7th Annual In-House Counsel Forum on Government Regulation of

Prescription Drug Pricing

Wednesday, March 11, 2009

About

Our delegates say it best: This is the “Best pricing conference in existence” Jessi Gottlieb, Counsel, Hoffmann LaRoche

As the premier legal and regulatory pricing and reimbursement event that for the past 7 years, this is the only conference that allows you to see the complete pricing and reimbursement picture. This seventh annual program gives full coverage of all the new developments from the leading industry experts, including in-house pricing experts and a regular stellar faculty of government enforcers.

With changes to AMP, increased transparency and the uncertainty of AWP's future, the time is critical to have a comprehensive pricing strategy in place. To ensure your rebate reimbursement exposure is limited, that you are being adequately reimbursed for drugs provided to beneficiaries or that pricing for government programs is not negatively affecting commercial prices, you need to understand the changes that are taking place and devise a strategy to deal with them.

Nearly every major component of the pharmaceutical industry, as well as public and private healthcare, is in a tailspin. R&D, IP, product and formulary placement, and patient access all have been touched by these reforms in some way. These newest reforms are at the root of new and continuing anxieties over pricing transparency and fraud and abuse. They also exacerbate the scope of existing dilemmas, such as public and private pricing litigation and criminal enforcement actions.

Designed especially for Pharma/Biotech in-house counsel, officers, directors, managers, you will come away from this event able to:

  • Make sense of all new laws and regulations affecting drug pricing and reimbursement
  • Recognize new pricing and reimbursement risks and hotspots
  • Benefit from the insights and knowledge of pricing and reimbursement experts
  • Update compliance programs and business strategies to account for evolving laws
  • Chart the course of pricing and reimbursement in relation to the changing role of government payor programs and the evolution of American healthcare

Contents & Contributors

About

Our delegates say it best: This is the “Best pricing conference in existence” Jessi Gottlieb, Counsel, Hoffmann LaRoche

As the premier legal and regulatory pricing and reimbursement event that for the past 7 years, this is the only conference that allows you to see the complete pricing and reimbursement picture. This seventh annual program gives full coverage of all the new developments from the leading industry experts, including in-house pricing experts and a regular stellar faculty of government enforcers.

With changes to AMP, increased transparency and the uncertainty of AWP's future, the time is critical to have a comprehensive pricing strategy in place. To ensure your rebate reimbursement exposure is limited, that you are being adequately reimbursed for drugs provided to beneficiaries or that pricing for government programs is not negatively affecting commercial prices, you need to understand the changes that are taking place and devise a strategy to deal with them.

Nearly every major component of the pharmaceutical industry, as well as public and private healthcare, is in a tailspin. R&D, IP, product and formulary placement, and patient access all have been touched by these reforms in some way. These newest reforms are at the root of new and continuing anxieties over pricing transparency and fraud and abuse. They also exacerbate the scope of existing dilemmas, such as public and private pricing litigation and criminal enforcement actions.

Designed especially for Pharma/Biotech in-house counsel, officers, directors, managers, you will come away from this event able to:

  • Make sense of all new laws and regulations affecting drug pricing and reimbursement
  • Recognize new pricing and reimbursement risks and hotspots
  • Benefit from the insights and knowledge of pricing and reimbursement experts
  • Update compliance programs and business strategies to account for evolving laws
  • Chart the course of pricing and reimbursement in relation to the changing role of government payor programs and the evolution of American healthcare

Contents & Contributors

Preparing for Potential Changes to AMP and Examining How Those Changes Will Affect the Pricing Sector
Don L. Bell, II, Senior Vice President and General Counsel, National Association of Chain Drug Stores (Alexandria, VA)
Benjamin S. Martin, Attorney, Epstein Becker & Green, P.C. (Washington, DC)

Navigating Compliance Obligations Under New TRICARE Regulations
Howard Crawford, CPT, USAFR, MSC, (Ret.), Federal Account Manager, Genentech, Inc. (Washington, DC)
Constance A. Wilkinson, Partner, Epstein Becker & Green, P.C. (Washington, DC)

Resolving Disputes with State Medicaid Programs and CMS
Edith S. Marshall, Counsel, Arnold & Porter LLP (Washington, DC)

Tracking the Evolution of MDL 1456
William F. Cavanaugh, Jr., Partner, Patterson Belknap Webb & Tyler LLP, (New York, NY)
Blakely J. Pryor, Attorney, Shook, Hardy & Bacon L.L.P. (Kansas City, MO)
Tina M. Tabacchi, Partner, Jones Day (Chicago, IL)

Mastering the Mechanics and Operational Challenges Associated With the Final DRA Rule
Timothy J. Nugent, Managing Director, FTI Consulting (New York, NY)
Larri A. Short, Partner, Arent Fox LLP (Washington, DC)

Countering Evolving Theories of Liability in AWP Cases
C. Michael Moore, Partner, Sonnenschein Nath & Rosenthal LLP (Dallas, TX)
D. Jacques Smith, Partner, Arent Fox LLP (Washington, DC)

Negative Pricing: When Statutory Discounts Create a Profit Center for Government Programs
Meghan Davis, Director, Huron Consulting Group, LLC (New York, NY)
Curtis Moore, Associate Director of Health Outcomes and Strategic Pricing, Genzyme (Cambridge, MA)
John D. Shakow, Partner, King & Spalding (Washington, DC)

Grappling With The Uncertain Future of AWP: Preparing For the Changing Reimbursement Landscape
Christopher Stomberg, Ph.D., Partner, Bates White, LLC (Washington, DC)
Lyndon M. Tretter, Partner, Hogan & Hartson LLP (New York, NY)

Creating a Robust Pricing Compliance/Audit Program That Will Provide the Most Accurate Calculations and the Ability to Verify Them
Dennis K. Barnes, JD, CPA, Director, Advisory Services, KPMG LLP (Philadelphia, PA)
Lena Robins, Partner, Foley & Lardner LLP (Washington, DC)



DOCUMENT TYPES: PPT PPTX DOC PDF PRESENTATIONS AVAILABLE: 20

7:15
Registration and Continental Breakfast
8:15
Co-Chairs' Welcoming Remarks
Ms. Anne Flaherty
Director Government Pricing
Sepracor Inc
-Larri A. Short
Partner
Arent Fox LLP
8:30
Preparing for Potential Changes to AMP and Examining How Those Changes Will Affect the Pricing Sector
Mr. Don L. Bell‚ II
Senior Vice President and General Counsel
National Association of Chain Drug Stores
1 file
Preparing For Changes To AMP
280.5 KB 23 pages Presentation
PPT - Preparing For Changes To AMP
Mr. Benjamin S. Martin
Member of the Firm
Epstein Becker & Green‚ P.C.
1 file
Preparing for Potential Changes to AMP
572.5 KB 21 pages Presentation
PPT - Preparing for Potential Changes to AMP
9:45
Morning Coffee Break
10:00
Navigating Compliance Obligations Under New TRICARE Regulations
Mr. Howard Crawford‚ CPT‚ USAFR‚ MSC‚ (Ret.)
Federal Account Manager
Genentech‚ Inc.
1 file
Navigating Obligations Related to Tricare Retail Pharmacy Program
304.5 KB 30 pages Presentation
PPT - Navigating Obligations Related to Tricare Retail Pharmacy Program
Constance A. Wilkinson
Member of the Firm
Epstein Becker & Green‚ P.C.
1 file
Navigating Obligations Related to Tricare Retail Pharmacy Program
304.5 KB 30 pages Presentation
PPT - Navigating Obligations Related to Tricare Retail Pharmacy Program
11:15
Resolving Disputes with State Medicaid Programs and CMS
Ms. Edith S. Marshall
Counsel
Arnold & Porter LLP
1 file
Resolving Disputes With States and CMS The Medicaid Dispute Resolution Program
317.3 KB 30 pages Presentation
PPTX - Resolving Disputes With States and CMSThe Medicaid Dispute Resolution Program
12:15
Networking Luncheon for Speakers and Delegates
13:30
Breakout Session 1 - A - Tracking the Evolution of MDL 1456
Mr. William F. Cavanaugh, Jr.
Partner
Patterson Belknap Webb & Tyler LLP
1 file
AWP Litigation Update
630.5 KB 56 pages Presentation
PPT - AWP Litigation Update
Mr. Blakely J. Pryor
Attorney
Shook Hardy & Bacon LLP
Ms. Tina M. Tabacchi
Partner
Jones Day
13:30
Breakout Session 1 - B - Mastering the Mechanics and Operational Challenges Associated With the Final DRA Rule
Mr. Timothy J. Nugent
Managing Director
Huron Consulting Group
1 file
Mastering the Mechanics and Operational Challenges Associated with the CMS Final Rule
888 KB 48 pages Presentation
PPT - Mastering the Mechanics and Operational Challenges Associated with the CMS Final Rule
-Larri A. Short
Partner
Arent Fox LLP
1 file
Mastering the Mechanics and Operational Challenges Associated with the CMS Final Rule
888 KB 48 pages Presentation
PPT - Mastering the Mechanics and Operational Challenges Associated with the CMS Final Rule
15:00
Afternoon Refreshment Break
15:15
Breakout Session 2 - C - Countering Evolving Theories of Liability in AWP Cases
Mr. Raymond C. Winter
Assistant Attorney General
Chief‚ Civil Medicaid Fraud Division
Mr. W. Daniel Miles‚ III
Section Head of Consumer Fraud/Commerical Litigation
Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. (Washington, DC)
Mr. C. Michael Moore
Partner
Sonnenschein Nath & Rosenthal LLP
1 file
AN OVERVIEW OF STATE AWP LITIGATION AND ISSUES
84.5 KB 12 pages Presentation
DOC - AN OVERVIEW OF STATE AWP LITIGATION AND ISSUES
Mr. D. Jacques Smith
Partner
Arent Fox LLP
1 file
AN OVERVIEW OF STATE AWP LITIGATION AND ISSUES
84.5 KB 12 pages Presentation
DOC - AN OVERVIEW OF STATE AWP LITIGATION AND ISSUES
15:15
Breakout Session 2 - D -Negative Pricing: When Statutory Discounts Create a Profit Center for Government Programs
Ms. Meghan Davis
Director
Huron Consulting Group‚ LLC
1 file
How a Drug Gets To Negative Pricing:
229.4 KB 9 pages Presentation
PPTX - How a Drug Gets To Negative Pricing:
Mr. Curtis Moore
Associate Director of Health Outcomes and Strategic Pricing
Genzyme Corporation
1 file
Negative Pricing: When Statutory Discounts Create a Profit Center for Government Program
326.5 KB 21 pages Presentation
PPT - Negative Pricing: When Statutory Discounts Create a Profit Center for Government Program
John D. Shakow
Partner
King & Spalding
1 file
Negative Pricing: When Statutory Discounts Create a Profit Center for Government Programs
205.5 KB 26 pages Presentation
PPT - Negative Pricing:  When Statutory Discounts Create aProfit Center for Government Programs
16:15
Breakout Session 3 - E -Grappling With The Uncertain Future of AWP: Preparing For the Changing Reimbursement Landscape
Christopher Stomberg‚ Ph.D.
Partner
Bates White LLC
1 file
Pharmaceutical pricing: a future without AWP?
495 KB 24 pages Presentation
PPT - Pharmaceutical pricing: a future without AWP?
Mr. Lyndon M. Tretter
Partner
Hogan & Hartson LLP
1 file
Pharmaceutical pricing: a future without AWP?
495 KB 24 pages Presentation
PPT - Pharmaceutical pricing: a future without AWP?
16:15
Breakout Session 3 - F -Creating a Robust Pricing Compliance/Audit Program That Will Provide the Most Accurate Calculations and the Ability to Verify Them
Mr. Dennis K. Barnes‚ JD‚ CPA
Director‚ Advisory Services
KPMG LLP
1 file
Creating a Robust Pricing Compliance / Audit Program That Will Provide the Most Accurate Calculations and the Ability to Verify Them
1.5 MB 21 pages Presentation
PPT - Creating a Robust Pricing Compliance / Audit Program That Will Provide the Most Accurate Calculations and the Ability to Verify Them
Ms. Lena Robins
Partner
Foley & Lardner LLP
1 file
CREATING A ROBUST PRICING COMPLIANCE/ AUDIT PROGRAM THAT WILL PROVIDE THE MOST ACCURATE CALCULATIONS AND THE ABILITY TO VERIFY THEM
0 bytes 27 pages Presentation
 - CREATING A ROBUST PRICING COMPLIANCE/AUDIT PROGRAM THAT WILL PROVIDE THE MOST ACCURATE CALCULATIONS AND THE ABILITY TO VERIFY THEM
17:15
Day 1 Concludes
8:00
Continental breakfast
9:00
Co-Chairs' Welcoming Remarks
9:15
New Legislative and Regulatory Developments in Drug Pricing
Mr. Tim Hermes
Principal
GRQ‚ LLC
1 file
Controversies Surrounding Comparative Effectiveness Research
532.5 KB 15 pages Presentation
PPT - Controversies Surrounding Comparative Effectiveness Research
Ms. Kathleen M. Weldon
Vice President‚ Government Strategy
Biogen Idec
1 file
Overview of Potential Government Reforms Impacting on Drug Pricing and Reimbursement
91.5 KB 10 pages Presentation
PPTX - Overview of Potential Government Reforms Impacting on Drug Pricing and Reimbursement
Mr. David L. Ralston
Division Counsel‚ Legal Regulatory and Compliance
Abbott Laboratories
Steven Stranne, MD, JD
Shareholder
Polsinelli PC
1 file
New Legislative and Regulatory Development in Drug Pricing
247.5 KB 19 pages Presentation
PPT - New Legislative and Regulatory Development in Drug Pricing
10:30
Morning Coffee Break
10:45
Identifying Pricing Related Government Enforcement Trends
Ms. Riza Dagli
Director‚ Medicaid Fraud Control Unit
Office of the New Jersey Attorney General
Ms. Marilyn May
Assistant U.S. Attorney
Office of the U.S. Attorney for the Eastern District of Pennsylvania
Mr. Daniel R. Miller
Attorney
Berger & Montague‚ P.C.
Mr. Joseph Trautwein
Assistant U.S. Attorney
Office of the U.S. Attorney for the Eastern District of Pennsylvania
Ms. Beth Moskow-Schnoll
Partner
Ballard Spahr Andrews & Ingersoll‚ LLP
12:15
Networking Luncheon for Speakers and Delegates
13:30
Identifying New and Continuing OIG Target Areas
Mr. John Kern
Partner
Manatt‚ Phelps & Phillips‚ LLP
1 file
Identifying New and Continuing OIG Target Areas
324.5 KB 12 pages Presentation
PPT - Identifying New and Continuing OIG Target Areas
Ms. Carolyn McElroy
Vice President & General Counsel
Pacific Pulmonary Services
1 file
Identifying New and Continuing OIG Target Areas
324.5 KB 12 pages Presentation
PPT - Identifying New and Continuing OIG Target Areas
14:30
Afternoon Refreshment Break
14:45
Antitrust Considerations in Pricing
Mr. Harvey Kaish
Senior Counsel
Bristol-Myers Squibb
1 file
PRESCRIPTION DRUG PRICING: ANTITRUST CONSIDERATIONS IN PRICING
84.4 KB 20 pages Presentation
PDF - PRESCRIPTION DRUG PRICING: ANTITRUST CONSIDERATIONS IN PRICING
Mr. John Roberti
Partner
Mayer Brown LLP
1 file
PRESCRIPTION DRUG PRICING: ANTITRUST CONSIDERATIONS IN PRICING
84.4 KB 20 pages Presentation
PDF - PRESCRIPTION DRUG PRICING: ANTITRUST CONSIDERATIONS IN PRICING
Mr. John Clayton Everett‚ Jr.
Partner
Morgan‚ Lewis & Bockius LLP
1 file
PRESCRIPTION DRUG PRICING: ANTITRUST CONSIDERATIONS IN PRICING
84.4 KB 20 pages Presentation
PDF - PRESCRIPTION DRUG PRICING: ANTITRUST CONSIDERATIONS IN PRICING
15:45
Insights Into 340B Legislative‚ Regulatory and Litigation Changes That Will Impact All Pricing Stakeholders
Ms. Virginia A. Gibson
Partner
Hogan Lovells LLP
1 file
Drug Pricing and Fraud Issues for 340B Institutions
252.4 KB 30 pages Presentation
PDF - Drug Pricing and Fraud Issues for 340B Institutions
-Mr. William von Oehsen
President and General Counsel, Safety Net Hospitals for Pharmaceutical Access &
Principal, Powers Pyles Sutter & Verville PC
1 file
INSIGHTS INTO 340B LEGISLATIVE, REGULATORY AND LITIGATION CHANGES THAT WILL IMPACT ALL PRICING STAKEHOLDERS
543.5 KB 27 pages Presentation
PPT - INSIGHTS INTO 340B LEGISLATIVE, REGULATORY AND LITIGATION CHANGES THAT WILL IMPACT ALL PRICING STAKEHOLDERS
16:45
Conference Concludes