Day One - ET (Eastern Time, GMT-05:00)
- Miree Lee, MS, MBA - Bio/Pharma Pricing, Contracts & Compliance Consultant, M.Lee Consulting LLC
Review nuances of different types of reporting and laws, portal access, timing, organization, documentation, fines and fees, state registration, acquisition and take part in interactive Q&A. We will focus on:
- AMP, 5iAMP, ASP and Best Price
- 340B Drug Discount Program
- NFAMP, FCP, FSS
- Coverage Gap Program
- Ryan White invoices
- Miree Lee, MS, MBA - Bio/Pharma Pricing, Contracts & Compliance Consultant, M.Lee Consulting LLC
Deep dive into advanced topics related to your daily tasks and frustrations in your role:
- Breakdown of contract types and agreements
- Overview of contracting process and key stakeholders
- Basic pricing terminology and concepts (WAC, contract price, chargeback)
- Operational procedures for contract management
- Common chargeback errors
- Rosalind Davis - Director, Government Pricing and Contracts, CSL Vifor
- End-to-end transaction flow explanation
- WAC to chargeback to final net price walkthrough
- System validations and checkpoints
- Manual vs. automated processes across major distributors
- Contract price update checklist and validation points
Join this contextual session on the social and operational history of the Medicaid program which will cover:
- Government timeline of when/why Medicaid started
- Switchover to Rebates in 1991
- Growth over that decade with supplementals, SPAPs
- Extreme changes with the Affordable Care Act (MCOs, Medicaid Expansion, AMP definition change)
- How populations changed over time
- How COVID changed how we work
- Possible things on the horizon: work requirements, drug importation, prescription drug affordability boards, AMP Cap removal, etc
- Josephine Hawkins - Associate Director, Medicaid, AstraZeneca
Background, operationalizing finalized updates, potential pain points
- Nicolette Dione, PharmD - Drug Rebate Services Manager, Gainwell Technologies
- Nichole Palusinski Pharm.D - Clinical Pharmacist, Drug Rebate Unit, Bureau of Budget and Cash Management, IL HFS Medicaid Drug Rebate Unit
- Josephine Hawkins - Associate Director, Medicaid, AstraZeneca
Join this contextual session on the social and operational history of the Medicaid program which will cover:
- Government timeline of when/why Medicaid started
- Switchover to Rebates in 1991
- Growth over that decade with supplementals, SPAPs
- Extreme changes with the Affordable Care Act (MCOs, Medicaid Expansion, AMP definition change)
- How populations changed over time
- How COVID changed how we work
- Possible things on the horizon: work requirements, drug importation, prescription drug affordability boards, AMP Cap removal, etc.
- GPO roster management fundamentals
- Tools and processes for eligibility verification
- Managing mixed-use accounts and classifications
- 340B eligibility basics and compliance considerations
- Best practices for maintaining clean membership data
- Bob Steller - Industry Principal of Life Sciences, Vistex
- Beth Stevens - Director, Contracts & Pricing, Tolmar Inc.
- Setting up initial commercial infrastructure
- Basic wholesaler agreement components
- NDC setup through first commercial ship
- Key operational considerations for new products/companies
- Common pitfalls and how to avoid them
- Rosalind Davis - Director, Government Pricing and Contracts, CSL Vifor
Deep exploration of nuanced trade class determinations in gray areas and their cascading implications for government price reporting
- Overview covering clinical trial phases, FDA approval pathways (fast track, PDUFA), fees, and how commercial/pricing considerations influence drug development
*Voluntary contract options for generics
Join us for this deep dive workshop into the everchanging 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
Join your industry colleagues during this 80 minute, informal and interactive roundtable discussion on your greatest barriers and pain points to drive results back at your organization.
- Operationalizing the IRA and Part D redesign implications
- SPTR and PDAB requirements
- PBM vertical integration
- Exponential 340B growth
- Kaelyn Buck - Senior Director, Regeneron Pharmaceuticals
- Tom Evegan - Principal, Life Sciences Consulting Leader, RSM US LLP
20-minute blocks for Wholesalers and Manufacturers:
Who do you contact with questions for errors? Who do you contact when you need details on the process for filing this and that? Sign up your team to meet your contacts at some of the top wholesalers nationwide. These meet-and-greets are for connecting and learning the processes and needs for each stakeholder to work collaboratively together.
- Amanda Bounds - Director, Contract Administration, McKesson
- Julia Williams - Manager, Supplier, Buy-side relations/chargebacks, McKesson
- Stephanie Kupski - Director, U.S. Pricing & Government Reporting, CSL Behring
- Chris Weiser - Senior Corporate Counsel, US Market Access Legal, Sanofi
- Design cross-functional workflows integrating legal, pricing, regulatory and finance to maintain clear accountability for state reporting obligations
- Create comprehensive tracking systems for managing registrations, fees, reports and contacts
- Develop standardized processes for trade secret justifications and supporting documentation
Walk through a true to life experience navigating challenges around a non-price change trigger. Model out potential reporting impacts when considering product changes
- Amie Piddington - Compliance Specialist II, Chiesi
What factors do PDABs consider when evaluating drug value beyond cost? Explore how states assess clinical impact, patient outcomes, and market dynamics
- Walk through the complete process when a drug comes under PDAB review - from notification through assessment to decision-making
- Best practices for transparency and collaboration between manufacturers, PDABs and state agencies
- Andrew York, Pharm.D., J.D. - Executive Director, Maryland Prescription Drug Affordability Board
Examine how pricing decisions intersect with Medicaid, VA, and IRA regulations, and learn how to model the downstream financial effects to support more informed pricing strategies and better stakeholder alignment.
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.
- Josephine Hawkins - Associate Director, Medicaid, AstraZeneca
Who do you contact with questions for errors? Who do you contact when you need details on the process for filing this and that? Sign up your team to meet your contacts at some of the top wholesalers nationwide. These meet-and-greets are for connecting and learning the processes and needs for each stakeholder to work collaboratively together.
- Amanda Bounds - Director, Contract Administration, McKesson
- Julia Williams - Manager, Supplier, Buy-side relations/chargebacks, McKesson