This session, featuring Lowenstein FDA Regulatory Chair James C. Shehan, will focus on the fundamentals of pharmaceutical pricing related to government payor programs and obtain an in-depth working knowledge of these programs which will lay the foundation for the more in-depth discussions that will take place throughout the main conference. Points of discussion will include:

  • Reviewing applicable legislation such as the IRA, MMA, DRA, ACA, and recently enacted IRA and key agency rules/guidance
  • Tracking the flow of payments and reimbursements in the health care supply chain
    • Identifying stakeholders within the chain and their roles
    • Tracking the flow of drugs, payments, and services
  • Deciphering commonly used acronyms and terminology
  • Surveying the different pricing benchmarks and calculations
    • AWP, WAC, AMP, BP, URA, ASP, PHS, non-FAMP, and FCP
  • Understanding the implications of different pricing methodologies, calculations, and benchmarks for different stakeholders
  • Examining the key pricing concepts and calculations for government drug pricing and rebate programs
    • Medicaid Drug Rebate program
    • Medicare Part B and D
    • 340B Drug Pricing program
    • Federal Supply Schedule/Federal Ceiling Price
  • Considering the interactions among the programs
  • Understanding how participation in the Medicaid Drug Rebate Program impacts participation in the PHS 340B program


  • James C. Shehan, Senior Counsel; Chair, FDA Regulatory, Lowenstein Sandler LLP
  • Joseph Metro, Partner, Reed Smith LLP

Time: 9 a.m. - 12:30 p.m. ET

Location: NYC Bar Association, New York, NY

*Disclaimer: This event is open to the public but requires a registration fee.