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DISCLOSURE SUMMIT AGENDA: PRECONFERENCE
Monday, March 26, 2012


11:00 am Registration Commences

PRECONFERENCE: SUNSHINE ACT, AGGREGATE SPEND AND DISCLOSURE 101
1:00 pm Welcome & Introductions

Jeffrey L. Handwerker, Esq.
Partner, Arnold & Porter, Washington, DC (Co chair)
1:15 pm Overview of the Physician Payment Transparency Provisions of the Affordable Care Act
  • Basic Reporting Requirements, Procedures, and Timeline
  • Who is an Applicable Manufacturer?
  • What is a Transfer of Value?
  • Who are Covered Recipients?
  • What are Covered Products?
  • Other Definitions
  • Transfers of Value through Third Parties
  • Delayed Publications for Payments made Pursuant to Product Research or Development Agreements and Clinical Investigations
  • Payments to US Physicians by ex-US Affiliated Entities
  • Exclusions
  • Sample Reporting
  • Physician Ownership Reporting Requirements
  • Penalties for Non-compliance
Daniel A. Kracov, Esq.
Partner and Chair, FDA and Healthcare Practice, Arnold & Porter, Washington, DC
Presentation Material (Acrobat)
2:15 pm Examination of Hypothetical Affordable Care Act Transparency Reporting Scenarios

Jeffrey L. Handwerker, Esq.
Partner, Arnold & Porter, Washington, DC

Daniel A. Kracov, Esq.
Partner and Chair, FDA and Healthcare Practice, Arnold & Porter, Washington, DC

Jack T. Tanselle
Managing Director, Navigant Consulting, Inc., Indianapolis, IN
3:15 pm Break
3:45 pm State Transparency Reporting Requirements
  • The Affordable Care Act Preemption Provision
  • Current State Provisions
  • State Requirements Post-Affordable Care Act Transparency Implementation
Jeffrey L. Handwerker, Esq.
Partner, Arnold & Porter, Washington, DC
Presentation Material (Acrobat)
4:30 pm Developing International Transparency Requirements

Jack T. Tanselle
Managing Director, Navigant Consulting, Inc., Indianapolis, IN
Presentation Material (Acrobat)
5:15 pm Creating a Compliant Global Aggregate Spend and Disclosure Program

Jeffrey L. Handwerker, Esq.
Partner, Arnold & Porter, Washington, DC

Daniel A. Kracov, Esq.
Partner and Chair, FDA and Healthcare Practice, Arnold & Porter, Washington, DC

Jack T. Tanselle
Managing Director, Navigant Consulting, Inc., Indianapolis, IN
6:00 pm Adjournment





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