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Expert Guidance: Your Definitive Resource for Medicaid Drug Rebate Program Insights
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Session Spotlights
Navigating the Intersection: 340B, IRA, MFP
- This live stream examines how 340B programs intersect with the Inflation Reduction Act and Medicare Fair Pricing.
- Learn optimization strategies for 340B pricing under IRA impacts, understand MFP reforms' effects on participation requirements, and discover compliance approaches across these overlapping policies.
- The session also addresses PBM formulary decisions in the MFP landscape and strategies to maintain patient access.
340B Program Evolution, Court Decisions, Compliance Implications and Policy Developments
- This session analyzes pharmaceutical import policies, including tariffs on products from China, India, and EU, and their cost impacts.
- Explore "Made in America" requirements for FSS products, tariff policies' intersection with supply chain challenges, and strategies for managing cross-border product movements.
- Track B addresses state-level pharmaceutical policy complexities.
IRA Implementation at the Crossroads: Strategic Decision Framework for 2026 and Beyond
- This session examines the IRA's transition from implementation to mature operations, exploring necessary adjustments for commercial planning and portfolio optimization.
- Learn how organizations are adapting beyond compliance, developing data-driven approaches for negotiations and contracting, and balancing short-term tactics with long-term strategy as the program expands to Part B drugs and additional therapeutic categories.
Recent OIG Evaluations Involving Prescription Drug Pricing, Payment, and Coverage
- This session examines recent OIG investigations, audit findings, and enforcement actions in government pricing programs, highlighting upcoming enforcement priorities and compliance implications for pharmaceutical manufacturers.
Key topics being explored at MDRP Summit
What are the key components of the Inflation Reduction Act (IRA) affecting pharmaceutical pricing?
The IRA introduces significant changes to drug pricing, including Medicare price negotiation authority, inflation rebate requirements, and redesign of Medicare Part D benefit. These provisions impact manufacturer pricing strategies, government price reporting, and overall market access approaches.
How are state Medicaid programs evolving their approaches to drug rebates?
States are implementing increasingly sophisticated approaches to maximize rebate collection, including enhanced data validation processes, supplemental rebate programs, and targeted auditing strategies. Many states are also exploring value-based arrangements within the constraints of current rebate regulations.
How are recent court decisions affecting 340B contract pharmacy arrangements?
Recent judicial rulings have created a complex landscape for 340B contract pharmacy relationships. Manufacturers must navigate varying interpretations of program requirements while maintaining compliance with HRSA guidance and addressing duplicate discount concerns.
How might upcoming legislative changes affect pharmaceutical pricing strategies?
Potential legislative developments could impact areas such as price transparency requirements, expansion of government negotiation authority, changes to Medicaid rebate calculations, and modifications to 340B program eligibility. Manufacturers should develop scenario planning for various potential outcomes.
What are the implications of recent CMS guidance on price reporting?
Recent guidance has clarified expectations around reasonable assumptions, documentation requirements, and methodologies for handling specific pricing scenarios. Manufacturers should ensure their processes align with these clarifications and update their policies accordingly.
What's new at MDRP this year?
The 2025 pharmaceutical landscape faces unprecedented challenges with policy shifts affecting pricing and compliance requirements. As Medicare negotiations expand and regulations tighten, manufacturers risk significant penalties for compliance failures. The MDRP Summit offers critical peer benchmarking, regulatory access, and strategic guidance to navigate this complex transformation period.
