The Leading Forum on Clinical Research Billing Compliance Limited Early Bird Pricing Available, Register by January 10th

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1 The Leading Forum on Clinical Research Billing Compliance Limited Early Bird Pricing Available, Register by & January 10th 8th Annual Clinical Billing Research Compliance Conference Aligning Strategies with Goal Oriented Solutions to Meet the Challenges Facing Sites, Payers, CROs and Sponsors in Billing & Reimbursement Key Topics Site-Sponsor Relations CQI Process for IRB Subject Injury and Medicare Secondary Payer Responsibilities of a PI in Compliance GCP Audits and Billing Conflict of Interest Leveraging Private and Commercial Payers Contracting for Clinical Trials Two Interactive Master Classes Master Your Skills: Advanced Billing Institute Kelly Willenberg, MBA, BSN, CHRC, CHC, Kelly Willenberg, LLC Rhonda A. Hoffman, CCR, Norton Healthcare Office of Research Administration (NHORA) Patricia Green Sharpe RN, MSN, MHSA, Memorial Health University Medical Center Event Sponsors February 23 26, 2014 Loews Vanderbilt Hotel Nashville, TN Medicare Advantage Plans Auditing for Billing Compliance Financial Management Kathleen Hurtado, RPh, Kelly Willenberg, LLC Building Foundation and Infrastructure Forum Challenges and Best Practices in Program Development Jamie Harper, MHA, CCRP, Illinois CancerCare, P.C. Featured Session Assessing Therapeutic Intent Carolyn Cunningham, MD, National Government Services, Inc. Bernice Hecker, MD, MHA, FACC, Noridian Supporting Partner Chairperson Kelly Willenberg KELLY WILLENBERG, LLC With Participants From Bio-Optronics, Inc. Cleveland Clinic Fletcher Allen Health Care Gilead Sciences Greenville Health System HCA Houston Methodist Texas Medical Center Huntington Hospital Illinois CancerCare, P.C. Liberty IRB, Inc. Medelis, Inc. Memorial Health University Medical Center National Government Services Noridian Administrative Services Norton Healthcare Penny S. Smith Life Science Law Group, LLC Prometheus Laboratories, Inc. Sheridan Clinical Research St. Jude Children s Research Hospital St. Vincent Hospital & Healthcare, Inc. The Ohio State University Wexner Medical Center University Hospital Case Medical Center For More Information Contact

2 Dear Colleague, Welcome to the 8th Annual Clinical Billing and Research Compliance Conference! We have put together a conference that you cannot afford to miss in February. With both Dr. Hecker and Dr. Cunningham from two of the Medicare Contractor regions and our Sponsors Bio- Optronics, Inc., Liberty IRB and Penny S. Smith Life Science Law Group, this is a forum on billing and research compliance that will be the best yet in our eight years. Join us for an Advanced Billing Institute on Sunday, too! If you have attended one of our Clinical Trial Billing Bootcamps, this workshop is an extension and more advanced to tighten up and talk about the challenges we face in billing. If you have not yet attended a bootcamp, we invite you to attend and polish your skills. With Sponsors, CROs, Community Sites, Physician Practices and Academic Medical Centers represented on our expert speaking faculty, you will take practical, goal oriented solutions home with you and your team to set new strategies in billing compliance. Seek approval now for February 23 26, 2014 in Nashville, Tennessee at the Lowes Vanderbilt Hotel. We promise we will examine the billing compliance challenges we all now face! We also promise that we will boot scootin boogie together as colleagues, peers and friends. Join us! We guarantee you will gain knowledge and have fun while doing it! Sincerely, Kelly Willenberg Kelly Willenberg, LLC. Bryon Main President & CEO ExL Pharma Who Should Attend This conference is designed for professionals from Sites, Payers, CROs and Sponsors with roles and responsibilities in the following areas: Venue Loews Vanderbilt Hotel Nashville 2100 West End Avenue Nashville, TN Phone: 1 (800) 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 If you require overnight accommodations, please contact the Loews Vanderbilt Hotel Nashville at 1 (800) and request the negotiated rate for ExL s 8th Billing and Research Compliance. You may use the following weblink to make reservations online: The group rate is available until January 31, Please book your room early as rooms available at this rate are limited. Sponsorship and Exhibiting Opportunities Do 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: Eric Morrin, Business Development Manager (212) emorrin@exlpharma.com

3 Master Class Session A February 23, :30 REGISTRATION OPENS AND CONTINENTAL BREAKFAST FOR WORKSHOP PARTICIPANTS 8:30 WORKSHOP BEGINS 10:30 NETWORKING BREAK 12:00 LUNCHEON FOR WORKSHOP PARTICIPANTS 2:30 NETWORKING BREAK 4:30 END OF WORKSHOP DAY MASTER YOUR SKILLS Advanced Billing Institute This session will provide techniques and tactics for anyone in an advanced billing compliance role. Designed for all who have previously attended a Clinical Trial Billing Compliance Bootcamp and anyone who feels they need further clarification on the advanced topics we face, we will have a full day of discussing the advanced topics.» To master billing challenges from a real world view point» Devices including HUDs» Studies with both IND and IDE» Demands from multiple payers» MCA development to meet CTMS requirements» Using the MCA to improve sponsor negotiations and maximize your CTA terms» To know hands-on methods of auditing from a best practices view point» To understand how compliance is viewed and dealt within billing» To walk through the life of a claim» A chance to get all difficult questions answered WORKSHOP LEADERS Kelly Willenberg, MBA, BSN, CHRC, CHC, Kelly Willenberg, LLC Kathleen Hurtado, RPh, Kelly Willenberg, LLC Main Conference Day One February 24, :00 MAIN CONFERENCE REGISTRATION AND CONTINENTAL BREAKFAST 8:00 CHAIRPERSON WELCOME & OPENING PLENARY Current Issues in Clinical Trials Billing Compliance Kelly Willenberg, MBA, BSN, CHRC, CHC, Kelly Willenberg, LLC 8:30 USING A CTMS AS PART OF A SUCCESSFUL BILLING COMPLIANCE STRATEGY» Key Elements of a successful billing compliance strategy» Using a financially oriented CTMS to develop budgets and billing templates» Working with third party providers and external vendors» Tracking activity and assuring compliance across an extended network of sites and service providers» Using data metrics and analytics to gain insight into performance» Tips for choosing the right financial CTMS Mike Kamish, Vice President and CTO, Bio-Optronics, Inc. Jeanne Lewis, BS, CIM, Research Finance Compliance Analyst, St. Vincent Hospital & Healthcare, Inc. 9:30 NETWORKING BREAK 10:00 CLINICAL TRIAL AGREEMENTS» Drafting terms to address and minimize billing and reimbursement risks» Sample language» Common problems 11:00 CLINICAL OPERATIONS FROM A SPONSOR S POINT OF VIEW Best Practices For Sponsor Invoicing And Implementation of Coverage Analysis: What you can do to simplify, conform and work with sites» Expense Invoices» Escalation Path for Problems» Billing Compliance» Study Reconciliation» Utilization of the coverage analysis process Carey L. True, Finance Director, Manager, Clinical Contracts & Finance, Gilead Sciences Jacqueline Blem, Senior Clinical Study Manager, Prometheus Laboratories, Inc. 12:00 LUNCHEON 1:15 CQI PROCESS FOR IRBs We tend to think our job is to monitor the research, and it may be. However, we also should be evaluating our own performance and quality. Therefore, we will look at case study examples of CQI projects to see how they evaluate performance and quality.» External sites» Pre-recommendation» Funding proposals» Individual project audit Kathy Price, RN, MBA, CIP, Director, Office of Human Subjects Protection, St. Jude Children s Research Hospital Penny S. Smith, Attorney, Founder, Life Science Law Group, LLC. For More Information Contact

4 Main Conference Day One continued February 24, 2014 Panel Discussion 2:00 SUBJECT INJURY AND MEDICARE SECONDARY PAYER REGULATION Moderator Deena Bernstein, BA, MHS, Director Clinical Research, Sheridan Research Panelists: Sponsors Jacqueline Blem, Senior Clinical Study Manager, Prometheus Laboratories, Inc. Carey L. True, Manager, Clinical Contracts & Finance, Gilead Sciences Panelist: Site Damon Michaels, Director Clinical Trials Research, Anesthesiology, Vanderbilt University Medical Center Panelist: CRO Brad Phillips, Sr. Clinical Project Manager, Medelis, Inc. 3:00 NETWORKING AND REFRESHMENT BREAK 3:30 THE PRINCIPAL INVESTIGATOR AND COMPLIANCE RESPONSIBILITIES» Supervising the conduct of research» Protecting the rights of the human subject» Doing the right thing in compliance in billing Vicki L Keedy, MD, MSCI, Assistant Professor of Medicine; Clinical Director, Sarcoma Program; Medical Director, Clinical Trials Shared Resource, Vanderbilt-Ingram Cancer Center 4:15 GCP AUDITS AND BILLING Double Your Pleasure And Double Your Fun» Discuss how to integrate a billing audit into a GCP audit» Discuss why it is important to do both in order to achieve true regulatory and billing compliance and to establish a best practice» Discuss process improvement tools that can be implemented throughout the process» Discuss how to report the findings as an upside and as a learning moment for the institution Kathleen Hurtado, RPh, Kelly Willenberg, LLC Pauline Todd, RN, BSN, MBA, Director of Research, Methodist DeBakey Heart and Vascular Center 5:30 CLOSE OF DAY ONE Main Conference Day Two February 25, :00 CONTINENTAL BREAKFAST FOR CONFERENCE PARTICIPANTS 8:00 CHAIRPERSON S RECAP OF DAY ONE Featured Session 8:15 ASSESSING THERAPEUTIC INTENT: DEFINITION Assessing meaning of therapeutic intent and how what region you are in plays into how you bill Phase I and even Phase I/II trials» Define Therapeutic Intent» Interpretation vs. Reality» What is a Justifiable Objective? Moderator Kelly Willenberg, MBA, BSN, CHRC, CHC, Kelly Willenberg, LLC Speakers Carolyn Cunningham, MD, Medicare Contractor Medical Director, J6, National Government Services, Inc. Bernice Hecker, MD, MHA, FACC, Medicare Contractor Medical Director, Parts A&B, Noridian Administrative Services, Jurisdiction F & Minnesota 9:30 NETWORKING AND REFRESHMENT BREAK Panel Discussion 10:00 MEASURING THE VALUE OF PRIVATE PAYERS IN THE CLINICAL TRIAL COMPLIANCE ARENA Leveraging Payer Information And Knowledge Within The Guidelines With The Affordable Care Act And Compliance Moderator David Vulcano, LCSW, MBA, CIP, RAC, AVP & Responsible Executive, Clinical Research, Clinical Services Group HCA Panelists Carolyn Cunningham, MD, Medicare Contractor Medical Director J6, National Government Services, Inc. Bernice Hecker MD, MHA, FACC, MMedicare Contractor Medical Director, Parts A&B, Noridian Administrative Services, Jurisdiction F & Minnesota For More Information Contact

5 Main Conference Day Two February 25, :15 THE CONFLICT OF INTEREST CHANGES OF 2012 How it Changed, How we do Business, and The Story Of 2½ Angry Docs» Required to have compliant policy» Required to post your policy» Optional: Register with Clearinghouse» The Changes that impacted HMH:» Lowered threshold to $5,000 for reporting income from publicly traded companies» Lowered threshold to $5,000 for reporting stock held in publicly traded companies» Lowered threshold to $5,000 for reporting income from non- publicly traded companies» Lowered threshold to $5,000 for reporting stock held in non-publicly traded companies Denise Pitt, JD, Clinical Trials Program Manager, Huntington Hospital 12:00 LUNCHEON 1:15 MEDICARE ADVANTAGE PLANS How to Manage the Processes for Cost Sharing and Issues with Gap» Overview of Medicare Advantage Plans and Cost Sharing» Review historical positions» Review exceptions for device studies» Describe Operational Solutions» Billing process with claims» Value Codes, Appeals, Monitoring» Resolution Idea» Working with Account Representatives» Payment Contract Solutions Jennifer Lanter, RN, CCRC, MSPH, Director, Research Billing Office, The Ohio State University s Wexner Medical Center 2:00 AUDITING, PLAIN AND SIMPLE How to Get the Most Out of Your Efforts» Auditing your research billing» Types of audits or reviews» Planning the scope of your audit» Reports and follow-up» Re-audits» Real-life examples Christy Fleming, BS, CHRC, Manager, Corporate Compliance, Office of Corporate Integrity, Greenville Health System Denise Quint, Compliance Analyst, Integrity and Compliance Department, Fletcher Allen Health Care 2:45 THE RESEARCH COMPLIANCE EDGE DISCUSSION» Education, Development, Growth and Enrichment Kelly Willenberg, MBA, BSN, CHRC, CHC, Kelly Willenberg, LLC 3:30 NETWORKING & REFRESHMENT BREAK 4:15 CLINICAL OPERATIONS FROM A SITE S POINT OF VIEW Best Practices for Comprehensive Financial Management of Clinical Trials» Budget Development» Invoicing» Charge Management Katherine Hammerhofer, Finance Director, Center for Clinical Research & Technology, University Hospital Case Medical Center Kelly Nottingham, MPH, CHES, Cleveland Clinic 5:15 CONCLUSION OF MAIN CONFERENCE Master Class Session B February 26, :30 REGISTRATION OPENS AND CONTINENTAL BREAKFAST FOR POST-CONFERENCE WORKSHOP PARTICIPANTS 8:00 WORKSHOP BEGINS 10:00 NETWORKING BREAK 12:00 LUNCHEON FOR WORKSHOP PARTICIPANTS 3:00 END OF WORKSHOP DAY BUILDING FOUNDATION AND INFRASTRUCTURE FORUM Challenges And Best Practices In Program Development Bring your job descriptions, policies and procedures, educational training materials, contract and budget issues and we will explore how you build an innovative clinical trial office. Come prepared to interact and work with small groups. Rhonda A. Hoffman, CCR, System Director, Norton Healthcare Office of Research Administration (NHORA) Patricia Green Sharpe RN MSN MHSA, Manager, Department of Clinical Trials, Memorial Health University Medical Center Jamie Harper, MHA, CCRP, Director of Clinical Research, Illinois CancerCare, P.C. For More Information Contact

6 CCB Continuing Education Credits This conference program has been approved for 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 content or sponsors. A one hour session translates into 1.2 CCB CEUs for CHC, CHRC, CHPC and CCEP. Available Credits All-Inclusive Pass Conference + 1 Master Class Conference Only 31.5 CCB Credits 23.5 CCB Credits 15.5 CCB Credits Valued Words from Our Past Attendees Jeanne Lewis Research Finance Compliance Analyst, St. Vincent Hospital and Healthcare, Inc. I could not have grown in billing compliance at this pace had I not attended ExL Pharma s Annual Billing Compliance Conferences. The people you meet and networking are invaluable. Shanna Ford Research Billing Analyst, Intermountain Healthcare Marion Fisher, Shae Owens, Shawn Sundbert Kootenoi Medical Center Thank you for a great conference! The Billing Compliance Conference met all of our needs. The Clinical Billing and Research Compliance Conference is invaluable! It is the only conference that deals specifically with research billing compliance. The speakers are truly experts in this field and every year I learn so much. If you are involved in research billing, this is a CAN T MISS conference. I will be there!

7 Registration Information Online: Phone: Mail: ExL Events, Inc th Ave, Fourth Floor New York, NY Registration Fees Early Bird Rate Standard Rate Onsite Rate Academic Rate* Before Jan 10, 2014 After Jan 10, 2014 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 Group Discount Programs 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. Offers cannot be combined, early bird rates do not apply. To learn how you can take advantage of these group discounts, call Media Partners PAYMENT Make checks payable to ExL Events, Inc. and write code C427 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. 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. Please note, there will be an administrative charge of $300 to substitute, exchange and / or replace attendance badges with a colleague occurring within five business days of any ExL conference. CANCELLATION POLICY If you need to cancel your registration for an upcoming ExL conference, please note the following policies derived from the Start Date of the event: Four weeks or more: A full refund (minus a $295 processing fee), or a voucher to another ExL event valid for 18 months from the voucher issue date. Four weeks or less: A voucher to another ExL event valid for 18 months from the voucher issue date. If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less. To receive a refund or voucher, please fax your request to or call ExL Pharma reserves the right to cancel any conference it deems necessary and will not be responsible 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. TERMS AND CONDITIONS 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 continental breakfasts lunches and refreshments. The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL Events, Inc. s ( ExL s ) designated speakers and is designed for informational purposes for its attendees, and is NOT INTENDED for purposes of copywriting, nor redistribution to other outlets without the express written permission of ExL s designated speaking par- ties. 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, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY THE 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 guarantee the accuracy of or endorse the views or opinions given by any third party content provider. ExL presentations may point to other Internet sites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

8 Register Today ExL Events, Inc th Ave, Fourth Floor New York, NY Method of Payment: p Check p Credit Card Make checks payable to ExL Events, Inc. Card Type: p MasterCard p Visa p Discover p AMEX p Register me for an All Inclusive Pass p Register me for the Conference and Master Class A p Register me for the Conference and Master Class B p Register me for the Conference Only Name: Title: Company: Dept: Address: City: State: Zip: Phone: Fax: Card Number: Name on Card: Signature: Please contact me: p I wish to receive updates on ExL Pharma's upcoming events CONFERENCE CODE: C427 PLEASE MENTION PRIORITY CODE Exp. Date: The Leading Forum on Clinical Research Billing Compliance & 8th Annual Clinical Billing Research Compliance Conference Aligning Strategies with Goal Oriented Solutions to Meet the Challenges Facing Sites, Payers, CROs and Sponsors in Billing & Reimbursement February 23 26, 2014 Loews Vanderbilt Hotel Nashville, TN Limited Early Bird Pricing Available, Register by January 10th Key Topics Site-Sponsor Relations CQI Process for IRB GCP Audits and Billing Conflict of Interest Medicare Advantage Plans Subject Injury and Medicare Secondary Payer Leveraging Private and Commercial Payers Auditing for Billing Compliance Responsibilities of a PI in Compliance Contracting for Clinical Trials Financial Management