“BIG FOUR” Pharmaceutical Pricing Boot Camp - DS by C5Group

EARN CLE/CPE CREDITS

Virtual Conference

“BIG FOUR” American Conference Institute’s 15th Annual

Pharmaceutical Pricing May 25 – 26, 2021 (Eastern Daylight Time)

BOOT CAMP The complete guide to pricing methodologies, contracting strategies, and operational best practices for the “Big Four” agencies: VA, DoD, PHS and, Coast Guard

CO-CHAIRS HIGHLIGHTS FOR 2021

Gain valuable insights from representatives of the VA’s Office of Inspector General in Washington, DC Lorraine Campos Partner Crowell & Moring LLP

Merle DeLancey Partner Blank Rome LLP

Michael Grivnovics Director, FSS Contracts VA Office of Inspector General

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

Melodee Snoke-Bullock Audit Manager, Public Law Compliance Group VA Office of Inspector General

PLUS! JOIN US FOR OUR IN-DEPTH PRE-CONFERENCE WORKSHOP: CALENDAR-ALT Tuesday, May 25, 2021 clock 9:00 AM – 12:00 PM (EDT)

“Big Four” 101: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies

AmericanConference.com/BigFourPharma • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Gain a thorough understanding of the core pricing competencies utilized by the “Big Four” government agencies in purchasing biopharmaceutical products. ACI’s 15th Annual “Big Four” Pharmaceutical Pricing Boot Camp will provide attendees with a comprehensive guide to pharmaceutical pricing methodologies used in contracting with the Big Four agencies, as well as best practices for their implementation. Both government speakers and leading counsel will walk attendees through the process of obtaining a government contract in the pharmaceutical space, as well as the proper calculations and pricing methodologies that are necessary to engage with the Big Four agencies. We have assembled an esteemed faculty of experienced government representatives, counsel, and consultants to ensure you have a complete understanding of pricing concepts and challenges in a pandemic environment. Built in networking breaks and Q&A sessions in our new interactive virtual platform will also allow for you to benchmark with colleagues and make meaningful connections. Register now to ensure you don’t miss this essential event that will provide you with unparalleled access to key information on:

» FSS Contracting and the Big Four through the Lens of the Biden Administration

» How the VA Pre-Award Review Process Works and Relevant

Distinguished Faculty CO-CHAIRS: Lorraine Campos Partner Crowell & Moring LLP (Washington, DC)

Merle DeLancey Partner Blank Rome LLP (Washington, DC)

SPEAKING FACULTY: Michael Grivnovics Director, FSS Contracts VA Office of Inspector General (Washington, DC) Margaux Hall Partner Ropes & Gray LLP (Washington, DC) James Kim Partner McDermott Will & Emery LLP (Washington, DC) Kristen Knapp Counsel Sidley Austin LLP (Washington, DC) Annamarie Lee Director, Advisory Services IntegriChain (Philadelphia, PA) Elizabeth Lindquist Partner King & Spalding LLP (Denver, CO)

Cheryl Nagowski Principal & Co-Founder Clarus Access Group LLC (Boston, MA) Erica Petersohn Sr. Mgr., GP & Contracting Solutions Leader Baker Tilly US, LLP (Raleigh, NC) Helen Pfister Partner Manatt, Phelps & Phillips, LLP (New York, NY) Jennifer Plitsch Partner Covington & Burling LLP (Washington, DC) Stephen Ruscus Partner Morgan, Lewis & Bockius LLP (Washington, DC) Melodee Snoke-Bullock Audit Manager, Public Law Compliance Group VA Office of Inspector General (Washington, DC)

Regulations and Policies

Gregory Madden Managing Member Orlaithe Consulting LLC (Aurora, IL)

Impacting Big Four Contracting

Jesse Mendelsohn Vice President Model N (Chicago, IL)

Joy Sturm Partner Hogan Lovells LLP (Washington, DC)

Rick Moore Managing Partner Federal Compliance Solutions LLC (Philadelphia, PA)

Michele Zarychta Sr. Corporate Counsel Pfizer Inc. (Collegeville, PA)

» FAMP, Non-FAMP and FCP Pricing Calculations » How Buy American/Country of Origin Challenges are » PHS 340B: Proper Rate Discounts & Partnerships with the Federal Government, Covered Entities and Manufacturers

» Appropriate circumstances for the utilization of single and dual pricing models

2 | #ACIBigFour twitter: @ACI_Pharma

Mark Myers Director, Healthcare Resources Division VA Office of Inspector General, Office of Contract Review (Washington, DC)

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Pre-Conference Workshop Tuesday, May 25, 2021 9:00 AM – 12:00 PM (EDT)

“Big Four” 101: An Introduction to Key Agencies, Applicable Programs and Pricing Methodologies microphone-alt Mark Myers, Director, Healthcare Resources Division,

VA Office of Inspector General, Office of Contract Review (Washington, DC)

Melodee Snoke-Bullock, Audit Manager, Public Law Compliance Group, VA Office of Inspector General (Washington, DC)

This pre-conference workshop will introduce attendees to the laws, regulations, and pricing methodologies utilized by the “Big Four” agencies in formulary determinations and securing contracts. Speakers will provide an overview to prepare you for the more in-depth discussions that will take place throughout the conference. • Identifying the “Big Four” agencies: VA, DoD, PHS, and Coast Guard • The Federal Acquisition Regulations (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 • Determining the mechanics of FSS contracts and the schedules associated with it • Examining reporting requirements when contracting with the “Big Four” » Accurately completing the CSP sheets and the related disclosure requirements • Examining the treaties by which GSA/FSS contracts are bound • Identifying FSS eligible entities • Complying with FSS clauses regarding socioeconomic programs

• Entering into the Master Agreement (MA) and a Pharmaceutical Pricing Agreement (PPA) • The relationship of OBRA to Medicaid rebate • Introduction to the non-FAMP and FCP calculations • Examining terms that fall under VA and PHS discount programs • 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) • Understanding the PHS 340B program within the context of VHCA 601 • Overview of VA and DoD PPV Programs

• Exploring the Veterans Health Care Act of 1992 » Introduction to Section 602 – pricing for Public Health Services Act (PHS) covered entities » Section 603 – authorization for the VA to negotiate drug prices

hands-helping BECOME A SPONSOR With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The 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

About us:

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company. For over 30 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities. Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

AmericanConference.com/BigFourPharma • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Main Conference Day One

Tuesday, May 25, 2021 (EDT)

1:00 PM

3:10 PM Refreshment Break

Co-Chairs’ Opening Remarks

microphone-alt Lorraine Campos, Partner,

Crowell & Moring LLP (Washington, DC)

Merle DeLancey, Partner, Blank Rome LLP (Washington, DC)

3:30 PM

What Every Pharmaceutical Manufacturer Needs to Know About the VA OIG Pre-Award Review Process

microphone-alt Michael Grivnovics, Director FSS

1:15 PM

Transitioning to a New Administration: A New Look at FSS Contracting and the Big Four

Contracts, VA Office of Inspector General (Washington, DC)

microphone-alt James Kim, Partner, McDermott Will & Emery LLP (Washington, DC)

Gregory Madden, Managing Member, Orlaithe Consultine LLC (Aurora, IL)

This session will offer insights on pricing challenges that pharmaceutical manufacturers face when working through the Federal Supply Schedule (FSS) process, and what changes they anticipate under the Biden administration. 2:00 PM CASE STUDY

Success Stories: Developing Successful Strategies for Negotiating FSS Contracts for Pharmaceuticals

microphone-alt Erica Petersohn, Sr. Mgr., GP

& Contracting Solutions Leader, Baker Tilly US, LLP (Raleigh, NC)

Kristen Knapp, Counsel, Sidley Austin LLP (Washington DC)

Utilizing a case study on a mock product, speakers will guide attendees through best practices for navigating the FSS contracting process.

Rick Moore, Managing Partner, Federal Compliance Solutions LLC (Philadelphia, PA)

• Examining the purpose of the VA OIG Pre-Award program • Analyzing key government regulations and policies related to the program • Exploring the concept of achieving fair and reasonable prices while working with government vendors • Addressing Pre-Award Review when reseller/ distributer involved • Developing best practices for participation in the VA OIG Pre-Award program • Anticipating potential actions taken by the VA when awarding a Rx Pharmaceutical government contract

Joy Sturm, Partner, Hogan Lovells LLP (Washington, DC)

• Completing CSP disclosures

Michele Zarychta, Sr. Corporate Counsel, Pfizer Inc. (Collegeville, PA)

1:1 Networking

• When must these calculations be reported to Veterans Affairs? • Assessing the role of the price reduction clause • Exploring the abnormalities seen when calculating the non-FAMP, and their causes • Correctly calculating pricing while incorporating lagged price reductions • Developing pricing calculations when working with new and transferred pharmaceuticals • Maintaining compliance when communicating price reductions with wholesalers • Securing sub-ceiling and non-ceiling sales related to the 340B program 5:15 PM

Conference Adjourns to Day 2

Public Law Compliance Group, VA Office of Inspector General (Washington, DC)

• Examining the role the Federal Ceiling Price (FCP) plays in discounts related to pharmaceutical pricing discounts within the “Big Four” agencies • Implementing the correct formula for calculating the FCP

4 | #ACIBigFour twitter: @ACI_Pharma

• Assessing additional discount adjustments based on calculations

A Guide to Non-FAMP and FCP Pricing Calculations and Mishap Corrections: Addressing Common Pricing Challenges Under Section 603 of the Veteran’s Health Care Act

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

3:00 PM

• Analyzing how the FCP and Non-FAMP affect one another

4:15 PM

microphone-alt Melodee Snoke-Bullock, Audit Manager,

• Establishing compliance policies and procedures

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

• Assessing the agency’s cost savings associated with the pre-award program

• Addressing strategies for contract development and renewal, while meeting timelines during the bidding process

• Negotiating a customer or category of customers of comparability

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

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

Main Conference Day Two

Wednesday, May 26, 2021 (EDT)

9:00 AM

10:10 AM

Crowell & Moring LLP (Washington, DC)

Unlocking The Secrets of Successful Contracting Longevity: Developing Strategies for Extended Product FSS Placement and Post Award Compliance

Merle DeLancey, Partner, Blank Rome LLP (Washington, DC)

microphone-alt Merle DeLancey, Partner,

Co-Chairs’ Opening Remarks and Recap

microphone-alt Lorraine Campos, Partner,

9:10 AM

Trends in Domestic Sourcing for Pharmaceuticals and Related Requirements: Analyzing How Buy American and Country of Origin Challenges are Impacting Big Four Contracting

Michael Grivnovics, Director, FSS Contracts Division VA Office of Inspector General (Washington, DC)

King & Spalding LLP (Denver, CO)

Once a pharmaceutical product is placed on Federal Supply Schedule, only part of the work is done. With options, renewals, contract expiration dates, and future bidding, it is imperative to develop strategies to keep your products on the FSS for the long haul.

Stephen Ruscus, Partner, Morgan, Lewis & Bockius LLP (Washington, DC)

• Identifying the agencies entitled to make purchases off the FSS, and the pricing methodologies associated with each

microphone-alt Elizabeth Lindquist, Partner,

Blank Rome LLP (Washington, DC)

This panel will explore key contracting considerations surrounding current and prior Administration Buy American initiatives, Country of Origin issues, Executive Orders, the Defense Production Act, etc.

» Consolidated Mail Out Patient Pharmacy System (CMOPS) » Indian Health Services (IHS) » Department of Defense (DoD)

• Ensuring public law pricing policies are upheld to avoid overcharges and any associated penalties • Addressing payment overcharge requests stemming from purchases at open market prices • Conditions for modifying product pricing • Ensuring compliance with reporting requirements 11:10 AM

The TRICARE Program: How to Secure Successful Formulary Placement for Your Pharmaceutical Product

microphone-alt Cheryl Nagowski, Principal & Co-Founder, Clarus Access Group LLC (Boston, MA)

• 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

• Determining proper FSS contracting provisions that are relevant to the TAA

• Assessing the reasons why government facilities may purchase a product at a higher price than it is listed at on the FSS

• Understanding the current state of the law on TAA compliance

• Putting strategies in place to encourage purchases directly from the manufacturer

• Developing best practices when contracting for products manufactured in non-TAA designated countries

• Sales to/through Prime Vendors

• Minimizing the risk of non-TAA compliance when self-certifying

• Determining how both FSS schedules and FSS national contracts impact the pricing of a product

» Ensuring that the necessary calculations are being utilized for the different pricing groups

• Analyzing the requirements when working with MFC pricing and the criteria associated with it

» Reviewing the challenges of accounting for TRICARE sales in your pricing calculations

• Negotiating Customer(s) of Comparability for the Price Reductions-Clause to expand the opportunities of a product when working with FSS customers

» Accounting for price fluctuations that may occur during the period between time of sale and receipt of utilization data

• Understanding the intended impacts of Trump and Biden Executive Orders government purchases of pharmaceuticals during and outside the pandemic • Examining the impact of the DPA on purchases of pharmaceuticals and investment in the US pharmaceutical industrial base

• Examining how the FSS price is connected to discount benchmarks

» 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

» What initiates a price reduction?

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» Methods to track changes to customer pricing requirements

• Determining the outcomes of refusal to comply with price reduction clauses

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• Properly monitoring active buyers from government agencies

11:55 AM

1:1 Networking

» What disclosures are required when working with the Basis of Award?

12:10 PM Lunch Break

AmericanConference.com/BigFourPharma • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Main Conference Day Two 12:55 PM

340B Part 1: Properly Calculating Discounted Rates for Participants of the PHS 340B Program

microphone-alt Margaux Hall, Partner,

Wednesday, May 26, 2021 (EDT) • Status of the 340B administrative dispute resolution process • Covered entity and manufacturer litigation • Reactions from federal/state officials • What the future holds

Ropes & Gray LLP (Washington, DC)

Jesse Mendelsohn, Vice President, Model N (Chicago, IL)

2:30 PM Refreshment Break

• Determining covered entities under the 340B program • Reviewing contract pharmacies and providing an overview of the current disputes

microphone-alt Melodee Snoke-Bullock, Audit Manager,

Public Law Compliance Group, VA Office of Inspector General (Washington, DC)

• Reviewing the 340B-related revenue of 340B covered entities • Examining Medicaid pricing arrangements at 340B facilities and duplicate discounts

• 340B dispute resolution processes: » The Alternative Dispute Resolution final rule » Strategies for dispute resolution, e.g.: • Identifying 340B facilities who have purchased products at incorrect prices • Devising methods to calculate refunds owed to purchasing institutions • Developing audit records to review vendor accounts • Working with pharmaceutical vendors to retrieve sales data to rectify overcharges

microphone-alt Helen Pfister, Partner,

Manatt, Phelps & Phillips, LLP (New York, NY)

Jennifer Plitsch, Partner, Covington & Burling LLP (Washington, DC)

• 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 • Utilizing the proper pricing methodology to ensure the correct model is being implemented • Determining the FCP’s effect on the expansion of the duel pricing model • Assessing the positives associated with each of the pricing strategies

1:45 PM

340B Part 2: An Analysis of the Stakeholders and the Stakes: Dissecting the Discord Between the Federal Government, Covered Entities and Manufacturers

Preparing for A “Big Four” Agency Audit: Establishing Protocols and Best Practices for Proper Record Retention and Avoiding Costly Penalties

microphone-alt Melodee Snoke-Bullock, Audit Manager,

Public Law Compliance Group, VA Office of Inspector General (Washington, DC)

2:45 PM

Single Pricing or Dual Pricing? Ensuring Optimal Results by Selecting the Proper Pricing Methodology

• Understanding how the 340B program works with Medicaid, FSS, and TRICARE

3:45 PM

Annamarie Lee, Director, Advisory Services, IntegriChain (Philadephia, PA)

• 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 • Determining a company’s obligations regarding record retention • Avoiding actions that can result in costly penalties » Refusing a VA request for information » Knowingly providing false information • Developing methods for preparing voluntary disclosures • Efficiently conducting self-audits to ensure compliance • Reviewing the penalties levied for noncompliance » Monetary penalties

» Best Price implications

» Termination of the Master Agreement or PPA

» What are the effects of these models on overall pricing?

» Prohibitions from entering into new agreements

» 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

• Enacting the proper steps for appealing decisions 4:45 PM

Closing Remarks, Conference Concludes

This session will address concerns regarding adequate federal oversight to monitor the 340B program, pending lawsuits, and the implications for the future of the 340b contract pharmacy program, and will include: • Review of manufacturer restrictions on the distribution of 340B drugs to contract pharmacies • Discussion of the December 2020 HHS advisory opinion on contract pharmacy arrangements

6 | #ACIBigFour twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

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All program participants will receive an online link to access the conference materials and recordings as part of their registration fee. Additional copies of the Conference Materials available for $199 per copy.

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Continuing Legal Education Credits EARN CLE 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. For more information on ACI’s CLE process for virtual events visit: www.americanconference.com/accreditation-instructions-for-virtual-attendance/

Continuing Professional Education Credits American Conference Institute is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of Continuing Professional Education (CPE) on the National Registry of CPE Sponsors. Boards of Accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.nasbaregistry.org. COURSE OBJECTIVE: Timely updates on pricing and rebate requirements for participation in and pharmaceutical formulary placement on the VA, DOD, PHS and Coast Guard, (aka the Big Four”) prescription drug programs. • FSS Contracting and the Big Four through the Lens of the Biden Administration • How the VA Pre-Award Review Process Works and Relevant Regulations and Policies • FAMP, Non-FAMP and FCP Pricing Calculations • How Buy American/Country of Origin Challenges are Impacting Big Four Contracting • PHS 340B: Proper Rate Discounts & Partnerships with the Federal Government, Covered Entities and Manufacturers • Appropriate circumstances for the utilization of single and dual pricing models There are no pre-requisites and advance preparation is not required to attend this conference.

FIELD OF STUDY: Business Law PREREQUISITE: None. Level of knowledge: Beginner/Intermediate Advanced Preparation: None. WHO SHOULD ATTEND: Vice Presidents, Officers, Directors and Managers for: Pricing, Pricing Strategy, Pricing Analytics, Contracts and Reimbursement, Managed Markets, Managed Care, Government Programs, Medicaid/Medicare Rebates, Finance/Accounting/Audit, Government Affairs. Compliance Officers. TEACHING METHOD: Group-Live presented online due to COVID-19. DELIVERY METHOD: Group-Live presented online due to COVID-19. Participants will earn up to 15.0 CPE credits. To be awarded full credits, you must actively participate in activities (such as polling) and submit the verification codes presented in the chat. For more information and to submit your CPE request visit: www.americanconference.com/accreditation-instructions-for-virtualattendance/#CPE Refunds and Cancellations: Requests for refunds must be received in writing by May 15, 2021 and will be subject to a cancellation fee. No refunds will be granted after May 15, 2021. For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.

C5 GROUP’S VIRTUAL EVENTS

Join Us Virtually this May! As the current global situation continues to unfold, we understand that it may not be possible to attend our events in person. At the same time, we also understand that collaboration is more vital than ever and for that, you can still rely on ACI to bring the industry together but in a different way. We are transforming quickly to ensure you can now connect virtually and continue to gain unparalleled access to market leading intelligence and to the facilitation of a global exchange of expertise. Our new virtual events continue to be guided by our unifying philosophy: we believe that growth and success occurs when the power of people and the power of information come together. We may not be able to gather in person, but nothing stops connection and innovation.

Participate in Meaningful Networking Enjoy an Easy to Use, Dynamic Online Platform

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Immerse Yourself in Live Presentations and Panel Discussions

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For more information and answers to many of your questions, please visit:

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