20th Annual Rx Drug Pricing Bootcamp - WEB

EARN CLE/CPE CREDITS

20th Annual

Drug Pricing BOOTCAMP

May 11 – 12, 2022 (EDT) Virtual Conference Intensive training in the essentials and complexities of pricing calculations, rebates, and reporting under the Medicaid, Medicare, PHS 340B Programs

Co-Chairs

Elizabeth Lindquist Partner King & Spalding LLP

A leading faculty of experienced practitioners will help you master core drug pricing concepts and calculations, and help you: CHEVRON-DOUBLE-RIGHT

UNDERSTAND how price is established and how the rebate system works

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BUILD a live glossary of Medicaid and Medicare terminology

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DEVELOP a thorough understanding of different pricing benchmarks and calculations including: AMP, BP, ASP and AWP

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UNDERSTAND the mechanics of Medicare Part B and D

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COMPREHEND the nuances of pricing and reimbursement under the Public Health Service 340B program

Stephanie Trunk Partner Arent Fox LLP

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DECIPHER the complexities of co-pay coupons, maximizers, and accelerators

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DETERMINE appropriate coding, coverage, and reimbursement for new products

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LEARN, APPLY AND BENCHMARK during an interactive lab that will demonstrate key concepts using a series of hypothetical examples

AmericanConference.com/RxDrugPricing • 888 224 2480

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Master critical prescription drug pricing concepts under Medicaid, Medicare, and PHS 340B Downward pressure on drug pricing has sparked several proposals that could significantly impact how manufacturers engage and comply with government programs such as Medicaid and Medicare.

It’s a critical time to gain a clear understanding of the foundational pharmaceutical pricing calculations, work through some of the most complex and vexing challenges in public payor pricing and prepare for what’s coming next.

ACI’s Rx Drug Pricing Boot Camp is a comprehensive two-day program dedicated to helping you and your team gain a thorough understanding of core pricing concepts under Medicaid, Medicare, and PHS 340B, including legal and compliance obligations, while also tackling the latest developments impacting the pharmaceutical pricing landscape. This course offers key content for professionals who are newer to pharmaceutical pricing, while also delving into more complex challenges that will serve the industry veteran.

 A MUST-ATTEND EVENT FOR: \ Pharmaceutical Companies • Corporate Counsel/General Counsel • Vice Presidents, Officers, Directors and Managers for: - Pricing, Pricing Strategy, Pricing - Medicaid/Medicare Rebates Analytics - Finance/Accounting/Audit - Contracts and Reimbursement - Government Affairs - Managed Care - Marketing - Government Programs • Compliance Officers \ Law Firms • Attorneys with practice areas in: - Pharmaceuticals - Healthcare

- Food & Drug

\ PBMs • Corporate Counsel/General Counsel • Vice Presidents, Officers, Directors and Managers for: - Contract Management - Pricing and Operations - Network Pharmacy - Clinical Operations - Retail Pharmacy Operations - Industry Relations/Government Affairs - Government Programs • 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 - Clinical - Pharmaceutical Contracting - Pharmacy Services

2 | #DrugPricing

twitter: @ACI_Pharma linkedin: ACI Pharma / Biotech / Medical Device

Speaker Faculty Emily Cook Partner McDermott Will & Emery Meenakshi Datta Partner Sidley Austin LLP Tom Evegan Principal, Strategy & Management Consulting RSM Margaux Hall Partner Ropes & Gray LLP Kirstin Hicks Partner Arnold & Porter Chris Jackson Partner The Law Office of Chris Jackson Miree Lee Principal M. Lee Consulting, LLC Hae-Won Min Liao Vice President, U.S. Pricing & Access, Commercial Legal Gilead Sciences Elizabeth Lindquist Partner King & Spalding Nick Lynch Partner Federal Compliance Solutions LLC Joseph Metro Partner Reed Smith Linda Pissott Reig Partner Buchanan, Ingersoll, Rooney Andrew Ruskin Partner K&L Gates LLP Chris Schott Partner Latham and Watkins Stephanie Trunk Partner Arent Fox William van Oehsen Principal Powers Pyles Sutter & Verville Connie Wilkinson Partner Epstein, Becker & Green Melissa Wong Partner Holland & Knight LLP

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Day 1• Wednesday, May 11, 2022 (EDT)

– VP US Commercial Legal, Lundbeck LLC

1:30

9:50

Co-Chairs’ Opening Remarks microphone-alt Elizabeth Lindquist, Partner, King & Spalding LLP

Medicare Part B Pricing Methodologies, Coverage and Coding microphone-alt Kirstin Hicks, Partner, Arnold & Porter LLP

Stephanie Trunk, Partner, Arent Fox LLP 10:00

Tracking What’s Happening on the Hill: Insights on the Latest Drug Pricing & Reporting Proposals microphone-alt Stephanie Trunk, Partner, Arent Fox LLP Andrew Ruskin, Partner, K&L Gates LLP This session will take a closer look at current legislative proposals to reform drug pricing and reporting laws: where they are heading, the implications for manufacturers, and what’s on the horizon as we move through 2022.

• Build Back Better Act’s proposed provisions, including the potential for government negotiations on Medicare Part B and D drug prices • COVID-19 Stimulus Bill and the expansion of Medicaid 10:45

Medicare and Medicaid Pricing Fundamentals: Key Terminology and Essential Calculations for an Evolving Payor Market microphone-alt Meenakshi Datta, Partner, Sidley Austin LLP Chris Schott, Partner, Latham and Watkins LLP This session will offer an in-depth analysis of government payor programs including the differences in the terminology and calculations amongst the federal programs, including the AMP, WAC, and BP (Best Price). In addition, this discussion will explore where coverage for product may exist under one program but not another, and the related penalties imposed on companies for making incorrect statements and overcharging for a product.

• Analysis of the Medicaid rebate system’s components: » Reimbursements vs. volume discounts • Medicaid Rebate terminology: Best Price; AMP » Defining “retail community pharmacy” class of trade (COT) for AMP calculations • Best Price: what is it and how is it calculated? » How are the calculations different for generic products?

• AMP: what is it and how is it calculated? » What are the variables in AMP price calculation?

• URA: what is it and how is it calculated?

• Overview of Medicare drug coverages and pricing essentials 11:45

Excellent and fully capable list of speakers.

2:30

Break

3:00

Understanding the Mechanics of Medicare Part D microphone-alt Melissa Wong, Partner, Holland & Knight LLP Identifying coverages under Part D Understanding the mechanics of Part D What subsidies and payments do Part D plans receive?

Reporting of Part D rebates and PBM administrative fees Assessing Part D fraud and abuse concerns Examining Part D formulary requirements Developing rebate contracting strategies under Part D Accounting for specialty pharmaceuticals Assessing potential legislative changes Understanding the CMS program design relative to the Part D Coverage Gap Discount • Managing the logistics of payments to multiple plan sponsors • Assessing CGDP payment disputes • Conducting CGDP audits • • • • • • • • • •

4:00

Planning for Drug Launch, Distribution, and Commercial Contracting: A Focus on Service Fees & Related Government Pricing Considerations microphone-alt Margaux Hall, Partner, Ropes & Gray LLP Nick Lynch, Partner, Federal Compliance Solutions LLC

Break

12:30

Status of the MDRP Final Rule and the Implications for Manufacturers microphone-alt Connie Wilkinson, Partner, Epstein, Becker & Green This session will explore the aspects of CMS’ latest MDRP proposed rule that are likely to have the greatest impact if finalized. Highlights will include the background for these proposals, the challenges which they present, and how these proposals might affect price reporting and business operations.

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Defining Part B Drugs Understanding Part B pricing methodologies, coverage and coding Average Sales Price (ASP) Recognizing the differences in coverage, pricing and coding among various outpatient settings • Calculation of ASP » Inclusions and exclusions » Exempt and non-exempt sales » Smoothing • How late filed ASPs are dealt with when calculations are done? » Bundling • Assessing the implications of the refund requirement for certain discarded drugs on government price reporting • • • •

• Understand planned distribution model and commercial contracting landscape risks & considerations • Bona fide service fee (“BFSF”) overview & planning for BFSF and fair market value (“FMV”) analysis • Tips for conducting a successful FMV analysis • Understand impacts of BFSF determinations on government pricing, gross to net, and reimbursement 4:45

Conference Adjourns

AmericanConference.com/RxDrugPricing • 888 224 2480

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Day 2 • Thursday, May 12, 2022 (EDT) 9:30

Co-Chairs’ Opening Remarks microphone-alt Elizabeth Lindquist, Partner, King & Spalding LLP Stephanie Trunk, Partner, Arent Fox LLP 9:45

Status of State Drug Pricing Transparency Laws and Reporting Requirements microphone-alt Linda Pissott Reig, Partner, Buchanan, Ingersoll, Rooney Elizabeth Lindquist, Partner, King & Spalding LLP Hae-Won Min Liao, Vice President, U.S. Pricing & Access, Commercial Legal, Gilead Sciences • Overview of enacted SPTR laws and timelines • Examining state drug price transparency reporting requirements • Exploring where challenges have arisen and how to devise effective compliance strategies 10:45

340B Drug Pricing: Examining Key Calculations and How Recent Litigation Could Impact the Program microphone-alt William van Oehsen, Principal, Powers Pyles Sutter & Verville Emily Cook, Partner, McDermott Will & Emery • 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

All encompassing overview of government programs and current issues.

– Director, Pricing and Contracts, Horizon Pharmaceuticals

12:15

Co-Pay Coupons, Accelerators, and Maximizers: Examining the Impact on Medicare and Medicaid Pricing microphone-alt Joseph Metro, Partner, Reed Smith LLP • Defining coupons, accelerators and maximizers and examining their similarities and differences • How are the parameters for such discount mechanisms set?

• Reviewing these mechanisms as a whole and understanding how they are affecting Medicare and Medicaid pricing • In what ways do these mechanisms impact out of pocket expenses?

• How do they relate to the Medicare “donut hole”?

• What to consider when working with a coupon vendor • What are the types of pharmaceuticals and biologics sold under these mechanisms?

• Insights on recent litigation surrounding the use of co-pay coupons • Examining the HHS blueprint as to whether coupons are considered a discount • Can the removal of safe harbors be considered in the future relative to these mechanisms?

1:15

From Pre-Commercialization to Product Launch: Critical Drug Pricing and Reimbursement Considerations for Manufacturers microphone-alt Christopher Jackson, Partner, The Law Office of Christopher Jackson

Tom Evegan, Principal, Strategy & Management Consulting, RSM Miree Lee, Principal, M. Lee Consulting, LLC

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

• Procedural approaches to set a launch price for a new drug

• Key 340B program amendments

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

» Orphan drug limitation

• Ensuring transparency for the pricing process

» ADR process and civil money penalties

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

• 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 11:45

Break

• Accessing government and commercial programs to secure appropriate coding, coverage, and reimbursement for new products 2:15

Break

2:45

Interactive LAB – Learn, Apply, Benchmark microphone-alt Chris Schott, Partner, Latham and Watkins LLP Joseph Metro, Partner, Reed Smith LLP

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Andrew Ruskin, Partner, K&L Gates LLP This hands-on session will draw from hypothetical examples to show how the pricing and reimbursement concepts you have just learned about fit together in the real world.

4:00

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Conference Adjourns

twitter: @ACI_Pharma linkedin: ACI Pharma / Biotech / Medical Device

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: 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 is not required to attend this conference.

Field of Study: Business Law Email: education@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 Delivery Method: Group Internet Based Participants will earn up to 10.50 CPE credits.

To be awarded full credits, you must actively participate in activities (such as polling) Refunds and Cancellations: Requests for refunds must be received in writing by April 29, 2022 and will be subject to a cancellation fee. No refunds will be granted after April 29, 2022. For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.

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/

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