Day Three - ET (Eastern Time, GMT-05:00)
- Stephanie Fussell - Senior Counsel, Commercial Operations, Bioventus
How government policies seek to corral all of branded pharma into discount regimes that may break the American model.
- John Shakow - Partner, King & Spalding
- Product selection - what are the competitive effects and impact on overall market access
- Methodology on how manufacturers should prepare for IRA
- Impact on R&D and clinical opportunities
- Litigation status
- Medicaid proposed rule updates and implementation, 340B implications, stacking and disputes
- Biosimilars and industry innovation
- Changes to Medicare Part B and D, coverage gap, inflation penalties, negotiations
- Tom Evegan - Principal, Life Sciences Consulting Leader, RSM US LLP
- Margaux Hall - Partner, Ropes & Gray LLP
- Ken Choe - Health Partner, Hogan Lovells
- Meena Datta - Partner, Sidley Austin LLP
- Rujul Desai - Partner, Covington & Burling LLP
- Stephanie Trunk - Partner, ArentFox Schiff LLP
- Fallout of product selection for negotiation and insights on the process with CMS
- Accounting and accruing for negotiation, inflationary rebate and penalty
- How are you calculating and what tool are you doing it with
- Guidance on the inflation rebates
- Debjani Mukherjee - Senior Director, Regulatory Affairs, PCMA
- Rey Cruz - Vistex Product Manager, Vistex
- Current state of market and expected shifts
- Reinventing the pricing arrangements scheme
- Overview of the contract process-divestitures and acquisitions
- Lisa Clayton - Senior Director, Government Pricing and Reporting, The Pricing Group, LLC
- Sarah Schumacher - Senior Director, Financial Planning and Analysis, Upsher-Smith
- Compliance and alignment assurance for standard data assessment
- Building strong partnerships for customer success
- Jesse Mendelsohn - Senior Vice President, Model N
- Explore the potentially compounding effect of amp removal on stacking with examples
- What to think about to think about if you are buying drugs from other companies and it hits amp cap
- Limits to price increases you can take on your products
- How to manage lowering WAC
- Chris Weiser - Senior Corporate Counsel, US Market Access Legal, Sanofi
When Congress established Average Sales Prices (ASPs) as the basis for reimbursement for Medicare Part B drugs, it also provided a mechanism for monitoring market prices and limiting potentially excessive payment amounts. The Social Security Act mandates that OIG compare ASPs with AMPs. If OIG finds that the ASP for a drug exceeds the AMP by 5 percent, the Social Security Act directs the Secretary of Health and Human Services (HHS) to substitute the ASP-based payment amount with a lower calculated rate. This presentation will review the history of OIG’s mandated pricing comparisons with a particular emphasis on the role of AMP data in this process.
A brief history of OIG’s oversight work related to drug prices.
An overview of the OIG’s quarterly process to compare ASPs to AMPs
A better understanding of the role Average Manufacturer Price (AMP) data plays in OIG’s quarterly comparisons of drug pricing
- Tanaz Dutia - Team Leader and Rapid Response Technical Expert, Office of Inspector General
Hear from PhRMA on the interrelatedness of price controls such as the IRA, PDABs, and 340B, and their impact on company R&D and innovation
- James Stansel - Executive Vice President, General Counsel and Corporate Secretary, PhRMA
Review key items from the last few years of regulations and what is coming down the pipeline at the federal and state level. We will tackle how to best manage regulations with agreements in 2025.
- Christopher Schott - Partner, Latham & Watkins
- Lynn Robson - Vice President, Associate General Counsel, Market Access, United Therapeutics