Passport to Proficiency on Rx Drug Pricing & Rebate Fundamentals - WEB

EARN CLE/CPE CREDITS

Passport to Proficiency on

Rx Drug Pricing & Rebate Fundamentals Intensive training in essential pricing and rebate concepts, methodologies, and strategies for key government payor programs Medicaid • Medicare • PHS • VA • DOD CALENDAR-ALT November 1 to December 1, 2021

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

lightbulb Practical sessions on pricing and rebate considerations for new products

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

VIRTUAL SERIES

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

Check CPIU

Check AWP

Check ASP

Check WAC

Check FCP

Check BP

Check FAMP and

Check WAMP

non-FAMP

APPLY all you will learn through ACI's Exclusive LAB — Learn, Apply, and Benchmark Exercise on Drug Pricing and Reimbursement

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

Master the essentials of key pricing and rebate concepts and methodologies 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 payor programs, including those under the auspices of PHS 340B, the VA, and DoD.

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. 1 & 3

WEEK 2 Nov. 8 & 10

WEEK 3 Nov. 15 & 17

WEEK 4 Nov. 29 & Dec. 1

Drug Pricing and Rebate Essentials and Introduction to Medicaid

Medicare Pricing and Rebate Essentials, and VA and DoD Rx Pricing and Rebates

PHS 340 B, 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 340 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 340b litigation to the most favored nation model and more…

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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BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

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

Nneka Onwudiwe Former PRO/PE Regulatory Review Officer Food and Drug Administration

Merle DeLancey Partner Blank Rome LLP

Erica Petersohn Sr. Manager, Life Sciences Consulting, Government Pricing & Contacting Solutions Leader Baker Tilly U.S.

Stefanie Doebler Partner Covington & Burling LLP Margaux Hall Partner Ropes and Gray LLP Kristin Hicks Partner Arnold & Porter LLP Mark Horner Managing Consultant Akara Group LLC Ted Karnezis Owner Karnezis Consulting LLC James Kim Partner McDermott, Will & Emory LLP

Christopher H. Schott Partner Latham and Watkins LLP Andy Ruskin Partner K&L Gates LLP T Reed Stephens Partner Winston & Strawn LLP Stephanie Trunk Partner Arent Fox LLP Joy Sturm Partner Hogan Lovells LLP

Elizabeth Lindquist Partner King and Spalding LLP

Keren Tenenbaum General Counsel, Vice President of Legal & Compliance US Vifor Pharma

Jennifer Lospinoso Managing Director & Consulting Lead Riparian LLC

Trevor Wear Partner Sidley Austin LLP

Joseph Metro Partner Reed Smith LLP

Melissa Wong Partner Holland & Knight LLP

This Rx Drug Pricing and Rebate Proficiency Series is for: PHARMACEUTICAL COMPANIES • Corporate Counsel/General Counsel • Vice Presidents, Officers, Directors and Managers for: - Pricing, Pricing Strategy, Pricing Analytics - Contracts and Reimbursement - Managed Markets - Managed Care - 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 • Corporate Counsel/General Counsel

• Vice Presidents, Officers, Directors and Managers for:

quote-left All encompassing overview of government program and current issues. quote-right

– Director of Pricing and Contracts Horizon Pharmaceuticals

Register Now

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

- 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 1 • Eastern Standard Time 1:00

Analysis of the National Rebate Agreement and the Mechanics of the Rx Drug Rebate System Elizabeth Lindquist Partner King and Spalding LLP

Trevor Wear Partner Sidley Austin LLP

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. ….

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.

The National 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 the Medicare Drug benefit? (i.e., Medicare Part D)

Mechanics of the Rx 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 » PHS » DOD » Medicaid

» VA

– Medicaid Drug Rebate Program, cms.gov

2:10

AWP (Average Wholesale Price) and WAC (Wholesale Acquisition Cost): What You Need to Know Merle DeLancey Partner Blank Rome LLP • How is AWP calculated?

• What is included in WAC, and when?

• When is AWP still used?

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

2:30

Break

3:00

Medicaid Pricing and Rebate 1.0: Key Terminology Stefanie Doebler Partner Covington & Burling LLP • Analysis of the Medicaid rebate system’s components: » Reimbursements vs. volume discounts º What are they?

» 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?

º When is each used?

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

º To whom are they given?

• Status of additional rebate under CPIU

• 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?

• Is there a nominal price exception to the reporting requirements under Medicaid? » How is this exception determined?

• What is the overall effect of nominal pricing on the rebate system?

4:00

Recap and Q & A 4:30

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End of Monday Session BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

WEEK 1: Drug Pricing and Rebate Essentials and Introduction to Medicaid Wednesday, November 3 • Eastern Standard Time 1:00

Medicaid Pricing and Rebate 2.0: Complexities and Challenges Melissa Wong Partner Holland & Knight LLP • 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 » Customary Prompt Pay Discounts (CPPD)

» Patient transactions — coupons, vouchers and patient assistance programs » Sales at nominal prices » Invoice adjustments: Returns, price corrections and order corrections • Understanding what constitutes a bundle arrangement and developing an unbundling methodology

» Chargebacks

• Developing a smoothing methodology for lagged price concessions

» Commercial rebates — when and how 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

• Employing the 5(i) alternate AMP calculation • AMP calculation for non-5(i) products not generally sold to the retail community pharmacy COT • Calculating AMP for Authorized Generics (AGs) AMP and URA calculations for line extension products » Accounting for the entry of authorized generics and biosimilars

1:45

Analysis of Key Aspects of The CMS’ MDRP Final Rule Trevor Wear Partner Sidley Austin LLP

Christopher H. Schott Partner Latham and Watkins LLP

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.

• Impact on price reporting for MA Plans • Value-based purchasing arrangements » Reporting multiple BPs

Among the topics covered will be: 2:45

• PBM accumulator programs

• Line extensions, and Authorized generics

Break

3:15

Analysis of State Drug Transparency Laws Merle DeLancey Partner Blank Rome LLP

Elizabeth Lindquist Partner King and Spalding 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.

• 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 4:30

End of Wednesday Session

Register Now

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 2: Medicare Pricing and Rebate Essentials Monday, November 8 • Eastern Standard Time 1:00

Medicare Part B: Coverage and Pricing Essentials Andy Ruskin Partner K&L Gates LLP

Kristin Hicks Partner Arnold & Porter LLP • Submission of ASP data: timing

• Identifying drug coverages under Medicare Part B • Understanding Part B pricing methodologies, coverage and coding

» OIG and state AG efforts to obtain data » How late filed ASPs are dealt with when calculations are done?

» Average Sales Price (ASP) » Recognizing the differences in coverage, pricing and coding among various outpatient settings • Calculation of ASP

» Impact of COVID relief fund provisions on reporting • Bundling • Special concerns for radiopharmaceuticals

» Inclusions and exclusions

• Reimbursement under Part B

» Exempt and non-exempt sales

» Most Favored National Model

» Smoothing

• Reimbursement of generic specialty drugs

» The three-quarter lag

• Biosimilars

» Free goods » Patient assistance 2:15

Break

2:45

Medicare Part D: Coverages and Rebate Contracting Essentials Stephanie Trunk Partner Arent Fox LLP

Mark Horner Managing Consultant Akara Group LLC

• Identifying coverages under Part D

• Taking advantage of plan Star Ratings

• Understanding the mechanics of Part D

• Accounting for specialty pharmaceuticals

» What subsidies and payments do Part D plans receive?

• Assessing potential legislative changes

» Interaction with 28% Retiree Drug Subsidy and commercial rebates

• Understanding the CMS program design relative to the Part D Coverage Gap Discount

• Reporting of Part D rebates and PBM administrative fees • Reviewing Part D fraud and abuse concerns

• Managing the logistics of payments to multiple plan sponsors • Assessing CGDP payment disputes

• Examining Part D formulary requirements • Developing rebate contracting strategies under Part D

• Conducting CGDP audits

4:00

Recap and Q & A 4:30

End of Monday Session

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BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

WEEK 2: VA and DoD Rx Pricing and Rebates Wednesday, November 10 • Eastern Standard Time 1:00

A Guide to the Essentials of FSS Contracting for Pharmaceuticals with the VA and DOD T Reed Stephens Partner Winston & Strawn LLP

Ted Karnezis Owner Karnezis Consulting LLC

• Examining overall obligations when contracting with the federal government with respect to:

• Understanding the significance of bifurcated tracks and when they are used

» General Services Administration (GSA) Federal Supply Schedule (FSS): what are the requirements? » VA (Veteran’s Affairs)/ DOD (Department of Defense)

• How is non-FAMP (non-Federal Average Manufacturer Price) calculated? » how do you calculate the FSS price from non-FAMP? » which entities are eligible?

» Tricare » PHS – 340B 2:00

Break

2:30

Advanced VA and DoD Pricing and Contracting Joy Sturm Partner Hogan Lovells LLP

Merle DeLancey Partner Blank Rome LLP

• 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 » Bottle caps

• 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

» Safety seals

» Supply considerations and challenges

» 30% up front requirement for VA mail order

» Comparative pricing

• Understanding the factors for creating the requirements in the estimated volume of purchase

• Understanding the differences in the processes used by the VA National Acquisition Center and Defense Logistics A

» Formulary status changes » Automatic substitution by Pharmaceutical Prime Vendor » Changes with pricing for other drugs in the class 4:00

Recap and Q & A 4:30

End of Wednesday Session

quote-left Excellent and very capable list of speakers.

Not always this good and comprehensive at other programs. quote-right – VP, U.S. Commercial Legal Lundbeck LLC Register Now

AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 3: PHS 340 B Pricing and Rebates Monday, November 15 • Eastern Standard Time 1:00

PHS 340B 1.0 – Introduction to the 340B Program and the Link to Medicaid Rebate T Reed Stephens Partner Winston & Strawn LLP

Jennifer Lospinoso Managing Director & Consulting Lead Riparian LLC

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

• Discounts to wholesalers – how do they affect Best Price/AWP within the 340B context?

• PHS 602: navigating the complexities of determining who qualifies for 340B

• Re-packaging and re-labeling: understanding how they affect pricing in the context of 340B

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

• Understanding how bundling, tying, and GPO arrangements impact 340B • When do orphan drugs qualify for a 340B discounting arrangement?

2:00

PHS 340B 2.0 James Kim Partner McDermott, Will & Emory LLP

Joseph Metro Partner Reed Smith LLP

• Examining continuing 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

» 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 º Implications of recent cases

» Distribution systems

• Protecting against duplicate discounts

» Calculation of the 340B price

» Analyzing claims data

• Validating the eligibility of purchasers

• Assessing the pros and cons of turning 340B into a rebate program

• 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?

• 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

• Restrictions for participating covered entities 3:15

Break

3:30

LAB — Learn, Apply, and Benchmark: Pricing and Rebate Exercise Under Medicaid, Medicare, and 340B Joseph Metro Partner Reed Smith LLP

Christopher H. Schott Partner Latham and Watkins LLP

Jennifer Lospinoso Managing Director & Consulting Lead Riparian LLC

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.

4:30

End of Monday Session

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BUSINESS INFORMATION IN A GLOBAL CONTEXT #DrugPricingProficiency twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

WEEK 3: Advanced CMS Pricing and RebateTopics Wednesday, November 17 • Eastern Standard Time 1:00

Understanding How Co-Pay Coupons, Accelerators, and Maximizers Impact Medicaid and Medicare Pricing and Rebates Andy Ruskin Partner K&L Gates LLP

Trevor Wear Partner Sidley 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?

• What are the types of pharmaceuticals and biologics sold under these mechanisms?

• How do these mechanisms s effect specialty products?

• Reviewing 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?

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

• How do these mechanisms affect patients in the public payor realm • Exploring the process for working with a coupon vendor 2:00

Break

2:30

Views from the Hill: The Latest Proposals on Drug Pricing and Reporting and What They May Signify James Kim Partner McDermott, Will & Emory LLP

Stephanie Trunk Partner Arent Fox LLP

The panel will analyze the status of the previous administration’s Executive Orders aimed at addressing drug prices and price reporting and what to expect under Biden. This panel will explore where proposals have landed and the implications for manufacturers.

• Eliminating “kickbacks” to middlemen

• Tying drug prices to international benchmarks

• Improving access to affordable life-saving medications

• Increasing drug importation, implications for Medicaid, 340b programs

3:30

Medicaid/Medicare Recap and Q & A 4:30

End of Wednesday Session

Related Event CALENDAR-ALT May 25 – 26, 2022 LOCATION-CIRCLE New York, NY

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AmericanConference.com/Proficiency-DrugPricing • 888 224 2480

Part of ACI’s PROFICIENCY SERIES

WEEK 4: Pricing and Reimbursement for New Products and Therapies Monday, November 29 • Eastern Standard Time 1:00

Will Your Product Be Eligible for Reimbursement?: Pre-Commercialization Concerns in New Therapeutic Development Keren Tenenbaum General Counsel, Vice President of Legal & Compliance US Vifor Pharma New considerations:

Questions to ask now:

• Understanding the distinction between FDA approval and commercial viability

• When should you start talking to payors about coding, coverage and reimbursement?

• Planning to secure appropriate coding, coverage and reimbursement for new products

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

• Assessing the competition landscape and articulating a compelling value composition 2:15

• How can you compliantly market 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?

Break

2:45

New Product Launch – Government Pricing and Contracting Considerations Margaux Hall Partner Ropes and Gray LLP • 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

Erica Petersohn Sr. Manager, Life Sciences Consulting Baker Tilly U.S. • Understanding legal, policy, and reputational risks around price setting Exploring the uses of list prices versus other pricing metrics in supply chain agreements

4:00

4:30

Recap and Q & A

• 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?

End of Monday Session

Wednesday, December 1 • Eastern Standard Time 1:00

Value of Therapy to Value Proposition: Sources and Uses of Pricing Data in Prescription Drug Advertising and Promotion Nneka Onwudiwe Former PRO/PE Regulatory Review Officer Food and Drug Administration • Understanding key variables in the determination of value to key stakeholders • What is a value proposition?

2:30

Elizabeth Lindquist Partner King and Spalding LLP

• Identifying databases of pharmaceutical benchmark prices for economic analyses

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

Break

3:00

Delving Deeper into Critical Drug Pricing-Related Pre-Launch Considerations Margaux Hall Partner Ropes and Gray LLP This session will delve into pre-launch drug pricing related considerations that can either help smooth the path to a successful launch or cause ongoing challenges. This session will focus on the following aspects:

4:00

Recap and Q & A

Craig Bleifer Principal Craig B. Bleifer LLC • FDA considerations (e.g., approval pathway, special designations, or patient populations) • Method and setting of administration • Unit of measure/dosage form • Billing codes

4:30

• 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

End of Wednesday Session and Series

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

• DRUGHUB

• Lowenstein Sandler

• Sanofi

• Almirall SA

• EnvisionRx

• McDermott Will & Emery LLP

• Scilex Pharmaceuticals Inc

• Analysis Group

• Epstein Becker & Green PC

• Sidley Austin LLP

• Ani Pharmaceuticals Inc

• Genfit

• MN Department of Administration

• Arent Fox LLP

• Greenwich Biosciences

• Morgan Lewis & Bockius LLP

• Therapeuticsmd

• Astellas Pharma Inc

• Grifols

• Bristol-Myers Squibb Company

• Hercules Pharmaceuticals Inc • Hyman Phelps & McNamara PC

• Buchanan Ingersoll & Rooney PC

• Incyte Corporation • Intercept Pharmaceuticals Inc

• Covington & Burling LLP

• Invictus Pharmacy

• CSL Behring

EARN CLE CREDITS

• King & Spalding

• Office of the US Attorney

• PhRMA

• U.S. Department of Health and Human Services

• Reed Smith LLP

• UCB Inc

• Ropes & Gray LLP

• US Attorney's Office for the District of Massachusetts

• R-Pharm US

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.

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

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 340 and other key government payor programs • Make sense of complex pricing and rebate calculations that go beyond the essentials

• Tolmar Pharmaceuticals Inc

• PhillyCooke Consulting

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.

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

• Theravance

• Otsuka Pharmaceutical

Continuing Legal Education Credits

Continuing Professional Education Credits

• Sunovion Pharmaceuticals Inc

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, Pricing Analytics

- Government Programs

- Contracts and Reimbursement

- Finance/Accounting/Audit

- Medicaid/Medicare Rebates

- 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 21.0 CPE credits.

• Examine the latest developments impacting the drug pricing and rebate programs, from the CMS final rule on MDRP and 340B litigation to the most favored nation model and more

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

• Comprehend pricing strategies and key considerations for new products and therapies

Refunds and Cancellations: Requests for refunds less the cancellation fee must be received in writing by October 22, 2021. For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.

Field of Study: Business Law Prerequisite: None.

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Level of knowledge: Basic Advanced Preparation: None

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Engage with Attendees and Speakers in an Interactive Format

Immerse Yourself in Live Presentations and Panel Discussions

Meet 1-on-1 with Your Fellow Attendees

To view the complete list of our events, please visit:

AmericanConference.com/conferences/proficiency/