Day One - ET (Eastern Time, GMT-05:00)
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
- Doan Finch - Director, Government Pricing & Contracting, Genmab
Deep dive into advanced topics related to your daily tasks and frustrations in your role:
- Why and how to best process rebates
- Drafting and maintaining reasonable assumptions
- Calculating and benchmarking bona fide service fees
- Potential pitfalls with best price
- Nichole Palusinski Pharm.D - Clinical Pharmacist, Drug Rebate Unit, Bureau of Budget and Cash Management, IL HFS Medicaid Drug Rebate Unit
- Chris Cobourn - Managing Director GP Practice Lead, Helio
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
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
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
- Federal contracting vehicles within FSS and DOD and ways you can contract with Federal entities to get broader utilization of your product
- Allison Pugsley - Partner, Hogan Lovells US LLP
- How to operate within the strict confines to best enter a contract
- How to start out with a robust board build
- How to document and come up with grants of authority
- Nick Olivares - Controller, Lundbeck
- Tara Brodo - Senior Director, Pricing and Contracting, Accord BioPharma
- A review and interactive discussion of the newest and most active state regulations on reporting fresh off the press
- What these updates might mean for the regulatory landscape and federal implications
- How to best implement at both an operational and strategic level
- Rachel Young - Senior Operations Counsel, Viatris
- David Savidge - Director of Accounts, G&M Health LCC
- Addressing evolving requirements with SOPs and documentation – how to pivot if needed and beginning implementation
- Perspectives of brand, biologics, devices, generic companies sharing hurdles across the industry
- Effectively gather all the information needed with company silos and communicate importance of timelines and failure to report fines
- Create tools for success in organization, documentation, and staying informed
- Operationalize new technology and build infrastructure around SOPs
- Work directly with states on clarification for language and properly document their responses
- Outsourcing based on size and resources
- Sharon Small - Director, Counsel Market Access, Government Pricing & Policy, Novartis
- Cathy Zhang - Director Government Reporting & Pricing Compliance, SK Life Science, Inc
- Sarah McClure - Vice President, Knowledge Management, RLDatix
- Nancy Henshaw - Regulatory Lead, RLDatix
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
- Susan Lowe - Senior Vice President, Supply Chain Operations, FFF Enterprises
- Julia Williams - Manager, Supplier, Buy-side relations/chargebacks, McKesson
Breakdown of contract types and agreements
Operational process and procedures for efficient contract management
Challenges and solution-oriented approaches to focus on per each agreement
- Stephanie Fussell - Senior Counsel, Commercial Operations, Bioventus
- Joan Rizal - Director, Commercial Counsel, Amneal Pharmaceuticals
- Rosalind Davis - Director, Government Pricing and Contracts, CSL Vifor
Join us for a live forum to benchmark on pain points related to Medicaid and Government Pricing and seek actionable solutions together. This session is a continuation of our May 2023 conversation What Would your Medicaid Wishlist Be?
- Retroactive invoices, the future of the program, automation, acquisitions, requirement management, etc.
- Josephine Hawkins - Associate Director, Medicaid, AstraZeneca
- Jorge Lopez - Associate Director, Government Pricing, Hikma
- James Kelly - Director, Medicaid, Novartis
With Part D already in full swing, do you have a game plan on how to deal with Part B and D?
- Odalys Caprisecca - Vice President, Managed Markets Finance, Novartis Pharmaceuticals Corporation
- Rey Cruz - Vistex Product Manager, Vistex
- Articulate internally how siloed decisions can impact overall pricing strategy
Governance pertaining to commercial activities and treatment of it in GP
Walk through scenarios in GP and commercial and formulate responses that take strategy and operationalization into account
- Philip Coburn - Director, U.S. Government Pricing Compliance, Pfizer, Inc
- Kathleen Dynan Black - Director Government Operations, Global Access & Value, US Market Access, Pfizer Inc
If you understand the foundations of GP, next you must be strategic in how to understand your obligations regarding anomalies, odd scenarios and exceptions to the rules:
Learn how to open your mind and think differently at the highest level
Walkthrough and share your odd scenarios and how to problem solve
- Jean Pathil - Director of Government Pricing, Sumitomo Pharma America
- Melody Hamel - Senior Life Sciences Counsel & Legal Business Partner, Viatris
- Illustrating strategy implications: What SPTR means for pricing launch strategy, contracting strategy, mature product pricing, etc.
- Modeling multiple price increases per year and multiple years of price increases per product
- Overcoming information overload when compiling and sharing ST output with pricing committees
- Using the ST output to schedule upcoming reporting responsibilities by time period and by brand
- Stephanie Kupski - Director, U.S. Pricing & Government Reporting, CSL Behring
- Sara Simon, JD - Counsel, Porzio, Bromberg and Newman
- Chris Weiser - Senior Corporate Counsel, US Market Access Legal, Sanofi
Interactive end to end walkthrough of 5 hypothetical products taking a price increase
- Amie Piddington - Compliance Specialist II, Chiesi
- Caitlyn Ozier - Counsel, King & Spalding 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
- Susan Lowe - Senior Vice President, Supply Chain Operations, FFF Enterprises
- Julia Williams - Manager, Supplier, Buy-side relations/chargebacks, McKesson
Contracting Nuances for Gene Therapy and Oncology
Creating valuable contract agreements in these spaces
Challenges that impact contract creation and manageability
CMS pricing
- Tom Dugan - Senior Director, Market Access, Biodesix
- Keri Cavanagh - Head of Contracts, Pricing, and Analytics, Takeda Oncology
Eliminating chargeback errors with real-time chargeback adjudication.
Pricing & customer eligibility alignment between trading partners.
Automating customer membership management.
Minimizing price discrepancies and misalignment.
Reducing revenue leakage and chargeback write offs
- Haris Kamal - Chief Revenue Officer, Chronicled
We live in a complex world of government pricing. How can you effectively manage it all? Join this session to discuss:
- Building a supportive business foundation
- Learnings from the 2003 OIG compliance guidance, enforcement actions and DOJ sentencing guidelines
- Importance of the intersection between commercial transactions and government pricing when building out your foundation
- Dissecting the seven elements of an effective compliance program and a dive into theoretical models
- Supporting pillars for your individual team members and government pricing certifiers
- Lynn Robson - Vice President, Associate General Counsel, Market Access, United Therapeutics
- Sharon Small - Director, Counsel Market Access, Government Pricing & Policy, Novartis
- Kristin Hicks - Partner, Arnold & Porter
- Clay Willis - Director, BRG
- Intersection of operationalizing the MFP and 340B to ensure program integrity
- Trickle down from IRA negotiations – the impacts of Part D re-design
- Understanding 340B Alternative Distribution Models by Hospitals and Other Entities and associated non-compliance
- State 340b Issues
- What’s happening with entities creating workarounds to manufacturer 340B contract pharmacy policies
- Odalys Caprisecca - Vice President, Managed Markets Finance, Novartis Pharmaceuticals Corporation
- Katie Verb, JD - Senior Director, Executive Branch Strategy, U.S. Policy & Government Affairs, Bristol Myers Squibb