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.

Join CMS and other industry leaders who have significant health care public service experience as they discuss the major legal and policy announcements made by CMS under the Trump Administration on drug pricing. The panel will also discuss how public service has shaped their industry careers and how it impacts their advocacy approach with government agencies like CMS.

The concept of a 340B Rebate Model is somewhat new to the industry as a whole so in this session we will discuss how the industry got here, an overview of the 340B Rebate Model Pilot Program and its requirements, and manufacturer considerations for both those that can participate and those who (for now) cannot participate in the pilot program.

• Overview of the regulatory backdrop and market dynamics driving FMV requirements
• Key process challenges including cross-functional ownership, data / documentation inconsistencies, and evolving engagement models
• Common approaches to FMV governance, internal rate-setting vs. external benchmarks, determination of approach (e.g., Cost vs. Market), and the role of technology in workflow and audit readiness
• Best practices for FMV processes to optimize contract authoring, enhance transparency and reduce risk
• Lessons from real-world implementations including strategies to centralize data / models to a single source of truth for all rate-related information and access to historical assessments
• Key takeaways for manufacturers to be operationally efficient and audit ready

• 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