LIVE DAY 2 ✦ September 19 - CST/CDT (Central Daylight, GMT-5)
LIVE DAY 2 ✦ September 19 - CST/CDT (Central Daylight, GMT-5)
- Odalys Caprisecca - Vice President, Managed Markets Finance, Novartis Pharmaceuticals Corporation
- Scott LaGanga - Senior Vice President, State Advocacy, PhRMA
- Matt Salo - Founder and CEO, Salo Health Strategies
- How difficult will it be to calculate price reporting and track units
- Rujul Desai - Partner, Covington & Burling LLP
- Jake Keenan - Senior Director, Federal Compliance Solutions
- Alice Valder Curran - Partner, Hogan Lovells US LLP
- Insights into the selection of drugs up for negotiation – why were they selected?
- Where are we in the process of operationalizing the IRA and what has happened since the most recent comment period?
- 80% of Pharma is reconsidering R&D of new products because of the IRA – considerations for manufacturers
- Judd Caulfield - Lead Counsel, Oncology Business Unit, Takeda Pharmaceuticals
- Harmeet Dhillon - Head of Public Policy, GlaxoSmithKline
- Jeff Baab - Vice President, Operational Consulting, IntegriChain
- Financial impact of Part D redesign
- Downstream implications of the “Medicare Drug Price Negotiation Program,” including Best Price and potential commercial segment impacts
- New world of product development
- Updates on the inflation penalties
- Operational/compliance impacts and complexities
- 340B Considerations
- Kristin Hicks - Partner, Arnold & Porter
- Clay Willis - Director, BRG
What keeps YOU up at night? Are they the newest requirements for State Drug Pricing? Is it the circling litigation with 340B and contract pharmacies? Or the complexities of Line Extensions? Join this open Q&A with External Counsel to bring and get answers to your most challenging questions. We’ll also hear about issues that keep them up at night and how it will impact you. **Pre-Conference we’ll poll the attendees for questions to ask our speakers.
- Anthony Greco - Managing Director, PwC
- Christopher Schott - Partner, Latham & Watkins
- Stephanie Trunk - Partner, ArentFox Schiff
- Rujul Desai - Partner, Covington & Burling LLP
- Current state of value based agreements
- With market access teams more willing to make VBAs, how will state Medicaid agencies capture outcome-based data more available to private commercial companies?
- Reviewing Biden’s executive order on innovative payment models and resulting CMS guidance
- Jennifer Lospinoso - Managing Director & Consulting Lead, Riparian
- Faraz Siddiqui - JD MPH, Associate, Hyman, Phelps & McNamara
- Susan Dunne - Senior Director, Riparian
How you can model, forecast and report the impacts of your pricing and commercial strategy on each of the government pricing calculations
• What government pricing calculations are impacted and why
• What are the timing impacts you should be aware of
• Keys to communicating the key government pricing components for your team
• Best practices for building models to capture the impact of WAC changes and contract changes
• Highlighting and reporting the financial and business impacts of these decisions
- Scott Hoffman - Head of Client Services, Woven Data
- Mike Rowland - Senior Director, Pricing Contract and Analytics, Acadia Pharmaceuticals
- Legislative priorities for the coming year, drug pricing and PBMs
- Updates on all changes to rules, regulations and calculations in the past year and the impact on product and delivery based on type — Specialty, oncology, rare, orphan, generic, etc.
- Interconnectedness of commercial and GP explained – how to avoid damaging the pricing of a product through informing both sides of the coin on pricing decisions
- Felecia Manning - Director, Managed Markets Contracts & Government Pricing, United Therapeutics Corporation
- Melody Hamel - Senior Life Sciences Counsel & Legal Business Partner, Viatris
With the removal of the AMP Cap, the inclusion of US Territories, the changes introduced from the Inflation Reduction Act, and the CMS Proposed Rule, there is a lot for manufacturers to consider. In this session we’ll look at:
-How might the various changes impact a product based on the product type and where it is in its life cycle?
-What potential changes could manufacturers make to contracting strategies in response to the new legislation and rules?
-What are some areas where manufacturers may need to make “reasonable assumptions”?
-What due diligence issues do these changes raise, especially with regard to mergers and acquisitions?
- Elizabeth Lindquist - Partner, Arnold & Porter
- Judd Caulfield - Lead Counsel, Oncology Business Unit, Takeda Pharmaceuticals
- Katie Lapins Trujillo - Executive Director, The Pricing Group
• Timeline overview of the history and progression of the 340B program — How did we get to where we are today?
• Current state of litigation on contract pharmacies by manufacturers
• What do court findings mean for the futureof the program and manufacturer approaches?
• Insights on policy on patient definition and eligibility
- William Sarraille - Partner, Sidley Austin LLP
- Understanding the evolution and growth of the 340B program and different stakeholders’ interest for legislative change
- Understanding the workload associated with data sharing and concerns about privacy/transparency
- The value of 340B Clearing House in simplifying data validation across all stakeholders
- What are the pros and cons of moving 340B discount administration to a rebate option instead of the direct purchase option?
- Mesfin Tegenu, MS, RPh - CEO and Chairman, RxParadigm
- Cathy Burton-Meza - Associate Director, Government Rebates, Gilead Sciences
- Maureen Testoni - President and Chief Executive Officer, 340B Health
- Updated data on growth in 340B programs: Hear real-time data on growth in 340B programs and resulting impact
- IRA-340B operationalization of the price effectuation
- MFP effectuation, MFP diversion, 340B non-duplication, inflation rebate 340B removal
- Josef Magpantay - Director, RSM US LLP
Review best practices for smaller manufacturers looking to contest offering 340B pricing to contract pharmacies
Ideas to manage utilization going through 340B programs
340B duplicate billing in Medicaid: Recent action by manufacturers to increase ability to detect in real-time if payment should be made
Upfront 340B disputes: best practices to not pay versus pay and chase
- Amanda Tucker - Associate Director, Solution Delivery, Northridge Insight
- Sharon Small - Director, Counsel Market Access, Government Pricing & Policy, Novartis
- Ryan Bruce - Associate Director of Medicaid, AstraZeneca
- Criteria for solution selection: create a checklist of requirements
- Implementation tools and tips
- The role of advisory consultants
- Overview of different areas that have technology available
- Manufacturer-led case study on successful tool implementation
- How can we incorporate new tech into GP in the future (AI, bots, cloud etc.)?
- Daniel Yerves - Director, Government Pricing and Contracting, scPharmaceuticals, Inc.
- Jesse Mendelsohn - Senior Vice President, Model N
- Overview of GP calculations and reporting in acquisition and divestiture situations: Where can GP add value with bundling data
- How the federal government perceives bundling – what to include and exclude and other learnings
- Government guidance on package sizing
- Avoiding operational errors in product blending
- Data that needs to be received from seller or needs to be shared (acquisition or divestiture)
- Insights on stacking discounts: what to consider when deciding whether discounts should be stacked and documenting your stacking reasonable assumptions
- Installment pricing and contracting strategies
- Stephanie Kupski - Director US Pricing & Government Reporting, CSL Behring
- Elizabeth Wicyk-McGovern - Senior Manager Pricing & Reimbursement, Pfizer
- Michael Kurland - Vice President, Revenue Management & Compliance, EVERSANA
- Driving effective government pricing restatements – strategies for success
- Gaining valuable insights and implementing best practices
- Understanding the ongoing benefits of government pricing restatements
- Terry Pierce - Senior Director, Government Reporting, McKesson
- Greg Wiefel - Senior Manager, Ernst & Young LLP
- Matthew Newman - Manager, Government Contract Services, Ernst & Young, LLP
Join this closed-door roundtable consisting of small tomid-size life sciences manufacturers discussing andparticipating in live polling to benchmark on the mostpressing pain points to problem solve across industry.
- Funso Olufade, PhD, MBA - Sr. Director – Head, Commercial Finance, Ascendis Pharma
- Joe DeLuca - Senior Manager, CSL Behring