Day Three - CT (Central Time)
Day Three - CT (Central Time)
- J'Amie Conrod, MSPH - Vice President, Government Business & Healthcare Policy, Amneal Pharmaceuticals
- Improving the math for holistic view on value and negotiation leverage with CMS and PDABs
- Revaluating modeling to avoid undercounting value in certain therapies and products based on quantifiable values
- Peter Rubin - Executive Director, No Patient Left Behind
Hear from an expert panel of attorneys as they each moderate a topic and interactive discussion among attendees, and themselves, on the most pressing issues facing MDRP and Government Pricing.
- Copay maximizers and accumulators
- Drug shortages and accommodations
- PBMs and FMV
- Tom Evegan - Principal, Strategy & Management Consulting, RSM US LLP
- Jeffrey Handwerker - Partner, Arnold & Porter LLP
- Margaux Hall - Partner, Ropes & Gray LLP
- Alice Valder Curran - Partner, Global Regulatory, Hogan Lovells
- John Shakow - Partner, King & Spalding
- Rujul Desai - Partner, Covington & Burling LLP
Hear from the Consulting, Legal and Industry perspectives discussing the complex and evolving requirements of recalculations, and how to keep executive management informed on requirements, options, and key decision points
The potential drivers of a recalculation
The evolution of regulatory requirements, and the regulations, requirements and best practices today
The varying approaches across Medicaid, Medicare, VA and 340B, and agency communications Exploring the topic of materiality
What executive management needs to know, and how to build a mitigation plan
The approach and steps of a recalculation
- Chris Cobourn - Managing Director GP Practice Lead, Helio
- William Sarraille - Regulatory Consultant, Sarraille & Associates
- Joe Skupen - GP Advisory Technical Lead, Helio GP Advisory Services
- Marijo Bustos - Head of Government Pricing & Reimbursements, UCB, Inc.
Hear from Medicare and payers on their perspective on this new program:
- Smoothing program – also being called the Medicare prescription payment program - is going to allow patients that opt into Medicare to pay monthly
- Process: Plans will pay upfront and collection in the back end
- Possible impact on industry stakeholders
- What manufacturers can do to prepare their patients
- Mallory O’Connor - Executive Director, Public Policy, Mallinckrodt Pharmaceuticals
- Chris Callahan - Associate Director, Riparian
The panel will discuss the supply, distribution, promotion and reimbursement of buy-and-bill drugs, including key risk areas such as pharmacy/medical benefit switches, coverage of service and administration fees, and reimbursement support for providers, including under the Anti-Kickback Statute and government price reporting laws.
- How to manage each individual state and retain accuracy of the data
- 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
- Elizabeth Lindquist - Partner, Arnold & Porter
- J'Amie Conrod, MSPH - Vice President, Government Business & Healthcare Policy, Amneal Pharmaceuticals
- Katheryne Richardson, PharmD - Vice President, Global Pricing and Health Systems Analytics, Bristol Myers Squibb
- Rosalind Davis - Director, Government Pricing and Contracts, CSL Vifor
- David Tawes - Regional Inspector General, Department of Health and Human Services, Office of Inspector General
- Michael Kvassay - Social Science Research Analyst, Office of Evaluation and Inspections, HHS Office of Inspector General
- What does the public health emergency coming to a head mean for enrollment?
- What does Medicaid expansion look like in the future? Potential solutions and how other key stakeholders are handling this seamlessly
- Medicaid data quality, forward-looking rate assumptions and lagged claims challenges
- Latest on government re-writing starting price for pharma
- State engagement on Medicaid/340B compliance and claim reconciliation
- What does Medicaid utilization look like post pandemic?
- The different process by each state for invoicing manufacturers – bulk vs. line item
- James Kelly - Director, Medicaid, Novartis Pharmaceuticals Corporation
Hear from gene therapy company on their huge innovation in high-cost gene therapy approvals in various states for value-based agreements and SRAs:
- How to decide if a VBA or SRA is right for your product
- Market access for your product
- Working with states to formalize and employ
- How to implement VBAs within MDRP
- Jeremy Allen - Head Vice President, Government Affairs, Spark Therapeutics