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
- TRICARE
- Considering the interactions among the programs
- Understanding how participation in the Medicaid Drug Rebate Program impacts participation in the PHS 340B program
Speakers:
- 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.
