Day Two - ET (Eastern Time, GMT-05:00)
- Felecia Manning - Senior Director, Managed Markets Pricing & Government Programs, United Therapeutics Corporation
- Analyze how FTC investigations, proposed rules and transparency initiatives are reshaping PBM business models and stakeholder relationships across the healthcare ecosystem
- Understand the transformation from traditional cost management to today's integrated marketplace through unique insights from executives with both PBM and manufacturer experience
- Discover collaborative approaches for manufacturers and PBMs to navigate new regulatory requirements while balancing market access, patient needs and system sustainability
- Rahul Rao - Deputy Director, Bureau of Competition, Federal Trade Commission
- Annie Wong, PharmD - Senior Director, Pricing and Contracting, Celltrion
- Exploring data transparency initiatives between manufacturers and covered entities
- Building effective partnerships between stakeholders to prevent duplicate discounts
- Balancing program sustainability with expanding access
- Andrew Brownlee - Associate Director, BRG
The IRA’s Part D benefit redesign is a transformational policy with significant impacts on manufacturers, payers, patients and the government. This session will:
· Address the growing importance of Medicare Part D
· Unpack the mechanics of the Part D redesign
· Work through the ‘phase in’ schedule, TrOOP changes, and other critical elements
· Explore changing payer economics and why they are meaningful to manufacturers
· Discuss payer coverage and contracting implications
- Jeff Baab - Vice President, Operational Consulting, IntegriChain
- Pillars of a 340B Center of Excellence – Review key pillars/components of a 340B Center of Excellence (COE) and what would be included in each
- 340B Operational Excellence – Explore how establishing a 340B COE can manage all 340B initiatives including how to streamline current and future 340B operations associated contract pharmacy, patient definition, duplicate discounts, 340B eligibility, etc. This will include ways to make historically multi-stakeholder and inconsistent and disjointed approaches more efficient and effective and what an overall governance and operating model would look like
- Business Approach to 340B Operations – Explore ways to improve 340B operations so you can begin to manage it like a business including how business and financial reporting and investigation can begin to inform overall 340B strategy
- Clay Willis - Director, BRG
- State litigation involving 340B contract pharmacy policies
- Implications of the Genesis case and the IRA on 340B identification
- Updates on 340B sales to contract pharmacy court rulings
- Review of the history of regulatory updates, lawsuits that informed policies and what is in the pipeline
- Analysis of state laws limiting manufacturer contract pharmacy policies
- William Sarraille - Regulatory Consultant, .
Systemic challenges that face all stakeholders in the 340B Drug Pricing Program today
Evolving trends set to intensify revenue leakage due to noncompliant drug discounts
Past, present, and future impact of 340B modifier usage
Critical considerations and responsibility for stakeholders involved in 340B management
- Gavin Magaha, PharmD, MS - Senior Director Value Delivery, Kalderos
Manufacturers often need to refund 340B covered entities for product overcharges, and covered entities often need to refund manufacturers when they have received incorrect 340B discounts. Hear directly from representatives of manufacturers and a covered entity in this panel led by the 340B Prime Vendor, Apexus.
• Define the guidelines for refunds in the 340B Drug Pricing Program.
• Identify the potential reasons necessitating both manufacturer and covered entities to conduct refunds.
• Discuss leading practices, considerations, and potential obstacles in the refund process for both manufacturers and covered entities.
• Examine perspectives on good-faith inquiries when potential discrepancies are discovered.
- Cathy Gilgore - Associate Principal, Manufacturer Refund Service, Apexus
- Katy Lees, BS, 340B ACE - Policy and Business Strategy, University of Rochester Medical Center
- Kaelyn Buck - Senior Director, Regeneron Pharmaceuticals
- Jennifer Lospinoso - Managing Director & Consulting Lead, Riparian
GP is a gold mine of data with everything funneling into it:
- How to better leverage data in GP for your financial and commercial analytics
- How to look at sales trends, make customer decisions, etc.
- Alixe Bonelli - Principal, EY
- Ian Jacobson - Senior, EY
- Stephanie Moy - Senior, EY
Welcoming manufacturers who are newcomers to AI and looking for ideas and inspiration from what peers are utilizing it for:
How will AI impact GP professionals?
What tools are available?
What tasks can be automated using AI?
What can we do in the near future?
- Glenn Jory - Director, Government Pricing & Reporting, Dermavant Sciences, Inc
Although your Product Master may seem like a basic dataset, it ultimately guides a company’s decision-making when it comes to Government Pricing. With all of the recent legislative and regulatory changes, this session will walk through those areas that may require another look to ensure your assumptions are still correct and your reporting is compliant, including:
What is a “Covered Drug” for each program
Determination of Line Extensions
AMP Cap Removal
Bundling
- Katie Lapins Trujillo - Executive Director, The Pricing Group
- Sarah Schumacher - Senior Director, Financial Planning and Analysis, Upsher-Smith
- Expert forecasting and review of the IRA effect on DPT and SPTR
- State level legislations coming down the pipeline – litigation on state level taking precedent over federal
- State allowances for contract pharmacies and 340B entities
- Tactical questions for SPTR – Breakdown of where the states are going
- Joanne Chan - Senior Assistant General Counsel and Head of State Legal Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA)
- Uptick in PDAB purpose, actions and creation
- Review Colorado and Oregon
- How were products selected?
- Engaging with PDABs and protecting proprietary and sensitive information
- Mallory O’Connor - Executive Director, Public Policy, Mallinckrodt Pharmaceuticals
- Lila Cummings - Prescription Drug Affordability Director, State of Colorado
- Kate Davidson - Manager of Insurance Data Science, State of Colorado
- Andrew York, Pharm.D., J.D. - Executive Director, Maryland Prescription Drug Affordability Board
As states continue to implement enforcement procedures in their drug pricing transparency laws and pursue enforcement actions for noncompliance, manufacturers face ongoing practical issues. These issues include the risk analysis involved in untimely reporting, responding to information requests and investigations, and negotiating penalties. This presentation will cover these issues as well as:
• A survey of states’ primary approaches in enforcement
• Case studies and practical tips
• What to expect from states going forward in their enforcement policies and practices
- Sophia Gaulkin - Food & Drug Law Associate, Hyman, Phelps & McNamara
- What is the current landscape and what is upcoming?
- Policy updates that will affect contracting operations
- Strategic approach to navigate upcoming movement in the industry
- Rodney Emerson - Vice President, Pricing & Contracts, Sandoz
- Partha Chatterjee - Co-Founder & Partner, Akara Group
- Join a workshop to discuss the latest government updates from OIG, IRS and others
- Discuss best practices and alternative options for documentation
- Review Department of Justice and court perspectives on FMV
- Meena Datta - Partner, Sidley Austin LLP
- Trevor Wear - Partner, Sidley Austin LLP
Aligning your contracts to your organizational goals
• Common contract components to assist in achieving your organization goals
• Contracting Best Practices
• Real World Scenarios and Case Studies
- Jennifer Katona - Partner, Client Services, Woven Data
- Mike Dinneen - Senior Director, Pricing and Contracting, BioXcel Therapeutics
- Billing timelines and important updates surrounding date of effect
- Granular details on the updates in policy pertaining to chargebacks
- Katie Lapins Trujillo - Executive Director, The Pricing Group
- Megan Falkowski - Director, Government Pricing & Government Contracting Policy, Pfizer Inc
- Nancy Bell - Vice President, Head of US Patient Value & Access, Takeda Oncology
IRA implications that will impact operations
Data processing and forecasting systems
Patient access management
- Walt Worsham - Managing Director, Federal Compliance Solutions
- The current risks businesses face
- SOX and compliance considerations
- Revenue management systems implementation and utilization
- Cayce Gallo - Manager, Chargeback Administration, Teva Pharmaceuticals
- Leonard Rampersaud - Senior Manager, Contracting & Commercial Operations, Jazz Pharmaceuticals
In the spring with IRA drugs identified and the AMP Cap removal states are looking at drugs and seeing generics being made preferred where they haven’t in the past:
- How can manufacturers validate preferred drug lists?
- How are states preparing?
- How are manufacturers preparing?
- Josef Magpantay - Director, RSM US LLP
- Dan Boyarsky - Director, Life Sciences Revenue Contract Management, RSM US LLP
- Pressure on price gouging via legislation and excessive price lowering
- Overall economics that affected the viability of emerging biotech companies
- Election year – bipartisan effort to make drug pricing top of list
- Potential causes of drug shortages and policy views on how to address it
- Mallory O’Connor - Executive Director, Public Policy, Mallinckrodt Pharmaceuticals
Discover the key variables and considerations in determining whether your company should opt for in-house development or outsourcing when it comes to certain software solutions. Gain insights from different—and commonly conflicting—viewpoints including those of executives, business stakeholders, and IT support staff, as we navigate this strategic decision-making process together.
- Daniel Choi, PMI-PMP, ACP - Sr. Manager - Technology & Advanced Data Analytics, Riparian.com
- Michael Murphy - Associate Manager, Riparian
- Roneil Narciso - Senior Director Strategic Pricing & Contracting, AVEO Oncology
- How to navigate and combat sharing trade secrets and proprietary information yet comply with your obligations to the state
- How to designate trade secrets and flag issues
- State confidentiality restrictions and intentions
- Reviewing valuable takeaways from litigation
- Grant Ostlund - Director, Ethics & Compliance, Novo Nordisk
- Amie Phillips Pablo - VP, Corporate Compliance & Privacy Officer, Novo Nordisk
- Caitlyn Ozier - Counsel, King & Spalding LLP
- Pros and cons of combining these concepts to streamline responses and obligations
- Logistics to consider when attempting to share vendor support on each
- Felecia Manning - Senior Director, Managed Markets Pricing & Government Programs, United Therapeutics Corporation
- Nick Olivares - Controller, Lundbeck
Join us for an engaging conversation where we delve into the transformative power of AI-driven solutions in the pharmaceutical industry. We will present a case study on how one of the world's leading pharmaceutical manufacturers is revolutionizing their rebate contract, business and revenue performance. The session will explore:
Connecting contracts to rebate business performance
Leveraging AI automation for efficient forecasting and analysis
Preventing revenue leakage with data insights
In-house vs. outsourced solutions
- Addressing current challenges- prior authorization, step edits, formulary
- Coverage gap discount program perspective
- Trade-offs between market access and rebates
- Collaborating with PBMs for accurate forecasting
- Rujul Desai - Partner, Covington & Burling LLP
- Josef Magpantay - Director, RSM US LLP
- GPO membership maintenance
- Ensuring accuracy for chargeback claims
- Leveraging GPOs and impact on price
- Current state of fee structures
- Tracy Zheng - Senior Market Access Operations Director, Exelixis
- Julia Williams - Manager, Supplier, Buy-side relations/chargebacks, McKesson
- Sean Lawrence - Manager, Membership & Contract Validation, Teva Pharmaceuticals
- 340b chargebacks
- Rebate programs and discounts
- Medicare Part D- view for 2025
- Coupons and co-pays