16th Annual "Big Four" Pharmaceutical Pricing Boot Camp - Govt

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“BIG FOUR” 16th Annual

Pharmaceutical Pricing VA • DOD • PHS • Coast Guard

BOOT CAMP

May 18 – 19, 2022 (EDT) • Virtual Conference A comprehensive guide to pharmaceutical pricing methodologies used in contracting with the Big Four agencies, as well as best practices for their implementation.

This intensive two-day course on essential government contracting processes and pricing concepts for the Big Four will help attendees:

EARN CLE/CPE CREDITS

Receive Practical Guidance Straight from the VA OIG: Michael Grivnovics VA Office of Inspector General, Office of Contract Review

Angle-Right Understand terminology, functions, and operational components for contracting with the Department of Veterans Affairs

Angle-Right Negotiate FSS contracts for pharmaceutical products

Mark Myers VA Office of Inspector General, Office of Contract Review

Angle-Right Troubleshoot pricing challenges involving Non-FAMP and FCP calculations

Angle-Right Prepare for a ‘Big Four’ agency audit Angle-Right Apply compliance best practices to avoid costly penalties

cogs

PRE-CONFERENCE WORKSHOP: Keys to a Successful Relationship with the BIG FOUR: Deep Dive into the Agencies, Applicable Programs, Contracting, and Pricing Methodologies

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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Establish firm footing in the world of government contracting with this advanced course of study in Big Four pharmaceutical purchasing.

ACI’s Big Four Pharmaceutical Pricing Boot Camp will introduce and reinforce core pricing competencies for FSS contracting with the Big Four agencies – VA, DOD, PHS, and Coast Guard. Our distinguished faculty of speakers, including government authorities and leading pricing practitioners, will go beyond the mechanics, to help you overcome calculation conundrums and operational challenges.

This is a critical opportunity to gain practical insights on the latest developments in government contracting for pharmaceuticals with the Big Four, and how they trickle down into drug pricing methodologies and businesses processes. Join us for this essential guide to building a successful relationship with the ‘Big Four.”

HIGHLIGHTS FOR 2022 Angle-Right Examining the Pharmaceutical Supply Chain, Domestic Sourcing, and the Future of Drugs under the TAA

Angle-Right Analysis of 340B Pricing, the Recent Uptick in Litigation, and the Implications for Manufacturers

Angle-Right Guidance on How to Approach Restatements to Mitigate Liability Risk Angle-Right Compliance Best Practices when Contracting with the Big Four

First-time attendee and it exceeded my expectations.

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

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

We look forward to seeing you in May! REGISTER NOW

2 | #ACIBigFour twitter: @ACI_Pharma

linkedin: ACI: Pharmaceutical/Biotech/Medical Device

2022 Faculty List CO-CHAIRS

DISTINGUISHED FACULTY

Felecia Manning Director, Managed Markets Contracts and Government Pricing United Therapeutics Corporation Allison Pugsley Partner Hogan Lovells LLP GOVERNMENT SPEAKERS Mark Myers Director, Healthcare Resources Division VA Office of Inspector General, Office of Contract Review Michael Grivnovics Director, FSS, Contracts Division VA Office of Inspector General

Jeff Blake Managing Partner Federal Compliance Solutions LLC

James Phillips Partner Roeder, Cochran, Phillips, PLLC

Merle DeLancey Partner Blank Rome LLP

Jennifer Plitsch Partner Covington & Burling LLP

Margaux Hall Partner Ropes & Gray Ted Karnezis Owner Karnezis Consulting

Allison Pugsley Partner Hogan Lovells LLP

James Kim Partner Arnold & Porter LLP

Stephen Ruscus Partner Baker Hostetler

Elizabeth Lindquist Partner King & Spalding LLP

William A. Sarraille William Sarraille Partner Sidley Austin LLP

Jennifer Lospinoso Managing Director and Consulting Lead Riparian LLC Lisa C. McNair Senior Manager, Government Programs Lupin Pharmaceuticals, Inc.

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Greg Madden Managing Member Orlaithe Consulting LLC

PA R T N E R

Healthcare

Privacy and Cybersecurity

WSA RR A I L L E @SI D L E Y. C O M

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T. Reed Stephens Partner Winston & Strawn LLP

BILL SARRAILLE is a senior member of the Healthcare practice group and a nationally-recognized lawyer in healthcare law. Bill concentrates on a variety of healthcare matters, including Medicare and Medicaid reimbursement, coverage and coding, pharmaceutical price reporting, issues related to the marketing and promotion of pharmaceuticals and medical devices, internal investigations, clinical research issues, Stark and Anti-Kickback Law analyses, Medicare and Medicaid audits, healthcare acquisitions and due diligence, compliance program audits, managed care matters, healthcare contracts, administrative litigation, legislative matters, privacy and security, coverage for new devices and services, the Foreign Corrupt Practices Act, international compliance and healthcare contracting, the representation of witnesses and companies before Congressional Committees, and the defense of healthcare criminal and False Claims Act matters. Bill has defended clients in some of the largest healthcare fraud investigations brought by the U.S. Government.

Joy Sturm Partner Hogan Lovells LLP

Bill’s clients have included pharmaceutical companies, biotechnology companies, device and equipment manufacturers, diagnostics manufacturers, academic medical centers, hospitals, health systems, faculty practice plans, durable medical equipment suppliers, healthcare consulting firms, ambulatory surgical centers, physician practice management companies, managed service organizations, managed care organizations, large physician group practices, imaging centers, financial institutions, contract research organizations, and leading healthcare trade associations and professional societies.

Bill is consistently recognized as a leading healthcare lawyer in Chambers USA and LMG Life Sciences. He was named an LMG Life Sciences star in 2013–2015 and 2019, and has been recognized every year since 2013 in Chambers USA as a leading lawyer both in D.C. and nationwide. Chambers notes that sources describe Bill as a "terrific regulatory healthcare lawyer" with a "wide range of experience" and noted he is "an excellent reimbursement lawyer." The directory has also described him as "an intellectual heavyweight.

He is hugely professional on every issue." It also listed Bill as "a very good communicator and a trusted

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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

PRE-CONFERENCE WORKSHOP

cogs Wednesday, May 18, 2022

CONFERENCE DAY ONE Wednesday, May 18, 2022

9:00am–12:00pm

12:55

Keys to a Successful Relationship with the Big Four: Deep Dive into the Agencies, Applicable Programs, Contracting and Pricing Methodologies

Co-Chairs’ Opening Remarks microphone-alt Felecia Manning, Director, Managed Markets Contracts and Government Pricing, United Therapeutics Corporation

microphone-alt Jennifer Lospinoso, Managing Director and Consulting Lead, Riparian LLC Mark Myers, Director, Healthcare Resources Division, VA Office of Inspector General, Office of Contract Review This pre-conference workshop will act as an introduction to, as well as a refresher on the laws, regulations, and pricing methodologies utilized by the “Big Four” agencies as the basis for contract and formulary determinations. This workshop will provide an overview of core concepts, preparing you for the more in-depth discussions that will take place throughout the conference.

Allison Pugsley, Partner, Hogan Lovells LLP 1:00

The Future of Contracting with the VA: Tracking the Latest Trends, and Developments at the National Acquisition Center microphone-alt Margaux Hall, Partner, Ropes & Gray 1:30

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

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

• Examining the Federal Acquisition Regulation (FAR) and its relation to government procurement and “Big Four” contracting

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

• 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)

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

» National formularies

• Implementing clauses in pricing reductions to expand the opportunities of a product when working with FSS customers

» 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

4 | #ACIBigFour twitter: @ACI_Pharma

James Phillips, Partner, Roeder, Cochran, Phillips, PLLC

» 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

linkedin: ACI: Pharmaceutical/Biotech/Medical Device

2:30

Break

3:00

How to Overcome Complex Pricing Challenges Under the VHCA Section 603: Non-FAMP, and FCP Calculations microphone-alt Felecia Manning, Director, Managed Markets Contracts and

8:50

Co-Chairs’ Opening Remarks microphone-alt Felecia Manning, Director, Managed Markets Contracts and

Government Pricing, United Therapeutics Corporation

Government Pricing, United Therapeutics Corporation

Joy Sturm, Partner, Hogan Lovells LLP

Allison Pugsley, 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

9:00

Special Focus on FSS Post Award Compliance and Audits microphone-alt 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 10:00

Single and Dual Pricing in Practice: Pros, Cons, and Factors to Consider When Deciding Which Methodology to Use microphone-alt Mark Myers, Director, Healthcare Resources Division,

VA Office of Inspector General, Office of Contract Review Jennifer Plitsch, Partner, Covington & Burling LLP

4:00

Pharmaceutical Supply Chain, Domestic Sourcing, and the Future of Drugs under the TAA microphone-alt Stephen 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 5:00

CONFERENCE DAY TWO Thursday, May 19, 2022

Conference Adjourns

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 11:00

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Break

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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

11:30

System for Award Management: 5 Proactive Steps to Take to Streamline the Registration Process As always the ‘Big Four’ Boot Camp bring together the best in regulatory, legal, and government personnel for an open and honest dialogue.

microphone-alt 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 12:15

LIVE POLLING

Developing a Compliance Action Plan: Practical Guidance on How to Meet Federal Contract Obligations microphone-alt Greg Madden, Managing Member, Orlaithe Consulting LLC Lisa C. McNair, Senior Manager, Government Programs, Lupin Pharmaceuticals, Inc.

2:45

How to Approach Pricing Restatements: Steps to Take When a Reporting Error Occurs microphone-alt 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

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.

3:30

Key topics of discussion include:

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

• 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 1:00

Break

3:45

microphone-alt 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 qualifies for 340B • What steps does a 340B entity need to take to qualify for the program’s benefits?

Break

• Key 340B program amendments

1:45

TRICARE: A Guide to Successfully Securing Formulary Placement microphone-alt 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?

» 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 4:45

Conference Adjourns

» 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

6 | #ACIBigFour twitter: @ACI_Pharma

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

linkedin: ACI: Pharmaceutical/Biotech/Medical Device

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. 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

Level of knowledge: Basic

Prerequisite: None

Advanced Preparation: None

WHO SHOULD ATTEND: For Pharmaceutical Companies •

Corporate Counsel/General Counsel

•

Vice Presidents, Officers, Directors and Managers for:

•

-

Pricing, Pricing Strategy, Pricing Analytics

- Government Programs

-

Contracts and Reimbursement

- Medicaid/Medicare Rebates

-

Managed Markets

- Finance/Accounting/Audit

-

Managed Care

- Government Affairs

Compliance Officers

TEACHING METHOD: Group Internet Based DELIVERY METHOD: Group Internet Based Participants will earn up to 6.5 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 May 8, 2022 and will be subject to a cancellation fee. No refunds will be granted after May 8, 2022.

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

REGISTER NOW

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Government Attendees Save 25% on Conference Registration* PRICING ALL ACCESS PASS Virtual Conference + Pre-Conference Workshop

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Register & Pay by March 18, 2022

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GOVERNMENT REGISTRATION CODE:

H25-899-899L22.OIG CONFERENCE CODE:

Virtual Conference Only Pre-Conference Workshop

899L22-VRT

Special Discount

$395

* To use the Government 25% discount code, email customerservice@americanconference.com or call 1-888-224-2480.

This code is call-in or email only, and will not work on the website.

ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.

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.

To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/.

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Related Conference: May 11–12, 2022 (EDT) Virtual Conference

Big Four Boot Camp Attendees Receive a 10% Discount USE REGISTRATION CODE: D10-831-831L22.BND

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CO-CHAIRS

CONFERENCE CO-CHAIRS

Patricia Harden Head of Sanctions Miyuki Johnson VP, Manufacturing

Felecia Manning Brennan Torregrossa Director, Managed Markets Contracts Senior Vice President, Head of Global Litigation and Government Pricing GSK Therapeutics United

Allison Pugsley Lisa Dunkin Partner Assistant General Counsel, Hogan Lovells LLP Litigation Zimmer Biomet

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