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

Kelly WillenbergPresidentKELLY WILLENBERG, LLC

Kathleen Hurtado, R.Ph.KELLY WILLENBERG, LLC*

� 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 E� ective 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

Boot Camp Faculty Receive Training and Expert Guidance Around Pressing Clinical Trial Billing Issues:

Sponsors:

*Subject to change per boot camp

WILL NB RGK LLYE

Research Compliance AdvocatesEE

DEVELOP AN ACTION PLAN FOR YOUR CLINICAL TRIAL BILLING COMPLIANCE ISSUES

ALL-NEW DATES AND LOCATIONS FOR 2015 INCLUDE:April 30 - May 1 / Embassy Suites Atlanta - Galleria / Atlanta, GA

July 27-28 / Embassy Suites Chicago O’Hare/Rosemont / Chicago, IL

September 16-17 / Embassy Suites Denver Stapleton / Denver, CO

December 7-8 / Embassy Suites Phoenix Airport / Phoenix, AZ

Register Now | Call: 866-207-6528 | Visit: www.exlevents.com/bootcamps

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.

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:

• Di� erences in Medicare claims processing for research

• Other payers and oddities — device and o� -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

Sincerely,

Kelly WillenbergPresident, KELLY WILLENBERG, LLC

Dear Colleague,

Welcome to the CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP

� Clinical Trial Billing

� Clinical Research

� Operations

� Contracts and Budgeting

� Research Compliance

� Clinical Trial Management

� Clinical Finance

� Site and IRB Relations

� Grants

THIS BOOT CAMPis designed for professionals from pharmaceutical organizations and academic research, hospitals and physician-based practicesinvolved in clinical trial research with responsibilities in the following areas:

CCB CEU Available

ALL-NEW DATES AND LOCATIONS FOR 2015 INCLUDE:April 30 - May 1 / Embassy Suites Atlanta - Galleria / Atlanta, GA

July 27-28 / Embassy Suites Chicago O’Hare/Rosemont / Chicago, IL

September 16-17 / Embassy Suites Denver Stapleton / Denver, CO

December 7-8 / Embassy Suites Phoenix Airport / Phoenix, AZ

Register Now | Call: 866-207-6528 | Visit: www.exlevents.com/bootcamps

Prior to becoming an independent consultant, Kathleen Hurtado was the Chief Executive Offi cer

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 affi liated 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.

BOOT CAMP FACULTY

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 certifi ed in Healthcare Research Compliance (CHRC)

and Healthcare Compliance (CHC), and is a Certifi ed 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 Offi ce for the Cancer Center. She has owned her

own consulting business for the past six years.

Kelly WillenbergPresidentKELLY WILLENBERG, LLC

Kathleen Hurtado, R.Ph.KELLY WILLENBERG, LLC

Register Now | Call: 866-207-6528 | Visit: www.exlevents.com/bootcamps

DAY ONE 8:00 Continental Breakfast

8:30 CMS Website and the Rules � Understanding the rules, statutes, regulations, manuals, transmittals and guidelines of the CMS website

� Researching the website to fi nd 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

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 suffi cient protocol billing plan template (paper/electronic)

� Developing a necessary and suffi cient 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

8:00 Continental Breakfast

8:30 Must-Know Billing and Coding Fundamentals of Research

� Reviewing key fi elds on UB forms for research � Identifying condition codes, revenue codes and modifi ers � 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

� Defi ning 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 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 benefi ts (EOB) impacts the process

� Reviewing the differences between professional billing versus facility billing

� Defi ning the steps in performing an audit � Learning how to fi ne tune a written audit report

4:30 Boot Camp Ends

DAY TWO

AGENDA

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

Register Now | Call: 866-207-6528 | Visit: www.exlevents.com/bootcamps

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

PRICING FOR EXL’S CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMP

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 o� er‚ 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 � ve 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 toanother 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 888-221-6750.

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 � ve 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 re� ect 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, signi� cant e� ort to � nd a suitable replacement will be made.

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.

ACADEMIC/NONPROFIT/GOVERNMENT RATE: q Main Conference $1,495

CORPORATE RATE: q Main Conference $1,895

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Register Now | Call: 866-207-6528 | Visit: www.exlevents.com/bootcamps

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CLINICAL TRIAL BILLING COMPLIANCE BOOT CAMPBecome Clinical Trial Billing Proficient at the Only Hands-On Workshop to Guide You Through All of Your Billing Compliance Challenges

DEVELOP AN ACTION PLAN FOR YOUR CLINICAL TRIAL BILLING COMPLIANCE ISSUES

ALL-NEW DATES AND LOCATIONS FOR 2015 INCLUDE:April 30 - May 1 / Embassy Suites Atlanta - Galleria / Atlanta, GAJuly 27-28 / Embassy Suites Chicago O’Hare/Rosemont / Chicago, ILSeptember 16-17 / Embassy Suites Denver Stapleton / Denver, CODecember 7-8 / Embassy Suites Phoenix Airport / Phoenix, AZ

PRICING FOR EXL’S CLINICAL TRIAL BILLING COMPLIANCE

ACADEMIC/NONPROFIT/GOVERNMENT RATE: q Main Conference $1,495

CORPORATE RATE: q Main Conference $1,895

Register Now | Call: 866-207-6528 | Visit: www.exlevents.com/bootcamps