Day ThreeWednesday, 17 September 2025 - CT (Central Time)

• Examine strategic inflection points as the IRA transitions from initial implementation to mature program operations, including essential recalibrations for commercial planning, forecasting, and portfolio optimization
• Analyze emerging patterns in market response across different stakeholder groups, illuminating how successful organizations are adapting their decision frameworks beyond basic compliance
• Explore the evolution of data-driven approaches for navigating negotiation preparation, financial modeling, and commercial contracting in response to early program experiences
• Develop forward-looking strategies that balance short-term tactical needs with long-term portfolio considerations as the program expands to include Part B drugs and additional therapeutic categories

Hear from an expert panel of attorneys as they each moderate a topic and interactive discussion among attendees, and themselves, on the most pressing issues facing MDRP and Government Pricing.

• Explore effective collaboration models between manufacturers and covered entities, including advisory councils and structured engagement protocols that address program challenges while maintaining compliance
• Understand manufacturers' approaches to organizing stakeholder engagement responsibilities across market access, government contracting, and policy teams
• Develop strategies for navigating complex compliance discussions and program integrity issues while fostering relationships that support patient access
• Establish formal advisory board structures with clear composition, governance protocols, and compliance guardrails
• Implement best practices for documenting engagement and measuring outcomes that translate insights into program improvements

• Examine the evolution of 340B management systems from basic spreadsheets to sophisticated platforms that address transparency, compliance verification, and claims adjudication challenges
• Discover insights from manufacturers and covered entities implementing these technologies, including integration challenges, data management approaches, and strategies for accurate discount administration
• Evaluate methodologies for identifying eligible claims, preventing duplicate discounts, and implementing rebate models, with practical insights on system selection and ROI metrics for senior leadership
• Investigate implementation considerations across different organizational sizes, including technology selection criteria, timelines, and resource requirements for effective system deployment

• Review of recent OIG investigations, audit findings, and enforcement actions related to government pricing programs, with focus on upcoming enforcement priorities.

• Understand the complex regulatory landscape for products paid like drugs but regulated as devices
• Address recent enforcement actions and compliance expectations for ASP reporting of skin substitutes and similar products
• Develop effective approaches for classifying products and ensuring accurate reporting
• Explore potential policy changes affecting ASP reporting requirements under the new administration