Agenda (Eastern Daylight Time)
Day 1
June 23, 2025
9:00 am
Workshop A – Drug Prices in Federal Programs and Big Four Building Blocks: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies
In Part I of this workshop, workshop facilitators will take you through the essentials of how prices of prescription drugs are determined through the key federal programs. Part II will focus on the essential building blocks of FSS contracting.
Part I: Overview of key federal programs and agencies
- Identifying the “Big Four” agencies: Veteran Affairs (VA), Department of Defense (DoD), Public Health Service (PHS) and the Coast Guard
- Examining the Federal Acquisition Regulation (FAR) and the Veterans Health Care Act of 1992 and their relation to government procurement and “Big Four” contracting
- Understanding the essentials of drug pricing under key federal programs:
- Medicare and Medicaid (including the 340B Program)
- DoD’s TRICARE program
- VA’s prime vendor program
- the Federal Supply Schedule (FSS) for pharmaceuticals program
Part II: Essentials of VA FSS contracting
- Understanding VA FSS contracts, statutory price controls, and market access considerations
- Comprehending the mechanics of FSS contracts and the associated timelines
- Completing the Commercial Sales Practices and its disclosures
- Examining non-FAMP and FCP calculations
- Entering into the Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA)
- Complying with ongoing contractor obligations
- Preparing for and navigating audits
11:30 am
Lunch Break
12:00 pm
Co-Chairs Opening Remarks
Big Four Year in Review: An In-Depth Analysis of Recent Critical Developments Impacting Rx Pharmaceutical Contracting with the Big Four Agencies
In this opening session, the conference Co-Chairs will provide a high-level overview of the industry impacts resulting from the policy changes enacted by the Trump Administration.
12:30 pm
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 and influence 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
- Reviewing the 340B program: covered entities, duplication discounts, and diversion concerns
- Exploring Medicaid’s relationship with the 340B program and the impact on pricing strategies
- 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:
- VA FSS pricing and statutory discounts (VHCA section 602)
- The significance of Non-FAMP and FCP in VA contracts
1:30 pm
Break
1:40 pm
Advanced Considerations: How the Private Market and the Inflation Reduction Act Relate to VA FSS Pricing
Broader policy and market forces—including new legislation, PBM negotiations, and private sector pricing trends—can have significant downstream effects on Non-FAMP and FCP. This session will explore how these evolving external factors influence VA pricing compliance, market access, and commercial strategy.
- Analyzing the impact of policy changes and legislation, including the Inflation Reduction Act (IRA), on pharmaceutical pricing
- How federal price negotiations under IRA affect brand lifecycles and market prices
- PBM market consolidation and vertical integration—implications for FSS pricing
- How PBM rebates and formulary positioning affect manufacturer discounts and Non-FAMP calculations
- How commercial rebate structures influence FSS pricing compliance
- Assessing the impact of tariffs and trade policies on manufacturer pricing strategies
- Understanding the ripple effect of private market dynamics on federal pricing compliance
- How commercial insurer negotiations impact federal pricing benchmarks
- The role of biosimilars, generics, and competitive pricing strategies in VA FSS pricing
2:30 pm
Once manufacturers understand how government drug pricing programs and external factors influence 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
- 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
- Reviewing Dear Manufacturer Letters for insights on VA’s evolving interpretation of Non-FAMP calculations
- Determining when and how the Price Reductions Clauses (PRC) apply to VA contracts
3:30 pm
Break
3:40 pm
Joining the VA FSS program requires strategic planning and a clear understanding of both your business goals and the regulatory requirements. The speakers will guide you through the key preliminary considerations for entering the FSS as well as best practices for preparing the necessary documentation for your Solicitation.
- Determining capacity and market access strategy considerations: what makes sense for your business and products?
- Understanding the difference between purchase-based vs utilization-based programs
- Exploring how Class of Trade (COT) affect eligibility for government pricing and contracting
- Preparing necessary documentation and compiling the Solicitation:
- CSP data and pricing details to demonstrate how your products are priced in commercial markets
- Most Favored Customer (MFC) disclosure, e.g., identifying your lowest commercial price and justifying discrepancies
- Demonstrating compliance with the Trade Agreements Act, FCP limits, contractor code of conduct, and industrial funding fee payments
- Developing best practices for negotiating with the VA to determine an appropriate federal price
4:40 pm
- 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
5:15 pm
5:30 pm
Day One Adjourns
Day 2
June 24, 2025
8:20 am
Co-Chairs Opening Remarks
8:30 am
- Understanding the reasons for implementing a single or dual pricing model: e.g., product portfolio, sales volume to non-Big Four, internal pricing infrastructure and compliance risk tolerance, etc
- Determining which of the agencies are eligible for each pricing model
- Exploring the requirements for transitioning between the two models and the calculations associated with this transition
- Determining the FCP’s effect on the expansion of the dual pricing model
- Analyzing the effects of single pricing and dual pricing on manufacturers and overall pricing, including Best Price implications
- Correctly incorporating FSS pricing into the FCP to achieve positive results
- Ensuring compliance with Price Reduction Clauses
9:30 am
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 requirements to appear on TRICARE’s formulary
- Determining which drugs will be listed on the formulary for TRICARE
- Exploring the negotiations which companies must partake in when attempting to reach the TRICARE formulary
- Approaching PBMs strategically
- Analyzing eligible retroactive rebates manufacturers may request
- What are the DoD requirements when responding to a manufacturers’ waiver requests?
- What is the waiting period for a waiver request?
- Applying TRICARE utilization to pricing calculations for different price types – non-FAMP, FCP, AMP, and BP
- Ensuring that the necessary calculations are being utilized for the different pricing groups
- Reviewing the challenges of accounting for TRICARE sales in your pricing calculations
- Accounting for price fluctuations that may occur during the period between time of sale and receipt of utilization data
VANF:
- Assessing the requirements to appear on the VA’s national formulary
- Exploring the negotiations which companies must partake in when attempting to reach the VA National Formulary
10:30 am
Morning Break
10:45 am
This session will provide a comprehensive look at “Big Four” contract deliverables and guidance on how to build a best-in-class compliance program to fulfils 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
- Post award most important FAR/GSAR/VAAR clauses from a compliance standpoint
- Price Adjustments (Defective Pricing)
- Price Reductions
- racking Customer Price and Ratio
- Preparing for other potential FSS compliance traps, e.g., industrial funding fee, economic price adjustments, Trade Agreements Act
- Establishing best practices for modifications (product addition and removal)
- Securing the renewal of the contract
11:45 am
- Examining the audit process in relation to FSS contracting
- What does the VA OIG look for during the audit process?
- Understanding the scope of the audit – FCP applicable to VA and DoD
- Confidential Customer Contract
- Pre-award vs. Post-award Audits
- Efficiently conducting self-audits to ensure compliance
- Developing methods for preparing voluntary disclosures
- Avoiding actions that can result in costly penalties
- Refusing a VA request for information
- Knowingly providing false information
- Reviewing the penalties levied for non-compliance
12:45 pm
Lunch Break
1:15 pm
- Examining core cybersecurity requirements flowing from the NIST SP 800-171
- Basic security controls
- Completing the self-assessment with Supplier Performance Risk System (SPRS)
- Examining the requirements from DoD’s Cybersecurity Maturity Model Certification
- Examining the cybersecurity requirements flowing from Section 889 Part B
- Developing a robust cybersecurity program
- Is dual authentication sufficient?
- What cyber risks do manufacturers need to be mindful of?
- Identifying best practices for drug manufacturers to mitigate cyber risks
1:45 pm
- Key 340B program amendments
- Orphan drug limitation
- ADR process and civil money penalties
- Exploring 340B program growth
- HRSA 340B program enforcement
- Examining the latest developments in 340B related litigation and the implications for manufacturers
2:30 pm
2:45 pm
Main Conference Concludes
2:50 pm
Workshop B – Federal Government Market Access Working Group: A Guide to Optimizing Revenue and Creating Federal-Specific Value to the Big Four Agencies
This post-conference workshop will explore what drug manufacturers can do to ensure Federal-specific value creation and optimize revenue by looking beyond statutory contracting and pricing into the full range of levers manufacturers can use to successfully launch products in Federal Agency Health Systems. Topics of discussion will include:
- Market Access Levers in the VA and DoD
- Identifying the nuances of contracting as an access lever
- Examining the scope of strategic tips for account optimization
- Measuring Business Opportunity
- Analyzing calculations for revenue potential
- What should you be mindful of for product success?
- Reviewing Points of Success in the Commercial Markets
- What spillover and leveraging points work?
- Developing a roadmap to Market Entry in Federal Health Systems
- Build a working guideline to prepare your product for market
- Outlining strategies for a successful launch
- Optimizing value by successfully marketing your VA contract
- Identifying sources of business e.g., VA Advantage!, FedBizOpps, the Defense Logistics Agency, Federal Procurement Data System – Next Generation (FPDS-MG) and more
- Additional purchasing programs such as Blanket Purchase Agreements or small business subcontracting opportunities
- Developing sales strategies to optimize the value of your contract
5:00 pm