17th Annual "Big Four" Pharmaceutical Pricing Boot Camp - WEB

BIG FOUR

The complete guide

methodologies, contracting strategies, and operational best practices for the “Big Four” agencies

Develop a deeper understanding of key pricing concepts and confidently navigate government contracting processes with this thorough, two-day training course designed to help attendees:

Caret-right Assess the impact of the Inflation Reduction Act on government pricing calculations

Caret-right Troubleshoot complex pricing challenges involving Non-FAMP and FCP calculations

Caret-right Implement FSS Post Award Compliance Best Practices and Audit Preparedness measures

Caret-right Analyze the advantages and disadvantages of single and dual pricing methodologies

Caret-right Secure placement on the TRICARE formulary

PRE-CONFERENCE WORKSHOP

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

James W. Kim Partner Arnold & Porter Kaye Scholer LLP

Merle DeLancey Partner Blank Rome LLP

ACI’s 17th Annual “Big Four” Pharmaceutical Pricing Boot Camp is back in the Big Apple this Spring with a comprehensive agenda designed to provide foundational and supplemental training in government contracting processes and pricing within the context of the biggest development of the year—the Inflation Reduction Act.

Our distinguished faculty of speakers, including government authorities and leading pricing practitioners, will equip you with the terminology and pricing calculation skills necessary to negotiate contracts with the “Big Four” government agencies.

This program will also delve into more complex pricing questions that come up under VHCA Section 603 and provide timely analysis of latest developments impacting government contracting for pharmaceuticals, including the IRA, and new compliance requirements.

Join us on May 1-2, for this essential guide to building a successful relationship with the ‘Big Four.”

ACI’s “Big Four” Pharmaceutical Pricing Boot Camp and Rx Drug Pricing Boot Camp are taking place the first week of May in New York City.

If you and/or one of your colleagues would like to attend both these events, you will receive a 10% discount OFF YOUR COMBINED REGISTRATION.

Groups registering for both events from the same company save even more.

To register an individual or a group for both events, please reach out directly to our Customer Service team by emailing customerservice@americanconference.com or calling 1-888-224-2480 to ensure best rates.

2023 Co-Chairs

Merle DeLancey Partner Blank Rome LLP

2023 Faculty

Jeff Blake Managing Partner Federal Compliance Solutions LLC

Ted Karnezis Principal Owner Karnezis LLC

Greg Madden Managing Member Orlaithe Consulting LLC

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

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

Michelle Scheid Meyer Director, Government Pricing Riparian LLC

James S. Phillips Partner Roeder, Cochran, Phillips PLLC

hands-helping BECOME A SPONSOR

James W. Kim Partner Arnold & Porter Kaye Scholer LLP

Jennifer Plitsch Partner Covington & Burling LLP

Colonel (retired) Dan Remund President Remund Group, LLC

Stephen Ruscus Partner BakerHostetler

Catherine Y. Starks Partner Sidley Austin LLP

T Reed Stephens Partner Winston & Strawn LLP

Joy Sturm Partner Hogan Lovells LLP

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

PRE-CONFERENCE WORKSHOP

Monday, May 1, 2023

9:00am–12:30pm

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

microphone-alt Jennifer Plitsch, Partner, Covington & Burling LLP

This post-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

• Learn about the mechanics of FSS contracts and the associated timelines

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

» How to accurately complete 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)

• Introduction to the 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

» 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 under the Affordable Care Act

» Examining the discounts available under the 340B program

» Determining methods to monitor HRSA data

» Exploring the restrictions that exist for participating covered entities

MAIN CONFERENCE DAY ONE

Monday, May 1, 2023

1:15

Co-Chairs’ Opening Remarks

microphone-alt Merle DeLancey, Partner, Blank Rome LLP

James Kim, Partner, Arnold & Porter LLP

1:30

FSS Contracts: A Practical Guide to Successfully Securing and Managing a VA Contract

microphone-alt Jeff Blake, Managing Partner, Federal Compliance Solutions LLC

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

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.

• 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)

• 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 MFC 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

First-time attendee and it exceeded my expectations. The program was very informative and the opportunity to hear from change agents was invaluable.

2:30 Networking and Refreshment Break

2:45

VHCA Section 603: Non-FAMP/Inflation Reduction Act Implications

microphone-alt Joy Sturm, Partner, Hogan Lovells LLP

James Kim, Partner, Arnold & Porter LLP

In this session our panelists will discuss the VHCA calculations, from nuts and bolts to complex issues, and will also provide a timely analysis of the IRA and how it “imports” the Non-FAMP into the new IRA pricing program.

PART I: IRA & VHCA Section 603 Interconnectedness

• Summary of IRA program and drug price negotiation / MFP

• Leveraging of Non-Federal Average Manufacturers Price (Non-FAMP)

PART II: VHCA Section 603 Non-FAMP & FCP Calculations and Reporting

• The Framework for Calculation and Reporting

• “Nuts and bolts” of the Non-FAMP and FCP calculations

• Annual and quarterly reporting requirements and their intersection with FSS contract

• Best practices for obtaining data necessary for Non-FAMP calculation

• Overlapping issues as between Medicaid (BP & AMP) and VHCA (Non-FAMP)

» Wholesaler fees, BFSF, 340b, definition of Wholesaler

3:45 Break

4:15

PART III: Complex Issues in VHCA Section 603 Calculations

Among the key topics to be discussed:

• Non-FAMP and FCP Calculation Refinements

• “Smoothing”

• How to address anomalies

• Rules for new and transferred products

5:00 Conference Adjourns

MAIN CONFERENCE DAY TWO

Tuesday, May 2, 2023

8:45

Co-Chairs’ Opening Remarks

microphone-alt Merle DeLancey, Partner, Blank Rome LLP

James Kim, Partner, Arnold & Porter LLP

9:00

Best Practices for FSS Post Award Compliance and Audit Preparation

microphone-alt Merle DeLancey, Partner, Blank Rome LLP

• Post award: examining the most important FAR/GSAR clauses from a compliance standpoint

» Price Adjustments (Defective Pricing)

» Price Reductions

ƒ Tracking Customer Price and Ratio

• Other potential FSS compliance traps

» Industrial Funding Fee

» Economic Price Adjustments

» Trade Agreements Act

» Making modifications

ƒ Modification request form

ƒ Product addition

ƒ Price changes

ƒ Deletions

• Potential penalties for non-compliance

• Key provisions of a compliance plan

10:00

Complying with Buy American and TAA Country of Origin Requirements when Contracting with the “Big Four”

microphone-alt Stephen Ruscus, Partner, BakerHostetler

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

• Understanding the current state of the law on TAA compliance

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

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

• How contracting was impacted during the pandemic government purchases of pharmaceuticals during the pandemic

• Examining the impact of the DPA on purchases of pharmaceuticals and investment in the US

10:45 Morning Coffee and Networking Break

Comprehensive course. Reinforces current understanding of calculations and obligations under the program while keeping apprised of current issues and considerations.

11:15  DOD DRUG COVERAGE

Securing a Spot on the Formulary: Key Requirements, Calculations, and Considerations for Manufacturers

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

• Examining three points of service

» Military Treatment facilities, Mail Order and Tricare

• Strategic considerations for manufacturers when developing a bid

• Assessing the requirements to appear on TRICARE’s formulary

• Determining which drugs will be listed on the formulary for TRICARE

12:15 Networking Lunch

1:15

Single and Dual Pricing Models: Determining the Best Route for Your Product

microphone-alt Catherine Y. Starks, Partner, Sidley Austin 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

2:15

Navigating the Latest Changes to the System for Award Management

microphone-alt Lisa McNair, Senior Manager, Government Programs, Lupin Pharmaceuticals, Inc.

Ted Karnezis, Principal Owner, Karnezis LLC

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 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

3:00 Afternoon Coffee Break

3:30

Developing a Compliance Action Plan: Practical Guidance on New ESG Requirements and Other Key Federal Contract Obligations

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

James Phillips, Partner, Roeder, Cochran, Phillips PLLC

• 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

• Examining new ESG and cybersecurity reporting obligations

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

• How to develop policies and processes to minimize exposure

4:00

Forecasting the Future of the 340B Drug Program: Examining Key Calculations, and the Implications of Recent Court Decisions

microphone-alt Michelle Scheid Meyer, Director, Government Pricing, Riparian LLC

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 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

5:00 Conference Concludes

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

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

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 State Bar of California.

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

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/

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. State 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:

To provide instruction in core drug pricing calculations and contract compliance competencies for key government payor programs, including VA, DOD, PHS, Coast Guard.

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

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

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

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

Field of Study: Business Law

Prerequisite: None

WHO SHOULD ATTEND: For Pharmaceutical Companies

• Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

- Pricing, Pricing Strategy, Pricing Analytics

- Contracts and Reimbursement

- Managed Markets

- Managed Care

• Compliance Officers

TEACHING METHOD: Group Live and Group Internet Based

DELIVERY METHOD: Group Live and Group Internet Based

Level of knowledge: Basic Advanced Preparation: None

- Government Programs

- Medicaid/Medicare Rebates

- Finance/Accounting/Audit

- Government Affairs

Participants will earn up to 10.5 CPE credits for the main conference and 3 credits for the pre-conference workshop.

Group Internet Based Participants, please note: 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: https://www.americanconference.com/accreditation-instructions-for-virtual-attendance/#CPE.

Refunds and Cancellations: Requests for credit memos or refunds must be received in writing by April 21, 2023 and will be subject to a cancellation fee. No refunds will be granted after April 21, 2023.

For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.

Book with confidence!

Register and pay to lock in your early rate and be eligible for a full refund until April 17, 2023

If you are unable to attend for any reason, you will have the following options:

y A full credit note for you, or a colleague to attend another event.

y A full refund.

All cancellations and changes must be submitted to CustomerService@AmericanConference.com by April 17, 2023

Building VENUE INFORMATION

New York Bar Association

Address: 42 West, 44th Street, New York, NY 10036-6689

Bed HOTEL ACCOMMODATIONS

Sofitel New York Hotel

Address: 45 West, 44th Street, New York, NY

Reservations: 1-212-782-3015

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “ACI”

Please note that the guest room block cut-off date is March 31st, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Interested in attending virtually?

If you choose to attend via livestream you can expect true interaction virtually — from start to finish. Contact our customer service team at 1-888-224-2480 or CustomerService@AmericanConference.com to learn more about this option.

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