Pharmaceutical Subcommittee Agenda and Updates - 2021 Focus
Explore the latest developments from the Pharmaceutical Subcommittee meeting, including updates on acquisition policies, domestic onshoring initiatives, and insights from key industry leaders. Stay informed on Federal Leadership Executive Orders and actions by the Biden Administration to boost U.S. production and strengthen American manufacturing capabilities.
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Presentation Transcript
Pharmaceutical Subcommittee February 2, 2021
Agenda 1. Welcome 2. Introduction to the 2021 Agenda I. The Transition II. Domestic Onshoring and Buy American III. DHA IV. VA V. Federal Agency Outreach VI. Education and Training 3. Member Feedback Slide 2
Healthcare Committee Medical/Surgical Pharmaceutical Subcommittee Subcommittee Slide 3
Our Focus Acquisition Policy Contract Programs Education Compliance Contract Management And More Slide 4
Pharmaceutical Subcommittee Co-chairs J Aime Conrod, Head of Government Accounts, Market Access & Pricing, UCB James Kim, Partner, McDermott Will & Emery Greg Madden, Managing Member, Orlaithe Consulting Stephen Ruscus, Partner, Morgan & Lewis Slide 5
The Transition Update members on acquisition policy developments and new Federal Leadership Executive Orders to date: Unified and Effective Response to Combat COVID-19 Sustainable Public Health Supply Chain Strengthening Buy American Provisions and Ensuring the Future of America is Made in America Regulatory Freeze Pending Review VA Leadership Secretary of Veterans Affairs Nominee, Denis McDonough Acting Principal Executive Director of OALC and Chief Acquisition Officer, Phil Christy Slide 6
Domestic Onshoring and Buy America Biden Administration actions thus far indicate continued focus on increasing U.S. production White House COVID-19 Plan proposes: Full use of the Defense Production Act to boost manufacturing of certain medical supplies to combat COVID-19 Boosting domestic supply (in general) in order to build a future, flexible American-sourced and manufactured capability EO on Ensuring the Future Is Made in All of America Increases domestic content thresholds and the price preferences for domestic products (versus foreign goods) Opportunity to implement domestic preference policies from Trump Administration (e.g., EO 13944) FY21 NDAA Section 713 Inclusion of Drugs, Biological Products, and Critical Medical Supplies in National Security Strategy Slide 7
Defense Health Agency Uniform Formulary Drug Utilization Report Request that DHA include State level Retail and TMOP data, along with MTF level data, in the UFDUR reports Communicate value to both Government and industry TRICARE Address issue of double-dipping with DHA and the current burden of compliance on manufacturers Recommend that the PBM obtain the information in order to ensure that DoD complies with its own regulations Slide 8
Department of Veterans Affairs Status of Temporary Suspension of Visits Policy and potential alternatives Updated Guidance on Covered Drug Classifications WAC reductions for generic drugs and the application of the PRC Reseller own-labeler issues and related VA policy Confirm the flow of the dollar of medical benefit drugs within the Community Care Network Slide 9
Federal Agency Outreach Continue outreach and engagement with: VA Pharmacy Benefits Management (PBM) VA National Acquisition Service DoD Pharmacy Operations Division DLA Troop Support Medical Extend outreach in 2021 to: Indian Health Service HHS ASPR Strategic National Stockpile Slide 10
Education and Training Proposed Topics: Strategic National Stockpile Contractor Obligations under the Defense Production Act (Part II) Buy American and Trade Agreements Act Domestic Onshoring Pricing Calculations under Federal Drug Pricing Programs Upcoming Virtual Events Coalition Spring Training Conference, May 2021 (TBD) Annual VA NAC Meeting, August 2021 (TBD) Slide 11
