Day TwoTuesday, 16 September 2025 - CT (Central Time)

• Evaluate the administration's approach to pharmaceutical imports, including tariff policies affecting products from China, India, and the EU, and their impact on cost structures and supply decisions
• Interpret "Made in America" requirements for Federal Supply Schedule (FSS) products and their implications for manufacturing, sourcing strategies, and government contracting
• Investigate the intersection of tariff policies with supply chain pressures, including shortage mitigation efforts, onshoring incentives, and manufacturing quality requirements
• Formulate effective approaches for navigating cross-border product movements, including customs classifications, country-of-origin determinations, and documentation requirements

Pharmaceutical manufacturers and third-parties (e.g., GoodRx) are increasingly adopting consumer-directed health care initiatives. These initiatives, which focus on giving patients enhanced choices and access to health care, may offer consumers “one stop” access to prescription drugs through cash-pay discount drug programs (that operate outside of insurance), telehealth prescribing, and/or online pharmacies. The market for these types of offerings is rapidly developing, presenting alternative channels to commercialize drugs, with a wide range of related legal considerations. This session will:

• Identify trends in consumer-directed health care initiatives, taking a detailed look at common structures
• Provide an overview of potential legal considerations and concerns
• Examine recent government scrutiny and enforcement actions
• Highlight key “watch outs” in implementing initiatives and options to mitigate risk

• Outline essential MFP requirements and implementation status, including practical approaches for meeting program guidelines and strategic considerations for compliance across different company sizes
• Guide manufacturers through September deadline preparations, covering documentation requirements, operational readiness assessments, and compliance verification processes

• Understand the specific considerations for physician-administered drugs entering Medicare negotiation in Round 3, including ASP reporting requirements and distinct operational challenges
• Assess the potential marketplace impacts of MFP on Part B drug reimbursement, formulary positioning, and future investment decisions for injectable and infused therapies
• Explore strategies for communicating with providers and health systems about Part B drug pricing changes and their potential effects on acquisition costs and administration fees
• Examine policy considerations and potential regulatory changes that may affect Part B drug pricing and reimbursement as IRA implementation evolves

This session explores the complex and evolving requirements of recalculations and effective executive management communication. Topics include potential recalculation drivers, current regulatory requirements across Medicaid, Medicare, VA and 340B programs, agency communications, materiality considerations, executive management information needs, mitigation planning strategies, and step-by-step recalculation approaches.

• Navigate evolving state transparency requirements while effectively safeguarding sensitive pricing information through proven trade secret protection strategies
• Understand current enforcement priorities and respond strategically to state inquiries based on recent case studies from Oregon, New York, and Colorado
• Develop cross-functional protocols to streamline reporting processes while maintaining consistency across multiple state submissions
• Implement practical approaches to engage constructively with state regulators while advocating for reasonable interpretations of disclosure requirements

• Review practical experiences from the first invoicing cycles for inflation rebates, including calculation methodologies, dispute resolution processes, and system integration challenges
• Develop effective approaches for evaluating inflation rebate invoices and managing the compressed timeframe for appeals and adjustments
• Inspect the complex interplay between price increase decisions, inflation rebates, and other pricing considerations in today's regulatory environment
• Explore innovative strategies for maintaining product lifecycle value while navigating the constraints of inflation penalties across Medicare and commercial markets
• Establish cross-functional workflows connecting government pricing, finance, and treasury functions to manage the evolving payment requirements across inflation rebates and MFP implementation
• Design system integration approaches that ensure accurate calculation, timely payment, and proper financial reporting in the new regulatory landscape

• Analyze early market signals regarding PBM and health plan treatment of MFP-negotiated products, including formulary positioning, prior authorization requirements, and utilization management strategies
• Develop commercial strategies that address the changing rebate dynamics for products subject to MFP, including approaches to maintaining competitive formulary positioning
• Understand the implications of IRA implementation on biosimilar and generic competition, including potential shifts in market entry timing and pricing strategies
• Explore the evolving landscape of patient affordability programs for products subject to MFP, including benefit design optimization and alternative access models