Day One - EST/EDT (Eastern Daylight, GMT-4)
Day One - EST/EDT (Eastern Daylight, GMT-4)
- Donna White - Vice President, Contracts & Compliance Officer, Chiesi USA Inc.
- Review of current hot button state and federal issues
- 10,000 feet overview of all pressures impacting drug pricing simultaneously
- Understand payer perspectives and long-term reality of pricing motives
- Launch pricing legislation in 2025: Will IRA incentivize pharma back to a world of higher launch drug prices?
- Amp ceiling issues impact on pricing
- Joanne Chan - Senior Assistant General Counsel and Head of State Legal Affairs, Pharmaceutical Research and Manufacturers of America (PhRMA)
- John Murphy III - Chief Policy Officer, Biotechnology Innovation Organization (BIO)
- Enforcement trends: What’s on the horizon for copay, drug rebates, Medicaid, generic price fixing and triggers for investigation on prices
- Implication of recent legislation on strategy and operating in a new environment, where things are trending and the decisions coming down from courts
- Deciphering political direction and focus of pricing pressure
- Generics competing against brand drugs that have lost their patent life and the resulting changes in how those drugs are priced vs. the last five years
- Trickle down: Are newly launched authorized generics launching at a higher price?
- Paragraph 4 litigation on the horizon affecting pricing decisions
The commercial contracts space is ever evolving. Success in this industry requires manufacturers, wholesalers, trading partners, etc., to keep up with policy changes, regulations, and increasing competition. Join us in this session as we delve into the hot topics surrounding:
- Updates on current policies and reforms
- Examining current and future pricing initiatives
- Managing WAC changes
- And more!
- Rosalind Davis - Director, Government Pricing and Contracts, Vifor Pharma, Inc.
- Mallory O’Connor - Public Policy Executive Director, Mallinckrodt Pharmaceuticals
Join the panel of experts to discuss questions about the latest in drug pricing transparency requirements and gain practical tips for implementing the state requirements.
- How to interpret and plan out political impacts on pricing
- Benchmark on items of concern and stay vigilant
- Donna White - Vice President, Contracts & Compliance Officer, Chiesi USA Inc.
- Christopher Schott - Partner, Latham & Watkins
- Sophia Gaulkin - Food & Drug Law Associate, Hyman, Phelps & McNamara
- Sara Simon, JD - Compliance Associate, Porzio Life Sciences
As the 340B Program has grown exponentially over the last few years and due to lack of transparency and collaboration across the pharmaceutical supply chain (i.e wholesalers, Medicaid State Agencies, PBM(s), healthcare providers), it has become of utmost importance that Pharmaceutical Manufacturers adopt a data analytics enabled approach and have ongoing monitoring mechanisms in place to monitor 340B utilization at Covered Entities. This will help pharmaceutical manufacturers gain AI- enabled insights and facilitate data driven decision making to increase oversight over third parties and reduce revenue leakage.
- Mitesh Ghia - Director, Chargebacks, Membership, Rebates & Contract Administration, Novartis Pharmaceuticals Corporations
- Partnering with distributors and wholesalers to ensure overall customer success
- Overcoming terminology challenges
- GPO perspective — roster management, membership, and administration.
- MediLedger perspective – Updates on removing manual process
- Beth Stevens - Associate Director, Contracts & Pricing, TOLMAR Pharmaceuticals
- Maria Garcia Hay - Senior Analyst, Trade, Contracts & Operations, Regeneron Healthcare Solutions
- Elizabeth Johnson - President, National Association of Medication Access & Patient Advocacy
- Sean Lawrence - Associate Director, Chargebacks & Memberships, Teva Pharmaceutical
- MDRP Overview and Evolution
- AMP, 5iAMP, ASP and Best Price
- 340B Drug Discount Program
- NFAMP, FCP, FSS
- Coverage Gap Program
- Interactive Q&A
- Miree Lee, MS, MBA - Bio/Pharma Pricing, Contracts & Compliance Consultant, M.Lee Consulting LLC
- Josephine Hawkins - Associate Director, Medicaid, AstraZeneca
Review of active & pending SPTR Laws from the legal and operational perspectives including:
- Soup to Nuts requirements (where to go, what to do for new products etc.)
- Lessons learned and future outlook
- CA, Minnesota interpretations
- Guidance from States on what triggers and doesn’t trigger an alert
- Tennessee Care and the new waiver/changes/updates
- Examples of reasonable assumptions – difference in terms/definitions across different States
- John McGrory - Chief Executive Officer, ClassOne Insight
Deep dive into reporting requirements, pain points and how to best stay informed.
- Benchmarking industry status, experiences, and best practices
- Industry-wide reporting issues to keep in mind when creating reports
- Long term view forecasting coupled with contingences to adapt in any political shift
- High level review of state-by-state changes, regulation process and implementations
- Managing mergers and acquisitions with the states, and reporting for tele sales activities (e.g. NV and Miami-Dade, Oregon rep operationalization)
- CO WAC forms: How often are these being distributed and changes to implementation
- Walk through the process with mockup data in an excel module
- John McGrory - Chief Executive Officer, ClassOne Insight
In this session we will discuss the complexities in managing GPO, 340b, and individual hospital system contracts. It will specifically cover ways to streamline the management process, avoid mishandling contracts.
- Jennifer Crosswell - Director, Contracts & Pricing, Accounting, Azurity Pharmaceuticals
As wholesalers outsource their chargebacks processes, reconciling chargebacks gets challenging. Join industry experts as they discuss the best solutions for navigating recurring disputes, open payments, and working with suppliers that are not currently EDI compliant.
- How sufficient data is being pulled and segmented
- Applying robust data analytics and machine learning to pharma claims
- identifiying and preventing revenue leakage through data control
Rethinking EDI format with Blockchain. This session will go into depth on Blockchain and how it aims to improve accuracy within the chargebacks process.
Join this facilitated and interactive discussion with peers across industry to hear how their internal teams are set up and share strategies around efficiency and innovations, including the structure of resources for near term implementation of the IRA and long-term strategy, hiring to manage 340B and more. Topics will include:
- Current case studies on department set up/reviewing organizational structure
- Outsourcing pros and cons
- Challenges faced with current set up
- How is your company planning to structure resources and plan for the addition of the IRA responsibilities? Will this fall under Gov’t Rebates or Commercial Rebates? (panel)
- Strategies to identify and cultivate qualified and diverse talent for roles in this space (including analysts etc.)
- Erika Chiles-George - Head of Pricing, Contracting and Trade, Neurocrine Biosciences
- Susan Dunne - Senior Director, Riparian
- Lynn Buhl - Senior Director, Riparian
- Case study examples of Colorado and Ohio – setting upper limits for all pharma expenditures in their State agencies
- Review how States are approaching managing specialty drugs vs. Primary care drugs – how will it affect contracting, formulary, patients?
- Kathryn Chandra, MA - Senior Director, State Policy, Genentech, A Member of the Roche Group
- Ashley Bender Spirn - Senior Counsel, U.S. Pricing and Access, Gilead Sciences
- Review overall data sources
- What should manufacturers be aware of regarding accuracy of reports
- Felecia Manning - Director, Managed Markets Contracts & Government Pricing, United Therapeutics Corporation
Join this facilitated and interactive discussion with peers across industry to hear how their internal teams are set up and share strategies around efficiency and innovations, including the structure of resources for near term implementation of the IRA and long-term strategy, hiring to manage 340B and more. Topics will include:
- Current case studies on department set up/reviewing organizational structure
- Outsourcing pros and cons
- Challenges faced with current set up
- How is your company planning to structure resources and plan for the addition of the IRA responsibilities? Will this fall under Gov’t Rebates or Commercial Rebates? (panel)
- Strategies to identify and cultivate qualified and diverse talent for roles in this space (including analysts etc.)
- Erika Chiles-George - Head of Pricing, Contracting and Trade, Neurocrine Biosciences
- Lynn Buhl - Senior Director, Riparian
- Susan Dunne - Senior Director, Riparian
- State confidentiality restrictions and intentions
- PhRMA litigation on confidentiality: Reviewing valuable takeaways on the case and industry-wide impact
- Examples of best practices in protecting proprietary information
- Enforcement implications and what to expect from policy makers going forward
- Brian Savage - Vice President and General Counsel, US Antitrust & Commercial Litigation, Teva Pharmaceuticals
- Maria Lesny - Associate Director, Business Services, Model N
- Internal communication: Keeping the pricing committee and management informed of regulatory requirements to manage advanced reporting requirements
- Managing reporting prices and products in advance
- Coordination between pricing, regulatory, and legal teams to provide detailed pricing methodology replies to states that require it
- Overview of current pending state legislation
- Nancy Henshaw - Manager, Compliance Services, Porzio Life Sciences
- Sarah E. McClure - Senior Director, Revenue Management and Compliance Services, iContracts
Explore this gray area for manufacturers and gain a deeper understanding of the PDABs role and reach, estimated time until full implementation, the triggers and who the decision makers are.
- Engaging with PDABs and protecting proprietary and sensitive information
- What types of products will be most impacted?
- Expected state PDAB activity in 2023
- Potential impacts of the IRA on setting upper payment limits
- Sara Simon, JD - Compliance Associate, Porzio Life Sciences
- Andrew York, Pharm.D., J.D. - Executive Director, Maryland Prescription Drug Affordability Board
- Mallory O’Connor - Public Policy Executive Director, Mallinckrodt Pharmaceuticals
- Grant Ostlund - Associate Director, Ethics and Compliance, Novo Nordisk
- Melissa DeHonney - Assistant General Counsel, Market Access & Public Affairs, Novo Nordisk
- 25-minute blocks
- 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.
- Erika Chiles-George - Head of Pricing, Contracting and Trade, Neurocrine Biosciences
- Lynn Buhl - Senior Director, Riparian
- Susan Dunne - Senior Director, Riparian