Co-Chairs’ Opening Remarks

Felecia Manning
Director, Managed Markets Contracts and Government Pricing
United Therapeutics

Allison Pugsley
Partner
Hogan Lovells LLP

The Latest Trends and Developments for Manufacturers to Watch: The Future of Contracting with the Government

Margaux Hall
Partner
Ropes & Gray LLP (Washington, DC)

FSS Lifecycle Management: Strategies for Successfully Securing Contracts, and Extending Product Placement

Jeff Blake
Managing Partner
Federal Compliance LLC

James Phillips
Partner
Roeder, Cochran, Phillips, PLLC

This session will examine what to do prior to receiving a contract, what happens once the contract has been awarded, and the process to getting your contract successfully renewed.

Part I: Practical Examples Using Mock Products

• Implementing contracting fundamentals and meeting legal requirements when offering a contract proposal
• Developing guidelines for securing and maintaining contracting Information

Part II: Extended Product Placement Strategies

• Identifying the agencies entitled to make purchases off the FSS, and the pricing methodologies associated with each
• Consolidated Mail Outpatient Pharmacy System (CMOPS)
• Indian Health Services (IHS)
• Department of Defense (DoD)
• Assessing the reasons why government facilities may purchase a product from a PBM at a higher price than it is listed at on the FSS
• Putting strategies into place which will encourage purchases directly from the manufacturer
• Examining how the FSS price is connected to discount benchmarks
• Determining how both FSS fees schedule and FSS nation contracts impact the pricing of a product
• Analyzing the requirements when working with MCF pricing and the criteria associated with it
• Implementing clauses in pricing reductions to expand the opportunities of a product when working with FSS customers
• What initiates price reduction clauses
• What disclosures are required when working with the Basis of Award
• Methods to track changes to customer pricing requirements
• Determining the outcomes of refusal to comply with price reduction clauses
• Properly monitoring active buyers from government agencies

Break

How to Overcome Complex Pricing Challenges Under the VHCA Section 603: Non-FAMP, and FCP Calculations

Felecia Manning
Director, Managed Markets Contracts and Government Pricing
United Therapeutics

Joy Sturm
Partner
Hogan Lovells LLP

• Implementing the correct formula for calculating the FCP
• Examining how FCP affects discounts related to pharmaceutical pricing discounts within the “Big Four” agencies
• Determining the role of the Non-Federal Average Manufacturers Price (Non-FAMP) within the contracting process and ensuring the proper calculations
• Identifying the sources of data necessary to calculate the non-FAMP
• Best practices for data collection to ensure accurate calculations
• Analyzing the interplay between FCP and Non-FAMP
• Assessing additional discount adjustments based on calculations
• When must these calculations be reported to Veterans Affairs?
• What are the ways in which changes to Medicaid calculations can affect non-FAMP calculations?
• Assessing the role of the price reduction clause
• Exploring the abnormalities seen when calculating the non-FAMP, and their causes
• Preparing for irregularities when calculating prices
• Penny pricing
• “Smoothing” prices
• Notifying the VA of these irregularities
• Correctly calculating pricing while incorporating lagged price reductions
• Developing pricing calculations for new and transferred pharmaceuticals
• Maintaining compliance when communicating price reductions with wholesalers
• Securing sub-ceiling and non-ceiling sales related to the 340B program

Pharmaceutical Supply Chain, Domestic Sourcing, and the Future of Drugs under the TAA

Stephen E. Ruscus
Partner
Baker Hostetler

• Analyzing supply chain and domestic sourcing legislative and regulatory issues persisting post-pandemic
• Overview of proposed legislation and regulatory developments and the implications for manufacturers
• Defense Production Act and Essential Medicines issues
• Examining current TAA requirements for pharmaceuticals
• VA covered drug exception
• Where does the TAA show up in the FSS contract and related modifications

Conference Adjourns

Co-Chairs’ Opening Remarks

Felecia Manning
Director, Managed Markets Contracts and Government Pricing
United Therapeutics

Allison Pugsley
Partner
Hogan Lovells LLP

Special Focus on FSS Post Award Compliance and Audits

Merle DeLancey
Partner
Blank Rome LLP

Michael Grivnovics
Director, FSS, Contracts Division
VA Office of Inspector General

• Post award FAR/GSAR clauses and compliance
• Price Adjustments (Defective Pricing)
• Price Reductions
• Tracking Customer Price and Ratio
• Other potential FSS compliance traps
• Industrial Funding Fee
• Economic Price Adjustments
• Trade Agreements Act
• Modifications — Product Addition and Removal
• Potential penalties for non-compliance
• Key provisions of a compliance plan

Single and Dual Pricing in Practice: Pros, Cons, and Factors to Consider When Deciding Which Methodology to Use

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General, Office of Contract Review

Jennifer Plitsch
Partner
Covington & Burling LLP

• Understanding the reasons for implementing a single or dual pricing model
• Exploring the requirements for transitioning between the two models and the calculations associated with this transition
• Determining which of the agencies are eligible for each pricing model
• Analyzing the changes to agencies on a yearly that will affect each of these pricing models
• What are the considerations given during the first year of the contract?
• Utilizing the proper pricing methodology to ensure the correct model is being implemented
• Determining the FCP’s effect on the expansion of the dual pricing model
• Assessing the positives associated with each of the pricing strategies
• Best Price implications
• What are the effects of these models on overall pricing?
• What are the effects of single pricing and dual pricing on manufacturers?
• Comprehending how the FCP and the FSS affect one another
• Correctly incorporating FSS pricing into the FCP to achieve positive results
• Analyzing methods for price reduction

Break

System for Award Management: 5 Proactive Steps to Take to Streamline the Registration Process

Ted Karnezis
Owner
Karnezis Consulting

James Kim
Partner
Arnold & Porter LLP

• 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

Live Polling

Developing a Compliance Action Plan: Practical Guidance on How to Meet Federal Contract Obligations

Greg Madden
Managing Member
Orlaithe Consulting LLC

Lisa C. McNair
Senior Manager, Government Programs
Lupin Pharmaceuticals, Inc.

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 fulfill those obligations and mitigate risk.

Key topics of discussion include:

• Overview of annual and quarterly reporting requirements
• Applicable sales reports
• Small business sub-contracting plan requirements
• Tips on how to approach internal communication and coordination
• How to comply with new affirmative action reporting obligations for federal contractors and subcontractors
• How to develop policies and processes to minimize exposure

Break

TRICARE: A Guide to Successfully Securing Formulary Placement

Allison Pugsley
Partner
Hogan Lovells LLP

• 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
• Analyzing eligible retroactive rebates manufacturers may request
• Overpay
• 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

How to Handle Pricing Restatements: Steps to Take When a Reporting Error Occurs

Elizabeth Lindquist
Partner
King & Spalding LLP

This session will provide practical insights on how manufacturers can limit liability when a pricing error occurs in reporting to government agencies. Using hypothetical examples, explore critical actions to take internally and externally, and best practices for avoiding costly missteps.

• Immediate actions to consider when a pricing error is made
• How to organize internally before making a disclosure to the VA
• Practical examples of how to correct pricing and submit a restatement to the VA

Break

Examining the Impact of the Latest Developments in 340B Pricing and Litigation on Manufacturers

William Sarraille
Partner
Sidley Austin LLP

T. Reed Stephens
Partner
Winston & Strawn LLP

• What is a PHS 340B entity and why do they receive special pricing on drugs?
• PHS 602: navigating the complexities of determining who qualifiesfor 340B
• What steps does a 340B entity need to take to qualify for the program’s benefits?
• Key 340B program amendments
• Orphan drug limitation
• ADR process and civil money penalties
• Exploring 340B program growth
• Examining manufacturers’ obligation, or lack thereof, to offer 340B pricing on drugs dispensed by contract pharmacies
• HRSA 340B program enforcement
• Implications of recent cases
• Protecting against duplicate discounts and diversion of products
• Examining the latest developments in 340B related litigation and the implications for manufacturers

Conference Adjourns