Describe the CMS Rules, Statutes, Regulations, Manuals, Transmittals and Guidelines

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1 CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP Become Clinical Trial Billing Proficient at the Only Hands-On Workshop to Guide You through All of Your Billing Compliance Challenges Choose a Date and Location that Works for Your Schedule and Budget! September 23-24, 2013 Hilton Houston Plaza Medical Center, Houston November 11-12, 2013 Loews, Nashville Boot Camp Faculty: *Subject to change per boot camp Kelly Willenberg President KELLY WILLENBERG LLC Kathleen Hurtado, R.Ph. INDEPENDENT CONSULTANT Sponsors: Receive Training and Expert Guidance Around the Following Pressing Issues Surrounding Clinical Trial Billing: Describe the CMS Rules, Statutes, Regulations, Manuals, Transmittals and Guidelines Apply the Essentials for Determining Qualifying Status of a Clinical Trial Participate in a Team Exercise and Gain a Greater Understanding on How to Do a Coverage Analysis from Beginning to End Critique Your Knowledge of the Billing and Coding Fundamentals of Research K LLY WILL NB RG E E Research Compliance Advocates Develop An ACTION PLAN For Your Clinical Trial Billing Compliance Issues Tackle Billing System Challenges Write Consent Language to Ensure Billing Compliance Apply Effective Contract Language Congruent to Billing Plan Critique Your Current Bill Hold or Review Create a Plan of Action to Put a Complaint Billing Action Plan in Place for Clinical Trials

2 WELCOME TO THE CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP Dear Colleague, THIS BOOT CAMP The Clinical Trial Billing Bootcamp uses a combination of lecture, class discussion, and hands-on exercises with people who are desiring to learn the coverage analysis process at the front end and a bill hold and review at the backend. This intensive two day program not only teaches you the rules for billing compliance, but gives you the tools and skills to set up your own Clinical Trials Billing Compliance program. It also puts you in a room of your peers for an engaged learning environment. is designed for professionals from academic research, hospitals and physician based practices and pharmaceutical organizations involved in clinical trial research with responsibilities in the following areas: By attending, you understand the rules to improve both the front-end processes and back-end processes before you realize you have billed a government payor incorrectly. Learn how to successfully accomplish the following by joining us at one of our upcoming Boot Camps: Maintain compliance with the latest rules and regulations Clinical Trial Billing Prevent missed revenue and denials Prepare for government audits Clinical Research Code for clinical trials Conduct a bill hold and review Operations How to perform a consistency check Increase your accounts receivables Contracts and Budgeting Medicare Claims Processing for Research What s Different? Other payers and Oddities Device and Off Label Use Billing Research Compliance Prevent Missing Revenue When Its Research Medicare Advantage Plans and What to Do for Drug Trials Clinical Trial Management Healthcare Reform and Latest Insight Putting It All Together For Your Site Clinical Finance Process Improvement for Your Operations Auditing Bills Site & IRB Relations Training Sincerely, Grants Kelly Willenberg, President, KELLY WILLENBERG LLC September 23-24, 2013 Hilton Houston Plaza/ Medical Center 6633 Travis St Houston, TX CCB CEU Available November 11-12, 2013 Loews Vanderbilt Hotel Nashville 2100 West End Avenue Nashville, TN 37203

3 BOOT CAMP FACULTY Kelly Willenberg President KELLY WILLENBERG LLC Kelly Willenberg is the owner of Kelly Willenberg, LLC. Kelly has a vast array of knowledge and with a variety of research compliance advocates to meet the needs of her clients. Kelly has extensive knowledge in clinical trials management and research compliance, including all aspects of billing compliance. She has nearly thirty years of clinical research experience with 15 in billing compliance. She is an experienced oncology nurse and has presented at HCCA, ONS, ASCO, AHLA, MAGI, ExL Pharma and other professional organizations. She assisted in writing the Research Compliance Professional s Handbook for Healthcare Compliance Association (HCCA) and serves as a faculty member for HCCA s Research Compliance Academy. She also is serving as an editor for the 3rd Addition of the ONS Manual for Clinical Trials Nursing and authoring a variety of chapters in that edited publication. She is certified in Healthcare Research Compliance (CHRC) and Healthcare Compliance (CHC). Kelly worked for over twelve years at Vanderbilt University Medical Center as both the Director of Billing Compliance and as the Director of the Clinical Trials Office for the Cancer Center. She has owned her own consulting business for the past four years. Kathleen Hurtado, R.Ph. INDEPENDENT CONSULTANT Kathleen Hurtado most recently was the Chief Executive Officer of Health Research Association, a University of Southern California subsidiary, a full- service clinical trial suppor t to the researchers and faculty of USC faculty. Now as an independent consultant, Ms. Hur tado brings her experience as a senior executive in the pharmaceutical and biotechnology industries to the client. Ms. Hurtado has spent her career successfully developing, marketing and selling ethical pharmaceuticals. Prior to joining HRA she served as the Director of Operations at the American College of Surgeons Oncology Group at Duke University. Kathleen began her career as a pediatric oncology pharmacist at the MD Anderson Cancer Center in Houston,Texas. Ms. Hurtado was educated at the University of Houston, where she earned her BS in Pharmacy. Ms. Hur tado is affiliated with numerous organizations including the American College of Healthcare Executives, Board of Directors of Priority Healthcare Corporation, Board of Directors for the Westside Family Center and a volunteer at the Downtown Womens Center. In her spare time she enjoys hiking, biking, reading and spending time with her dogs and family.

4 DAY ONE Prerequisites: A mock-up protocol, budget, consent and contract will be circulated during the session for hands on learning. 8:00 CMS Website and the Rules How to Understand the Rules, Statutes, Regulations, Manuals, Transmittals and Guidelines Researching the Website to Find Sources Essentials for Deciding if a Study is Qualifying Tools to Decipher the Term Qualifying Differences in Device Studies and Drug Studies How to Calculate Qualifying Status 10:15 12:15 1:15 Coverage Analysis, Soup to Nuts End Your Confusion on How to Do A Coverage Analysis with Hands On Fundamentals How to Find the Rules to Match the Items Listed on Your Budget Documenting the Support for Billing Routine Costs Designing a necessary and sufficient Protocol Billing Plan template (paper/ electronic) Designing a necessary and sufficient coverage analysis template (paper/ electronic) Sample tools to take with you! Networking Break 3:30 Networking Break Working Lunch 5:00 End of First Day DAY TWO 8:00 Must Know Billing and Coding Fundamentals of Research Key Fields on UB Forms for Research What Are the Condition Codes, Revenue Codes, and Modifiers Outpatient vs. Inpatient How Do You Insure The Codes Are Being Done Correctly? The Consent and Contract Sorting Out What the Consent Actually Means Working with, NOT Against Your IRB for Promoting Billing Compliance Patient Responsibility Especially When It Comes to Medicare Advantage Plans Words Matter How You Can Ensure that the Words in the Contract Say What You Are Actually Doing When a Bill Drops 10:15 Networking Break and Room Check Out Billing System Challenges Medicare Advantage (MA) reroute to Medicare Differential copayment when Medicare pays MA pt bill Coverage with Evidence Development copay waiver IDE number, study object addition to bill Potential NCT number addition (voluntary now) "One of the best conferences I have been to! Relevant, informative, and an excellent opportunity to network with colleagues that perform the same duties as myself. Would highly recommend this to anyone that needs to learn more about clinical trial billing and compliance" - Susie Owenby, RN, CCRP Center for Biomedical Research, LLC 12:15 Working Lunch System Use and The Bill Hold Tools and Practicality in How to Do A Bill Hold Medicare Claims Processing for Research What s Different? Other payers and Oddities Device and Off Label Use Billing Prevent Missing Revenue When Its Research Putting It All Together For Your Site Process Improvement for Your Operations Set an Action Plan towards Successful Clinical Trial Billing 2:30 Boot Camp Ends The information that is shared at the billing compliance boot camp is essential to managing a research program. There is a lot of interaction among the participants which creates a great learning experience also. This meeting is a must if you are involved with research billing. - Research Manager, GREENVILLE HOSPITAL SYSTEM

5 MEDIA PARTNERS PM36O THE FULL SPECTRUM OF PRODUCT MANAGEMENT CCB CEU Available Five Ways to Register Mail: ExL Events, Inc th Avenue, 4th floor New York, NY Phone: Fax: Online: Make checks payable to ExL Events, Inc. and write Bootcamp and City of event on your check 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. Pricing for ExL s Clinical Trial Billing Compliance Academic/Non-Profit/Government Rate: Main Conference $1295 Corporate Rate: Main Conference $1895 Group Discount Program 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). This is a savings of 25% per person. SAVE 15% per person when registering three Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call Please note that offers cannot be combined and group discount is off the standard registration rate. Terms & 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. Payment: 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. Group discounts available to individuals must be registered simultaneously and employed by the same organization. Cancellation and Refund Policy If you need to cancel your registration for an upcoming ExL event, 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. Less than four weeks: 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 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 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. *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. 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 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, 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

6 CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP Choose a Date and Location that Works for Your Schedule and Budget! September 23-24, 2013 Hilton Houston Plaza Medical Center, Houston Develop An ACTION PLAN For Your Clinical Trial Billing Compliance Issues November 11-12, 2013 Loews, Nashville Yes! Register me Academic/Non-Profit/Government Rate: Main Conference $1295 Corporate Rate: Main Conference $1895 NAME: TITLE: COMPANY: DEPT.: ADDRESS: CITY: STATE: ZIP: TELEPHONE: FAX: PLEASE CONTACT ME: I m interested in marketing opportunities at this event I wish to receive updates on ExL Pharma s upcoming events PAYMENT TYPE: MASTERCARD VISA DISCOVER AMEX CHECK (Make checks payable to ExL Events, Inc.) CARD NUMBER: EXP. DATE: NAME ON CARD: SIGNATURE: