5th Annual Passport to Proficiency on Rx Drug Pricing & Rebate Fundamentals - DS

EARN CLE/CPE CREDITS

5th Annual Passport to Proficiency on

Rx Drug Pricing & Rebate Fundamentals Medicaid – Medicare – PHS 340B – VA – DOD Updates on IRA Reforms and Proposed Revisions to MDRP

CALENDAR-ALT November 4 to December 4, 2024

VIRTUAL SERIES

Intensive training in essential pricing and rebate concepts, methodologies, and strategies for key government payor programs

Your 1-Month Passport to Rx Drug Pricing and Rebate Proficiency: CALENDAR-ALT

4 weeks, 2x weekly

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28 hours of interactive learning

PENCIL-ALT

6+ hours of instruction on advanced and complex pricing and rebate scenarios

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Class recordings for future reference

Register Now

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MASTER key pricing and rebate concepts and how they are applied including:

Practical sessions on pricing and rebate considerations for new products

resource File-Alt Substantive materials for your daily work Certificate of completion + CLE credits

Check AMP

Check CPIU

Check AWP

Check ASP

Check WAC

Check FCP

Check BP

Check FAMP and

Check WAMP

non-FAMP

LEARN about IRA Reforms and Proposed Revisions to MDRP APPLY all you will learn through ACI’s Exclusive LAB — Learn, Apply, and Benchmark Exercise on Drug Pricing and Reimbursement

AmericanConference.com/Drug-Pricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

Master the essentials of key pricing and rebate concepts and methodologies, including IRA reforms and Proposed Revisions to the MDRP. Welcome to ACI’s Passport to Proficiency on Rx Drug Pricing and Rebate Fundamentals. We have designed this course to make you proficient in essential pricing and rebate concepts under Medicaid, Medicare, and other related government drug payor programs, including those under the auspices of PHS 340B, the VA, and DOD. We have refreshed our course agenda to include in-depth sessions on changes to the pricing and rebate system under the Inflation Reduction Act (IRA) – nearly one year after CMS announced the first 10 Part D drugs subject to price negotiation. We will also cover proposed changes to the Medicaid Drug Rebate Program under CMS’s newly Proposed Rule: Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program.

This intensive training program will give novices and experienced practitioners alike a thorough understanding of core pricing competencies and applicable changes in the reimbursement structures of key payor programs.

Gain exclusive and unparalleled access to an in-depth guide on navigating the legal and regulatory maze of prescription drug pricing and rebates.

ACI’s goal is to provide you with a live glossary of essential pricing terminology, as well as analysis of the latest developments affecting Rx drug pricing and rebates including the CMS final rule on MDRP, actions on 340B pricing and co-pays and more.

We will provide a complete course of study for foundational elements, as well as a strategy guide for tackling complex challenges that will benefit the industry novice and the veteran.

Let us help you master the basics and prepare for the complexities.

We will meet each Monday and Wednesday afternoon over the course of four weeks and examine:

WEEK 1 Nov 4 & Nov 6

WEEK 2 Nov 12 & 13

WEEK 3 Nov 18 & 20

WEEK 4 Dec 2 & 4

• Drug Pricing and Rebate Essentials and Introduction to Medicaid

• PHS 340B, VA and DOD Rx Pricing and Rebates

• Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics

• Pricing and Reimbursement for New Products and Therapies

This intensive training program will help you: UNDERSTAND how price is established and how the rebate system works DEFINE key pricing terms under Medicaid, Medicare, PHS 340B and other key government payor programs MAKE sense of complex pricing and rebate calculations that go beyond the essentials EXAMINE the latest developments impacting government drug pricing and rebate programs, from reforms instituted under the IRA to CMS’s newly Proposed Rule which would significantly amend the MDRP

COMPREHEND pricing strategies and key considerations for new products and therapies A renowned faculty of experienced counsel and consultants will present these key concepts to ensure you have a well-rounded understanding of the current pricing and rebate environment. Built in networking breaks and Q&A sessions in our new interactive virtual platform will also allow for you to benchmark with colleagues to confirm that best practices are in place.

Register now to ensure you don't miss this unique and important course.

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Fast Track Your Learning with Guidance from a Renowned Faculty of Masters in Rx Drug Pricing and Rebates Craig Bleifer

Partner Akin Gump & Strauss LLP

Ross Margulies Partner Foley Hoag LLP

Claire E. Castles

Scott A. Memmott

Partner Jones Day

Partner Morgan Lewis & Bockius LLP

Merle DeLancey

Joe Metro

Stefanie Doebler

Timothy Nugent

Tiffany Frankson

Andrew Ruskin

Partner Blank Rome LLP

Partner Covington & Burling LLP Assistant General Counsel, Global Pricing and Health & Value Pfizer

Margaux Hall

Partner Ropes & Gray LLP

Chris Hatwig President Apexus

Mary Hendrickson Partner Foley & Lardner LLP

Christopher Jackson

Partner Reed Smith LLP Managing Director Baker Tilly LLP Partner K & L Gates LLP

Chris Schott

Partner Latham & Watkins LLP

Sharon Small

Director, Counsel – Market Access Govt. Pricing and Policy Novartis

T. Reed Stephens

Partner Winston & Strawn LLP

Managing Member The Law Office of Christopher Jackson LLP

Joy Sturm

Dennis Kim

Stephanie Trunk

Senior Engagement Manager Syneos Health Consulting

James Kim

Shareholder Polsinelli PC

Katie Lapins Trujillo Executive Director The Pricing Group

Miree Lee

Principal M. Lee Consulting LLC

Elizabeth Lindquist Partner Arnold & Porter LLP

Jennifer Lospinoso

Partner Hogan Lovells LLP Partner Arent Fox Schiff LLP

Trevor Wear

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 - Government Programs - Medicaid/Medicare Rebates - Finance/Accounting/Audit - Government Affairs • Compliance Officers LAW FIRMS • Attorneys with practice areas in: - Government Contracts and Managed Markets - Pharmaceuticals - Healthcare - Food & 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

Partner Sidley Austin LLP

• Corporate Counsel/ General Counsel

Matthew Wetzel

• Vice Presidents, Officers,

Partner Goodwin Procter LLP

Constance Wilkinson

Member of Team Epstein Becker & Green, P.C.

Melissa Wong

Partner Holland & Knight LLP

Managing Director & Consulting Lead Riparian LLC

Register Now

This Rx Drug Pricing and Rebate Proficiency Series is for:

AmericanConference.com/Drug-Pricing • 888 224 2480

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

Part of ACI’s PROFICIENCY SERIES

WEEK 1: Drug Pricing and Rebate Essentials and Introduction to Medicaid Monday, November 4 • Eastern Standard Time

1:00

Analysis of the National Rebate Agreement and the Mechanics of the Rx Drug Rebate System

The Medicaid Drug Rebate Program (MDRP) is a program that includes Centers for Medicare & Medicaid Services (CMS), state Medicaid agencies, and participating drug manufacturers that helps to offset the Federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. …

Dennis Kim

Senior Engagement Manager Syneos Health Consulting

The program requires a drug manufacturer to enter into, and have in effect, a national rebate agreement with the Secretary of the Department of Health and Human Services (HHS) in exchange for state Medicaid coverage of most of the manufacturer’s drugs. …

Manufacturers are required to report all covered outpatient drugs under their labeler code to the MDRP. Manufacturers may not be selective in reporting their National Drug Code’s (NDC) to the program. Manufacturers are then responsible for paying a rebate on those drugs for which payment was made under the state plan. These rebates are paid by drug manufacturers on a quarterly basis to states and are shared between the states and the Federal government to offset the overall cost of prescription drugs under the Medicaid Program.

In addition to signing a national rebate agreement, drug manufacturers are required to enter into agreements with two other Federal programs in order to have their drugs covered under Medicaid: a pricing agreement for the Section 340B Drug Pricing Program, administered by the Health Resources and Services Administration, and a master agreement with the Secretary of Veterans Affairs for the Federal Supply Schedule.

— Medicaid Drug Rebate Program, cms.gov

The National Drug Rebate Agreement • Understanding the agreement’s terms and purpose • What is required to participate in the agreement?

• Why is participation in the Medicaid outpatient drug program contingent on participation in the PHS 340B and VA programs?

• How is the PHS program linked to Medicaid?

• What relation does the agreement have to Medicare benefits? (i.e., Medicare Part B and Part D)

Mechanics of the Medicaid Drug Rebate System • Survey of applicable drug pricing legislation such as the MMA, DRA, and ACA • Overview of Medicaid, Medicare, and PHS Programs relative to prescription drug coverage • How is price established?

• How does the rebate system work?

• Under which of the payor systems are rebates available? » Medicare » Medicaid » PHS » VA » DOD

2:00

AWP (Average Wholesale Price) and WAC (Wholesale Acquisition Cost): What You Need to Know

• How is AWP calculated?

• When is AWP still used?

• What is included in WAC, and when?

Stephanie Trunk

Partner Arent Fox Schiff LLP

• Defining the relationship between AWP and WAC » What are their roles in the calculation of Medicaid Rebates?

2:30

Break

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WEEK 1: Drug Pricing and Rebate Essentials and Introduction to Medicaid Monday, November 4 • Eastern Standard Time

2:45

Medicaid Pricing and Rebate 1.0: Key Terminology

• Analysis of the Medicaid rebate system’s components:

Miree Lee

• Best Price: what is it and how is it calculated? » How are the calculations different for generic products? » Recent court and regulatory developments

Principal M. Lee Consulting LLC

Stefanie Doebler

• AMP: what is it and how is it calculated? » Defining “retail community pharmacy” class of trade » What are the variables in AMP price calculation?

Partner Covington & Burling LLP

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

• CPIU: what is it and how is it calculated » When is it triggered? » Does it ever reset?

• Nominal Pricing: when is it relevant to calculating URA?

3:45

Medicaid Pricing and Rebate 2.0: Complexities and Challenges

• Validating transactional data » Ensuring the completeness of direct sales, indirect sales, price concession (rebates, discounts, etc.), fee, returns, and adjustment data • Analyzing AMP and BP included and excluded transaction types

Claire E. Castles Partner Jones Day

» Customary Prompt Pay Discounts (CPPD) » Chargebacks » Commercial rebates — when and how are they included? » Rebates for drugs reimbursed through federal government programs » Rebates for drugs reimbursed through SPAPs » Manufacturer coupons, vouchers and Patient Assistance Programs (PAPs) » Free goods — same product, other Medicaid product, and other items » Sales at nominal prices » Invoice adjustments: Returns, price corrections and order corrections • Understanding what constitutes a bundle arrangement and developing an unbundling methodology • Developing a smoothing methodology for lagged sales and concessions • Employing the 5(i) alternate AMP calculation • AMP calculation for non-5i products not generally sold to the retail community pharmacy COT • Calculating AMP and identifying Best Price for Authorized Generics • URA calculations for line extension products

4:45

Recap and Q & A

5:15

End of Monday Session

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AmericanConference.com/Drug-Pricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 1: Drug Pricing and Rebate Essentials and Introduction to Medicaid Wednesday, November 6 • Eastern Standard Time 1:00

Analysis of Key Aspects of CMS’ Finalized MDRP Rule

The panel will analyze developments coming out of the CMS’ MDRP rule that was finalized in December 2020. Highlights will include the background for these proposals, the challenges which they present, and how the rule could affect price reporting and business operations.

Among the topics covered will be: • PBM accumulator programs • Impact on price reporting for MA Plans

Ross Margulies Partner Foley Hoag LLP

Craig Bleifer

Partner Akin Gump & Strauss LLP

• Value-based purchasing arrangements » Reporting multiple BPs • Line extensions, and Authorized Generics

1:45

Break

2:00

Analysis of Proposed Changes to the MDRP Under CMS’s Recently Proposed

In May 2023, CMS issued a Proposed Rule that would radically alter the Medicaid Drug Rebate Program. This session will provide an in-depth analysis of several key portions under the proposed Rule and their implications for drug manufacturers. Point of discussion will include: • Analysis and overview of the Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program Proposed Rule

Trevor Wear

Partner Sidley Austin LLP

Chris Schott

Partner Latham & Watkins LLP

• Examining the proposed new definition for misclassification • Exploring how proposals for aggregation or stacking of concessions would change how best price is set • Analyzing proposed new definitions for CODs, manufacturer, and market date • Understanding how the proposed new annual drug price verification survey would impact reporting obligations • Contemplating the effect of proposed time limits on manufacturer audits and drug cost transparency requirements with certain managed care contracts • Assessing the probability of possible suspension from National Drug Rebate Agreement (NDRA) for late reporting • Reviewing comment submissions and what we can glean from them

3:15

Compendium of State Drug Transparency Laws

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

Scott A. Memmott

Partner Morgan Lewis & Bockius LLP

» Manufacturer notifications and justifications requirements from the manufacturer » Enforcement and actions taken under existing laws • 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?

• Developing a system to keep track of these laws as well as a compliance program to address them • Impact of transparency laws on Medicaid pricing

4:00

Recap and Q & A

4:20

End of Wednesday Session

WEEK 2: PHS 340B, VA AND DOD RX PRICING AND REBATES Tuesday, November 12 • Eastern Standard Time 1:00

PHS 340B 1.0 - Pricing and Reimbursement Under the Public Health Service 340B Program and The Link to Medicaid Rebate

• What is a PHS 340B covered entity and why do they receive special pricing on drugs?

• Who qualifies as a 340B covered entity and for 340B pricing?

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

• How do discounts to customers affect 340B prices?

• Re-packaging and re-labeling: understanding how they affect pricing in the context of 340B • What impact do GPO arrangements have on covered entities access to 340B prices?

• When must 340B pricing be offered on orphan drugs?

2:00

Break

2:15

PHS 340B 2.0

Operational Challenges: • Examining the implications of the Supreme Court’s decision discontinuing reimbursement cuts to 340B hospitals and understanding how this impacts manufacturers • Analyzing important amendments to PHS 340B under the CMP final rule and how they affected pricing and rebates » Penny pricing

T. Reed Stephen

Partner Winston & Strawn LLP

Jennifer Lospinoso

Managing Director & Consulting Lead Riparian LLC

Chris Hatwig President Apexus

Constance Wilkinson

Partner Epstein Becker &Green LLP

» Limited distribution drugs » Calculation of the 340B price • Validating the eligibility of purchasers • Developing best practices for monitoring HRSA data • Distinguishing 340B sales from non-340B sales made to entities that fill both types of prescriptions » What data sources can manufacturers look to when attempting to make these distinctions?

Legal Challenges: • Restrictions for participating covered entities » The anti-diversion provisions • Exploring HRSA’s limited authority to enforce the 340B program » Examining manufacturers’ obligation, or lack thereof, to offer 340B pricing on drugs dispensed by contract pharmacies • Implications of recent cases • Protecting against duplicate discounts • Assessing the considerations around using rebates in the 340B program pros and cons of turning 340B into a rebate program • Examining current trends and updates on recent developments and whether agency guidance is enforceable • Evaluating the likelihood of future government audits of covered entities • Contract pharmacy developments

3:30

Recap and Q & A

4:00

End of Tuesday Session

Register Now

AmericanConference.com/Drug-Pricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 2: PHS 340B, VA AND DOD RX PRICING AND REBATES Wednesday, November 13 • Eastern Standard Time 1:00

A Guide to the Essentials of FSS Contracting for Pharmaceuticals with the VA and DOD

• Examining overall obligations when contracting with the federal government with respect to: » General Services Administration (GSA) Federal Supply Schedule (FSS): what are the requirements? » VA (Veteran’s Affairs)/ DOD (Department of Defense) » Tricare » PHS – 340B

Merle Delancey Partner Blank Rome LLP

Timothy Nugent Managing Director Baker Tilly LLP

• Understanding the significance of bifurcated tracks and when they are used • How is non-FAMP (non-Federal Average Manufacturer Price) calculated? » How do you calculate the FSS price from non-FAMP? » Which entities are eligible?

2:15

Break

2:30

Advanced VA and DOD Pricing and Contracting

• Specialized arrangements for personalized medicines • Reviewing criteria for a drug to be eligible for consideration under the FSS » Standardization versus therapeutic interchange contracts • Analyzing how target drugs are chosen by VA/DOD/IHS/BOP for joint national contract targets • What are the general requirements for issuing a drug contract? » Package size considerations

James Kim

Shareholder Polsinelli PC

Joy Sturm

Partner Hogan Lovells LLP

» Bottle caps » Safety seals » 30% up front requirement for VA mail order • Understanding the factors for creating the requirements in the estimated volume of purchase » Formulary status changes » Automatic substitution by Pharmaceutical Prime Vendor » Changes with pricing for other drugs in the class • Examining the contracting process » Pre-solicitation » Solicitations » Post-solicitation discussions • What is the process for having the contract for a drug renewed?

• Identifying the factors considered by the agencies when a drug is up for renewal » Supply considerations and challenges » Comparative pricing • Understanding the differences in the processes used by the VA National Acquisition Center and Defense Logistics Agency

3:45

Recap and Q & A

4:15

End of Wednesday Session

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WEEK 3: Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics Monday, November 18 • Eastern Standard Time 1:00

The Inflation Reduction Act (IRA): An In-Depth Review of Changes to Medicare Pricing under the IRA

The Inflation Reduction Act (IRA) marked a monumental shift in Medicare and to some extent Medicaid drug pricing policy. The drug pricing provisions set out in the IRA are complex and include a slate of new obligations and considerations for pharmaceutical manufacturers, most notably mandatory pricing negotiations on the costliest drugs.

Now, one-year into the first 10 drugs being chosen for the negotiation process, and this session will provide a timely analysis of drug pricing provisions under the IRA. Our speakers will examine the current and projected impacts on drug manufacturers and the pharmaceutical industry at large. Key points of discussion include:

Matthew Wetzel

Partner Goodwin Proctor LLP

Tiffany Frankson

Assistant General Counsel, Global Pricing and Health & Value Pfizer

• Breakdown the Inflation Reduction Act » Determining the impact of IRA on Medicare drug pricing » Examining concerns from Medicaid and dual-eligible • Understanding CMS’s negotiation of maximum fair prices under Medicare Parts B and D • Examining Inflation rebates payable under Part B and D • Analysis of Part D re-design, including new manufacturer discounts • Examining what has currently been implemented under the IRA • Anticipating what’s ahead and what will be implemented • Dissecting the misconceptions of the IRA • Examining key provisions in the IRA for manufacturers to consider • Review of first 10 drugs chosen for negotiation process and why? » What will the criteria for the next group of drugs be? » Negotiation timelines and process » Enforcement provisions • Analyzing the implications of the IRA for drug manufacturers » Examining how the negotiation provisions will impact product prices • Maximum fair price calculations » Understanding the mechanics of inflation rebate calculations for Medicare Part B and D • How does this play into the anticipated 2025 redesign for Part D • How would a new Administration in 2024 affect the redesign plan?

• Understanding of how drug pricing reforms will be applied in the real word through hypothetical examples • Status of the IRA lawsuits

2:15

Break

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Part of ACI’s PROFICIENCY SERIES

WEEK 3: Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics Monday, November 18 • Eastern Standard Time 2:30

Medicare Part B: Coverages and Rebate and Pricing Essentials

• Identifying drug coverages under Medicare Part B • Understanding Part B reimbursement methodologies, coverage and coding » Average Sales Price (ASP)

Katie Lapins Trujillo Executive Director The Pricing Group

» Recognizing the differences in coverage, pricing and coding among various outpatient settings • Calculation of ASP » Inclusions and exclusions » Exempt and non-exempt sales » Smoothing » The three-quarter lag » Free goods » Patient assistance • Submission of ASP data: timing » How late filed ASPs are dealt with when calculations are done?

• Bundling • Reimbursement under Part B • Congressional changes the reimbursement for Part B drugs » Reimbursement of generic specialty drugs » Biosimilars • Analyzing the Medicare Part B Drug Wastage Rule • Exploring the interplay between the IRA and the Drug Wastage Rule

3:30

Medicare Part D: Coverages and Rebate Pricing Essentials

• Identifying coverages under Part D • Understanding the mechanics of Part D » What subsidies and payments do Part D plans receive? » Interaction with 28% Retiree Drug Subsidy and commercial rebates • Reporting of Part D rebates and PBM administrative fees • Reviewing Part D fraud and abuse concerns • Examining Part D formulary requirements • Developing rebate contracting strategies under Part D • Taking advantage of plan Star Ratings • 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

4:30

Recap and Q & A

4:45

End of Monday Session

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WEEK 3: Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics Wednesday, November 20 • Eastern Standard Time 1:00

Understanding How Co-Pay Coupons, Accelerators, and Maximizers Impact Medicaid and Medicare Pricing and Rebates

• 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 were supposed to affect Medicaid best price liability

Andrew Ruskin Partner K & L Gates LLP

» In what ways do these mechanisms impact out of pocket expenses?

• How do these mechanisms affect patients in the public payor realm • Exploring the process for working with a coupon vendor • What are the types of pharmaceuticals and biologics sold under these mechanisms?

• How do these mechanisms effect specialty products?

• Reviewing recent litigation surrounding the use of co-pay coupons

2:15

How to Negotiate the Maximum Fair Price Under Medicare Part B and D

• Identifying selected drugs which will fall under the maximum fair price requirement category • Analyzing the fair pricing requirement • Detailing the HHS negotiation process and timeline

Mary Hendrickson Partner Foley & Lardner LLP

• Understanding the significance of the shift in responsibility to identify MFP • Calculating maximum fair pricing and why it is important to the negotiation requirement

2:45

Break

3:00

Simplifying Inflation Rebate Penalties Under Medicare Part B and D

• 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

Melissa Wong

Partner Holland & Knight LLP

• 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

4:00

LAB - Learn, Apply, and Benchmark: Pricing and Rebate Exercise Under Medicaid, Medicare, and 340B

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.

4:45

Recap and Q & A

5:00

End of Wednesday Session

Register Now

AmericanConference.com/Drug-Pricing • 888 224 2480

Joe Metro

Partner Reed Smith LLP

Part of ACI’s PROFICIENCY SERIES

WEEK 4: Pricing and Reimbursements for New Products and Therapies Monday, December 2 • Eastern Standard Time

1:00

Will Your Product Be Eligible for Reimbursement? Pre-Commercialization Concerns in New Therapeutic Development

New considerations: • Understanding the distinction between FDA approval and commercial viability • Planning to secure appropriate coding, coverage and reimbursement for new products • Assessing the competition landscape and articulating a compelling value composition Questions to ask now: • When should you start talking to payors about coding, coverage and reimbursement?

• What are the limitations on discussing coding, coverage, and reimbursement with prescribers?

• How can you stay compliant when marketing a new product in light of those restrictions?

• What types of products are drug, biotech, and biopharmaceutical companies seeking to develop now and why?

• What regulatory and commercial impediments are preventing these companies from pursuing the development of the desired product? » Will the product/technology be covered through government payor/pricing methodologies?

2:15

Break

2:30

New Product Launch – Government Pricing and Contracting Considerations

• Identifying the steps generally involved in setting a launch price for a new drug • Understanding the role of the pricing committee and other key stakeholders • Understanding legal, policy, and reputational risks around price setting

Christopher Jackson

Managing Member The Law Office of Christopher Jackson LLP

• Exploring the uses of list prices versus other pricing metrics in supply chain agreements • What is the role of pricing in connection with drug reimbursement under the Medicaid Drug Rebate Program, Medicare Program, 340B program, and the VA/FSS?

3:45

Recap and Q & A

4:15

End of Monday Session

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WEEK 4: Pricing and Reimbursements for New Products and Therapies Wednesday, December 4 • Eastern Standard Time

1:00

Value of Therapy to Value Proposition: Sources and Uses of Pricing Data in Prescription Drug Advertising and Promotion

• Understanding key variables in the determination of value to key stakeholders • What is a value proposition?

• Identifying databases of pharmaceutical benchmark prices for economic analyses

Elizabeth Lindquist

Partner Arnold & Porter LLP LLP

• Communicating why your medical product is worth paying for in quantitative terms

2:15

Break

2:30

Delving Deeper into Critical Drug Pricing-Related Pre-Launch Considerations

This session will cover the many pre-launch drug pricing related considerations that can either help smooth the path to a successful launch or cause ongoing challenges.

In particular, this session will address the role the following elements play in drug pricing: • FDA considerations (e.g., approval pathway, special designations, or patient populations) • Method and setting of administration

Margaux Hall

Partner Ropes & Gray LLP

Sharon Small

Director, Counsel – Market Access Govt.

Pricing and Policy Novartis

• Unit of measure/dosage form • Billing codes • Payor program (dis)alignment, including formulary and prior authorization considerations as part of market access strategy • Targeted patient population

• Likely customer type(s) and channel partners and types of common pricing arrangements with these partners

3:30

Recap and Q & A

4:00

End of Wednesday Session and Series

Past Rx Drug Pricing and Rebates attendees came from: • Alkermes

• EnvisionRx

• Lowenstein Sandler

• Sanofi

• Almirall SA

• Epstein Becker & Green PC

• McDermott Will & Emery LLP

• Scilex Pharmaceuticals Inc

• Analysis Group

• Genfit

• MN Department of Administration

• Sidley Austin LLP

• Ani Pharmaceuticals Inc

• Greenwich Biosciences

• Morgan Lewis & Bockius LLP

• Sunovion Pharmaceuticals Inc

• Arent Fox LLP

• Grifols

• Office of the US Attorney

• Therapeuticsmd

• Astellas Pharma Inc

• Hercules Pharmaceuticals Inc

• Otsuka Pharmaceutical

• Theravance

• Bristol-Myers Squibb Company

• Hyman Phelps & McNamara PC

• PhillyCooke Consulting

• Tolmar Pharmaceuticals Inc

• Buchanan Ingersoll & Rooney PC

• Incyte Corporation

• PhRMA

• Intercept Pharmaceuticals Inc

• Reed Smith LLP

• U.S. Department of Health and Human Services

• Invictus Pharmacy

• Ropes & Gray LLP

• King & Spalding

• R-Pharm US

• Covington & Burling LLP • CSL Behring • DRUGHUB

Register Now

AmericanConference.com/Drug-Pricing • 888 224 2480

• UCB Inc • US Attorney's Office for the District of Massachusetts

Part of ACI’s PROFICIENCY SERIES

EARN CLE CREDITS

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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.

To learn more about how to apply, please visit www.AmericanConference.com/ accreditation-instructions-for-virtual-attendance/ or email ACI-CLE@AmericanConference.com for further information.

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: To provide instruction in core prescription drug pricing and rebate competencies as well as applicable changes in the reimbursement structures of key government payor programs, including Medicare, Medicaid, PHS 340B, VA, and DOD. • Understand how price is established and how the rebate system works • Define key pricing terms under Medicaid, Medicare, PHS 340B and other key government payor programs • Make sense of complex pricing and rebate calculations that go beyond the essentials • Examine the latest developments impacting the drug pricing and rebate programs, from the CMS final rule on MDRP and PHS 340B litigation to the most favored nation model and more • Comprehend pricing strategies and key considerations for new products and therapies Field of Study: Specialized Knowledge Prerequisite: None.

Level of knowledge: Basic Advanced Preparation: None

WHO SHOULD ATTEND: For Pharmaceutical Companies, PBMs, Pharmacies, and Health Insurance Plans: • Corporate Counsel/General Counsel • Vice Presidents, Officers, Directors and Managers for: - Pricing, Pricing Strategy, - Government Programs Pricing Analytics - Medicaid/Medicare Rebates - Contracts and Reimbursement - Finance/Accounting/Audit - Managed Markets - Government Affairs - Managed Care • Compliance Officers TEACHING METHOD: Group Internet Based DELIVERY METHOD: Group Internet Based Group Internet Based Participants will earn up to 20.5 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: CPE for Livestream Refunds and Cancellations: Requests for refunds less the cancellation fee must be received in writing by October 25, 2024. For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.

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VA • DoD • PHS • Coast Guard

Spring 2025

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Summer 2025

14 | linkedin: Pharmaceuticals, Biotech & Life Sciences: Legal, Regulatory, and Compliance Professionals

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CHEVRON-DOUBLE-RIGHT Attend live sessions, ask questions, comment in the chat function, and take part in live polling.

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Use this opportunity to explore new products and services from C5 Group, leading providers, and meet with new and existing partners over video chat.

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WEEK 1 Nov 4 & Nov 6

WEEK 2 Nov 12 & 13

WEEK 3 Nov 18 & 20

WEEK 4 Dec 2 & 4

• Drug Pricing and Rebate Essentials and Introduction to Medicaid

• PHS 340B, VA and DOD Rx Pricing and Rebates

• Medicare Pricing and Rebate Essentials and Advanced CMS Pricing and Rebate Topics

• Pricing and Reimbursement for New Products and Therapies

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