9TH ANNUAL CLINICAL TRIAL BILLING - ExL...

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MAIN CONFERENCE SESSIONS INCLUDE: USING A CTMS AS PART OF A SUCCESSFUL BILLING COMPLIANCE STRATEGY EARLY PHASE CLINICAL TRIALS WITH THERAPEUTIC INTENT: MEDICARE’S PERSPECTIVE JUSTIFYING STANDARD OF CARE AND ROUTINE COSTS — WHAT’S BEST, WHAT’S ACCEPTABLE AND WHAT WILL WORK OVERCOMING THE CHALLENGES OF ADDING RESEARCH TO A BUSY PRIVATE PHYSICIAN PRACTICE RARE OPPORTUNITY! MEDICAL DIRECTOR PANEL: GET ANSWERS TO THE MOST VEXING QUESTIONS! UNIQUE OPPORTUNITY TO INTERACT WITH FOUR EXPERTS ON CLINICAL TRIAL BILLING AND REIMBURSEMENT CHALLENGES Carolyn Cunningham, MD, Medicare Contractor Medical Director, J6, NATIONAL GOVERNMENT SERVICES, INC. Chris L. Jagmin, MD, Senior Medical Director, National Medical Policy and Operations, AETNA Gary R. Oakes, MD, Contractor Medical Director, NORIDIAN HEALTH SPONSORS: FEBRUARY 8-11, 2015 // HOTEL CONTESSA // SAN ANTONIO, TX 9 TH ANNUAL Bringing Together Sites, Payers, CROs and Sponsors to Address Clinical Billing Challenges and Best Practices to Achieve Compliance proudly presents CLINICAL TRIAL BILLING & RESEARCH COMPLIANCE CONFERENCE Virginia Commonwealth University Health System Outlines Ethical Considerations in Research Billing Compliance Quincy Byrdsong, Ed.D., CIM, CIP, CCRP Vice President for Clinical Research Administration and Compliance Loyola University Chicago School Of Law Conducting Effective Due Diligence when Partnering with Physicians or Acquiring Practices Ryan Meade, JD, CHRC Director Regulatory Compliance Studies University of North Carolina at Chapel Hill Pinpoints How an Academic Medical Center Manages Billing Compliance Risks Christine Nelson, RN, BSN, MBA, CCRC Director, Office of Clinical Trials Celgene Corporation Meeting of the Sunshine Act Working Group and Development of White Paper Nancy DiCristo, MBA Independent Pharmaceutical Consultant Norton Healthcare & The University of Alabama at Birmingham Sets the Foundation of a Compliant Clinical Trial Billing Process Tracy Popp, MBA, CRCP, CCRP Director of Research Financial Operations Carolyn P. Whitmire, MBA, CHRC Director, Research Implementation Program, Office of the Vice President for Research and Economic Development TWO INTERACTIVE MASTER CLASSES: THE AFFORDABLE CARE ACT & CLINICAL TRIAL BILLING: THE PAYER’S PERSPECTIVE BUILDING WillPOWER! AT ANY AGE OR STAGE FAST FORWARD YOUR CAREER IN BILLING COMPLIANCE & YOUR DREAMS formerly of For More Information Call 866–207–6528 | www.exlevents.com/CBRC

Transcript of 9TH ANNUAL CLINICAL TRIAL BILLING - ExL...

Page 1: 9TH ANNUAL CLINICAL TRIAL BILLING - ExL Eventsinfo.exlevents.com/rs/exlevents/images/C553-Web.pdfThis year’s 9th Annual Clinical Trial Billing and Research Compliance Conference

MAIN CONFERENCE SESSIONS INCLUDE: ➜ USING A CTMS AS PART OF A SUCCESSFUL

BILLING COMPLIANCE STRATEGY

➜ EARLY PHASE CLINICAL TRIALS WITH THERAPEUTIC INTENT: MEDICARE’S PERSPECTIVE

➜ JUSTIFYING STANDARD OF CARE AND ROUTINE COSTS — WHAT’S BEST, WHAT’S ACCEPTABLE AND WHAT WILL WORK

➜ OVERCOMING THE CHALLENGES OF ADDING RESEARCH TO A BUSY PRIVATE PHYSICIAN PRACTICE

RARE OPPORTUNITY! MEDICAL DIRECTOR PANEL: GET ANSWERS TO THE MOST VEXING QUESTIONS! UNIQUE OPPORTUNITY TO INTERACT WITH FOUR EXPERTS ON CLINICAL TRIAL BILLING AND REIMBURSEMENT CHALLENGES

Carolyn Cunningham, MD, Medicare Contractor Medical Director, J6, NATIONAL GOVERNMENT SERVICES, INC.

Chris L. Jagmin, MD, Senior Medical Director, National Medical Policy and Operations, AETNA

Gary R. Oakes, MD, Contractor Medical Director, NORIDIAN HEALTH

SPONSORS:

FEBRUARY 8-11, 2015 // HOTEL CONTESSA // SAN ANTONIO, TX

9TH ANNUAL

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

proudly presents CLINICAL TRIAL BILLING

& RESEARCH COMPLIANCE CONFERENCE

Virginia Commonwealth University Health System Outlines Ethical Considerations in Research Billing ComplianceQuincy Byrdsong, Ed.D., CIM, CIP, CCRPVice President for Clinical Research Administration and Compliance

Loyola University Chicago School Of Law Conducting Effective Due Diligence when Partnering with Physicians or Acquiring Practices Ryan Meade, JD, CHRCDirector Regulatory Compliance Studies

University of North Carolina at Chapel Hill Pinpoints How an Academic Medical Center Manages Billing Compliance RisksChristine Nelson, RN, BSN, MBA, CCRCDirector, Office of Clinical Trials

Celgene Corporation Meeting of the Sunshine Act Working Group and Development of White PaperNancy DiCristo, MBAIndependent Pharmaceutical Consultant

Norton Healthcare & The University of Alabama at Birmingham Sets the Foundation of a Compliant Clinical Trial Billing Process Tracy Popp, MBA, CRCP, CCRPDirector of Research Financial Operations

Carolyn P. Whitmire, MBA, CHRCDirector, Research Implementation Program, Office of the Vice President for Research and Economic Development

TWO INTERACTIVE MASTER CLASSES:

➜ THE AFFORDABLE CARE ACT & CLINICAL TRIAL BILLING: THE PAYER’S PERSPECTIVE

➜ BUILDING WillPOWER! AT ANY AGE OR STAGE FAST FORWARD YOUR CAREER IN BILLING COMPLIANCE & YOUR DREAMS

WILL NB RGK LLYE

Research Compliance AdvocatesEE

formerly of

For More Information Call 866–207–6528 | www.exlevents.com/CBRC

Page 2: 9TH ANNUAL CLINICAL TRIAL BILLING - ExL Eventsinfo.exlevents.com/rs/exlevents/images/C553-Web.pdfThis year’s 9th Annual Clinical Trial Billing and Research Compliance Conference

DEAR COLLEAGUE,This year’s 9th Annual Clinical Trial Billing and Research Compliance Conference brings together senior leadership from sites, research teams, sponsors, Medicare, and other payers and financial groups to discuss strategies for process improvement for billing compliance in clinical trials. In hospital, physician practice and clinic settings, these topics still remain a challenge. Creating a collaborative culture between the government payers, the commercial payers, the sites and the patients will only enhance everyone’s effectiveness in preventing any type of incorrect billing and non-existent reimbursement. The conference addresses oversight issues as management, financial and research teams combine efforts to “do the right thing” and always seek reimbursement from the correct payer for routine costs in a qualifying trial. What makes a trial “qualifying”? How does a coverage analysis help? What tools do you need in place? Why is it that some of the rules with payers are confusing? How do device and drug studies differ? We examine risk management strategies to maintain compliance and achieve excellence at your facility.

We will have discussions on how we all interface with each other in this exciting field! Those responsible for billing and research compliance will benefit. The companies they represent will increase their billing compliance excellence across their organizations.

With increasing demands constantly needing to be addressed, you cannot afford to miss this excellent opportunity to network with thought leaders in our field of clinical trial billing compliance.

I look forward to welcoming you to the River Walk in San Antonio!

Sincerely, Kelly Willenberg, MBA, BSN, CHRC, CHCPresidentKelly Willenberg, LLC

• Clinical Research Billing

• Clinical Trials Management

• Research Finance

• Contracts & Budgeting

• Research Compliance

• Quality Assurance

• Investigator Sites

• Consulting Groups

• Coverage Analysis

• Grants Management

• Research Administration

• Compliance Operations

• Site Relations

• Legal & Regulatory

• IRBs

• SMOs

WHO SHOULD ATTEND This conference is designed for professionals from Sites, Payers, CROs and Sponsors with roles and responsibilities in the following areas:

SPONSORSHIP & EXHIBITING OPPORTUNITIESDo you want to spread the word about your organization’s solutions 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 Pharma 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 T: 212-400-6237 E: [email protected]

“How refreshing to hear someone from ‘CMS’ who seems to listen

and understand!” —Assistant Director Education and Training, UF

9TH ANNUAL

CLINICAL TRIAL BILLING & RESEARCH COMPLIANCE

CONFERENCE

2014 AUDIENCE PROFILE:

21% –Academic Research Sites

42% – Regional Hospital Systems

15% – Physician-Based Practices

14% –Sponsors

8% – Industry Service Providers

ATTENDEE PROFILE BY SECTOR:

11% – Coordinator

31% – Manager

14% – Analyst

35% – Director

9% – VP, SVP, Officer

ATTENDEE PROFILE BY SENIORITY:

21%

42%15%

14%

8%

35%

9%

14%

11%

31%

For More Information Call 866–207–6528 | www.exlevents.com/CBRC

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SUNDAY, FEBRUARY 8TH, 2015 // PRE-CONFERENCE WORKSHOP DAY

8:00 Registration and Continental Breakfast for Workshop Participants

9:00 WORKSHOP A: The ACA & Clinical Trial Billing: The Payer’s Perspective The Affordable Care Act (ACA) changed several rules regarding health care insurance coverage, including coverage of clinical trials. Generally, health plans or insurers can no longer deny patients’ participation in clinical trials, limit or deny coverage of routine costs to patients who choose to participate in an approved clinical trial, or increase charges because patients choose to participate in clinical trials.

This workshop will review the ACA, Medicare and state requirements regarding coverage of clinical trials. Specifically, the session will offer insight from the commercial payer’s perspective regarding coverage of items and services related to clinical trials. Additionally, the session will provide practical tools, templates and tips, and offer examples and case studies related to commercial payers in the context of clinical trials.

x Discuss regulatory requirements regarding coverage of clinical trials

x Discuss how commercial health plans operate and view coverage of “experimental and investigational” items and services including reinsurance considerations

x Review the patient’s health plan documents (Certificate of Coverage, Schedule of Benefits) to determine covered benefits, network requirements and authoriza-tion requirements

x Understand how commercial payers determine medical necessity and standard of care through care guidelines including InterQual and Milliman

x Communicate with commercial payers to facilitate authorization and reimbursement for items and services related to clinical trials including:

§ Initial and subsequent authorization

§ Peer-to-peer contact

§ Pre- and post-service appeal of denials

x Determine the commercial payer’s claims submission and coding requirements

x Coverage with Evidence Based Development

x How does this affect Sponsors and Sites?

Debbie Stubbs, RN, MS, CCM, Vice President, Managed Care Consultant, SUMMIT REINSURANCE SERVICES, INC.

Wendy Portier, MSN, RN, CHRC, CHC, Medical Management, LOUISIANA HEALTH COOPERATIVE, INC.

12:00 Lunch for Workshop Participants

1:00 WORKSHOP B: I willPOWER!

Do you find yourself having trouble working with various types of individuals in research compliance? Is it difficult to get motivated to keep going when there is so much to do? This class will help you find your willpower in working with conflict and demanding situations.

x Demystify the concept of willpower

x Identify the cognitive components of willpower

x Case study examples of how being motivated will help you in dealing with the difficulties

x Take home simple exercises and tools to accelerate your success

Morgan Gable, RN, CCRP & Certified Martha Beck Master Life Coach

Kelly Willenberg, MBA, BSN, CHRC, CHC, President, KELLY WILLENBERG, LLC

4:00 End of Workshop Day

VENUEHOTEL CONTESSA306 W. Market Street San Antonio, TX 78205

The Hotel Contessa is the only 265 all-suite property located directly on the River Walk. Our dedicated service team is devoted to making any stay – leisure or business – a memorable experience. Our chic and spacious guest rooms feature additional living space, specifically designed for privacy and relaxation. Guests will experience luxury and urban vibrancy in one of Texas’ most exciting cities. A gourmet restaurant, a heated rooftop pool and Jacuzzi, a full-service Woodhouse Day Spa, and a 24-hour fitness center crown this jewel of a hotel.

RESERVATIONS To make reservations guests can call 1-866-435-0900 and request the negotiated rate for the 9th Clinical Billing Conference.

The group rate is available until January 16, 2015. Please book your rooms early as rooms available at this rate are limited.

ExL Events, Inc. is not affiliated with any third-party booking agencies, housing bureaus, or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly e-mail us at [email protected].

For More Information Call 866–207–6528 | www.exlevents.com/CBRC

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7:30 REGISTRATION & CONTINENTAL BREAKFAST

8:15 Welcome by Conference Chair and Open Plenary Current Issues in Clinical Trials Billing Compliance

Kelly Willenberg, MBA, BSN, CHRC, CHC, President, KELLY WILLENBERG, LLC

8:30 USING A CTMS AS PART OF A SUCCESSFUL BILLING COMPLIANCE STRATEGY

To achieve an enterprise research model that combines hub and spoke efficiency with site and system risk mitigation and financial policy compliance, some sites choose a “financially aware” CTMS to help them. This can bring transparency in a complex network of various site structures, assuring financial traceability and visibility, while avoiding errors in payments or receivables. This presentation will address tips on how to find that type of CTMS.

x Key elements of a successful billing compliance strategy x Using a financially oriented CTMS to develop budgets and billing templates x Working with third party providers and external vendors x Tracking activity and assuring compliance across an extended network of sites and service providers

x Using data metrics and analytics to gain insight into performance x Tips for choosing the right CTMS

Jeff Markin, COO, BIO-OPTRONICS, INC. Damon Hostin, MS, Director, Market Development, CATHOLIC

HEALTH INITIATIVE INSTITUTE FOR RESEARCH AND INNOVATION

9:15 HOW DO YOU UTILIZE YOUR EXISTING RESOURCES TO BUILD A BEST PRACTICE MODEL

Analyzing your existing infrastructure to identify strengths and needs will be covered in this session. Most importantly, we will address how to work across operational areas to develop the necessary collaborations that lead to a successful compliance model.

x Infrastructure and expertise required x Training needs and who should be trained x Operational collaboration x Data sharing and reconciliation x QA Monitoring

Paul Papagni, JD, Executive Director, Clinical Research Programs, HOLY CROSS HOSPITAL

10:00 MORNING NETWORKING & REFRESHMENT BREAK

10:30 FOUNDATIONS OF A COMPLIANT CLINICAL TRIAL BILLING PROCESS

This presentation provides two institution’s perspectives on building an effective clinical trial billing process, including lessons learned, challenges and plans for future integration utilizing the electronic health record.

x Understand the keys to an accurate and compliant billing process for clinical trial participants

x Utilize a clinical trial management system to support the financial management of a clinical trial, identify risks and facilitate accurate clinical trial billing

x Identify opportunities in the electronic medical record/charge delineation system to facilitate billing compliance

Tracy Popp, MBA, CRCP, CCRP, Director of Research Financial Operations, NORTON HEALTHCARE

Carolyn P. Whitmire, MBA, CHRC, Director, Research Implementation Program, Office of the Vice President for Research and Economic Development, THE UNIVERSITY OF ALABAMA AT BIRMINGHAM

11:15 EARLY PHASE CLINICAL TRIALS WITH THERAPEUTIC INTENT: MEDICARE’S PERSPECTIVE

This presentation will review the regulatory basis for clinical trial coverage. You will take home an understanding of the term “therapeutic intent.”

x Understand regulatory background of clinical trial policy x Discuss how clinical trial design in Phase I and II trials can meet therapeutic

intent standard x Elucidate steps an investigator and site can take to insure compliance and

coverage

Richard K. Baer, MD, RICHARD K BAER, MD & ASSOCIATES, LLC HEALTHCARE CONSULTING

12:00 LUNCHEON

1:00 KEYNOTE ADDRESS: MEDICARE COVERAGE FOR CLINICAL STUDIES

x Hear from the senior research technical advisor on Medicare coverage and its future impact

x Gain a better understanding of this complex process and learn how to make adjustments at your site

x Get an overview of the intervention, product and campaign history

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

2:00 MEDICAL DIRECTOR PANEL: GET ANSWERS TO THE MOST VEXING QUESTIONS! UNIQUE OPPORTUNITY TO INTERACT WITH FOUR EXPERTS ON THE CLINCAL TRIAL BILLING AND REIMBURSEMENT CHALLENGES This session provides a rare opportunity to hear directly from these key perspectives in a unique question and answer format.

x Gain insight into what is coming next x Have your key questions answered directly

Carolyn Cunningham, Medicare Contractor, MD, J6, NATIONAL GOVERNMENT SERVICES, INC.

Olatokunbo Awodele, MD, Contractor Medical Director Medicare, WPS MEDICARE

Chris L. Jagmin, MD, Senior Medical Director, National Medical Policy and Operations, AETNA

Gary R. Oakes, MD, Contractor Medical Director, NORIDIAN HEALTH

es

3:30 AFTERNOON NETWORKING & REFRESHMENT BREAK

4:00 CONSIDERING CLINICAL TRIAL-ASSOCIATED WORKLOAD IN BUDGET PLANNING: FROM THE COMMUNITY-BASED RESEARCH PROGRAM PERSPECTIVE

Understanding clinical trial complexity and its relationship to staff workload can promote better optimization of staff assignments. This can promote efficiency and translate into a more effective use of budget dollars. Ensure your team is prepared to address this element which is sometimes not considered in budget planning.

x Learn how a clinical trial’s complexity can impact staff workload and as a result impact a research program’s budget

x Hear how the importance of research infrastructure and adequate resources with expertise can help in the process

Marge Good, RN, MPH, OCN, Nurse Consultant, NATIONAL CANCER INSTITUTE SHADY GROVE, DCP, COMMUNITY ONCOLOGY PREVENTION TRIALS RESEARCH GROUP (Tentative)

Connie Szczepanek, RN, BSN Director, CANCER RESEARCH CONSORTIUM OF WEST MICHIGAN (CRCWM), GRAND RAPIDS CLINICAL ONCOLOGY PROGRAM (GRCOP)

5:00 MAIN CONFERENCE DAY ONE CONCLUDES

MONDAY, FEBRUARY 9TH, 2015 // MAIN CONFERENCE DAY ONE

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7:30 REGISTRATION & CONTINENTAL BREAKFAST

8:15 CHAIRPERSON’S RECAP OF DAY ONE Kelly Willenberg, MBA, BSN, CHRC, CHC, President,

KELLY WILLENBERG, LLC

8:30 CONDUCTING EFFECTIVE DUE DILIGENCE WHEN PARTNERING WITH PHYSICIANS OR ACQUIRING PRACTICES

This session discusses legal considerations for taking on research studies when employing a physician, buying a physician practice, or entering into partnerships with established physician entities. The session reviews various ways studies can be transferred to a new employer and what legal liability could exist if research studies are not made part of the due diligence process.

x Challenges and complexities of merging workforces x Contractual considerations x Regulatory questions x Sponsor issues to consider

Ryan Meade, JD, Director Regulatory Compliance Studies, LOYOLA UNIVERSITY CHICAGO SCHOOL OF LAW

9:30 IMPORTANT ETHICAL CONSIDERATIONS IN RESEARCH BILLING COMPLIANCE

Regulations and guidelines sometimes seem to directly compete with the ethical side of billing compliance. How to you adhere to regulatory guidelines and laws and keep an ethical approach? Understand the intent of the ethical framework in research billing compliance.

x Review ethical considerations from a historical perspective x Identify particular areas of billing compliance which present ethical concerns x Using case analysis, apply a combination of practical, ethical and regulations in clinical trial billing effectively

Quincy Byrdsong, Ed.D., CIM, CIP, CCRP, Vice President for Clinical Research Administration and Compliance, VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM

10:15 MORNING NETWORKING & REFRESHMENT BREAK

10:45 MANAGING BILLING COMPLIANCE RISK TO AVOID INCORRECT BILLING FOR ACADEMIC CENTERS

Hear how one academic medical center enhanced its clinical trial billing compliance program with leveraging the EMR and home grown clinical trials management system.

x Identify the various risks associated with incorrect clinical trial billing for an academic medical center

x Describe the steps to implementing a clinical trial billing compliance program x Pull it all together by demonstrating how an EMR and CTMS can help to

create a culture of clinical trial billing compliance

Christine Nelson, RN, BSN, MBA, CCRC, Director, Office of Clinical Trials, UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL

11:30 JUSTIFYING STANDARD OF CARE AND ROUTINE COSTS — WHAT’S BEST, WHAT’S ACCEPTABLE AND WHAT WILL WORK

This session helps with the continuous struggle with what’s acceptable to serve as documentation for justifying a procedure/test as being SOC.  Since SOC is defined nationally, regionally and locally, which resources are adequate?  We will look at patient populations divided up throughout the US, how areas are the country are similar in SOC classifications and how they are different. Case studies will be presented.

x Defining Standard of Care (SOC) x Documentation to support SOC vs. routine cost determinations x Case studies reviewing SOC and research procedure x National vs. local determinations — just how different are they x Coverage analysis goals and challenges

Katie Wulff, MBA, MHA, Assistant Director, Clinical Research, UNIVERSITY OF WISCONSIN CARBONE CANCER CENTER

Casey Dawson, BBA, Project Manager, SOUTHWEST ONCOLOGY GROUP CHAIR’S OFFICE

12:15 NETWORKING LUNCHEON

1:15 OVERCOMING CHALLENGES OF ADDING RESEARCH TO A BUSY PRIVATE PHYSICIAN PRACTICE

Whether you are planning your first research study or putting together a larger research portfolio, there are many challenges to building research into a private practice. This session explores internal and integration obstacles faced by a large radiology private practice. Topics include getting buy-in from stakeholders, building the foundation for a research department, integrating with other departments (billing, accounting, etc.), working with a variety of IRBs, budgeting/contracting/subcontracting and integrating research into a regular clinic.

x Understand the unique challenges of conducting research within the context of private practice

x Understand that flexibility and adaptability are the keys to success — the practice of medicine is quickly evolving, and strategies must evolve in parallel

x Identify useful internal and external resources

Alicia Drew, MSN, RN, CNL, Research Manager, RADIOLOGY IMAGING ASSOCIATES, P.C.

2:00 FRAUD AND ABUSE IN CLINICAL TRIALS - A CASE STUDY x What are some unique examples of double billing x Demonstrate the challenges in working with non employed physician practices or other independent facilities

x Recent post marketing cases

Paul Papagni, JD, Executive Director, Clinical Research Programs, HOLY CROSS HOSPITAL Quincy Byrdsong, Ed.D., CIM, CIP, CCRP, Vice President for

Clinical Research Administration and Compliance, VIRGINIA COMMONWEALTH UNIVERSITY HEALTH SYSTEM

2:45 AFTERNOON NETWORKING & BREAK

3:15 SUNSHINE ACT WORKING GROUP DISCUSSION — GET UP TO DATE ON WHAT IS HAPPENING IN 2015

The Sponsor Sunshine Act Working Group (SAWG) and sites to discuss lingering questions and challenges with the Open Payments Sunshine Act. A White Paper will be developed from the discussion during the session.

x Meet with sponsor colleagues on impact of Sunshine Act x Discuss goals and white paper development x Develop next steps for group x Present findings from a recent survey done by the SAWG

Nancy DiCristo, MBA, Independent Pharmaceutical Consultant, formerly CELGENE CORPORATION

Kelly Willenberg, MBA, BSN, CHRC, CHC, President, KELLY WILLENBERG, LLC

4:15 WRAP UP BY CONFERENCE CHAIR

4:30 MAIN CONFERENCE DAY TWO CONCLUDES

TUESDAY, FEBRUARY 10TH, 2015 // MAIN CONFERENCE DAY TWO

“Very informative with extremely valuable information!”

– Clinical Research Financial and Compliance Coordinator, Penn State College of Medicine

For More Information Call 866–207–6528 | www.exlevents.com/CBRC

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8:00 REGISTRATION & CONTINENTAL BREAKFAST

8:30 AUDITING CLINICAL TRIALS Auditing clinical trials often bridges several departments in a health care environment. The study starts with a PI, involves contracts, clinical interventions and staff, and billing. How do you ensure that what was determined at the onset of the trial is billed appropriately? Where does one begin to tackle clinical trial billing audits? Do you have an entire staff to handle an audit? Who is responsible for what aspects of an audit? Does an audit cover the entire soup to nuts? Or just until the charges are generated? How do you engage all the necessary stakeholders in the process? Or are there just a couple of you in a clinical trials office attempting to handle everything? Do you understand the billing process to correctly identify how the V70.7 diagnosis code and modifiers are being added? Answers to the following questions will be answered and tools will be shared.

x Is the study a qualifying trial?

x Is there a study grid clearly delineating what is standard of care/routine and what is research?

x Are studies being redirected to Medicare Prime if the patient is enrolled in a Medicare Advantage Plan?

x Does the consent adequately articulate to the patient the dynamics of the Medicare Prime/Advantage or Medicaid?

x How is this process accomplished?

x Whose responsibility is it to ensure this occurs?

x How do you identify if a patient is enrolled in a clinical trial?

x Do you handle all insurances the same?

x Responsibility and role delineation

x Does your institution conduct risk-based assessments for auditing clinical trials?

x Does your institution generate and track metrics for addressing specific gaps for clinical trial billing?

Dorothy C. Sellers, BS, Director of Research Compliance, GEISINGER HEALTH SYSTEM

Frank Estala, BS, Research Compliance Manager, THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO

Alice Allen, Compliance Manager, THE UNIVERSITY OF TEXAS HEALTH SCIENCES CENTER AT SAN ANTONIO

Polina Eshkol, Clinical Research Billing Compliance Auditor and Trainer, THE UCLA OFFICE OF COMPLIANCE SERVICES

12:00 LUNCHEON

1:00 MASTER CLASS CONTINUES

3:00 MASTER CLASS CONCLUDES, END OF CONFERENCE

WEDNESDAY, FEBRUARY 11TH, 2015 // POST-CONFERENCE MASTER CLASS DAY

“Very valuable presentations, I enjoyed the different perspectives!”

—Grants and Research, Cook Children’s Hospital

“So valuable to hear the possible IT solutions right next to the

‘manual’ approach.” —Assistant Director Education and Training, UF

“As my first time, this was a great conference! I leave a little panic

stricken but excited to begin making my department better!”

—Director of Clinical Research, Illinois CancerCare

For More Information Call 866–207–6528 | www.exlevents.com/CBRC

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By registering for an ExL Events, Inc. (“ExL Pharma”) event, you agree to the following set of terms and conditions listed below:

REGISTRATION FEE: The fee includes the conference‚ all program materials‚ and designated conti-nental breakfasts‚ lunches and refreshments.

PAYMENT: Make checks payable to ExL Events, Inc. and write code C553 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full prior to the commencement of the conference. Any discount applied cannot be combined with any other offer‚ and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. Group discounts available to individuals must be registered simultaneously and employed by the same organization.

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ExL Pharma reserves the right to cancel any conference it deems necessary and will not be responsi-ble for airfare‚ hotel or any other costs incurred by registrants.

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

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

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.

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Save 25% 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).

Save 15% per person when registering three Can only send three? You can still save 15% off of each registration.

QUESTIONS? COMMENTS?Do you have questions or comments that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Program Director Kelly Willenberg at [email protected].

MEDIA PARTNERS

Academic Rate* Early Bird Rate Standard Rate *After Jan 9, 2015 Onsite Rate

All-Inclusive Pass $1,695 $1,895 $1,995

Conference + 1 Master Class $1,495 $1,695 $1,795

Conference Only $1,095 $1,295 $1,395

Corporate Rate

All-Inclusive Pass $2,095 $2,295 $2,395

Conference + 1 Master Class $1,895 $2,095 $2,295

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

*Must be full time to receive academic rate

REGISTRATION FEES:

www.centerwatch.com

Ways to Registerwww.exlevents.com

[email protected]

866-207-6528

888-221-6750

ExL Events, Inc. 494 8th Avenue, 4th FloorNew York, NY 10001

Page 8: 9TH ANNUAL CLINICAL TRIAL BILLING - ExL Eventsinfo.exlevents.com/rs/exlevents/images/C553-Web.pdfThis year’s 9th Annual Clinical Trial Billing and Research Compliance Conference

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CONFERENCE CODE: C553

FEBRUARY 8-11, 2015 // HOTEL CONTESSA // SAN ANTONIO, TX

9TH ANNUAL

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

proudly presents CLINICAL TRIAL BILLING

& RESEARCH COMPLIANCE CONFERENCE

MAIN CONFERENCE SESSIONS INCLUDE: ➜ USING A CTMS AS PART OF A SUCCESSFUL

BILLING COMPLIANCE STRATEGY

➜ EARLY PHASE CLINICAL TRIALS WITH THERAPEUTIC INTENT: MEDICARE’S PERSPECTIVE

➜ JUSTIFYING STANDARD OF CARE AND ROUTINE COSTS — WHAT’S BEST, WHAT’S ACCEPTABLE AND WHAT WILL WORK

➜ OVERCOMING THE CHALLENGES OF ADDING RESEARCH TO A BUSY PRIVATE PHYSICIAN PRACTICE

SPONSORS:

WILL NB RGK LLYE

Research Compliance AdvocatesEE

A RARE OPPORTUNITY TO SEE FOUR MEDICAL DIRECTORS ON A PANEL: Better Understand How Payers React to Clinical Trials and Ways to Improve Processes

For More Information Call 866–207–6528 | www.exlevents.com/CBRC

Ways to Registerwww.exlevents.com

[email protected]

866-207-6528

888-221-6750

ExL Events, Inc. 494 8th Avenue, 4th FloorNew York, NY 10001