Agenda for Day 3 - Wednesday October 7th, 2026
- Jennifer Plemmons Crosswell - Vice President, Government Pricing & Contract Operations, Accounting, Azurity
A keynote panel featuring industry leaders discussing the latest major legal and regulatory changes impacting the pharmaceutical sector.
- Kristie Gurley - Partner, Covington & Burling (former HHS Office of General Counsel, CMS Division)
- Maria Ghazal - CEO, Healthcare Leadership Council
- Rujul Desai - Senior Counselor to the Administrator, Centers for Medicare & Medicaid Services
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.
- Stephanie Trunk - Partner, ArentFox Schiff LLP
- John Shakow - Partner, King & Spalding LLP
This session explores the evolving dynamics of government pharmaceutical pricing and contracting, highlighting key regulatory shifts and emerging strategies for navigating compliance challenges.
- Kristin Hicks - Partner, Arnold & Porter
Delve into the strategic design of rebate models, focusing on how organizations can optimize financial outcomes while maintaining compliance
Examine operational challenges in implementing rebate models, including data management, contract negotiations, and payer engagement
Explore innovative rebate structures, such as value-based and outcomes-driven models, to address evolving market and payer demands
Discuss the intersection of rebate models with broader pricing strategies, ensuring alignment with programs like Medicaid and IRA without duplicating 340B-specific discussions
- Peter Avalos - Market Access Vice President, Geron Corp
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
Explore how DTP platforms and DTE contracts bypass traditional PBM frameworks to deliver value directly
Address compliance risks, including AKS, FCA, ERISA fiduciary standards, and new 2026 DOL rules
Evaluate the impact of cash-pay and fixed-price contracts on Medicaid Best Price and 340B pricing
Design workflows for telehealth prescribing and specialty medication carve-outs with seamless integration.
Leverage real-world evidence and transparent data to secure patient and employer buy-in
- Matthew Fornataro - Partner, Arnold & Porter
Explore bipartisan legislative efforts to shift PBM profits from percentage-based rebates to flat service fees, as proposed in the Modernizing and Ensuring PBM Accountability Act
Assess the potential impact of ongoing FTC investigations into PBM practices, including cost-sharing models tied to net prices rather than list prices.
Prepare for the growing trend of 100% rebate pass-through requirements in private contracts and state-level regulations
Develop systems to meet proposed federal reporting requirements and expanded audit rights, with significant penalties for non-compliance under pending legislation
Anticipate regulatory actions targeting formulary designs that favor high-list-price drugs, aligning strategies with evolving FTC policy priorities
Join senior pharma executives for interactive discussions bridging policy with business strategy. Limited to 40 participants.*
Policy & Regulatory:
Impact of PBM Reform/FTC Settlements (De-linking, etc.)
State Policy (PDABs, Pharmacy Restrictions)
IRA Negotiations
MFP Effectuation
340B Management
Federal Pricing Initiatives (MFN. GENEROUS, GLOBE, GUARD, BALANCE)
Direct-to-Patient (DTP)
Direct-to-Employer (DTE)
Gross-to-Net
Net Price Reduction and Impact to Distributors and Payer/PBMs
Enterprise Impact:
Field sales adaptation
Product lifecycle reassessment
Portfolio valuation shifts
Cross-functional alignment
M&A strategy evolution
Strategic Planning:
Policy-informed product valuation
R&D investment considerations
Regulatory-to-business translation
*Lunch will be provided to participants.
- Suzie Tam-Porter - VP, Channel & Contract Management, Genentech
Join senior pharma executives for interactive discussions bridging policy with business strategy. Limited to 40 participants.*
Policy & Regulatory:
- 340B litigation impacts
- PBM reform implications
- IRA implementation challenges
- State regulatory trends
- Drug shortage mitigation
- FSS "Made in America" requirements
Enterprise Impact:
- Field sales adaptation
- Product lifecycle reassessment
- Treasury cash flow management
- Portfolio valuation shifts
- Cross-functional alignment
- M&A strategy evolution
Strategic Planning:
- Policy-informed product valuation
- R&D investment considerations
- Regulatory-to-business translation
- Technology integration
- Treasury/BD/Regulatory collaboration
- GTN optimization strategies
*Lunch will be provided to participants.
- Suzie Tam-Porter - VP, Channel & Contract Management, Genentech
Review of recent OIG investigations, audit findings, and enforcement actions related to government pricing programs, with focus on upcoming enforcement priorities.
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
- Lorilyn Rosales Menzel - Senior Counsel, U.S. Market Access & Pricing, AbbVie
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