CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP

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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 ALL-NEW DATES AND LOCATIONS FOR 2015 INCLUDE: April 30 - May 1 / Embassy Suites Atlanta - Galleria / Atlanta, GA July / Embassy Suites Chicago O Hare/Rosemont / Chicago, IL September / Embassy Suites Denver Stapleton / Denver, CO December 7-8 / Embassy Suites Phoenix Airport / Phoenix, AZ DEVELOP AN ACTION PLAN FOR YOUR CLINICAL TRIAL BILLING COMPLIANCE ISSUES Boot Camp Faculty Kelly Willenberg President KELLY WILLENBERG, LLC *Subject to change per boot camp Sponsors: Kathleen Hurtado, R.Ph. KELLY WILLENBERG, LLC* Receive Training and Expert Guidance Around Pressing Clinical Trial Billing Issues: 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 Determine Routine Costs from Beginning to End Critique Your Knowledge of the Billing and Coding Fundamentals of Research Tackle Billing System Challenges Write Consent Language to Ensure Billing Compliance Apply Effective Contract Language Congruent to a Billing Plan Critique Your Current Bill Hold or Review Create an Audit Action Plan to Put a Billing Compliance Program in Place for Clinical Trials

2 Welcome to the CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP Dear Colleague, The Clinical Trial Billing Compliance Boot Camp uses a combination of lectures, class discussions and hands-on exercises with people who want to learn the coverage analysis process at the front end and the bill hold and review process at the back end. 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. THIS BOOT CAMP is designed for professionals from pharmaceutical organizations and academic research, hospitals and physician-based practicesinvolved in clinical trial research with responsibilities in the following areas: By attending, you understand the rules to improve both the front- 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 camp sessions: Maintain compliance with the latest rules and regulations Prevent missed revenue and denials Prepare for government audits Code for clinical trials Conduct a bill hold and review Perform a consistency check Increase your accounts receivables Preventing missing revenue by billing appropriately Our boot camps also discuss key topics such as: Differences in Medicare claims processing for research Other payers and oddities device and off-label use billing Medicare Advantage Plans and what to do for drug trials The latest insights regarding healthcare reform Operations process improvements Bill auditing Professional training Clinical Trial Billing Clinical Research Operations Contracts and Budgeting Research Compliance Clinical Trial Management Clinical Finance Site and IRB Relations Grants Sincerely, CCB CEU Available Kelly Willenberg President, KELLY WILLENBERG, LLC ALL-NEW DATES AND LOCATIONS FOR 2015 INCLUDE: April 30 - May 1 / Embassy Suites Atlanta - Galleria / Atlanta, GA July / Embassy Suites Chicago O Hare/Rosemont / Chicago, IL September / Embassy Suites Denver Stapleton / Denver, CO December 7-8 / Embassy Suites Phoenix Airport / Phoenix, AZ

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 works with a variety of research compliance advocates to meet the needs of her clients. Kelly has an extensive background in clinical trials management and research compliance, including all aspects of billing compliance. She has nearly 30 years of clinical research experience, 15 of which are in billing compliance. She is an experienced oncology nurse and has presented at events held by HCCA, ONS, ASCO, AHLA, MAGI, ExL Pharma and other professional organizations. She helped write the Research Compliance Professional s Handbook for the Healthcare Compliance Association (HCCA). She is serving as an editor for the 3rd edition of the ONS Manual for Clinical Trials Nursing and is authoring a variety of chapters in that publication. She is certified in Healthcare Research Compliance (CHRC) and Healthcare Compliance (CHC), and is a Certified Clinical Research Professional (CCRP). For more than 12 years, Kelly worked 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 six years. Kathleen Hurtado, R.Ph. KELLY WILLENBERG, LLC Prior to becoming an independent consultant, Kathleen Hurtado was the Chief Executive Officer of Health Research Association, a University of Southern California subsidiary offering full-service clinical trial support to the researchers and faculty of USC. Kathleen now brings her experience as a senior executive in the pharmaceutical and biotechnology industries to the client. She 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. Kathleen was educated at the University of Houston, where she earned her B.S. in pharmacy. Kathleen is affiliated with numerous organizations including the American College of Healthcare Executives, the Board of Directors of Priority Healthcare Corporation, and the Board of Directors for the Westside Family Center, and she is 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 AGENDA DAY ONE 8:00 Continental Breakfast 12:00 Working Lunch 8:30 CMS Website and the Rules Understanding the rules, statutes, regulations, manuals, transmittals and guidelines of the CMS website Researching the website to find sources 9:30 Essentials for Deciding if a Study Is Qualifying Using tools to decipher the term qualifying Analyzing differences in device studies and drug studies Calculating qualifying status 10:30 Networking Break 11:00 Device Trials and the Distinct Differences from Qualifying Drug Trials Reviewing the various types of device studies, including category A and B studies Discussing device challenges in regards to billing payers Evaluating the central review performed at CMS Addressing other trial types and the hard question answered DAY TWO 8:00 Continental Breakfast 8:30 Must-Know Billing and Coding Fundamentals of Research Reviewing key fields on UB forms for research Identifying condition codes, revenue codes and modifiers Examining outpatient versus inpatient bill rules Ensuring codes are input properly Preventing missing revenue when it s research 9:30 The Consent and Contract Sorting out what the consent actually means Working with, NOT against, your IRB for promoting billing compliance Reinforcing patient responsibility regarding Medicare Advantage Plans Developing a process to ensure that the words in a contract say what you are actually doing when a bill drops 10:30 Networking Break and Room Check Out 11:00 How to Correctly Reroute Medicare Advantage (MA) to Medicare Defining the differential copayment when Medicare pays a Medicare Advantage (MA) patient bill Reviewing patient billing implications, responsibilities and out-of-pocket costs Understanding the applicable coverage with Evidence Development and the copayment waiver Analyzing the impact of the change and compliance for billing Medicare Advantage (MA) patients 12:00 Working Lunch 1:00 Coverage Analysis, Soup to Nuts End Your Confusion on How to Do a Coverage Analysis with Hands-On Fundamentals Finding 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) Developing a necessary and sufficient coverage analysis template (paper/electronic) 3:00 Networking Break 3:30 Coverage Analysis, Soup to Nuts End Your Confusion on How to Do a Coverage Analysis with Hands-On Fundamentals Continued 5:00 End of First Day 1:00 System Use and the Bill Hold Reviewing tools and practicality in how to do a bill hold Understanding the differences in Medicare claims processing for research Discussing other payers and oddities, particularly device and off-label use billing Preventing missing revenue by billing appropriately 2:00 Putting It All Together for Your Site Developing process improvements for your operations Setting an action plan toward successful clinical trial billing 3:00 Networking Break 3:30 How to Perform a Billing Review and Audit Outlining the steps to follow in a claim review Examining how an explanation of benefits (EOB) impacts the process Reviewing the differences between professional billing versus facility billing Defining the steps in performing an audit Learning how to fine tune a written audit report 4:30 Boot Camp Ends 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

5 CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP 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 WAYS TO REGISTER: Phone: Media Partners Fax: Online: registration@exlevents.com Mail: ExL Events, Inc th Avenue, Fourth Floor New York, NY PRICING FOR EXL S CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP ACADEMIC/NONPROFIT/GOVERNMENT RATE: q Main Conference $1,495 CORPORATE RATE: q Main Conference $1, GROUP DISCOUNT PROGRAMS *Offers may not be combined. Early Bird rates do not apply.* Save 25% 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% Can only send three? You can still save 15% off of each registration. PAYMENT: Make checks payable to ExL Events, Inc. and write code BBC 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 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 12 months from the voucher issue date. Less than four weeks: A voucher to another ExL event valid for 12 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 Credit Vouchers are valid for 12 months from date of issue. Credit Vouchers 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 no longer 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. 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 costs 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 or venue. *The opinions of ExL speakers do not necessarily reflect those of the companies they represent or 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.

6 PRICING FOR EXL S CLINICAL TRIAL BILLING COMPLIANCE ACADEMIC/NONPROFIT/GOVERNMENT RATE: q Main Conference $1,495 CORPORATE RATE: q Main Conference $1,895 Method of Payment: Check Credit Card Make checks payable to ExL Events, Inc. Card Type: MasterCard Visa Discover AMEX Please contact me: I'm interested in marketing opportunities at this event I wish to receive updates on ExL Pharma's upcoming events Name: Title: Company: Dept.: Address: City: State: Zip: Phone: Fax: 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 ALL-NEW DATES AND LOCATIONS FOR 2015 INCLUDE: April 30 - May 1 / Embassy Suites Atlanta - Galleria / Atlanta, GA July / Embassy Suites Chicago O Hare/Rosemont / Chicago, IL September / Embassy Suites Denver Stapleton / Denver, CO December 7-8 / Embassy Suites Phoenix Airport / Phoenix, AZ DEVELOP AN ACTION PLAN FOR YOUR CLINICAL TRIAL BILLING COMPLIANCE ISSUES

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