6
June 7-8, 2012 • Hyatt at The Bellevue • Philadelphia, PA Featured Sessions: TO REGISTER CALL 866-207-6528 OR VISIT WWW.EXLPHARMA.COM/AGGSPEND The 3 rd Reporting Aggregate Spend & Sunshine Act Compliance Conference Strategies for Data Collection and Disclosure that Comply with Federal and State Requirements in an Era of Health Care Reform Presents ANALYZE THE NEW REGULATIONS RELEASED IN THE SUNSHINE ACT Luanna Saulino, Associate Director, Disclosure Law & Transparency Operation, BAYER PHARMACEUTICALS LEARN BEST PRACTICES IN DATA TRACKING, COLLECTION, AND INTERNAL AUDITING Bill Friedrich, Director of State Reporting / TIG, External Medical Communications, PFIZER UNDERSTAND THE CHALLENGES PHYSICIANS FACE AS A RESULT OF THE ADDITIONAL EXPOSURE Michael Varlotta, Senior Director Medical Education, JANSSEN SERVICES ADDRESS THE ISSUE OF WHO, WHAT, WHERE, WHEN AND HOW TO REPORT AGGREGATE SPEND Elizabeth Schwartz, Director, External Reporting, U.S. Center of Excellence, Global Operations, JOHNSON & JOHNSON Jennifer Daddazio, Pharmaceutical Group Health Care Compliance, Manager - Transparency, Metrics, & Reporting, JOHNSON & JOHNSON Join us and share best practices with these organizations: ACTELION BAYER BIOGEN IDEC CENTOCOR JANSSEN JOHNSON & JOHNSON PFIZER PhRMA PROMETHEUS LABORATORIES SANOFI US THE SPECTRANETICS CORPORATION AND MORE… SPONSORS & EXHIBITORS Plus! Regulatory Panel Discussion Updates from MN, VT and MD on Expectations for Reporting Requirements under the Sunshine Act

Global Impact Of Sunshine Act June 7 8 Philadelphia Yavuz Silay MD,MBA

Embed Size (px)

DESCRIPTION

3rd Reporting Aggregate Spend & Sunshine Act Compliance Conference

Citation preview

Page 1: Global Impact Of Sunshine Act June 7 8 Philadelphia Yavuz Silay MD,MBA

June 7-8, 2012 • Hyatt at The Bellevue • Philadelphia, PA

Featured Sessions:

TO REGISTER CALL 866-207-6528 OR VISIT WWW.EXLPHARMA.COM/AGGSPEND

The 3rd Reporting Aggregate Spend & Sunshine Act Compliance ConferenceStrategies for Data Collection and Disclosure that Comply with Federal and State Requirements in an Era of Health Care Reform

Presents

ANALYZE THE NEW REGULATIONS RELEASED IN THE SUNSHINE ACTLuanna Saulino, Associate Director, Disclosure Law & Transparency Operation,BAYER PHARMACEUTICALS

LEARN BEST PRACTICES IN DATA TRACKING, COLLECTION, AND INTERNAL AUDITINGBill Friedrich, Director of State Reporting / TIG, External Medical Communications, PFIZER

UNDERSTAND THE CHALLENGES PHYSICIANS FACE AS A RESULT OF THE ADDITIONAL EXPOSUREMichael Varlotta, Senior Director Medical Education, JANSSEN SERVICES

ADDRESS THE ISSUE OF WHO, WHAT, WHERE, WHEN AND HOW TO REPORT AGGREGATE SPENDElizabeth Schwartz, Director, External Reporting, U.S. Center of Excellence, Global Operations,JOHNSON & JOHNSON Jennifer Daddazio, Pharmaceutical Group Health Care Compliance, Manager - Transparency, Metrics, & Reporting, JOHNSON & JOHNSON

Join us and share best practices with these organizations:

ACTELION

BAYER

BIOGEN IDEC

CENTOCOR

JANSSEN

JOHNSON & JOHNSON

PFIZER

PhRMA

PROMETHEUS LABORATORIES

SANOFI US

THE SPECTRANETICS CORPORATION

AND MORE…

SPONSORS & EXHIBITORS

Plus! Regulatory Panel DiscussionUpdates from MN, VT and MD on Expectations for Reporting Requirements under the Sunshine Act

Page 2: Global Impact Of Sunshine Act June 7 8 Philadelphia Yavuz Silay MD,MBA

DEAR COLLEAGUE:

The Physician Payments Sunshine provisions in the healthcare reform legislation require drug and medical device manufacturers to publicly report gifts and payments made to physicians and hospitals. Companies must ensure that all data across various company departments is accurately captured, collected, and reported. If companies fail to do so, they could face a penalty with fines ranging anywhere from $150,000 to $1,000,000 per submission. With CMS just releasing the proposed regulations, and final regulations on the horizon, now is the time for companies to prepare themselves for the Sunshine Act and the impact it is likely to have on their company and clients.

ExL Pharma’s 3rd Reporting Aggregate Spend & Sunshine Act Compliance Conference is the perfect place to continue your preparation! This is the only national conference that offers professionals from pharmaceutical, medical device, and biotechnology companies a complete understanding of the requirements for aggregate spend reporting under the Sunshine Act. After attending this conference, attendees are able to walk away with a better understanding of:

• Proposed Regulations• Preemption• Data Management• Communication & Training

• Industry-Physician Relationships• System Integration• Accurate Reporting• Ancillary Value

We look forward to greeting you in June for what is sure to be the most valuable event of its kind!

Sincerely,

Kathryn Collins Matt MillmanConference Director Team Leader, [email protected] ExL Pharma

HOTEL INFO

HYATT AT THE BELLEVUE, PHILADELPHIA200 South Broad Street, Philadelphia, Pennsylvania, 19102 USAPhone: 1(888) 421-1442

The city is yours to discover from Hyatt at The Bellevue. From the historic Liberty Bell and Independence Hall to the Museum of Art and Eagles games at Lincoln Financial Field, you’ll find a wealth of attractions close to our Center City Philadelphia hotel. If you require overnight accommodations, please contact the Hyatt at the Bellevue at 1-888-421-1442 to book your room. ExL has reserved a block of rooms at a discounted rate for conference participants. Please mention “ExL June Meeting” to take advantage of the discount. You must book your room by May 16, 2012 to be eligible for the discounted rate. Please book your room early, as the rooms available at this rate are limited.

This conference is designed for representatives from pharmaceutical, biotechnology, and medical device companies with responsibilities in the following areas:

• CorporateCompliance

• RegulatoryCompliance

• StateReporting

• BusinessAnalysisandDevelopment

• Finance

• RegulatoryAffairs

• GovernmentAffairs

• Ethics

• Sales&Marketing

• CommercialOperations

• ClinicalOperations

• IT

• MedicalAffairs

Sponsorship and Exhibit Opportunities

Do you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact Mark Coulter, Senior Business Development Manager, by calling 917-258-5140 or by emailing [email protected]

The 3rd Reporting Aggregate Spend & Sunshine Act Compliance Conference

Page 3: Global Impact Of Sunshine Act June 7 8 Philadelphia Yavuz Silay MD,MBA

Main Conference Begins1:00 CHAIRPERSON’S WELCOME & OPENING REMARKS

Katherine Cartwright Norris, Director, Corporate Compliance, THE SPECTRANETICS CORPORATION

1:15 OPENING PANEL DISCUSSIONHow will the New Sunshine Act Regulations Affect Aggregate Spend Reporting?

• Review the status of the recently released regulations• Analysis of the necessary data that must be collected and reported • Implementation strategies including integration of stake-holders• Discuss the impact of the Sunshine Act as it relates to the future of

pharmaceutical relationships with healthcare providers

Moderator:Yavuz Silay, MD, MBA, Vice President, Medical Affairs, IPSEN

Panelists:Kendra A. Martello, Assistant General Counsel, PhRMA

Luanna Saulino, Associate Director, Disclosure Law & Transparency Operation, BAYER

Konstantinos Papandrikos, Director, Transparency Operations, US Medical Affairs, SANOFI US

2:15 Tracking and Disclosing Aggregate Spend Reporting 101: Addressing the Issue of Who, What, Where, When and How to Report Aggregate Spend

• Train and communicate efforts around data integrity and aggregate spend• Address transaction management system needs and reporting requirements• Understand and overcome the challenges around customer data• Integrate business process improvements for effective data capture

Elizabeth Schwartz, Director, External Reporting, U.S. Center of Excellence, Global Operations, JOHNSON & JOHNSON

Jennifer Daddazio, Pharmaceutical Group Health Care Compliance, Manager - Transparency, Metrics, & Reporting, JOHNSON & JOHNSON

3:00 Networking & Refreshment Break

3:30 Ensuring Spend is Accurately Accounted for Using Data Tracking, Data Collection, and Internal Auditing Best Practices

• Understand the scale of your business• Learn about the data format in your feeder system• Uncover your “data funnel” and how it needs to accept all data sources

Bill Friedrich, Director of State Reporting/TIG, External Medical Communications, PFIZER

Erik Hennings, Director, Compliance, AVANIR PHARMACEUTICALS

4:15 Managing Aggregate Spend Reporting Through Mergers and Acquisitions

• Analysis of Sunshine Act reporting requirements as it pertains to all parties involved in M&A

• Discussion of common questions — Who is required to report? Are reports filed separately for different groups/teams/organizations?

• Analysis of standing State guidelines that outline specific reporting requirements• Predictions for future reporting requirements based on pending legislation• Case studies: real-world examples of companies based in the U.S. but operated or

acquired by international companies, often with multiple subsidiaries — how is reporting handled?

Eric Saharig, Project Manager, QPHARMA, INC.

5:00 Current Impact of the Sunshine Act at the Global Level

• How Sunshine Act has been perceived in countries outside the US• Discuss the other countries who have implemented similar transparency measures

Yavuz Silay, MD, MBA, Vice President, Medical Affairs, IPSEN

5:45 Day One Concludes

Day One – Thursday, June 7, 20128:00 Registration and Continental Breakfast Opens for Workshop Participants

9:00 PRE-CONFERENCE WORKSHOP Implementation Basics and Beyond: An Aggregate Spend Solution for Sunshine Act Compliance

• Living with Aggregate Spend: understanding the basics and making it manageable • Evaluating reporting solutions to effectively identify what work will work for your company• Identifying, classifying, and integrating spend sources, and adapting internal disparate systems• What is an Aggregate Spend Master File? Why does it matter? How is it central to compliant and accurate reporting?• Effective procedures and training to ensure consistency and continuity across the enterprise• Reporting strategies for smaller companies • Supplement: Summary of state and federal spend and disclosure requirements

Kim Life, Esq., Principal, LIFE COMPLIANCE SOLUTIONS

Dean Rossi, President, ALANDA SOFTWARE

*There will be a 30-minute networking and refreshment break during the workshop session

12:00 Luncheon for Workshop Attendees and Registration Opens for Main ConferencePR

E-C

ON

FE

RE

NC

E W

OR

KS

HO

P

Page 4: Global Impact Of Sunshine Act June 7 8 Philadelphia Yavuz Silay MD,MBA

REGU

LATO

R PE

RSPE

CTIV

ES

8:00 Continental Breakfast

8:50 CHAIRPERSON’S RECAP OF DAY ONE Katherine Cartwright Norris, Director, Corporate Compliance, THE SPECTRANETICS CORPORATION

9:00 REGULATOR PANEL DISCUSSION Updates from the Key States and Regulators on Expectations for Reporting Requirements Under the Sunshine Act

• Examine what modifications have been made by each state as a result of the released regulations

• Hear from the states on their predictions of how regulations effect the industries involved in 2013 and beyond

Moderator:Katherine Cartwright Norris, Director, Corporate Compliance, THE SPECTRANETICS CORPORATION

Panelists:MINNESOTA: Cody Wilberg, Pharm.D., M.S., R.Ph., Executive Director, MINNESOTA BOARD OF PHARMACY

VERMONT: Kate Whelley McCabe, Assistant Attorney General, Public Protection Division, VERMONT OFFICE OF THE ATTORNEY GENERAL

MARYLAND: Delegate Dan Morhaim, MD, Deputy Majority Leader, MARYLAND HOUSE OF DELEGATES

10:00 Managing Customer Expectations Developing the Right HCP Disclosure & Transparency Communication Plan for Your Organization

Although the final requirements from CMS may be unknown at this time, we do know a significant number of physicians are still unaware of the disclosure requirements that may put their financial interactions with prescribed product manufacturers in the spotlight. The impact of public disclosure on physician behavior and relationships with sales and clinical is of growing concern to the industry. Many organizations have struggled with how to approach this communication problem, the message they want to deliver and how to cost effectively and efficiently communicate a message of corporate responsibility. This session focuses on the critical steps in developing a communication plan, key questions to ask yourself as an organization, and various methods of communication that can be used to effectively deliver your message to healthcare professionals.

Wanda Toro Turini, PharmD, President, BULL’S EYE INNOVATIONSDevelopers of The Aggregate Spend RoadMap®

10:45 Networking & Refreshment Break

11:15 Physician - Industry Relationships Internal Preparation and External Communication with Physicians Facing Additional Exposure from the Sunshine Act

• Understanding the reaction and response to public payment information• Preparing internal company personnel for how to respond to healthcare practitioner

questions and concerns about disclosure• Effectively communicating transparency initiatives to help raise awareness of

forthcoming disclosure requirements

Michael Varlotta, Senior Director Medical Education, JANSSEN PHARMACEUTICALS

12:00 Implement Proactive Strategies to Manage Physician Inquires Regarding Forthcoming Reporting Transparency

• Educate physicians effectively to ensure they receive accurate information about reporting regulations

• Successfully maintain industry-physician relationships through proper communication efforts

• Examples of best practices for preparation to the physician response

Konstantinos Papandrikos, Director, Transparency Operations, US Medical Affairs, SANOFI

12:45 Luncheon

1:45 The Health Care Transparency Ecosystem: Understanding Physician Attitudes and Opinions on Notification and Dispute Resolution

• Review of CMS Proposed Rules as they relate to physician notification/dispute resolution

• Review of AMA survey results on physician awareness and attitudes related to the notification/dispute resolution process

• Overview of Case Study/Pilot Program• Sunshine Act Aggregate Spend Awareness: Educating physicians in this new

age of transparency

Michaeline Daboul, President, MMIS, INC.

2:30 Assess the Ancillary Value of Aggregate Spend Data as an Internal Business Wide Monitoring Tool

• Understand perception, identification, and management strategy• Evaluation of current business practices and associated expenditures• Learn accurate compliance, auditing, and monitoring technique• Benchmark corporate policies and procedures

Katherine Cartwright Norris, Director, Corporate Compliance, THE SPECTRANETICS CORPORATION

3:15 Conference Concludes

Day Two – Friday, June 8, 2012

“Good tactical information supported by helpful examples!” – Senior Manager, Regulatory Compliance, PamLab Pharmaceuticals

“Thoughtful, articulate, and interesting commentary!” – Corporate Compliance, Medtronic

“Excellent speakers providing relevant examples and tips!” – Compliance Manager, Biotronik

Page 5: Global Impact Of Sunshine Act June 7 8 Philadelphia Yavuz Silay MD,MBA

Five Ways to Register

FAX: 888-221-6750

MAIL: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018

PHONE: 866-207-6528EMAIL: [email protected] ONLINE: www.exlpharma.com/aggspend

Media Partners

STANDARD PRICING Register after April 13, 2012

Conference + Workshop $2195Conference Only $1895

EARLY BIRD PRICING Register by April 13, 2012 to Take Advantage of Early-Bird Pricing:

Conference + Workshop $1995Conference Only $1695

ONSITE PRICING Conference + Workshop $2295 Conference Only $1995

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 866-207-6528.

Save 25% Per Person when Registering FourFor every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). This is a savings of 25% per person.

GROUP DISCOUNT PROGRAM:

IMPORTANT! Offers may not be combined. Discount only applies to standard rate. Make checks payable to ExL Events, Inc. and write code P1133 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full, two weeks prior to the commencement of the conference.

Conference registrations may be transferred to other colleagues in the event you are unable to attend. Please notify ExL Pharma, [email protected], prior to the event with the name and contact information of the replacement attendee. There will be an administrative charge of $300 to substitute, exchange, and/or replace attendance badge with a colleague occurring within five business days of the conference.

Registration Fees for Attending ExL’s

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 email Conference Director, Kathryn Collins at [email protected]

The 3rd Reporting Aggregate Spend & Sunshine Act Compliance Conference

Page 6: Global Impact Of Sunshine Act June 7 8 Philadelphia Yavuz Silay MD,MBA

Plus! Regulatory Panel DiscussionUpdates from MN, VT and MD on Expectations for Reporting Requirements under the Sunshine Act

June 7-8, 2012 • Hyatt at The Bellevue • Philadelphia, PA

Strategies for Data Collection and Disclosure that Comply with Federal and State Requirements in an Era of Health Care Reform

Presents

866-207-6528

888-221-6750

[email protected]

www.exlpharma.com/aggspend

Yes! Register me for the Conference and Workshop Yes! Register me for the Conference only

Please contact me: I’m interested in marketing opportunities at this event I wish to receive email updates on ExL Pharma’s upcoming events

Name: Title:

Company:

Dept.:

Address:

City: State: Zip:

Email:

Telephone: Fax:

Method of Payment: Check Credit Card Make checks payable to ExL Events, Inc.Card Type: MasterCard Visa Discover Amex

Card Number: Exp. Date:

Name on Card:

Signature:

PLEASE MENTION PRIORITY CODE:Conference Code P1133

ExL Events, Inc.555 8th Avenue, Suite 310New York, NY 10018

Featured Sessions:ANALYZE THE NEW REGULATIONS RELEASED IN THE SUNSHINE ACTLuanna Saulino, Associate Director, Disclosure Law & Transparency Operation,, BAYER

LEARN BEST PRACTICES IN DATA TRACKING, COLLECTION, AND INTERNAL AUDITINGBill Friedrich, Director of State Reporting / TIG, External Medical Communications, PFIZER

UNDERSTAND THE CHALLENGES PHYSICIANS FACE AS A RESULT OF THE ADDITIONAL EXPOSUREMichael Varlotta, Senior Director Medical Education, JANSSEN SERVICES

ADDRESS THE ISSUE OF WHO, WHAT, WHERE, WHEN AND HOW TO REPORT AGGREGATE SPENDElizabeth Schwartz, Director, External Reporting, U.S. Center of Excellence, Global Operations, JOHNSON & JOHNSON Jennifer Daddazio, Pharmaceutical Group Health Care Compliance, Manager - Transparency, Metrics, & Reporting, JOHNSON & JOHNSON

TO REGISTER CALL 866-207-6528 OR VISIT WWW.EXLPHARMA.COM/AGGSPEND

The 3rd Reporting Aggregate

Spend & Sunshine Act Compliance Conference

REGISTER TODAY . . .