVICESRosemarie Hakim, Ph.D., Senior Research Technical Advisor, Coverage and Analysis Group, CENTER FOR CLINICAL STANDARDS AND QUALITY, CENTERS FOR MEDICARE & MEDICAID SERVICES

10:00 NETWORKING BREAK

10:30 A PHYSICIAN’S PERSPECTIVE ON NAVIGATING THE CLINICAL TRIAL BILLING PROCESS: “I DON’T KNOW WHAT I DON’T KNOW”

Clinical investigators through the clinical trial process seek to identify new treatments and interventions to help their patients while advancing science. Physicians should play an important role and have ownership in creating a billing compliance environment and culture to facilitate and comply with this process. In this presentation, we will review the role and barriers to effective physician engagement and potential solutions.

g Identify the needs of physicians when moving toward more billing compliance g Review models for building relationships to engage physicians in good billing practices

g Describe what helps to improve compliance and efficiencies while changing culture

Dr. Victor M. Santana, Vice President Clinical Trials Administration, Associate Director for Clinical Research at St. Jude Comprehensive Cancer Center, ST. JUDE CHILDREN’S RESEARCH HOSPITAL

11:30 PANEL DISCUSSION: CTMS AND EMR — INTERFACE OR ABOUT FACE

This session will be a discussion on the use of a CTMS and an EMR. How can they work together? What must happen at the site level to ensure success? What are common pitfalls? How do you analyze the systems you have? Panelists will also critique the pros and cons of interfacing.

12:30 LUNCHEON

1:30 A 360-DEGREE VIEW OF THE PAPERLESS CLINICAL TRIAL OFFICE

This session will explore how storing and managing files electronically can create cohesion, foster collaboration, ensure transparency and improve compliance across the organization. Clinical research directors, managers and administrators will gain an understanding of how technology can improve clinical trial operations, documentation and collaboration to positively impact the efforts of the entire research team. The goal is to decrease errors and delays, while increasing transparency and shedding light on instances of non-compliance.

g Make a business case justification for a regulatory document management system

g Explore critical concepts for improvement in documentation, collaboration and tracking

g Learn how to implement a paperless Clinical Trials Office g Foster collaboration across clinical, finance and regulatory teams to ensure compliance and efficiency

Rick Arlow, Founder and CEO, COMPLION Candida Barlow, MSN, RN, Director of Clinical Research, ST. JOHN CLINICAL RESEARCH INSTITUTE

2:30 THE EVOLVING SITE LANDSCAPE AND ADVANTAGES OF SITE NETWORKS

The session will provide a view on changes in the site landscape in recent years, characteristics of successful sites from the perspective of a large CRO and likely future implications of these trends. The speakers will discuss the advantages of becoming part of a site network, including consistent processes, economies of scale, and more opportunities to leverage data and technology.

g Navigate trends in the site landscape g Examine summary data on Quintiles’ most successful US sites g Discuss the advantages of site networks, such as consistent processes, economies of scale, more opportunities to leverage data and technology

g Review tips to help your site stand out in this landscapeReg Blynn, Vice President of Client Services, Site and Patient Networks, QUINTILESIMS


BREAKOUT DISCUSSION GROUPS 4:00 RISKS ASSESSMENTS: LIVE ACTION THEATRE

This session will feature exploration and hands-on interaction with the audience. We will assign roles and see live reactions to scenarios that happen in clinical trial billing. With the help of audience volunteers, delegates will learn how to best assess risks and what to do to address them. Session Leaders: Kelly Willenberg, DBA, RN, CHRC, CCRP, CHC, President, KELLY WILLENBERG & ASSOCIATESKathleen Hurtado, RPH, Consultant, KELLY WILLENBERG & ASSOCIATES

4:00 CTMS, RESEARCH ACCOUNTING AND INVOICING How and when do you recognize research revenue? Who does your invoicing and what system do you use for billing? This session will give you a 360-degree view of the challenges of working with a CTMS and clinical research accounting. We will start with three scenarios from three different institutions. How do you incorporate reporting to senior management when you are developing processes? What are the compliance operational dilemmas? This session will have in-the-moment responses to real-life scenarios through strategic rehearsal. It will teach you how to apply techniques to expand your understanding of working with CTMS and equip you with decision-making frameworks to solve billing compliance dilemmas.Candice M. Vance, MBA, CHRC, Senior Manager, Clinical Research Revenue Cycle, MEDSTAR HEALTH RESEARCH INSTITUTE Emily Hoyle, MBA, B.A., CCRC, Clinical Research Administrator, MULTICARE INSTITUTE FOR RESEARCH & INNOVATIONEmmanuel Tunley, MBA, Business Manager, INSTITUTE FOR CLINICAL AND TRANSLATIONAL RESEARCH BAYLOR COLLEGE OF MEDICINE

5:30 MAIN CONFERENCE DAY ONE CONCLUDES

5:30 NETWORKING RECEPTION


TUESDAY, MARCH 7, 2017 MAIN CONFERENCE, DAY TWO

7:30 REGISTRATION AND CONTINENTAL BREAKFAST

BREAKOUT DISCUSSION GROUPS 8:00 THE DILEMMA OF PAYING PHYSICIANS FOR RESEARCH TIME

This discussion will explore potential solutions to paying physicians for research time. If you use RVUs, is there a limit at your site? We will try to interpret what works in this area and discuss employed versus non-employed physicians.Discussion Group Leader:D. Marie Jackson, Ph.D., MBA, Revenue Cycle, Director, Clinical Research Billing, UC SAN DIEGO HEALTH

8:00 INDs, COMPASSIONATE USE AND OFF-LABEL DRUGS Billing questions and dilemmas can be predicted in this area. Analyze what others do and how you might be doing it wrong.Discussion Group Leader:Kathleen Hurtado, RPh, Consultant, KELLY WILLENBERG & ASSOCIATES

9:00 BRIDGING THE LANGUAGE GAP BETWEEN BILLING COMPLIANCE ADMINISTRATION AND CLINICAL RESEARCH TEAMS

Billing compliance administration and clinical research teams often do not speak the same language, which can lead to misunderstandings, frustration and decreased collaboration. This session will review common causes of communication breakdowns and discuss ways to bridge that gap.Discussion Group Leader:Mikki O’Neal, MBA, CCRP, CCRC, CHRC, Independent Contractor

9:00 THE CLEAR INITIATIVE This discussion will revolve around the CLEAR (Common Language Evaluation and Reconciliation) initiative to streamline and remove obstacles in contracting. The goal is to improve efficiencies in getting CTAs negotiated with faster timelines. Discussion Group Leader:Deena Bernstein, MHS, Vice President, Site Services, QUINTILESIMS


10:30 MODELS TO SUPPORT DIFFERENT TYPES OF PIs AND UNDERSTANDING THE VALUE OF EACH: ACRP-CERTIFIED PIs AND RESEARCH-NAÏVE PIs

This talk will present two studies, one by a sponsor and one by a large site organization, on determining the quality of and compliance differences between certified and non-certified PIs. The first study uses protocol adherence as an endpoint and the other uses FDA audit results as an endpoint. Discussion Group Leader:David Vulcano, AVP and Responsible Executive for Clinical Research, HOSPITAL CORPORATION OF AMERICA

10:30 QUALITY MONITORING OF RESEARCH BILLING Monitoring billing compliance takes precision and requires a set process. What systems will help in your monitoring of claims? What are the efficient ways to complete monitoring in real time? This session will help you achieve success.Discussion Group Leaders:Candice Brown-Bishop, Manager, Research Billing, UF HEALTH Cynthie Lawson, BSBM, CHRC, CPC, Consultant, KELLY WILLENBERG & ASSOCIATES

11:30 LUNCHEON

12:30 RESEARCH BILLING CHALLENGES IN THE PEDIATRIC SETTING

Pediatric populations typically have a very small percentage of Medicare enrollees, but they have the same compliance risk as adult populations. Providing a detailed coverage analysis and budget is the first step in assuring investigators that billing insurance could be appropriate. Reviewing the daily research charges in conjunction with the billing plan assures correctness of claims delivered to payers. Standardized budgets matching the contracts enable the accounting group to perform timely invoicing and accurately track payments due.

g Initiate a culture change through the education of physicians and PIs g Learn to staff a clinical trial finance office successfully

g Establish efficient billing office operations g Standardize study budgets

René Jooste, M Pharm, CCRP, Director, Clinical Trials Finance Office, ST. JUDE CHILDREN’S RESEARCH HOSPITAL Lee Seabrooke, M.A., MBA, Director Research Programs, PHOENIX CHILDREN’S HOSPITAL

1:30 NCI’S INITIATIVES FOR NATIONAL CLINICAL TRIAL COVERAGE

Clinical trial billing compliance is a high-risk area for research programs and requires completion of a coverage analysis (CA) for every clinical trial. Research programs duplicate efforts by creating their own CA for each trial. Centralized coverage analyses and transparent trial documents can reduce site burden. Hear the latest from the National Cancer Institute (NCI) and the Cancer Trials Support Unit (CTSU) on important efforts to increase billing efficiency, transparency and compliance:

g ASCO-NCI Coverage Analysis Symposium Report g CTSU’s National Coverage Analyses g NCI’s Informed Consent Template updates g Upcoming initiatives

Dr. Lawrence Ragard, Senior Study Director, CTSU/WESTAT Andrea M. Denicoff, M.S., RN, Head, NCTN Clinical Trials Operations Scientific Liaison, Patient Reported Outcomes, Clinical Investigations Branch, CTEP, DCTD NATIONAL CANCER INSTITUTE, NIH

2:30 LILLY’S IMPLEMENTATION OF A BILLING COMPLIANCE PROGRAM

This session will outline Eli Lilly’s perspective on the billing compliance conundrum by sharing lessons learned and how they have worked to implement a process. Internal controls are set up at Lilly to outline routine costs by establishing where they are in the continuum, what happens when sites disagree, common themes for exceptions by sites and more. Sites and sponsors must work together to circumvent reimbursement issues from the patients’ perspective, and Lilly is a thought leader in the pharmaceutical industry.At the end of this session, attendees will be able to:

g Understand Lilly’s rationale for establishing criteria for defining routine costs and what they have gained by doing so

g Explain a monitoring system at Lilly when sites have exceptions to the established guidelines and implementation

g Demonstrate communication road maps for various scenarios and manage expectations

g Recognize that working together with sites is fundamental to the process Scott P. Jensen, Strategy and Transformation Leader, Global Clinical Budgeting and Contracting, ELI LILLY AND COMPANY


3:45 THE CLINICAL TRIAL BUSINESS PROCESSThis panel will discuss optimizing your business workflow in the clinical trial financial life cycle. Hear the pros and cons of centralization versus de-centralization and the impact of each on business operations.

g Utilize an outside source to act as a centralized office for de-centralized processes

g Demonstrate an approach of a fully centralized office for all research without a CTMS

g Explore partial centralization for certain functions in the financial life cycle with a CTMS interfacing with an EMR

g Weave training into the business processPanelists: Rhonda J. Paz, Ph.D., CRCP, Chief Operations Officer, GUIDESTAR CLINICAL TRIALS MANAGEMENTD. Marie Jackson, Ph.D., MBA, Revenue Cycle, Director, Clinical Research Billing, UC SAN DIEGO HEALTHCandice M. Vance, MBA, CHRC, Senior Manager, Clinical Research Revenue Cycle, MEDSTAR HEALTH RESEARCH INSTITUTEJohn W. Gomillion, MBA, M.S., CPM, Assistant Director, Clinical Trials Research Billing Compliance, VANDERBILT UNIVERSITY MEDICAL CENTERMarilyn Windschiegl, J.D., Manager, Contracts and Compliance, PFS CLINICAL

5:00 MAIN CONFERENCE DAY TWO CONCLUDES

“Wonderful conference! Enjoyed meeting some very knowledgeable and experienced people in the field to share ideas and questions with. Will definitely plan to attend future conferences you have.” —Clinical Trial Budget Specialist, MARY CROWLEY CANCER RESEARCH CENTERS


WEDNESDAY, MARCH 8, 2017 POST-CONFERENCE MASTER CLASS DAY

Questions? Comments?

Do you have a question or comment that you would like to be

addressed at this event? Would you like to get involved as a

speaker or discussion leader?

Please contact Program Director Kelly Willenberg at

[email protected].

8:30 MASTER CLASS SESSION A WALKING THE TIGHTROPE IN CLINICAL RESEARCH: IMPLEMENTING ELECTRONIC SYSTEMS WITHIN YOUR EMR

Integrating a CTMS into an already busy workflow can be a daunting task. Developing a plan is key to its success, and obtaining buy-in from all parties is essential to a positive outcome. It’s also important to understand what sites do first and how they work with the systems at hand. Join us for an interactive session on CTMS/EHR process flows and integration.

g Address how to be compliant with study information in your EHR while maintaining transparency and patient safety standards

g Implement an electronic research administration system to help manage your review and approval processes prior to starting the research, and maintain inventory of studies with the ability to generate reports

g Understand that access to portfolios in research enhances the ability of research administrators to effectively and timely inform senior leaders of problems

g Recognize that a revenue cycle impacts an institution’s bottom line — and that you can build systems that help with the claims for billing process

g Study the administrative research management systems in use and how they work

Candida Barlow, MSN, RN, Director of Clinical Research, ST. JOHN CLINICAL RESEARCH INSTITUTESusie Owenby, RN, CCRP, Clinical Research Manager, CENTER FOR BIOMEDICAL RESEARCHTracy Popp, MBA, CRCP, CCRP, Director of Research Financial Operations, NORTON HEALTHCAREDebbi Gilad, J.D., Director, Office of Research, BON SECOURS HEALTH SYSTEM, INC.Theresa “Terry” Stone, BBA, Director, Clinical Trials Office, BOSTON MEDICAL CENTER


MASTER CLASS SESSION B ADVANCED MCAS AND CODING: BRING YOUR QUESTIONS!

You know the basics, but what about all of those weird situations that just don’t fit into any particular category? Bring your questions/scenarios and be a part of this interactive workshop where we break things down into smaller chunks and come to a consensus on how to handle “special” situations. This session will cover:

g LCDs and NCDs that impact coverage analysis — “Beyond 310.1” g Sham procedures g Phase I trials g Basket trials g Medicare Secondary Payer situations g Group discussions, sample job aids and example scenarios

Denise Quint, CPC, CHC, CHRC, Research Compliance Analyst,UNIVERSITY OF VERMONT MEDICAL CENTERShauna Doughty, M.S., Revenue Analyst III, Financial and Accounting Services, Research Finance, MAYO CLINICChris Longspaugh, PharmD, Consultant, KELLY WILLENBERG & ASSOCIATES Christine de Leon, RN, CPC, Advanced Clinical Trials Specialist,SHARP HEALTHCARE

MEDIA PARTNERS

12:00 LUNCHEON

1:00 MASTER CLASS CONTINUES

3:00 MASTER CLASS CONCLUDES, END OF CONFERENCE


Academic, Government and Nonprofit Rate*Early Bird Rate

Before January 27, 2017 Standard Rate

After January 27, 2017 Onsite Rate

All-Inclusive Pass $1,795 $1,995 $2,095

Conference + Pre-Conference Workshop Day $1,595 $1,795 $1,895

Conference + Master Class Day $1,595 $1,795 $1,895

Conference Only $1,195 $1,395 $1,595

Corporate Rate

All-Inclusive Pass $2,095 $2,295 $2,495

Conference + Pre-Conference Workshop Day $1,995 $2,195 $2,395

Conference + Master Class Day $1,995 $2,195 $2,395

Conference Only $1,695 $1,895 $1,995

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CREDIT VOUCHERS: Credit vouchers are valid for 12 months from date of issue. Credit vouch-ers are valid toward one (1) ExL event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is not applicable now or in the future. Once a credit voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the credit voucher will no longer be valid.

ExL Events does not and is not obligated to provide a credit voucher to registered attendee(s) who do not attend the event they registered for unless written notice of intent to cancel is received and confirmed prior to the commencement of the event.

SUBSTITUTION CHARGES: There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference.

ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare‚ hotel or any other expenses incurred by registrants.

ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date‚ content‚ speakers and/or venue.

*The opinions of ExL’s conference speakers do not necessarily reflect those of the companies they represent, nor ExL Events.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL’s designated speakers and is designed for informational purposes for its attendees. It is NOT INTENDED for purposes of copywriting or redistribution to other outlets without the express written permission of ExL’s designated speaking parties. Neither ExL nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guaran-tee the accuracy of, or endorse the views or opinions given by any third-party content provider. ExL presentations may point to other websites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

GROUP DISCOUNT PROGRAMOffers may not be combined. Early bird rates do not apply. To find out more on how you can take advantage of these group discounts, please call 866-207-6528.

PER PERSON WHEN REGISTERING FOUR For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four at one time). This is a savings of 25% per person.

PER PERSON WHEN REGISTERING THREE Can only send three? You can still save 15% off of every registration.

SAVE 25%

SAVE 15%

*Must be full time to receive academic rate.

JOIN US AT THE 11TH CLINICAL TRIAL TRIAL BILLING & RESEARCH COMPLIANCE CONFERENCE WITH OUR CHARITABLE GIVING EVENT!

Please bring toiletries and/or cash donations for the Sugar Creek Baptist

Church, Urban Camp,

http://sugarcreek.net/urbancamp/.

To Register Contact: Joel Nunez 917-258-5157 or [email protected]

http://sugarcreek.net/urbancamp/

CLINICAL TRIAL BILLING & RESEARCH COMPLIANCE CONFERENCE

11TH

March 5 - 8, 2017 // The Woodlands Waterway Marriott Hotel & Convention Center // The Woodlands, TX

Bringing Together Sites, Payers and Sponsors to Address and Discuss Clinical Billing Challenges and Best Practices to Achieve Compliance Assurance

“Great conference for research billing compliance. I’ve been in attendance for seven years and always continue to learn how to make our program better.” —Research Finance Compliance Analyst, ST. VINCENT INDIANAPOLIS

CCB APPROVED FOR

CCB CREDIT(s)Compliance Certi�cation Board

36.3

Ryan Meade, J.D.,Director Regulatory Compliance Studies,LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW

Debra L. Patterson, M.D., FACP, Vice President, Clinical Affairs and Chief Medical Officer, NOVITAS SOLUTIONS, INC.

Olatokunbo Awodele, M.D., Contractor Medical Director, WPS

Carolyn Cunningham, M.D., Contractor Medical Director, NATIONAL GOVERNMENT SERVICES

Thomas R. Mitchell, M.D., FACEP, FACP,Senior Contractor Medical Director, CAHABA GBA, LLC

VISIONARY LEADERS WEIGH IN ON FACING CHALLENGES WITHIN THE CHANGING LANDSCAPE OF CLINICAL TRIAL BILLINGRosemarie Hakim, Ph.D., Senior Research Technical Advisor, Coverage and Analysis Group, CENTER FOR CLINICAL STANDARDS AND QUALITY, CENTERS FOR MEDICARE & MEDICAID SERVICES

Conference Code: C858

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To Register Contact: Joel Nunez

917-258-5157 [email protected]

c858-agenda

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