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Pre-Conference Workshop & Main Conference
June 24, 2026
Lunch Break
Co-Chairs Opening Remarks
Holistic Review of Major US Policy Developments and Their Impact on Drug Prices
Merle M. DeLancey Jr.Partner, Government ContractsBlank Rome LLP
James W. KimShareholderPolsinelli
Christopher WeiserAssociate General Counsel, Value & Access and PricingTeva Pharmaceuticals
Preeya Noronha PintoPartnerDLA Piper LLP
Thomas BarkerPartnerFoley Hoag LLP
A solid grasp of government payor programs is essential for manufacturers navigating VA FSS pricing and contracting. This session will break down two major federal drug pricing programs, Medicare and Medicaid, explaining how they interact with VA pricing. Key discussion points include:
- Reviewing the Medicaid Drug Rebate Program (MDRP), including Average Manufacturer Price (AMP), Best Price (BP), and Unit Rebate Amount (URA)
- Examining how changes in Medicaid rebate calculations may affect VA FSS pricing and Non-FAMP
- Differentiating between Medicare Part B (Average Sales Price (ASP)-based reimbursement) and Part D (private plan negotiations)
- Exploring how Medicare’s payment structures affect pricing strategies
- Defining how federal purchasing programs interact with Medicare and Medicaid pricing policies
Break
Joy E. SturmPartner, Global RegulatoryHogan Lovells LLP
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Overview of key sourcing rules: DFARS, Buy American Act, and Trade Agreements Act
- Country-of-origin determinations and certification requirements
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Understanding the substantial transformation test and the role of country-of-origin labelling
- Establishing product traceability for BAA component percentages, TAA substantial transformation, and DFARS origin certifications
- Appreciating the risks of non-compliance
- Lessons learned from recent court cases, including the U.S. Court of Appeals for the Federal Circuit decision in Acetris Health, LLC v. United States (No. 18-433C) and the U.S. Court of Federal Claims decision in Cosette Pharmaceuticals, Inc. v. United States (No. 25-cv-279)
Break
Michelle Scheid MeyerDirector of Government PricingRiparian LLC
Once manufacturers understand how government drug pricing programs and external factors interact with pricing strategies with VA FSS, the next step is mastering Non-FAMP and FCP calculations. Using practical examples, speakers will guide participants through best practices for:
- Discovering the formula for Non-FAMP and FCP calculations under VHCA Section 603
- When must these calculations be reported to the VA?
- Applying the correct formula for calculating FCP and Non-FAMP
- Understanding how MFC interacts with FCP and Non-FAMP calculations
- Establishing best practices for sourcing and managing pricing data
- Identifying which transactions and price concessions must be included in Non-FAMP calculations
- Addressing data gaps and ensuring accuracy in reporting
- Navigating complexities and anomalies in Non-FAMP calculations
- Handling “smoothing” methodologies and outliers
- Rules for new and transferred products
- Examining Dear Manufacturer Letters for insights on VA’s evolving interpretation of Non-FAMP calculations
Break
Ted Karnezis, RPh, BSPharmPrincipal OwnerKarnezis Consulting LLC
All entities wishing to do business with the federal government need to register in the System for Award Management (SAM). Topics of discussion include:
- Overview of new and changing requirements through SAM
- Forecasting timelines for registrations and renewals and how to prepare
- Assessing what information and documentation is required for SAM certification
- What’s required for domestic and foreign entities
- Practical examples of pitfalls that could be detrimental and how to avoid discrepancies
- FAR registration process and how it translates to SAM certification
Day One Adjourns
Main Conference & Post-Conference Workshop
June 25, 2026
Christopher WeiserAssociate General Counsel, Value & Access and PricingTeva Pharmaceuticals
Robert CuvalaRetired Senior Contract SpecialistDepartment of Veterans Affairs, FSS
For manufacturers moving forward with an FSS submission, pricing strategy is the decision that will shape compliance risk, operational complexity, and long-term commercial flexibility. This session centers on single vs. dual pricing, while highlighting the critical early considerations that must align with that choice.
- Determining whether a single or dual pricing model best aligns with portfolio strategy, customer mix, and risk tolerance
- Analyzing the regulatory and commercial implications of each model, including impacts on Best Price and “fair and reasonable” pricing
- Evaluating agency eligibility, Class of Trade considerations, and how each pricing approach applies across the Big Four
- Navigating transition pathways between single and dual pricing models, including timing, recalculations, and compliance triggers
Break
Jennifer Martin, PharmD, BCPPConsultantRemund Group LLCFormer VA Deputy Chief Consultant of Pharmacy Benefits Management Services
Jay Peloquin, PharmDSenior ConsultantRemund Group, LLC
Having a VA FSS contract does not automatically place you on the formularies of programs used by the Big Four agencies. In this session, topics of discussion will include:
TRICARE:
- Assessing the key elements of the TRICARE pharmacy benefit
- Navigating DoD Uniform Formulary policies and procedures
- Mapping the logistical steps and documentation needed for successful participation in drug class reviews
- Analyzing how pharmaceutical companies respond to requests for quotations (RFQs) for drug class reviews and newly approved drugs
- Identifying opportunities to strengthen product positioning and maximize federal market sales potential
VANF:
- Assessing the requirements to appear on VA’s national formulary
- Analyzing how pharmaceutical companies communicate clinical and economic information to attain inclusion on the VANF
Break
Stephen ForsterPartnerJones Day
Allan A. ThoenDirector & Associate General CounselSandoz Inc.
In this session, speakers will review the key aspects of the 340B program and then analyze the latest developments and what they mean for your contracts and pricing methodologies. Topics of discussion include:
- Diving into the key components of the 340B program
- Explaining the historical pathway that led stakeholders toward the rebate model and why this shift emerged
- Analyzing the evolution of contract pharmacies, limits to access, and new state legislation
- Highlighting key compliance and disclosure obligations
- Assessing the most recent developments related to the rebate model, including the proposed RFI and anticipated litigation that may shape future pricing and operational strategies
Break
Greg MaddenManaging Member, Former Chief of Contracting, VA NACOrlaithe Consulting LLC
Dan ShearerConsultant, Self-EmployedFormer Director, VA Medical Federal Supply Schedules
This session will provide a comprehensive look at “Big Four” compliance and provide guidance on how to build a best-in-class compliance program to fulfil those obligations and mitigate risk. Key topics of discussion include:
- Overview of annual and quarterly reporting requirements
- Tips on how to approach internal communication and coordination
- Developing policies and processes to minimize non-compliance
- Efficiently conducting self-audits to ensure compliance
- Establishing best practices for modifications (product addition and removal)
- Securing the renewal of the contract
Lunch Break
T. Reed StephensPartner, Co-Chair, Health Care and Life Sciences Industry GroupWinston & Strawn LLP
Merle M. DeLancey Jr.Partner, Government ContractsBlank Rome LLP
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Examining the audit process in relation to FSS contracting
- What does the VA OIG look for during the audit process?
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Understanding the scope of the audit – FCP applicable to VA and DoD
- Confidential Customer Contract
- Pre-award vs. Post-award Audits
- Preparing for and explaining Price Adjustments (Defective Pricing), Price Reductions, and tracking Customer Price and Ratio
- Developing methods for preparing voluntary disclosures
- Understanding when and why actions such as refusing a VA request for information can result in penalties
- Unpacking the penalties that can be levied for non-compliance
Eric CrusiusPartnerHunton Andrews Kurth LLP
Allison K. GiddensPresident of OperationsWin-Tech, Inc.
- Overview of U.S. regulatory cybersecurity trends, including government-wide cybersecurity initiatives
- Understanding the scope and requirements from the Defense Federal Acquisition Regulation Supplement (DFARS) and the DoD’s Cybersecurity Maturity Model Certification (CMMC)
- Navigating the cybersecurity standards and obligations per VA Directive 6500 (applicable when a contractor has VA information or provides IT-related goods and services)
- Complying with Section 899 of the National Defense Authorization Act
- Developing a robust cybersecurity program with key safeguards and compliance checkpoints