Aggregate Spend and Sunshine Conference

Transcription

1 5 th Aggregate Spend and Sunshine Conference proudly presents Preparing for Disclosure and Dispute Resolution while Applying Lessons Learned June 2-3, 2014 Ritz-Carlton Philadelphia, PA Data Collection Data Audits/Controls 1 2 Filing Report Data Consistency APPLY LESSONS LEARNED AND MAINTAIN COMPLIANT CULTURE Disclosure 4 3 Dispute Resolution Pre-Disclosure Communication Tools New For 2014 APPLY LESSONS LEARNED FROM FILING THE FIRST REPORT Donna Wesbecker, Associate Director, Ethics and Compliance Americas, Actavis IMPLEMENT INNOVATIVE DISPUTE RESOLUTION TOOLS Carrie Ann Ashcom, Director, Compliance Monitoring, BIOMET Continuous Improvement BENCHMARK WITH PEERS IN GRAY AREAS Lisa Noble, Senior Law Clerk, Manager Spend Reporting Legal Department, Valeant UNDERSTAND PHYSICIAN EXPECTATIONS Jeremy Lazarus, President, American Medical Association Enhance Your Skill Set and Register For Our Interactive Workshop! Ensure Data Quality and Consistency by Implementing Data Controls and Audits Greg Schuler, Senior Director, Information Systems, Incyte Tracey Basler, Senior Director, Compliance, Incyte PREPARE FOR DISCLOSURE Abe Welle, Prin. Compliance Specialist, Medtronic MAINTAIN COMPLIANT CULTURE IN LIGHT OF CONSTANT CHANGE Sergio Alegre, Senior Director Compliance, Pacira Pharmaceuticals

2 Dear Colleague, While you re still working on filing your first report, ExL Pharma has put together a program that assists you with your current challenges, prepares you for the next phase and helps you implement lessons learned from the aggregate spend journey so far. At the 5th Aggregate Spend and Sunshine Conference, Compliance, IT, Legal, Finance and Transparency professionals from companies such as Valeant, Draeger, Biomet, Shionogi, Medtronic, Actavis, Pacira Pharmaceuticals, Incyte, Meda, CareFusion, Johnson & Johnson and many more gather once more to share best practices and innovative tools, address challenges and discuss strategies how to overcome them. Benchmark with your peers to get a thorough understanding of the industry consensus regarding gray areas and learn about cutting-edge technologies that help facilitate dispute resolution. Find out how leading companies keep their staff up to date with the constant changes and maintain a compliant culture. Hot topics include: Discuss lessons learned from filing the first report Benchmark in gray areas to identify the industry s consensus on CME, research and covered recipients Understand physician expectations regarding aggregate spend reporting and create effective communication tools Implement audits and controls to ensure data quality and consistency Address challenges for research and academic medical centers with the Open Payment Act Ensure continuous improvement, monitoring and re-evaluation of existing processes Leverage best practices to maintain a compliant company culture and ensure your staff is up to date Apply a global approach to aggregate spend Understand what steps are required in case of a reporting error Outline effective strategies to prepare for pre-disclosure and disclosure Asses legal implications and enforcement post disclosure It s a long journey but you re not alone. SHARE DISCUSS IMPROVE to be ready for the September deadline and continuously enhance your systems and processes. We re looking forward to seeing you this June. Sincerely, Kai Hahn Senior Conference Director PS: Register for our interactive workshop to enhance your current processes, implement data controls and audits to ensure data quality! 2% 7% 4% Reporting/Transparency/Agg Spend Compliance IT/IS 5% Business Analysis 3% 2% 5% Who Should Attend This boot camp is designed for VP s, Dept Heads, Directors and Managers of Medical Device, Pharma and Biotech companies whose responsibilities include: Corporate Compliance & Ethics Regulatory Compliance Aggregate Spend State Reporting Transparency Business Analysis and Development Finance & Accounting Legal and Regulatory Affairs Government Affairs Sales & Marketing Commercial Operations Clinical Operations IT/IS Medical Affairs Contract Administrators Internal & External Training This program is also of interest to: CROs Technology experts Consultants Law Firms Meeting Planers PAST ATTENDEES BY TITLE 33% 28% 12% PAST ATTENDEES BY INDUSTRY 83% 16% Pharma/Biotech/Med Device Legal Counsel Finance Project Management Technology Providers Consulting What past attendees say: What a great venue to meet other Compliance professionals from a cross section of medical device and pharmaceutical industries! Lots of opportunities to share your own stories of success and/or challenges as you implement the new federal regulations it was a very informative conference. Not only did I learn a lot, I came away with many new connections and solutions and I had fun! Very well worth the time and effort to attend. - Susan Hanstad, Director, Corporate Compliance, Endologix Other

3 Monday, June 2, 2014 PRE-CONFERENCE WORKSHOP 8:00 Workshop Registration and Continental Breakfast for Workshop Participants 9:00 Ensure Data Quality and Consistency by Implementing Data Controls and Audits Implementing strict controls in the front end of your data collection can spare you a lot of headaches in the long run. Going back after the fact and trying to resolve discrepancies or fill data gaps can be a tedious if not impossible task. This in-depth workshop will walk you through common pitfalls and give you tools and strategies at hand how to resolve them. Learn how to streamline and fine-tune your reporting system to safe time and money and prevent fines. Link data sources seamlessly to prevent data gaps and inaccuracies Highlighting tools to overcome interoperability issues between different software and consolidate reports Customize your aggregate spend solution to fit your needs Discuss methods to validate and reconcile aggregate spend data and resolve discrepancies Segment and align data to meet sunshine and state requirements Implement automated processes Overcoming common pitfalls Greg Schuler, Senior Director, Information Systems, Incyte Tracey Basler, Senior Director, Compliance, Incyte 12:00 Lunch for Workshop attendees Monday, June 2, 2014 Main Conference Day 1 12:30 Registration Main Conference 1:00 Chairperson s Welcome and Opening Remarks 1:15 KEYNOTE: Understand Physician Expectations Regarding Sunshine and Create Effective Communication Tools Establish common ground and clarifying expectations between industry, physicians, and teaching hospitals Prepare for dispute resolution with education, innovative tools and good communication Understand how Sunshine affects the recruitment of KOL s for clinical trials and consulting Manage pushbacks and develop new approaches to engage HCPs Jeremy Lazarus, President, AMA 2:00 CASE STUDY: Create an Online Platform for Dispute Resolution to Settle Disputes Quickly Outline reportable recipient spend dispute resolution program Consulting HCP status review Consultant contract review and revision Fair market value policies and procedures Carrie Ann Ashcom, Director, Compliance Monitoring, BIOMET 2:45 Afternoon Networking and Refreshment Break 3:15 PANEL DISCUSSION: Prioritizing and Processing Disputes to Align with the Industry Benchmark Address the pro s and con s of pre-disclosure Implement an internal dispute committee to identify which disputes have priority Assess to what extend disputes are considered normal and the implications of CMS monitoring Eren Efe, Manager, General Accounting - Transparency Reporting, CareFusion Lisa Noble, Senior Law Clerk, Manager Spend Reporting Legal Department, Valeant Dan Spicehandler, Life Sciences Legal and Compliance, MEDA 4:00 ROUNDTABLES: Highlight Global Transparency Requirements In this interactive session you will get a chance to discuss your reporting challenges with peers and exchange views, find out what worked and what didn t work for others and learn how they have tackled various issues. Please come prepared with one challenge you d like to discuss Jennifer McGee, Senior Compliance Counsel, Otsuka 5:00 END OF DAY ONE

4 Tuesday, June 3, 2014 Main Conference Day 2 7:15 CONTINENTAL BREAKFAST 8:10 Chairperson s Recap of Day One 8:15 PANEL DISCUSSION: Outline Lessons Learned from Submitting the First Report Outline processes and tools that have proved effective Highlight challenges and methods to overcome them Discuss lessons learned and possibilities for enhancing the next report Donna Wesbecker, Associate Director, Ethics and Compliance AmericasActavis Stacy Aiken, Manager HCC, Johnson & Johnson Eren Efe, Manager, General Accounting - Transparency Reporting, CareFusion 9:15 KEYNOTE by CMS followed by Q&A Lindsy Massuda, Health Insurance Specialist, CENTERS FOR MEDICARE & MEDICAID SERVICES 10:15 Address Challenges for Research and Academic Medical Centers with the Open Payment Act Unique role of AMCs and the background for restrictions on acceptance of payments/ service on speaker s bureaus Bad facts make bad law: abuses by a few result in a very expensive and challenging regulatory structure, for the AMC community as well as industry Find ways to assure the collection of correct data attributed to correct recipients Errors and omissions: approaches to resolution and finding common ground Ann N. James, Senior University Counsel, Stanford University 11:00 Morning Networking and Refreshment Break 11:30 Benchmarking Session: Shedding Light on Gray Areas Post-Guidance Define research and the industry s course on research reporting Overcome challenges with CMS Teaching Hospital List Discuss textbooks and reprints Outline tips to deal with the uncertainty while anticipating further guidance on gray areas from CMS Lisa Noble, Senior Law Clerk, Manager Spend Reporting Legal Department, Valeant Michael Hunn, Quality System Management & Compliance Quality & Regulatory Affairs, Draeger Medical Systems 12:30 Networking Lunch 1:30 Understand the Status Quo of State and Federal Sunshine Law and Develop an Action Plan in Case of a Reporting Error Update on State and Federal Law: a State-by-State breakdown of disclosure and reporting requirements post- Sunshine Act How aggregate spend might impact enforcement of state and federal fraud and abuse laws Explain what kind of immediate actions are important when errors are found Explore the Amnesty State Program Abe Welle, Prin. Compliance Specialist, MEDTRONIC Jennifer McGee, Senior Compliance Counsel, Otsuka 2:15 Get Everybody on the Same Page Best Practices to Prepare for Disclosure Highlight strategies to prepare for public questions and inquiries Identify what should go into the assumptions document Discuss issues and challenges of public disclosure and strategies how to tackle these Prepare for increasingly aggressive enforcement activity and public scrutiny as government enforcers reveal how enforcers may view disclosed data Abe Welle, Prin. Compliance Specialist, Medtronic Dan Spicehandler, Life Sciences Legal and Compliance, MEDA 3:00 Afternoon Networking and Refreshment Break 3:30 IMPLEMENT PROCESS IMPROVEMENTS TO DRIVE DATA INTEGRITY THROUGH GOVERNANCE Utilize process mapping to identify opportunities and focus areas Implement data governance to ensure consistency and improve data integrity Use insights to drive business accountability Tammy Brintzinghoffer, Senior Manager HCC, Johnson & Johnson Stacy Aiken, Manager HCC, Johnson & Johnson 4:15 Keep your Staff up to Date with Constant Changes Best Practices for Continuous Training Implement Refresher trainings to keep your staff up to date with CMS updates and new industry benchmarks Understand who needs to know what and how to get the message across Establish a baseline of regulatory knowledge Provide educational tools and best practices to advance and maintain a compliant culture from newletters to webinars to agg spend champions in different departments Sergio Alegre, Senior Director Compliance, Pacira Heather McCollum, Director Compliance, SHIONOGI 5:00 Conference Concludes

5 5 Ways to Register: Media Partners Mail: ExL Events, Inc th Avenue, 4th floor, New York, NY Online: Phone: Fax: PM36O THE FULL SPECTRUM OF PRODUCT MANAGEMENT Registration Fees for attending ExL s 5th Aggregate Spend and Sunshine Conference: EARLY BIRD PRICING* Register by April 25, 2014 Conference & Workshop $2095 Conference Only $1795 STANDARD PRICING* Register after April 25, 2014 Conference & Workshop $2295 Conference Only $1995 ONSITE PRICING* Conference & Workshop $2395 Conference Only $2095 GROUP DISCOUNT PROGRAMS *Offers may not be combined. Early Bird rates do not apply* 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 4 at one time). Save 15% per person when registering three Can only send three? You can still save 15% off of each registration. VENUE Ritz-Carlton Philadelphia 10 Avenue Of The Arts Philadelphia, PA The Ritz-Carlton Philadelphia is a 394 feet 30-story skyscraper located south of City Hall in the Center City of Philadelphia, Pennsylvania. It was built in as the Girard Trust Building. To make reservations please call and request the negotiated rate for ExL s Aggregate Spend Program. The group rate is available until May 12, Please book your room early as rooms available at this rate are limited. SPONSORSHIP & 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: Sean Blank or sblank@exlpharma.com 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: Make checks payable to ExL Events, Inc. and write code C487 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. 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 INFORMA- TION 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 Questions? Comments? Do you have a question 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 Program Director, Kai Hahn, at khahn@exlpharma.com

6 5 Ways to Register: Mail: ExL Events, Inc th Avenue, 4th floor, New York, NY th Avenue, 4th floor New York, NY Conference Code: C487 Phone: Fax: Online: th Aggregate Spend and Sunshine Conference proudly presents Preparing for Disclosure and Dispute Resolution while Applying Lessons Learned June 2-3, 2014 Ritz-Carlton Philadelphia, PA New For 2014 APPLY LESSONS LEARNED FROM FILING THE FIRST REPORT Donna Wesbecker, Manager, Aggregate Spend and Compliance, Actavis IMPLEMENT INNOVATIVE DISPUTE RESOLUTION TOOLS Carrie Ann Ashcom, Compliance Manager, GE Healthcare PREPARE FOR DISCLOSURE Abe Welle, Prin. Compliance Specialist, Medtronic