Day TwoTuesday, 24 September 2024 - CT (Central Time)

With the highly anticipated election on the horizon, join us in a policy overview of different scenarios based on the election outcome. We will model out possibilities with experts in the field on health policy issues, drug pricing and treatment of Pharma.

• Review past initiatives by presidential candidates that impacted the industry and expected shifts
• Landscape for 2025 and beyond
• Implications for both the national and state level
• IRA impact on election and outlook for amendments post-election

Hear from expert manufacturers of various size and type on how policy has impacted their commercialized product.

• Appropriate weighting within organization and what it means for pricing long term
• Approaches to compliance and risk-based evaluation
• Tips for communicating updates and downside to senior leadership
• Implications of the IRA on development pipeline

This session will provide stakeholders with key policy, programmatic and compliance updates from the Office of Pharmacy Affairs, which oversees the federal 340B Drug Pricing Program.

• Refresh on the Medicare Drug Price Negotiation Program

• Insights from the publication of MFPs from the first round of negotiation

• How may future rounds of negotiation differ?

• What to prepare and best practices on process

• Market access implications of the MFP and changing Part D dynamics

What keeps YOU up at night? The newest requirements for State Drug Pricing? Is it the circling litigation with 340B and contract pharmacies? IRA and Medicaid negotiations? Smoothing and stacking? PBMs and PDABs? Join this open Q&A with external counsel to 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.

• Information regarding all modifications made to rules, regulations, and calculations over the past year, along with their effects on product and delivery processes
• Examine current litigation surrounding IRA
• IRA rebates impact on accruals, forecasting, and new product launches - how to tailor product launch strategy with rebate accruals in mind

• What are the operational considerations in receiving, validating, and paying the new invoices coming from the IRA and Discarded Drug Refund requirement
• How will systems and processes need to change in this new environment
• Discuss the next steps manufacturers should take to be ready to efficiently and accurately pay these new rebates and refunds

• If we are trailing the product from manufacturer to final customer, how do we account for those steps and verify the actions?
• Guiding through the steps for reporting back to CMS and the 14-day process
• How do you approach “following the pill” across all channels while addressing all possible discounts?
• Using the 10 products authorized, identify how the data was captured and possibilities for improvement upon the process

• How to prepare for inflation rebates, negotiated prices and other IRA changes in your contracts with customers

• Updating your contract operation strategies to accommodate these new programs

• What to consider when developing sound compliance policies around the IRA