Agenda for Day 1 - Monday October 5th, 2026
Start your journey through the complex world of government contracting with this essential primer.
- Miree Lee, MS, MBA - Bio/Pharma Pricing, Contracts & Compliance Consultant, M.Lee Consulting LLC
Comprehensive examination of core Medicaid pricing methodologies, calculation requirements, and reporting obligations that form the foundation of government pricing compliance.
- Miree Lee, MS, MBA - Bio/Pharma Pricing, Contracts & Compliance Consultant, M.Lee Consulting LLC
Examine the mechanics of state rebate programs, including documentation standards and approaches to processing both standard and supplemental rebates across different state systems.
Dive deep into Advanced AMP calculation scenarios using real-world, blinded case studies
Explore the impact of 70/30 calculations on AMP and learn strategic modeling techniques
Interactive workshop featuring insights from industry experts and legal perspectives
Practical guidance for navigating complex manufacturer pricing calculations
- Doan Finch - Director, Government Pricing & Contracting, Genmab US Inc
Quantify 340B impact, optimize rebate compliance, mitigate reimbursement risks
Evaluate specialty pharmacy partnerships, analyze exclusive distribution models, optimize channel economics
Design adaptive pricing models, integrate medical claims data, enhance gross-to-net forecasting
- Annie Wong - Pricing and Contracting Senior Director, Celltrion USA
Join us for this deep dive workshop into the ever-changing active and pending SPTR laws from the legal and operational perspectives.
- Gregg Kasten - Vice President, Products and Services, ClassOne Insight
- Trevor Wear - Partner, Sidley Austin LLP
- Cathy Burton-Meza, MJ - Associate Director, Government Rebates, Gilead Sciences
- Lisa Norton - Associate Director, Contract Administration, Value and Access, Eli Lilly and Company
- Ariel Simon - Drug Rebate Coordinator, Montana Department of Public Health & Human Services
Targeted discussions between manufacturers and States to resolve rebates, reporting, and compliance questions.
• AK, AZ, AR, CA (ADAP), CO, CT (ADAP), CT (DSP), DC, GA, ID (ADAP), ID, LA, MD, MI, MT, MN, NE, NH, NY, NV, NV (ADAP), NC, PA, RI, SC, VA, WI (DSP)
Essential structure for understanding 340B program eligibility, covered entity requirements, manufacturer obligations, and the fundamental principles governing this complex discount program.
- Heath Ingram - Partner, Goodwin Procter LLP
- Michelle Drozd - Executive Director and Head, US Pricing Policy & Analytics, Gilead Sciences
This session provides practical guidance on preparing for, negotiating, and implementing your FSS contract with the VA, including insights on how contracting officers are interpreting the FAR overhaul implementation, the shift to 20-year contract options under mass modifications for 651b, and what's changing in FSS contracting practices
- Ted Karnezis, RPh - President/Owner, Karnezis Consulting
Regulatory updates from OIG, IRS, and DOJ on FMV
Best practices for documentation, governance, and rate-setting
Solutions for data inconsistencies, ownership challenges, and evolving models
Technology’s role in transparency, workflows, and audit readiness
Insights on centralizing FMV data and optimizing processes to reduce risk and enhance value
- Meena Datta - Partner, Sidley Austin LLP
- Trevor Wear - Partner, Sidley Austin LLP
- Harmonizing methodologies and GP assumptions for product acquisitions, divestitures and launches
- Government program participation strategies
- Practical insights and best practices from recent experiences
Navigate historical data requirements and reporting obligations in M&A scenarios
Manage state agency relationships during ownership transitions
Create processes for combining disparate reporting systems post-merger
Implement verification protocols for historical data accuracy
- Amina Khan - US State Price Transparency & Healthcare Strategy Director, BMS
Updates directly from the manufacturers, vendors and CMS folks working to improve the health ecosystem from all sides. This industry group is here to answer questions on what they do, how they do it and what they are currently working on. During this session, event organizers will compile a list of ideas on behalf of manufacturers to CMS for consideration in hopes for direct action taken by the insights of this session.
One-on-One State Meetings
Targeted discussions between manufacturers and States to resolve rebates, reporting, and compliance questions.
Overview of Medicare Part B program structure, ASP calculation basics, and reporting requirements critical for products administered in physician offices and outpatient settings.
- Haile Dagne - Director, Policy and Reimbursement, GSK
Introduction to Medicare's prescription drug benefit program structure, manufacturer obligations, and key calculations affecting covered medications for beneficiaries.
- Jessica Catalano - Senior Director, Government Pricing & Compliance, Teva
Operational considerations for new pharmaceutical companies
Break down the key agreements required for entry into programs like MDRP, 340B, VA FSS, and Medicare Part D
How to leverage technology to meet ongoing regulatory reporting requirements
Strategies for launching new drugs
Develop multi-channel market access strategies
- Erin Mistry - Payee Strategy Government Affairs Senior Vice President, CorMedix
- Lauren Nelson - Head of Market Access and Trade, Tris Pharma
Developing Your Initial Government Pricing and Reimbursement Model
Developing internal calculation frameworks
Tools for accurate government pricing assessment
- Lisa Clayton - Senior Director, Government Price Reporting, The Pricing Group, LLC
- Michael Peters, PharmD, MBA, BCPS, 340B ACE - 340B Compliance Director, Apexus
- Describe 340B Program requirements and elements of the pharmaceutical pricing agreement.
- Discuss the civil monetary penalty (CMP) final rule and ceiling price calculation.
- Understand the guidelines for manufacturer audits of covered entities and the dispute resolution process.
- Summarize results of recent HRSA audits of manufacturers
- Phu Nguyen, PharmD, 340B ACE - Pharmacy Executive II, Apexus
- Sanaz Kelly, PharmD, MBA, 340B ACE - Associate Principal, Manufacturer Refund Service, Apexus
- Outline covered entity eligibility and registration requirements.
- Discuss compliance cornerstones, including prevention of diversion and duplicate discounts.
- Explain different inventory management models and purchasing accounts used by covered entities to ensure 340B compliance.
- Identify contracting methodologies and the procurement activities related to 340B program requirements.
- Natalie Russell, PharmD, MSHA, MBA, BCPS, 340B ACE - 340B Compliance Director, Apexus
- Broderick Olson, PharmD, MBA, MS, BCPS, 340B ACE - Senior Director, Sourcing, Apexus
Targeted discussions between manufacturers and States to resolve rebates, reporting, and compliance questions.
Please sign up onsite at registration desk on October 5.
• Maryland • Montana
- Ariel Simon - Drug Rebate Coordinator, Montana Department of Public Health & Human Services
- Dorine Rascoe - Division Chief, Drug Rebates and Lockbox Services, Office of Finance, Medical Care Programs, Maryland Department of Health
- Dani Feist - Pharmacy and Drug Rebate Section Supervisor, Allied Health Services Bureau, Montana Department of Public Health & Human Services
One-on-One State Meetings
Targeted discussions between manufacturers and States to resolve rebates, reporting, and compliance questions.
• AK, AZ, AR, CA (ADAP), CO, CT (ADAP), CT (DSP), DC, GA, ID (ADAP), ID, LA, MD, MI, MT, MN, NE, NH, NY, NV, NV (ADAP), NC, PA, RI, SC, VA, WI (DSP)
Best practices for cross-functional pricing governance and decision
- Eddie Pinon - Senior Revenue Analyst, Chiesi
- Dana Zelig - Director, Market Access Operations,, Tris Pharma
- David Ryan - Senior Vice President, Legal & Chief Compliance Officer, Ardelyx
Basic framework for understanding the Inflation Reduction Act's pharmaceutical provisions and initial steps toward implementing compliant processes and systems.
Discussion of models of cross-functional collaboration and their successes/challenges
Practical ideas to improve collaboration and manage data more effectively
Considerations and concerns for navigating an AI-forward future
- Marlon Tang - Associate Director, Product Management, IT Business Applications (Market Access), Exelixis
- Tracy Zheng - Senior Market Access, Operations Director, Exelixis
Identify price adjustment triggers across therapeutic categories
Build scenario planning models for IP and market disruptions
Develop dynamic pricing strategies responsive to market conditions
- Scott Hoffman - Co-Founder & Head of Client Services, Woven Data
The impact of recent court decisions on contract pharmacy models and alternative distribution strategies
Emerging state legislative measures and strategies for navigating overlapping federal and state requirements
Key compliance considerations and methodologies for managing discount integrity amid evolving 340B and IRA guidance
- Jennifer Plitsch - Partner, Covington & Burling
Collaboration models to ensure program integrity and compliance
Stakeholder engagement strategies addressing hospital constraints
Practical approaches to mitigate program disruptions and maintain care continuity
Best practices for translating insights into actionable improvements
- Bibi Wishart, PharmD, MBA, DPLA - Director of Pharmacy, 340B Program, Atrium Health
- Richard Meyers - Director State & Federal Policy, BMS
Targeted discussions between manufacturers and States to resolve rebates, reporting, and compliance questions. Please sign up onsite at registration desk on October 5.
• Maryland • Montana
- Ariel Simon - Drug Rebate Coordinator, Montana Department of Public Health & Human Services
- Dani Feist - Pharmacy and Drug Rebate Section Supervisor, Allied Health Services Bureau, Montana Department of Public Health & Human Services
- Dorine Rascoe - Division Chief, Drug Rebates and Lockbox Services, Office of Finance, Medical Care Programs, Maryland Department of Health
One-on-One State Meetings
Targeted discussions between manufacturers and States to resolve rebates, reporting, and compliance questions.
• AK, AZ, AR, CA (ADAP), CO, CT (ADAP), CT (DSP), DC, GA, ID (ADAP), ID, LA, MD, MI, MT, MN, NE, NH, NY, NV, NV (ADAP), NC, PA, RI, SC, VA, WI (DSP)