Agenda for Day 3 - Wednesday October 7, 2026Wednesday, 7 October 2026

A keynote panel featuring industry leaders discussing the latest major legal and regulatory changes impacting the pharmaceutical sector.

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.

This session explores the evolving dynamics of government pharmaceutical pricing and contracting, highlighting key regulatory shifts and emerging strategies for navigating compliance challenges.

This session will provide updates on the recent status of the rebate model pilot program #2, contract pharmacy / in-house pharmacy policies, patient definition, plus other activities occurring in the market. With the movement to collecting all 340B claims data getting all the headlines, what is often not discussed is that manufacturers don't have access to the claims and the operational barriers they face in using the 340B claims. We will explain why this is occurring and explore how manufacturers are moving past this to better identify and manage 340B duplicate discounts disputes but also to have the claims in one system of record for broader G2N, cross-channel analytics, and AI enablement.

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

• Streamline workflows across Government Pricing, Finance, and Treasury to manage the dual complexities of Maximum Fair Price (MFP) implementation and the first invoicing cycles for Part B and Part D inflation rebates

• Develop robust, audit-ready protocols to verify CMS inflation rebate calculations, address system integration challenges, and manage compressed appeals timelines to mitigate overpayment risks

• Redesign lifecycle pricing models to balance domestic price increases against inflation-penalty thresholds while safeguarding ASP, Medicaid Best Price, and commercial discounting strategies in an MFP-capped market

• Implement technical safeguards across 340B, Medicaid, and MFP, ensuring compliance with 2026 regulatory guidance and accurate financial reporting

• Assess the enterprise-wide impact of 340B dynamics, focusing on cross-functional operations across legal, compliance, finance, and market access

• Highlight effective program management strategies, including center of excellence models for streamlined oversight

• Explore risk mitigation approaches, tailored to product archetypes and stages in the product channel, with a focus on balancing patient access and liability

• Discuss key considerations for product launches, including compliance, rebate models, and engagement with covered entities

• Prepare for the 100% tariff on imported patented drugs and APIs starting July 31, 2026, with options for reduced rates through U.S. manufacturing commitments

• Comply with "Buy America" rules requiring 55% U.S.-sourced components for federally funded projects by October 1, 2026

• Leverage reduced tariffs for allies and temporary exemptions for India-origin generics through 2028

• Ensure compliance with enhanced Country of Origin certifications and documentation to maintain eligibility for federal contracts

• Address supply chain challenges by integrating onshoring incentives, managing tariffs, and mitigating shortages