Day Two - ET (Eastern Time, GMT-05:00)
Day Two - ET (Eastern Time, GMT-05:00)
- Funso Olufade, PhD, MBA - Sr. Director – Head, Commercial Finance, Ascendis Pharma
An out of the box forecast of upcoming regulations, litigation and policies affecting the healthcare industry in what is set to be an action-packed election year.
- Wendell Potter - President, Center for Health and Democracy, Publisher, HEALTH CARE un-covered
- Vital confluence of commercial and GP responsibilities when it comes to trickle down of every choice, the regulatory landscape, price protection, calculations and contracting
- How pricing committees can support GP on the business side with accruals, profitability and how commercial activities can set best price
- Value of commercial and GP and affairs folks linking efforts, bridging communication and collaborations
- Fostering a holistic workflow conversation, facilitating connections and building process
- Payer mix and life cycle management
- Managed care contracts, duplicate discounts, SPTR, assessing legal and financial risks equitably
- Rujul Desai - Partner, Covington & Burling LLP
- Judd Caufield - Lead Counsel, Oncology Business Unit, Takeda Pharmaceuticals International Co.
- Erin Mistry - Executive Vice President and Chief Commercial Officer, Cormedix, Inc
- Matthew Dean - Executive Director, US Value, Access, Pricing & Policy Strategy, Mirati Therapeutics
Best price stacking has been causing great noise in the industry, let’s contextualize this movement and how to optimize your unified response:
- What is stacking and the history?
- How are companies generally addressing it?
- What are the implications and possible downstream effects?
- Impact on contracting roles and decisions: customer and contract level stacking
- Jeff Baab - Vice President, Operational Consulting, IntegriChain
- Pillars of a 340B Center of Excellence – Review key pillars/components of a 340B Center of Excellence (COE) and what would be included in each
- 340B Operational Excellence – Explore how establishing a 340B COE can manage all 340B initiatives including how to streamline current and future 340B operations associated contract pharmacy, patient definition, duplicate discounts, 340B eligibility, etc. This will include ways to make historically multi-stakeholder and inconsistent and disjointed approaches more efficient and effective and what an overall governance and operating model would look like
- Business Approach to 340B Operations – Explore ways to improve 340B operations so you can begin to manage it like a business including how business and financial reporting and investigation can begin to inform overall 340B strategy
- Clay Willis - Director, BRG
- State litigation involving 340B contract pharmacy policies
- Implications of the Genesis case and the IRA on 340B identification
- Updates on 340B sales to contract pharmacy court rulings
- Review of the history of regulatory updates, lawsuits that informed policies and what is in the pipeline
- Analysis of state laws limiting manufacturer contract pharmacy policies
- William Sarraille - Regulatory Consultant, .
Systemic challenges that face all stakeholders in the 340B Drug Pricing Program today
Evolving trends set to intensify revenue leakage due to noncompliant drug discounts
Past, present, and future impact of 340B modifier usage
Critical considerations and responsibility for stakeholders involved in 340B management
- Gavin Magaha, PharmD, MS - Senior Director Value Delivery, Kalderos
Manufacturers often need to refund 340B covered entities for product overcharges, and covered entities often need to refund manufacturers when they have received incorrect 340B discounts. Hear directly from representatives of manufacturers and a covered entity in this panel led by the 340B Prime Vendor, Apexus.
• Define the guidelines for refunds in the 340B Drug Pricing Program.
• Identify the potential reasons necessitating both manufacturer and covered entities to conduct refunds.
• Discuss leading practices, considerations, and potential obstacles in the refund process for both manufacturers and covered entities.
• Examine perspectives on good-faith inquiries when potential discrepancies are discovered.
- Cathy Gilgore - Associate Principal, Manufacturer Refund Service, Apexus
- Katy Lees, BS, 340B ACE - Policy and Business Strategy, University of Rochester Medical Center
- Kaelyn Buck - Senior Director, Regeneron Pharmaceuticals
- Jennifer Lospinoso - Managing Director & Consulting Lead, Riparian
In the spring with IRA drugs identified and the AMP Cap removal states are looking at drugs and seeing generics being made preferred where they haven’t in the past:
- How can manufacturers validate preferred drug lists?
- How are states preparing?
- How are manufacturers preparing?
- Josef Magpantay - Director, RSM US LLP
- Pressure on price gouging via legislation and excessive price lowering
- Overall economics that affected the viability of emerging biotech companies
- Election year – bipartisan effort to make drug pricing top of list
- Potential causes of drug shortages and policy views on how to address it
- Mallory O’Connor - Executive Director, Mallinckrodt Pharmaceuticals
The industry needs to be fully serialized by November 2024 with the ability to track each and every vial of product. Explore new technology that tracks shipment and use (and reuse) of product.
How are manufacturers planning to meet the expectations and obligations of serialization?
Product protection and response to diversion
The history driving counterfeit concerns
Welcoming manufacturers who have established bots and newcomers to bots who are looking for ideas and inspiration from what peers are utilizing bots for:
- What are we currently using bots for?
- What do we dream/forecast bots doing in the future?
- Training AI to be a value add
- Are there solutions in this arena that have provided relief?
- Glenn Jory - Director, Government Pricing & Reporting, Dermavant Sciences, Inc
GP is a gold mine of data with everything funneling into it:
- How to better leverage data in GP for your financial and commercial analytics
- How to look at sales trends, make customer decisions, etc.
- Katie Lapins Trujillo - Executive Director, The Pricing Group
- Sarah Schumacher - Senior Director, Financial Planning and Analysis, Upsher-Smith
Hear about a myriad of technologies and platforms and the pros and cons to consider when deciding whether to own/install/maintain vs. outsource and be a user
- Daniel Choi, PMI-PMP, ACP - Sr. Manager - Technology & Advanced Data Analytics, Riparian.com
- Michael Murphy - Associate Manager, Riparian
- Roneil Narciso - Director Strategic Pricing & Contracting, AVEO Oncology
- Expert forecasting and review of the IRA effect on DPT and SPTR
- State level legislations coming down the pipeline – litigation on state level taking precedent over federal
- State allowances for contract pharmacies and 340B entities
- Tactical questions for SPTR – Breakdown of where the states are going
- 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)
- Uptick in PDAB purpose, actions and creation
- Review Colorado and Oregon
- How were products selected?
- Engaging with PDABs and protecting proprietary and sensitive information
- Potential impacts of the IRA on setting upper payment limits and 2025
- Mallory O’Connor - Executive Director, Mallinckrodt Pharmaceuticals
- Lila Cummings - Prescription Drug Affordability Director, State of Colorado
- Kate Davidson - Manager of Insurance Data Science, State of Colorado
As states continue to implement enforcement procedures in their drug pricing transparency laws and pursue enforcement actions for noncompliance, manufacturers face ongoing practical issues. These issues include the risk analysis involved in untimely reporting, responding to information requests and investigations, and negotiating penalties. This presentation will cover these issues as well as:
• A survey of states’ primary approaches in enforcement
• Case studies and practical tips
• What to expect from states going forward in their enforcement policies and practices
- Sophia Gaulkin - Food & Drug Law Associate, Hyman, Phelps & McNamara
- How to navigate and combat sharing trade secrets and proprietary information yet comply with your obligations to the state
- How to designate trade secrets and flag issues
- State confidentiality restrictions and intentions
- Reviewing valuable takeaways from litigation
- Grant Ostlund - Associate Director, Ethics and Compliance, Novo Nordisk
- Amie Phillips Pablo - Director, Ethics and Compliance, Novo Nordisk
- Pros and cons of combining these concepts to streamline responses and obligations
- Logistics to consider when attempting to share vendor support on each
- Felecia Manning - Senior Director, Managed Markets Pricing & Government Programs, United Therapeutics Corporation
- Nick Olivares - Controller, Lundbeck
- What is the current landscape and what is upcoming?
- Policy updates that will affect contracting operations
- Strategic approach to navigate upcoming movement in the industry
- Rodney Emerson - Vice President, Pricing & Contracts, Sandoz
- Join a workshop to discuss the latest government updates from OIG, IRS and others
- Discuss best practices and alternative options for documentation
- Review Department of Justice and court perspectives on FMV
- Meena Datta - Partner, Sidley Austin LLP
- Trevor Wear - Partner, Sidley Austin LLP
How trade contracts affect the rest of the contracting channel
Fees, transfers, and chargeback policies
- Jennifer Katona - Partner, Client Services, Woven Data
- Mike Dinneen - Senior Director, Pricing and Contracting, BioXcel Therapeutics
- Data maintenance for 340b chargebacks
- Improvements for contract rebate management
- Leveraging automation for efficient forecasting and analysis
- Preventing revenue leakage with data insight
- In-house vs. Outsourced solutions
- Addressing current challenges- prior authorization, step edits, formulary
- Coverage gap discount program perspective
- Trade-offs between market access and rebates
- Collaborating with PBMs for accurate forecasting
- Carol Vuceta - Senior Director, Market Access, Pricing, Contracting, Azurity Pharmaceuticals
- Billing timelines and important updates surrounding date of effect
- Granular details on the updates in policy pertaining to chargebacks
- Katie Lapins Trujillo - Executive Director, The Pricing Group
- Megan Falkowski - Director, Government Pricing & Government Contracting Policy, Pfizer Inc
- Nancy Bell - Vice President, Head of US Patient Value & Access, Takeda Oncology
- Cayce Gallo - Group Leader, Chargeback Administration, Teva Pharmaceuticals
IRA implications that will impact operations
Data processing and forecasting systems
Patient access management
- Walt Worsham - Managing Director, Federal Compliance Solutions
- The current risks businesses face
- SOX and compliance considerations
- Revenue management systems implementation and utilization
- Cayce Gallo - Group Leader, Chargeback Administration, Teva Pharmaceuticals
- GPO membership maintenance
- Ensuring accuracy for chargeback claims
- Leveraging GPOs and impact on price
- Current state of fee structures
- Tracy Zheng - Market Access Operations Director, Exelixis
- Amanda Bounds - Director, Contract Administration, McKesson
- Julia Williams - Manager, Supplier, Buy-side relations/chargebacks, McKesson
- Sean Lawrence - Manager, Membership & Contract Validation, Teva Pharmaceuticals
- 340b chargebacks
- Rebate programs and discounts
- Medicare Part D- view for 2025
- Coupons and co-pays