22nd Annual Rx Drug Pricing Bootcamp - DS

BOOT CAMP

March 20–21, 2024

New York City Bar Association, New York, NY

Intensive training in the essentials and complexities of pricing calculations, rebates, and reporting under the Medicaid, Medicare, and PHS 340B Programs.

A leading faculty of experienced counsel and consultants will help you master core drug pricing and rebate concepts and calculations. They will help you:

Angle-Right DECIPHER the ongoing complexities of the Inflation Reduction Act

Angle-Right COMPREHEND CMS’ new proposed MDRP Rule and what it will entail

Angle-Right DEFINE the mechanics of Medicare Part B and D, including the new Part D Redesign

Angle-Right ATTAIN a thorough understanding of different pricing benchmarks and calculations including AWP, AMP, BP and much more

Angle-Right UNDERSTAND the nuances of pricing and reimbursement under the Public Health Service 340B Program, including the ADR rule and recent Genesis case

Angle-Right DETERMINE appropriate coding, coverage, and reimbursement for new products

ATTEND the Pre-Conference Workshops to enhance your understanding of key concepts and the latest trends in pharmaceutical pricing:

Distinguished Co-Chairs:

TUESDAY, MARCH 19

WORKSHOP A Government Payor Program 101:

Primer on the Pricing Essentials of the Medicare, Medicaid, and PHS 340B Program

WORKSHOP B Data Package Master Class: A Guide for Manufacturers on Building Sufficient Data Packages for Drug Price Negotiations

Master the essentials and complexities of Rx Drug pricing calculations, rebates, and reporting under Government Payor Systems

American Conference Institute (ACI) is pleased to announce that the 22nd Annual Rx Drug Pricing Bootcamp will be back in-person in New York City on March 20-21, 2024.

With both federal and state law makers engaging in greater scrutiny of prescription drug pricing, now is the time when industry professionals must stay up to date on the latest amendments to government payor programs as well as their impact on the private sector. Join us to gain a holistic view of how these programs relate and often intersect with each other.

The Implementation of Drug Price Negotiations under the Inflation Reduction Act (IRA) takes effect on January 1, 2024. This raises a whole host of procedural questions for Rx Drug Pricing and Rebates for which this conference will provide answers.

The implementation of the IRA begins at the start of 2024 and will significantly impact Medicare, while posing indirect affects to the other government payor programs. Attend this event and understand the drug pricing and rebate provisions under the IRA. Explore and learn about the drug pricing negotiation program, dynamic changes to Medicare Part D redesign, Part B reimbursements for biosimilars, and the indirect consequences on PBM drug price negotiation.

Understand CMS’ New Proposed MDRP Rule and other Developments Potentially Impacting the Medicaid Program

Last summer, CMS announced a newly proposed rule which will totally revamp the MDRP. Current provisions and analysis under Medicaid often lead to confusion and improper calculations that pose severe consequences on professionals and companies involved. We will examine the formulas and correct calculations needed for drug pricing and rebates at present, while also diving into CMS’ new guidance on line extensions and the provisions of the new proposed MDRP rule.

Explore New Developments and Impacts of the PHS 340B Program

Recent updates to the 340B program have ground-shifting affects to drug pricing and coverage. Join us as we take a deep dive into the continuing evolution of this government payor program. Leading professionals will show you how to calculate pricing under 340B, while defining and redefining 340B entities as well as who qualifies for this program. We will take an in-depth look into the Genesis decision to understand the definition of a patient. Further, we will look at the 340B ADR rule and help you form strategies to address the limiting scope of the ADR timeline process.

Register today for the most comprehensive “how to” Rx Drug Pricing conference, where top minds convene to network and engage in thought-provoking discussions as well as provide practical advice for engaging in the pricing and rebate process.

Who Will You Meet?

PHARMACEUTICAL COMPANIES

• Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

- Pricing, Pricing Strategy, Pricing Analytics

- Contracts and Reimbursement

- Managed Care

- Government Programs

- Medicaid/Medicare Rebates

- Finance/Accounting/Audit

- Government Affairs

- Marketing

• Compliance Officers

LAW FIRMS

• Attorneys with practice areas in:

- Pharmaceuticals

- Healthcare

- Food and Drug

PBMS

• Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

- Contract Management

- Network Pharmacy

- Retail Pharmacy Operations

- Government Programs

- Pricing and Operations

- Clinical Operations

- Industry Relations/Government Affairs

• Financial Analysts

PHARMACIES

• Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

- Pricing

- Business Development

PLANS

• Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

- Pharmacy Networks

- Pharmaceutical Contracting

- Clinical

- Pharmacy Services

Distinguished Faculty

ESTEEMED SPEAKERS

Craig Bleifer Partner

Akin Gump Strauss Hauer & Feld LLP

Toni-Ann Citera Partner

Jones Day Merle DeLancey Partner

Blank Rome LLP

Rujul H. Desai Partner

Covington & Burling LLP

David J. Farber Partner

King & Spalding LLP

Jim Flowers Director Federal Compliance Solutions

CO-CHAIRS

Stephen Forster Partner

Morgan Lewis Bockius LLP

Tiffany Frankson

Assistant General Counsel, Global Pricing and Health & Value

Pfizer

Margaux Hall Partner

Ropes & Gray LLP

Chris Hatwig President

Apexus

Mary L. Hendrickson Partner

Foley & Lardner LLP

Robert J. Hill Partner

Reed Smith LLP

Dennis Kim Senior Engagement Manager

Syneos Health Consulting

James Kim Partner Arnold & Porter

Samantha D. Marshall Counsel

Hogan Lovells LLP

Michelle S. Meyer Senior Director, Consulting Riparian LLC

Chris Schott Partner

Latham & Watkins LLP

Sharon Small Director, Counsel –Market Access-Gov.t Pricing and Policy

Novartis

T. Reed Stephens Partner

Winston & Strawn LLP

Trevor Wear Partner

Sidley Austin LLP

Stephanie Trunk Partner

Arent Fox Schiff LLP

Matthew Wetzel Partner

Goodwin Procter LLP

Constance Wilkinson Board of Directors/ Member of the Firm

Epstein Becker & Green, P.C.

Melissa Wong Partner

Holland & Knight LLP

Pre-Conference Workshops

TUESDAY, MARCH 19, 2024

WORKSHOP A 9:30am–12:30pm (Registration starts at 9:00am)

Government Payor Program 101: Primer on the Pricing Essentials of the Medicare, Medicaid, and PHS 340B Program

microphone-alt Jim Flowers, Director, Federal Compliance Solutions

Join us for this primer on the fundamentals of pharmaceutical pricing related to government payor programs and obtain an in-depth working knowledge of these programs which will lay the foundation for the more in-depth discussions that will take place throughout the main conference.

Points of discussion will include:

• Reviewing applicable legislation such as the IRA, MMA, DRA, and ACA and key agency rules/guidance

• Tracking the flow of payments and reimbursements in the health care supply chain

» Identifying stakeholders within the chain and their roles

» Tracking the flow of drugs, payments and services

• Deciphering commonly used acronyms and terminology

• Surveying the different pricing benchmarks and calculations

» AMP, AWP, ASP, WAC, BP, PHS, FCP, and non-FAMP

• Understanding the implications of different pricing methodologies, calculations and benchmarks for different stakeholders

• Examining the key pricing concepts and calculations for government drug pricing and rebate programs

» Medicaid Drug Rebate program

» Medicare Part B and D

» 340B Drug Pricing program

• Considering the interactions among the programs

» Federal Supply Schedule/Federal Ceiling Price

» TRICARE

• Understanding how participation in the Medicaid Drug Rebate Program impacts participation in the PHS 340B program

WORKSHOP B 1:30–4:30pm (Registration starts at 1:00pm)

Data Package Master Class: A Guide for Manufacturers on Building Sufficient Data Packages for Drug Price Negotiations

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

It is important for manufacturers to know how to compile and thoroughly prepare their crossfunctional data packages. These data packages are scrutinized by the government when manufacturers propose for lower prices. Specifically, the government looks for extensive data in these packages, that is crucial for the purpose of price negotiations. This workshop will dive into everything a manufacturer ought to know when compiling their data packages.

Point of discussions include:

• What is a data package?

• Understanding the role of the data package in the negotiation process

• Assessing what the government looks for in a data package and what key elements manufacturers must have during price negotiations

• Developing strategies to ensure cross-functional information is collected accurately and in a timely manner to support negotiations

• Evaluating who gets to do the negotiations when there are multiple companies involved in the manufacturing of a drug

12:30pm–1:30pm

Light Lunch and Networking Break

Main Conference Day One

WEDNESDAY, MARCH 20, 2024

7:15am Continental Networking Breakfast and Registration

8:15am

Co-Chairs’ Welcome Remarks

microphone-alt Trevor Wear, Partner, Sidley Austin LLP

Stephen Forster, Partner, Morgan Lewis Bockius LLP

8:30am

FOCUS ON IRA DRUG PRICING AND REBATE

The Politics and Policy of Post -IRA Prescription Drug Pricing Under Government Payor Programs

microphone-alt Matthew Wetzel, Partner, Goodwin Procter LLP

The IRA is significantly impacting the commercial landscape for prescription drugs, including drug development. Two of the most significant developments of the IRA include the Medicare drug price negotiation and the Medicare Part D redesign. Points of discussion will include:

• Analyzing the impact of IRA reforms on the biopharmaceutical industry

• Review of first 10 drugs chose for negotiation process and why?

» What will the criteria for the next group of drugs be?

• How does this play into the anticipated 2025 redesign for Part D

» How would a new Administration in 2024 affect the redesign plan?

• Understanding how the Biden Administration’s plan to lower drug prices through the exercise of “march-in” rights under the Bayh-Dole Act and how this may further impact IRA pricing reforms

9:15am

IRA Implementation State of the Union: A Look Back and A Look Forward into the First Round of Drug Price Negotiations

microphone-alt Trevor Wear, Partner, Sidley Austin LLP

Tiffany Frankson, Assistant General Counsel, Global Pricing and Health & Value, Pfizer

The first round of IRA implementation begins January 1, 2024. Join our speakers as they dive into the realities of the IRA implementation from early lessons learned to the anticipation of the challenges of round two. Topics to be discussed include:

• Understanding how drug prices will be negotiated under the IRA

» Identifying what the current Administration and HHS are looking at in terms of negotiations?

» What has the first round of negotiations revealed in terms of both the government’s and manufacturers’ expectations?

• Dissecting the IRA implementation process

» How does it differ from negotiations in the pre-IRA era?

• Identifying key components that manufacturers need to keep in mind for successful negotiations

• Anticipating the next list of drugs that will be subject to the IRA and what their timelines will look like

10:00am

Focus on Part D Manufacturer Discount Program

microphone-alt Robert J. Hill, Partner, Reed Smith LLP

David J. Farber, Partner, King & Spalding LLP

• Identifying key differences with the Coverage Gap Discount Program

» Exploring the criteria for whether a claim qualifies for no discount, 10% or 20%

• Analyzing the requirements for paying lower discounts as a “specified manufacturer” or “specified small manufacturer”

» Evaluating how CMS will monitor for changes that could lead to a loss of such status

• Understanding manufacturers’ contractual obligations to CMS

• Exploring manufacturer audit rights and parameters

10:45am Morning Refreshment Break

11:00am

Simplifying Inflation Rebate Penalties Under Medicare Part B and D

microphone-alt Mary L. Hendrickson, Partner, Foley & Lardner LLP

• Understanding IRA inflation rebate requirements for Part B drugs and its relationship to ASP

• Examining the IRA inflation rebate requirement for Part D drugs and its relationship to AMP

• Analyzing the benchwork periods for evaluating inflation for both existing and new drugs

• Evaluating what utilization is and is not subject to the rebate requirements

• Working through the mechanics of precisely how the rebates are calculated

• Exploring penalties for manufacturers who do not comply with new rebate provisions

• Looking at the impact and interplay of the IRA inflation rebates on commercial sales

11:45am

Is it an Unlawful Taking? A Discussion of the Ongoing IRA Drug Price Negotiation Lawsuits

microphone-alt Toni-Ann Citera, Partner, Jones Day

T. Reed Stephens, Partner, Winston & Strawn LLP

In June of 2023, Merck filed its lawsuit against CMs over IRA drug negotiations alleging that this provision of the IRA is akin to an unlawful taking under the Fifth Amendment of the Constitution. Since that time Astra Zeneca, Boehringer Ingelheim, Bristol Myers Squibb, Johnson & Johnson, Novartis, and even PhRMA have filed similar lawsuits.

Despite the filing of these suits, many of the plaintiff manufacturers are still participating in the IRA pricing negotiations. In this highly anticipated session as our speakers will provide an analysis of these suits and their significance.

• Overview of all the cases filed against the US government

» What is still pending?

• Understanding what an unlawful taking is and why pharma companies claim that their constitutional rights are being infringed upon

• Analyzing the implications if pharmaceutical companies win

» How will this change the IRA implementation

» What are the benefits and consequences of this?

• Assessing the consequences if the US government wins the case

» What does this mean for IRA implementation

» Is it likely that the case will be appealed and ultimately go to SCOTUS?

12:45pm Networking Luncheon

1:45pm

Unintended Consequences: Understanding the Fallout of the IRA on Government Payor Programs and the Private Sector

microphone-alt James Kim, Partner, Arnold & Porter

Merle DeLancey, Partner, Blank Rome LLP

• Analyzing the consequences of the IRA on other government drug payor programs:

» Medicaid

» PHS 340B

» VA and DOD

• Understanding what the implications of the IRA are on the supply chain that inevitably affects cost and pricing

• Delving into how the private sector will be (or is) handling the IRA implementation

» Exploring how the price of drugs will vary

» Consequences for Medicare Advantage plans

• How will IRA- mandated pricing changes trickle through and affect the market to affect drug valuations as well as the economy

2:45pm Afternoon Refreshment Break

3:00pm

A Look at PBMs through the Lens of the IRA: Practices and Their Legal Challenges

microphone-alt Margaux Hall, Partner, Ropes & Gray LLP

• Understanding the impact of the IRA on PBMs

• Exploring the ongoing case litigation involving PBMs

• Evaluating the FTC’s investigation on PBMs

• Assessing the shift towards PBM transparency and what this means for manufacturers

• Identifying best practices and strategies for negotiating with PBMs

4:00pm

Understanding How the Pricing of Biosimilars Affects Government Drug Payor Programs

microphone-alt Craig Bleifer, Partner, Akin Gump Strauss Hauer & Feld LLP

Samantha D. Marshall, Counsel, Hogan Lovells LLP

Congress passed legislation providing a pathway for biosimilars over a decade ago, and the widespread adoption of biosimilars has been slower than many policymakers would have liked. As a result, biosimilars enjoy many distinct and preferential treatments under the various government programs.

Points of discussion will include:

• Understanding how biosimilars are treated and impacted under each of the government pricing programs

» Medicare

» Medicaid

» PHS 340B

• Identifying the impact biosimilars play in the Medicare Drug Price Negotiation process

• Evaluating why have stakeholders are hesitant to use available biosimilars

• Assessing the various measures currently in place at the federal and state level to encourage the movement to biosimilars

» Forecasting the future of biosimilars and its impact on the government pricing programs

5:00pm

Day 1 Recap & Day 1 Adjourns

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Main Conference Day Two

7:30am Continental Breakfast and Registration

8:30am

Co-Chairs’ Opening Remarks and Recap of Day 1

microphone-alt Trevor Wear, Partner, Sidley Austin LLP

Stephen Forster, Partner, Morgan Lewis Bockius LLP

FOCUS on MEDICAID PRICING ESSENTIALS

8:45am

Examining the Full Impact of CMS’ Ground-Shifting New Proposed Medicaid Drug Rebate Program Rule

microphone-alt Stephanie Trunk, Partner, Arent Schiff Fox LLP

• Reviewing how the 2023 MDRP proposed rule differs from the 2020 MDRP rule, currently in place

• Understanding how to identify best price and calculate URAs under the proposed rule

• Forecasting when the proposed rule will be finalized and what manufacturers will be required to follow

• Assessing the other significant impacts the proposed rule may cause

• Analyzing the possible legal challenges to the proposed rule

• Exploring the large provisions on the new process for audits

» What do manufacturers need to know

9:45am Morning Refreshment Break

10:15am

Dissecting CMS’ New Guidance on Line Extensions

microphone-alt Chris Schott, Partner, Latham & Watkins LLP

• Understanding CMS’ new guidance on line extensions

» How does this change things?

• Analyzing what the manufacturer release entails

» What can manufacturers now do?

11:00am

In-Depth Illustration of Medicaid Drug Pricing and Rebates

microphone-alt Melissa Wong, Partner, Holland & Knight LLP

• Exploring the components of Medicaid’s drug rebate system

» Defining AMP and the AMP cap

» What is “Best Price”?

• Outlining the formulas needed to determine unit rebate amounts

» Unit rebate amount for brand drugs

» Unite rebate amount for generic drugs

• Understanding the impact of price increases on unit rebate amounts

» What is the baseline period for brand drugs?

» What is the baseline period for generic drugs?

• Identifying line extensions and their impact on unit rebate amounts

• Dissecting manufacturer reporting requirements

» What are the best practices?

• Analyzing the downstream effects on AMP, Best Price, and unit rebate amounts

• Answering how the IRA impacts Medicaid indirectly (dual-eligible)

FOCUS ON PHS 340B

11:45am

PART I: An In-Depth Look at the Effects of the Genesis Case

microphone-alt Stephen Forster, Partner, Morgan Lewis Bockius LLP

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

• Delving into what happened in the Genesis Case

• Assessing the new patient definition

• Understanding the effects of Genesis on the 340B program

• Analyzing best practices that counsel and manufacturers need to know to navigate the implications of the Genesis case

12:45pm Networking Luncheon

1:45pm

PART II: Exploring Other Recent 340B Developments

microphone-alt Michelle S. Meyer, Senior Director, Consulting, Riparian LLC

Chris Hatwig, President, Apexus

• Examining the evolution of the PHS 340B program and recent developments

» Defining and redefining 340B entities

» Understanding how 340B pricing is calculated

• Analyzing specific state 340B legislation and related litigation

» Arkansas

• Examining the new 340B ADR rule

» Outlining the limitations on the scope of what can be litigated under the new rule

» Timeline/Timeframe changes

• Exploring recent case law and its affect on the 340B program

» American Hospital Association (AHA) v. Becerra

» PhRMA 340B Case

2:45pm

Analyzing Present and Pending State Drug Transparency Laws

microphone-alt Trevor Wear, Partner, Sidley Austin LLP

Stephen Forster, Partner, Morgan Lewis Bockius LLP

This session will explore the rise of state transparency laws across the country and how they are working in conjunction with government payor programs.

• Identifying states with current and pending drug pricing transparency laws under:

» Medicaid

» Medicare

» PHS 340B

• Assessing state drug price transparency reporting

• Understanding how states are using the information manufacturers report

• Addressing challenges with and finding solutions for reporting under non-uniform and sometimes conflicting state laws

» Can a state request supplemental rebates within these models?

» If the rebate is denied, can the state exclude the drug from Medicaid coverage?

3:45pm Afternoon Refreshment Break

4:00pm

A Manufacturer’s Guide to Critical Drug Pricing and Reimbursement Considerations when Launching New Products

microphone-alt Sharon Small, Director, Counsel – Market Access-Gov.t Pricing and Policy, Novartis

Rujul H. Desai, Partner, Covington & Burling LLP

• Examining pricing and reimbursement considerations form the pre-commercialization through product launch stages

• Analyzing the procedural approaches to set a launch price for a new drug

• Understanding legal, policy, and reputational risks around price setting

• Ensuring transparency for the pricing process

• Considering the role of traditional and non-traditional functions in setting price

• Accessing government and commercial programs to secure appropriate coding, coverage, and reimbursement for new products

• Examining how the IRA is impacting the pricing of new products

5:00pm

Day 2 Recap, Conference Adjourns

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.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

Related Event

“

BIG FOUR

18th Annual BOOT CAMP Pharmaceutical Pricing

Continuing Professional Education Credits

American Conference Institute (ACI) 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:

Essential training and timely updates on Medicare, Medicaid, and PHS 340B programs

• Medicare and Medicaid Pricing Fundamentals: Key Terminology and Essential Calculations for an Evolving Payor Market

• Planning for Drug Launch, Distribution, and Commercial Contracting: A Focus on Service Fees & Related Government Pricing Considerations

• Co-Pay Coupons, Accelerators, and Maximizers: Examining the Impact on Medicare and Medicaid Pricing

• Critical Drug Pricing and Reimbursement Considerations for Manufacturers: From Pre-Commercialization to Product Launch

There are no pre-requisites and advance preparation required to attend this conference.

”

Field of Study: Business Law

Email: aci-cle@americanconference.com for breakdown by credit

Prerequisite: None

Level of knowledge: Basic

Advanced Preparation: None

WHO SHOULD ATTEND:

CFO, General Counsel, VP or Director Government Compliance, VP or Director Finance, VP or Director Contracts, Procurement, Cost Accounting, Accounting Firms

TEACHING METHOD: Group Live

DELIVERY METHOD: Group Live

Participants will earn up to 16.5 CPE credits for the main conference and 3 credits for each of the pre-conference workshops.

Refunds and Cancellations: Requests for credit memos or refunds must be received in writing by March 7, 2024 and will be subject to a cancellation fee. No refunds will be granted after March 8, 2024. For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.

C5 celebrates 40 years of excellence! We are thrilled to have provided exceptional conference experiences globally with our outstanding team, speakers, sponsors, partners, and attendees. To mark this milestone, we're launching a new logo which represents our commitment to innovation, growth, and excellence, represented by the five Cs of C5: Current, Connected, Customer-Centric, Conscientious, and Committed.

Looking back on 40 years, we are grateful for our achievements—hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we're excited for the next 40 years of success.

Venue & Hotel

New

42 West, 44th

New York, NY 10036

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate at the Sofitel Hotel. To take advantage of these rates, please contact the hotel directly and quote "ACI's March Event".

Sofitel New York

45 West 44th Street

Reservations: anna.li@sofitel.com or 212-782-3015

To reserve online CLICK HERE

Please note that the guest room block cut-off date is February 19, 2024. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

Book

y

y A full refund.

All

another event.

Dan Manganiello, American Conference Institute

D.Manganiello@AmericanConference.com

1 212 352 3220 x5464

Use Registration Code: B00-999-DMO24

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by March 6.