18th Annual Big Four Pharmaceutical Pricing Boot Camp - WEB

Distinguished Co-Chairs:

Merle Delancey Partner

Blank Rome LLP

Felecia Manning

Senior Director, Managed

Markets Pricing & Government Programs

United Therapeutics Corporation

Joy Sturm Partner

Hogan Lovells LLP

June

17 – 18,

2024 • Virtual Event (EDT)

18th Annual

BIG FOUR

BOOT CAMP Pharmaceutical Pricing

VA • DoD • PHS • Coast Guard

The complete guide to pricing methodologies, contracting strategies, and operational best practices for the Big Four agencies

This two-day bootcamp will provide attendees a thorough understanding of essential government contracting processes and pricing concepts for the Big Four agencies. Our stellar faculty of leading pharmaceutical government pricing authorities will help you:

Location-Arrow ASSESS the impact of the Inflation Reduction Act on Big Four drug contracts

Location-Arrow EVALUATE complex pricing challenges involving Non-FAMP and FCP calculations

Location-Arrow COMPARE Government drug payor programs for Big Four Contractors

Location-Arrow DEVELOP a guide for FSS contracting of pharmaceutical products

PRE-CONFERENCE WORKSHOP A – JUNE 17, 2024

BIG FOUR Building Blocks: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies

Location-Arrow UNDERSTAND ESG reporting obligations and avoid penalties Location-Arrow ENFORCE FSS Post Award Compliance measures and System for Award Management Location-Arrow COMPREHEND Cybersecurity risk for Big Four Contractors Location-Arrow ESTABLISH best practices to secure a spot of the TRICARE Formulary

ANALYZE latest developments in PHS 340B pricing

POST-CONFERENCE

WORKSHOP B – JUNE 18, 2024

Federal Government Market Access Working Group: A Guide to Successfully Selling New Drug Products to the “Big Four” Agencies

Enhance your understanding of government contracting with this exclusive advanced bootcamp designed to equip you with strategical tools to overcome Big Four pharmaceutical contracting challenges.

American Conference Institute’s (ACI) 18th Annual Big Four Pharmaceutical Pricing Bootcamp returns to exclusively provide you with an in-depth guide to the fundamentals and complexities of FSS contracting with the Big Four agencies – VA, DOD, PHS 340B, and Coast Guard.

Our faculty is comprised of specialized pharmaceutical government contracting authorities. They will walk you through the process of obtaining a government contract in the pharmaceutical space, while clarifying critical calculations and pricing competencies that are essential when working with the Big Four agencies.

This program will also dive into the more complex pricing regime that comes up under VHCA Section 603 and provide thorough analyses of the latest developments impacting government contracting for pharmaceuticals, including the implementation of the IRA and new compliance obligations.

Participate in the Q&A sessions on our interactive virtual platform, which will also allow for you to benchmark with your peers while you learn from the masters of pharmaceutical government contracting.

To enhance your learning experience, attend one or both of our in-depth workshops:

A: BIG FOUR Building Blocks: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies

B: Federal Government Market Access Working Group: A Guide to Successfully Selling New Drug Products to the Big Four Agencies

Register today for the most comprehensive “how to” Big Four Pricing conference available, where top minds convene to network and engage in thought-provoking discussions as well as provide practical advice on conducting pricing contracts and rebate procedures.

EARN CLE CREDITS

CONTINUING LEGAL EDUCATION CREDITS

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.AmericanConference.com/Accreditation/CLE/

EARN CPE CREDITS

Main conference sessions will offer 10 CPE credits. Each workshop will offer 2 CPE credits.

Distinguished Faculty

CO-CHAIRS:

Merle DeLancey Partner Blank Rome LLP

Felecia Manning Senior Director, Managed Markets Pricing & Government Programs United Therapeutics Corporation

Joy Sturm Partner Hogan Lovells LLP

GOVERNMENT SPEAKERS:

Arron Clayton

Senior Contract Specialist, Pharm A U.S. Department of Veteran Affairs

Ursula Douglas

Senior Contract Specialist, Team Lead Pharm A U.S. Department of Affairs

ESTEEMED SPEAKERS:

Jeff K. Clayton Principal Baker Tilly

Eric Crusius Partner Holland & Knight LLP

Susan Dunne Managing Director Riparian

Ted Karnezis Principal Owner Karnezis LLC

Dennis Kim

Senior Engagement Manager Syneos Health Consulting

James Kim Shareholder Polsinelli, PC

Elizabeth Lindquist Partner Arnold & Porter LLP

Greg Madden Managing Member Orlaithe Consulting LLC

Ross Margulies Partner Foley Hoag LLP

Cheryl Middleton Independent Contractor

Jennifer L. Plitsch Partner Covington & Burling LLP

Colonel Dan Remund (retired) President Remund Group LLC

Stephen E. Ruscus Partner Baker & Hostetler LLP

Bill Sarraille Founder Sarraille & Associates

Catherine Starks Partner Sidley Austin LLP

Constance A Wilkinson Board of Directors/Member of the Firm Epstein Becker & Green P.C.

As always the ‘Big Four’ Boot Camp brings together the best in regulatory, legal, and government personnel for an open and honest dialogue.

The program was very informative and the opportunity to hear from change agents was invaluable.

DAY ONE – Monday, June 17, 2024

Pre-Conference Workshop A

9:30am – 11:30am

“BIG FOUR” Building Blocks: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies

microphone-alt Catherine Starks, Partner, Sidley Austin LLP

Susan Dunne, Managing Director, Riparian

This pre-conference workshop will introduce attendees to the laws, regulations, and pricing methodologies utilized by the “Big Four” agencies as the basis for contract and formulary determinations. This is an essential course of study for new pharmaceutical pricing practitioners and is a comprehensive refresher on core concepts for the industry veteran.

• Identifying the “Big Four” agencies: VA, DoD, PHS, and Coast Guard

• Examining 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

• Comprehending the mechanics of FSS contracts and the associated timelines

• Understanding reporting requirements when contracting with the “Big Four” and compliance best practices

» Completing CSP and related disclosure requirements

• Identifying FSS eligible entities

• Complying with FSS clauses regarding socioeconomic programs

• Entering into the Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA)

• Examining 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

11:30am – 12:00pm Lunch Break

» 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

» Examining the discounts available under the 340B program

» Determining methods to monitor HRSA data

» Exploring the restrictions that exist for participating covered entities

hands-helping BECOME A SPONSOR

With conferences in the United States, Canada, Latin America and Europe, the C5 Group of Companies: American Conference Institute, Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com

Main Conference Day One

12:00pm Co-Chair’s Welcome Remarks

Big Four Year in Review: An In-Depth Analysis of Recent Critical Developments Impacting Rx Pharmaceutical Contracting with the Big Four Agencies

microphone-alt Merle Delancey, Partner, Blank Rome LLP

Felecia Manning, Senior Director, Managed Markets Pricing & Government Programs, United Therapeutics Corporation

Joy Sturm, Partner, Hogan Lovells LLP

In this opening session, our esteemed co-chairs will set the stage for the conference with highlights of the latest developments impacting the Big Four. Join us for an in-depth discussion on the latest regulatory developments, agency advances, and litigation updates impacting drug pricing within the “Big Four” agencies.

12:30pm

The Evolving FSS Contract Lifecycle: A Practical Guide to Successful Procurement and Retention of Big Four

Contracts in 2024

microphone-alt

Arron Clayton, Senior Contract Specialist, Pharm A, U.S. Department of Veteran Affairs

Constance A Wilkinson, Board of Directors/Member of the Firm, Epstein Becker & Green, P.C.

With the use of hypotheticals, this session will examine how to successfully enter contract(s) to make sales to the Big Four, what happens once the contract has been awarded, and how to have your contract successfully renewed.

• Implementing contracting fundamentals and meeting legal requirements when offering a contract proposal

» Hypothetical using mock products

• Developing guidelines for securing and maintaining contracting information

• 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)

• Sales through Prime Vendor Programs

• 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 encourage purchases directly from the manufacturer

• Examining how the FSS price is connected to discount benchmarks

• 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

• Seeking Economic Price Adjustments

1:30pm

An In-Depth Comparison of Government Drug Payor Programs for Big Four Contractors

microphone-alt Dennis Kim, Senior Engagement Manager, Syneos Health Consulting

It is crucial to maintain a well-versed understanding of how government drug contracts are made and how drug price negotiations occur. This session will provide an overview of government drug payor programs. Points of discussion include:

• Overview of each government program and their requirements:

» VA » PHS 340B » Medicare » Medicaid

• Understanding what beneficiary type falls under each program

» What are the statutory discounts within each program

• Dissecting the difference between purchase-based programs and utilization based programs

• Highlighting the significance of Class of Trade (COT) in driving accurate calculation and reporting within each program

• Medicaid Drug Rebate Program (MDRP) Overview

» Explanation of AMP

 Additional AMP considerations

• Medicare Overview

» Part B Overview

 Explanation of ASP

• 340B Overview

» Explanation of BP

 Additional BP considerations

» Explanation of URA

» Which entity types are considered covered entities

• Department of Veterans Affairs Overview

» Big4 and OGA Entities explained

» Federal Supply Schedule overview

» 340B revenue erosion inflection points

 Explanation of duplicate discounts

 Explanation of diversion

» Significance of non-FAMP

» Industrial Funding Fee explained

SPOTLIGHT ON VHCA SECTION 603

microphone-alt James Kim, Shareholder, Polsinelli, PC

Ted Karnezis, Principal Owner, Karnezis LLC

2:15pm

PART I – VHCA Section 603: Understanding how to Conquer Non-FAMP and FCP Calculation Challenges

• Examining the framework for calculations and reporting requirements under VHCA Section 603

» What is VA Office responsible for this Program?

» When must these calculations be reported to the VA?

» Implementing the correct formula for calculating the FCP

» “Nuts and Bolts” of the Non-FAMP and FCP Calculations

 Analyzing the interplay between FCP and Non-FAMP

• Determining the role of the Non-Federal Average Manufacturers Price (Non-FAMP) within the contracting process and ensuring the proper calculations

» What are the ways in which changes to Medicaid calculations can affect non-FAMP calculations?

» Identifying the sources of data necessary to calculate the non-FAMP

 Best practices for data collection to ensure accurate calculations

» Exploring the abnormalities seen when calculating the non-FAMP, and their causes

• Examining how FCP affects discounts related to pharmaceutical pricing discounts within the “Big Four” agencies

• Assessing the role of the price reduction clause

3:15pm Afternoon Break

3:30pm

PART II – Mock VHCA Section 603 Calculations

Our speakers will go through multiple in-depth mock calculations and illuminate how manufacturers can overcome calculation challenges and irregularities. Points of discussion include:

• Preparing for irregularities when calculating prices

» Penny pricing

» “Smoothing” prices

» Notifying the VA of these irregularities

• Correctly calculating pricing while incorporating lagged price reductions

• Assessing additional discount adjustments based on calculations

• 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

• Assessing best practices to maintain for price calculations

4:15pm

In-Depth Look into FSS Post Award Compliance and Audits

microphone-alt Jeff K. Clayton, Principal, Baker Tilly

Ursula Douglas, Senior Contract Specialist, Team Lead Pharm A, U.S. Department of Affairs

• Examining the audit process in relation to FSS contracting

» What does the VA OIG look for during the audit process?

» Scope of the audit – FCP applicable to VA and DoD

 Confidential Customer Contracts Claims

» Pre-award vs. Post-award Audits

• Determining a company’s obligations regarding record retention

• Avoiding actions that can result in costly penalties

» 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

 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

• Enacting the proper steps for appealing decisions

5:15pm Day 1 Wrap-Up & Adjourns

Excellent focus on covered topics –know what to cover and do it well.

DAY TWO – Tuesday, June 18, 2024

Main Conference Day Two

8:20am Co-Chairs’ Welcome Remarks

microphone-alt Merle Delancey, Partner, Blank Rome LLP

Felecia Manning, Senior Director, Managed Markets Pricing & Government Programs, United Therapeutics Corporation

Joy Sturm, Partner, Hogan Lovells LLP

8:30am

Single or Dual Pricing? Selecting the Proper Methodology for Optimal Results

microphone-alt Stephen E. Ruscus, Partner, Baker & Hostetler LLP

Jennifer L. Plitsch, Partner, Covington & Burling LLP

• Understanding the reasons for implementing a single or dual pricing model for Big Four contract(s)

• 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 an annual basis that may 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 Federal Ceiling Price (FCP) effect on the expansion of the dual pricing model

• Assessing the benefits 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

9:30am

Focus on System for Award Management Compliance

microphone-alt Elizabeth Lindquist, Partner, Arnold & Porter LLP

Merle Delancey, Partner, Blank Rome LLP

• Examining the evolving compliance requirements for the System for Award Management (SAM)

• Outlining best practices to build a compliance program that fulfills the obligations of SAM

» Ongoing evaluation of risk management

• Forecasting timelines for registrations and renewals and how to prepare

• Assessing what information and documentation is required for SAM certification

» Requirements for domestic and foreign entities

» Practical examples of pitfalls that could be detrimental and how to avoid discrepancies

• FAR representations and certifications process and how it translates to SAM registration

10:15am Morning Break

10:30am

ESG Deep Dive for Contracting with the Big Four: What Every Drug Manufacturer Needs to Know to Meet their ESG Obligations

microphone-alt Greg Madden, Managing Member, Orlaithe Consulting LLC

In recent years, the increasing concern about the environmental impact of single-use plastic has become impossible to ignore. Drug manufacturers are at a crossroads meeting ESG requirements and using single use plastics for their products. This session will explore ESG reporting requirements and related obligations – as they apply to the Big Four -- that manufacturers need to be aware of.

• Overview of annual and quarterly ESG reporting obligations

• Exploring single-use plastics used for prescription drugs

» Identifying other possible materials that manufacturers may substitute for plastic

 Pros vs. Cons

• Establishing best practices, policies, and processes to adhere to ESG obligations

» Devising a plan to best approach internal communication and coordination

11:15am

Cybersecurity Compliance and Risk Mitigation for Big Four Contractors

microphone-alt Eric Crusius, Partner, Holland & Knight LLP

In the last couple years, the US Government has been devising new rules to combat cybersecurity threats. As a result, federal contractors are required to provide cyber threat and incident reporting. This session will examine the specific obligations surrounding cybersecurity for each of the Big Four agencies.

• Examining evolving cybersecurity reporting obligations

» Is dual authentication sufficient?

• Analyzing how to comply with new affirmative action reporting obligations for federal contractors and subcontractors

• Devising optimal processes and policies to minimize exposure and risk

» What do manufacturers need to be mindful of?

• Identifying best practices for drug manufacturers to mitigate cyber risks

12:00pm Luncheon Break

12:30pm

TRICARE: How to Successfully Secure a Spot on the Formulary

microphone-alt Colonel Dan Remund (retired), President, Remund Group LLC

Post-Conference Workshop B

3:00pm – 5:00pm

• 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

1:30pm

Evaluating the Latest Developments in PHS 340B Pricing and Litigation

microphone-alt Ross Margulies, Partner, Foley Hoag LLP

William Sarraille, Founder, Sarraille Associates

• What is a PHS 340B entity and why do they receive special pricing on drugs?

• PHS 602: navigating the complexities of determining who qualifies for 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

» HRSA 340B program enforcement

» Implications of recent cases

• Examining the latest developments in 340B related litigation and the implications for manufacturers

2:30pm Main Conference Adjourns – Break

Federal Government Market Access Working Group: A Guide to Successfully Selling New Drug Products to the “Big Four” Agencies

microphone-alt Cheryl Middleton, Independent Contractor

A look beyond statutory contracting and pricing into the full range of levers manufacturers can use to successfully launch products in Federal Agency Health Systems. This post-conference workshop will explore what drug manufacturers can do to ensure Federal-specific value creation and optimize revenue in VA & DoD. Our speaker will walk you through key market entry best practices and outline what “good” looks from the perspective of Federal stakeholders. Points of discussion 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

• Clarifying who to contact at the VA and DoD to contract with them

• Measuring Business Opportunity

» Analyzing calculations for revenue potential

ƒ What should you be mindful of for product success?

» Understanding the implications of indirect and spillovers

» Evaluating and measuring Return of Investment Assessments

• Creating Market Events in the VA and DoD

» Assessing best practices for account management

» Dissecting the rules of engagement

ƒ Official vs. Unofficial

• Reviewing Points of Success in the Commercial Markets

» What spillover and leveraging points work?

• Roadmap to Market Entry in Federal Health Systems

» Build a working guideline to prepare your product for market

» Outlining strategies for a successful launch

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