Workshop A – “BIG FOUR” Building Blocks: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies

Jun 17, 2024 9:30am – 11:30 AM

Susan Dunne
Managing Director
Riparian LLC

Catherine Starks
Partner
Sidley Austin LLP

This pre-conference workshop will introduce attendees to the laws, regulations, and pricing methodologies utilized by the “Big Four” agencies as the basis for contract and formulary determinations. This is an essential course of study for new pharmaceutical pricing practitioners and is a comprehensive refresher on core concepts for the industry veteran.

  • Identifying the “Big Four” agencies: VA, DoD, PHS, and Coast Guard
  • Examining the Federal Acquisition Regulation (FAR) and its relation to government procurement and “Big Four” contracting
  • Exploring the Department of Veterans Affairs’ delegated authority in relation to FSS pharmaceutical contracts
  • Comprehending the mechanics of FSS contracts and the associated timelines
  • Understanding reporting requirements when contracting with the “Big Four” and compliance best practices
    • Completing CSP and related disclosure requirements
  • Identifying FSS eligible entities
  • Complying with FSS clauses regarding socioeconomic programs
  • Entering into the Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA)
  • Examining non-FAMP and FCP calculations
  • Exploring the Veterans Health Care Act of 1992
    • Introduction to Section 602 – pricing for Public Health Services Act (PHS) covered entities
    • Section 603 – authorization for the VA to negotiate drug prices
  • Examining terms which fall under each discount program
  • Analyzing the Federal Supply Schedule related to government contracting in the pharmaceutical space
  • Identifying key pricing terms related pricing within government pharmaceutical programs
    • Federal Ceiling Price (FCP)
    • Pharmacy benefits management programs (PBMs)
    • National formularies
    • VA National Formulary
    • DoD Uniform Formulary
  • Assessing the functions of the PHS 340B program and identifying qualified entities
    • Examining the discounts available under the 340B program
    • Determining methods to monitor HRSA data
    • Exploring the restrictions that exist for participating covered entities