national disclosure summit on Pharmaceutical and Medical Device Disclosure, Transparency and Aggregate Spend Conference
national disclosure summit on Pharmaceutical and Medical Device Disclosure, Transparency and Aggregate Spend Conference
national disclosure summit on Pharmaceutical and Medical Device Disclosure, Transparency and Aggregate Spend Conference
national disclosure summit on Pharmaceutical and Medical Device Disclosure, Transparency and Aggregate Spend Conference
national disclosure summit on Pharmaceutical and Medical Device Disclosure, Transparency and Aggregate Spend Conference
national disclosure summit on Pharmaceutical and Medical Device Disclosure, Transparency and Aggregate Spend Conference



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DISCLOSURE SUMMIT AGENDA: DAY II
Thursday, February 6, 2014


7:00 am Registration Commences

MORNING PLENARY SESSION: THE SUNSHINE ACT
8:00 am

Welcome and Overview

Trudy J. Seeley
Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ (Co-chair)
Presentation Material (Acrobat)
8:15 am Interaction and Coordination between State and Federal Reporting Requirements: Strategies to Limit Risk
  • 2014 will mark the first year when companies will be required to juggle both federal and state transparency reporting simultaneously.
  • This session will identify new issues and practical considerations arising from the interplay between the federal physician payment sunshine act and state transparency requirements.
  • We will also review state-specific transparency requirements and enforcement activity, and discuss potential strategies for managing state-specific compliance risks.
  • States with reporting requirements:
    • Vermont
    • Massachusetts
    • Washington, DC
    • West Virginia
    • Minnesota (for 2014 data)
  • States with bans/restrictions impacted by sunshine reporting:
    • California (limit)
    • Minnesota (limit)
    • Louisiana (limit)
    • Vermont (ban)
Diane E. Bieri, Esq.
Partner, Arnold & Porter; Former Executive Vice President and General Counsel, Pharmaceutical Research and Manufacturers of America (PhRMA), Washington, DC
Trudy J. Seeley
Senior Manager, Transparency Operations, Sanofi US, Bridgewater, NJ
9:00 am Coordination of Compliance amongst Multiple Affiliates

Whether due to pending or in-progress mergers and acquisitions or the existence of independent corporate infrastructures, many companies operate as separate applicable manufacturers within the same corporate umbrella. This session will review compliance and business considerations such as:
  • Approaches to governance across applicable manufacturers
  • When to align: How to determine how much coordination is the right amount
  • Approach to shared business processes, systems and data
  • Challenges with customer communications
  • Considerations on when to file jointly vs. independently
Erik Gross
President, NUI, Danville, CA
Jon Wilkenfeld, MBA
President, Potomac River Partners, Vienna, VA
Presentation Material (Acrobat)
9:45 am

Challenges and Best Practices in Reporting Clinical Spend

Annadoir (Anna) Staveley
Compliance Manager, Ethics, Quality & Compliance, Otsuka America Pharmaceutical Inc., Rockville, MD
Seth Whitelaw, JD, LLM, SJD
Director, Life Sciences Regulatory Compliance Practice, Deloitte & Touche LLP; Former R&D Compliance Officer, GlaxoSmithKline; Former Legal Compliance Officer, SmithKline Beecham, Philadelphia, PA (Moderator)
Presentation Material (Acrobat)
10:15 am Break
10:45 am Transactions Reviews for Non-CIA Organizations
  • Reviews of HCP Payments to Assess Completeness, Accuracy and Controls
  • Requirements of an Independent Review Organization when Testing HCP Payments during an Annual Transactions Review
  • The Definition of "Control Documents" and their Relevance to the Sunshine Act and Transactions Review Testing
  • Key Steps in Conducting your own Transactions Review Tests to Assess for Gaps in Compliance to Internal Policies and Procedures
Gus Papandrikos, MBA
Director of Compliance, Daiichi Sankyo; Former Director, Transparency Operations, sanofi-aventis, New York, NY
Jack T. Tanselle
Managing Director, Navigant Consulting, Inc., Indianapolis, IN
Presentation Material (Acrobat)
11:30 am Protecting Reputation and Relationships with Physicians and Teaching Hospitals
  • Notification of Reported Physicians
  • Posting Information on Company Website in Advance of CMS
  • Preparing Physicians re: What they will see
  • Supplying Materials for Physicians re: Why Work with Industry
  • Supplying Materials for Patients on the Advantages of Working with Industry
  • Media before Launch of Public Website
  • Media after Launch of Public Website
Julia Galperin, Esq.
Director, Commercial Compliance Operations, Genentech, South San Francisco, CA
Presentation Material (Acrobat)
Andrew Rosenberg, Esq.
Co-Founder, Thorn Run Partners; Former Staff, Senate Health,
Sylvia J. Trujillo, MPP, JD
Legislative Counsel, Senior Attorney, Legislative Counsel Division, American Medical Association; Former Litigation Attorney, Office of the General, Centers for Medicare and Medicaid Services, Washington, DC
Presentation Material (Acrobat)
Thomas Sullivan
President, Rockpointe Corporation; Editor, Policy and Medicine, Columbia, MD (Moderator)
Presentation Material (Acrobat)
12:15 pm Networking Luncheon

1:15 pm Enforcement Panel
  • Federal Sunshine enforcement
  • State enforcement activity related to disclosure
  • Sunshine's impact on government investigations and other collateral consequences
Margaret (Peg) Hutchinson, Esq.
Assistant US Attorney, Civil Division, United States Attorney's Office, Eastern District of Pennsylvania, Philadelphia, PA
Roann Nichols, Esq.
Assistant US Attorney, United States Attorney's Office, District of Maryland, Baltimore, MD
Robert Patten, Esq.
Assistant Attorney General, Medicaid Fraud Division, The Commonwealth of Massachusetts; Co-chair, Global Case Committee, National Association of Medicaid Fraud Control Units, Holliston, MA
Jonathan Bach
Partner, Cooley, LLP, New York, NY (Moderator)
Presentation Material (Acrobat)
2:15 pm In-Flight Aggregate Spend Data Monitoring Examples

A source-by-source examination of prevailing data issues throughout the data management life-cycle: data collection, data remediation, data aggregation and reporting.
Rajiv Shah
Director, Pharmaceutical & Life Science Advisory Services, PwC, New York, NY
Sarah Volden
Manager, Pharmaceutical & Life Science Advisory Services, PwC, Los Angeles, CA
Presentation Material (Acrobat)
3:00 pm Break
3:30 pm Fair Market Value
  • Focus of Session will be on New Trends in Fair Market Value
  • Counsel's View
  • Impact of Sunshine Act on FMV for Clinical Activities and Grants
    • Challenges and Lessons Learned
  • Evolving International Transparency Initiatives and Global FMV Approaches and Lessons Learned
  • Service Fee FMV; GPOs and Distributors Exposure; New CMS Rules are Coming
Eve M. Brunts, Esq.
Partner, Ropes and Gray, Boston, MA
Janice D. Kam, Esq.
Assistant General Counsel, Eisai Inc., New York, NY
Mark A. DeWyngaert, MBA, PhD
Managing Director, Huron Consulting Group, New York, NY (Moderator)
Presentation Material (Acrobat)
4:15 pm Sunshine for Medical Device Manufacturers
  • Special Concerns of Medical Device Manufacturers
  • Including Demos/Loaners, Upgrades, Physician Ownership
Kevin Dill, Esq.
Chief Compliance Officer, Olympus Corporation of the Americas, Philadelphia, PA
Nate Hwang, Esq.
Chief Compliance Officer, Zimmer, Inc., Fort Wayne, IN
Christopher L. White, Esq.
Senior Executive Vice President, General Counsel, Advanced Medical Technology Association (AdvaMed), Washington, DC
Seth H. Lundy, Esq.
Partner, King & Spalding, Washington, DC (Moderator)
Presentation Material (Acrobat)
5:00 pm Sunshine Data: Will it Help Qui Tam Whistleblowers and their Attorneys?
  • Sunshine data will make available to the public information that may be used by private citizens in civil lawsuits against providers and manufacturers under the False Claims Act qui tam whistleblower law. This law allows those with knowledge of fraud on the government to sue on the government's behalf and share in the proceeds. Billions of dollars have been recovered from pharma and device manufacturers under this law.
  • The qui tam law prohibits the use of publicly disclosed information, subject to certain exceptions. Will this operate as a significant brake on the use of Sunshine data by qui tam whistleblowers and their counsel? Or will the combination of Sunshine data and the 2009 amendments to the ?public disclosure' bar provide a compounding effect that will expose the drug and device industry to more lawsuits?
  • The real world implications and potential for this newly available information to help potential qui tam plaintiffs mine for data or supplement information they have from non-public sources will be discussed by experienced practitioners.
Lesley Ann Skillen, Esq.
Partner, Getnick & Getnick LLP, New York, NY
Presentation Material (Acrobat)
5:45 pm Adjournment


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