Virtual Workshop — “Big Four” 101: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies

May 2020

Merle Delancey
Partner
Blank Rome LLP
(Washington, D.C.)

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review
(Jacksonville, NC)

Melodee Snoke-Bullock
Senior Auditor
Office of Inspector General/Contract Review, Department of Veterans Affairs (Washington, D.C.)

This pre-conference workshop will introduce attendees to the laws, regulations, and pricing methodologies utilized by the “Big Four” agencies in formulary determinations and securing contracts. Speakers will provide an overview to prepare you for the more in-depth discussions that will take place throughout the conference.

  • Identifying the “Big Four” agencies: VA, DoD, PHS, and Coast Guard
  • 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
  • Determining the mechanics of FSS contracts and the schedules associated with it
  • Examining reporting requirements when contracting with the “Big Four”
    • Accurately completing the CSP sheets and the related disclosure requirements
  • Examining the treaties by which GSA/FSS contracts are bound
  • Identifying FSS eligible entities
  • Complying with FSS clauses regarding socioeconomic programs
  • Entering into the Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA)
  • Introduction to the 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 under the Affordable Care Act
    • Examining the discounts available under the 340B program
    • Determining methods to monitor HRSA data
    • Exploring the restrictions that exist for participating covered entities
  • The relationship of OBRA to Medicaid rebate