critical policy updates and approaches to effectively ... · report and comply with state and...

CCB, CLE & CPE Credits Available!

Pending Approval

May 19-21, 2020

Disney’s Contemporary Resort

Orlando, FL

R E G I S T E R B Y J A N U A R Y 2 4 , 2 0 2 0 A N D S A V E $ 5 0 0 !

22nd ANNUAL

Rebecca Chan, Senior Director,

Government Programs and Pricing,

Gilead

CRITICAL POLICY UPDATES AND APPROACHES TO EFFECTIVELY CONTRACT, REPORT AND COMPLY WITH STATE AND FEDERAL HEALTHCARE PROGRAMS

David Tawes, Regional Inspector General,

Department of Health and Human Services,

OIG

Rajeev Devgan, Director, Government Rebate Operations, Johnson & Johnson

Health Care Systems

Lisa Kiniklis,Director, Government Pricing and Reporting,

Alnylam Pharmaceuticals

Rob LaPorte, Senior Director,

Government Pricing, Sun Pharmaceutical

Industries, Inc.

Ed McAdam,Director, Government Pricing, Contracting

Operations and Analytics, Indivior plc

Darnell Turner, Executive Director,

Government Price Reporting,

Exelixis

Mark Myers, Director, Healthcare Resources Division,

VA Office of Inspector General, Office of Contract Review

Nicholas Uehlecke,

Advisor, U.S. Department of Health and Human

Services (HHS) (Invited)

Rafael Angulo, Director,

Government Pricing, Novartis

Brought to you by

an informa business

INNOVATIVE PROGRAM HIGHLIGHTS TO ENHANCE KNOWLEDGE SHARING

Two In-Depth Symposia:

Nine Tailored Tracks of Content:

1

SMALL AND EMERGING BIOTECH 2

MID-LARGE PHARMA 3

GENERIC MANUFACTURERS

4 MEDICAID CLAIMS AND CONTRACT OPERATIONS 5 FEDERAL CONTRACTING

AND REPORTING 6

340B PROGRAM OVERSIGHT AND COMPLIANCE

7 PRICING, CONTRACTING AND REIMBURSEMENT 8

LEGAL AND COMPLIANCE 9

FINANCE OPERATIONS

GOVERNMENT PRICING AND REPORTING 101 BOOT CAMP A SENIOR-LEVEL THINK TANKB

W W W. C B I N E T. C O M / M E D I C A I D

PRICING & CONTRACTING SERIES

Bundling

Rebate Stacking

A.I and Machine LearningState

Pricing Transparency

Dispute Resolution

TAA Compliance

State Invoicing

ABOUT THE CONGRESS

2

Function

62% Pricing/Contracts/Reporting/MDRP

19% Finance/Accounting

12% Managed Markets/Market Access

7% Legal/Compliance

Company Size

60% Small

20% Large

12% Upper-Mid

8% Mid

Bona Fide Service Fees

340B Program

Supplemental Rebates

Backed by 21 years of industry expertise, the Medicaid and Government Pricing Congress convenes hundreds of executives within the GP community representing pharmaceutical, biotech, generic

and medical device manufacturers. This Congress arms attendees with action-oriented discussions and implementable takeaways led by the industry’s most authoritative government pricing experts for up-to-the

minute insights in an evolving and uncertain regulatory and political landscape.

Gross-to-Net

Value-Based ContractsFederal

Contracting

M&A

340B Duplicate Discounts

Class of TradeMedicare

Part B & DCPIU

Penalties

State Policy Medicaid

Rebate Processing

Government Price

Reporting

Who You'll Connect With — 2019 Attendee Profile

“Up to the minute updates, informative and great speakers. Conference is great for beginners to experts. I can always take something from this conference and enjoy the networking opportunities.”

“The quality of the speakers was outstanding — informative and insightful!”

“One of the best conferences I’ve seen that addresses the key issues facing the industry as it pertains to Medicaid and other pricing issues.”

I thought this was one of the most informative and well run GP and Medicaid Congresses yet. I really enjoyed the speakers — all of them did terrific jobs with their materials. I thought the choice of topics was well executed and the facilities of course were fantastic!”

PRE-CONFERENCE SYMPOSIA — TUESDAY, MAY 19, 20208:00 Pre-Conference Symposia Registration and Networking Breakfast

9:00 CHOOSE BETWEEN TWO SYMPOSIA BASED ON LEVEL OF EXPERTISE (A-B)

GOVERNMENT PRICING AND REPORTING 101 BOOT CAMP A SENIOR-LEVEL THINK TANKB10:30 Networking and Refreshment Break

12:00 Networking Luncheon

1:00 CHOOSE BETWEEN THREE TRACKS BASED ON COMPANY TYPE (1-3)

1:00 Track Chair’s Welcome

1:05 PANEL • Product Launch Roadmap — Best Practices to Establish a GP Strategy

1:45 2020 Industry Update — Emerging Biotech/New Launch

2:25 Align Operational Practices Around COT Assignments

1:00 Track Chair’s Welcome1:05 Technology and Automation Driving

GP Efficiencies 1:45 Keeping Compliant — Strategies to

Support Infrastructure and Processes to Enable Commercial, GP and Drug Pricing Teams

2:25 PANEL • Considerations and Approaches to Support Product and Business Success


1:05 CPIU Penalty Impact to Manufacturers 1:45 GP Considerations for Sourcing Programs 2:25 Generic Product Launch Approaches

and Considerations

1 SMALL AND EMERGING BIOTECH 2 MID-LARGE PHARMA 3 GENERIC MANUFACTURERS

3:05 Networking and Refreshment Break

3:35 CHOOSE BETWEEN THREE TRACKS (4-6)


3:40 Voluntary Contracting and Claims 4:20 Improve the Efficiency of Medicaid

Claims Validation

5:00 PANEL • State Invoicing and Dispute Resolution Think Tank


3:40 Country of Origin and Trade Agreement Act Compliance

4:20 Prepare, Negotiate and Implement FSS Contracts

5:00 Understand the Subcontractor Flow Down Requirements and Strategies for Compliance


3:40 340B Update — Policy Proposals, Regulatory Oversight and Compliance

4:20 340B Duplicate Discounts — What Happens When the Free Lunch is No Longer Available?

5:00 PANEL • 340B Refund Processing for New Products and Restatements and Restatements

4 MEDICAID CLAIMS AND CONTRACT OPERATIONS 5 FEDERAL CONTRACTING

AND REPORTING 6

340B PROGRAM OVERSIGHT AND COMPLIANCE

5:45 Close of Tracks / Welcome Reception Begins

MAIN CONGRESS DAY ONE — WEDNESDAY, MAY 20, 20207:30 Networking Breakfast

8:30 Chairman’s Welcome and Opening Remarks

8:45 KEYNOTE ADDRESS State of the Industry — Political and Legislative Trends

9:30 PANEL DISCUSSION Navigate Complexities of State Price Transparency and Reporting Requirements


10:45 Evaluate Impacts of Price Reporting on Government Program Liability

11:30 Cross-Functional Impact of Industry Trends and Hot Topics — Operational, Financial, Technological and Compliance Considerations


1:30 Operational Excellence and Process Efficiency Strategies for Government Pricing

2:15 OIG UPDATE OIG Work Plan and 2020 Initiatives


3:30 CMS REMOTE ADDRESS MDRP Policy Initiatives and Operational Updates

4:15 State Spotlight — Prevailing Trends and Key Factors Impacting State Policy

5:00 Close of Day One / Networking Cocktail Reception Begins

MAIN CONGRESS DAY TWO — THURSDAY, MAY 21, 20208:00 Networking Breakfast

8:30 CHOOSE BETWEEN 3 TRACKS BASED ON FUNCTION (7-9)


8:40 Understand and Integrate Government Pricing with Broader Market Access Trends

9:25 Innovative Contracting and Bundling


10:45 Navigate Evolving Value-Based Contracting Models and Overcome GP Implications


8:40 Ensuring Compliance with State Price Transparency Reporting

9:25 Bona Fide Service Fees and Fair Market Value Determination


10:45 Surviving a Government Pricing and Contracting Audit

8:30 Track Chair’s Welcome8:40 GTN Models and Best Practices for Forecasts,

Estimates and Accruals

9:25 PANEL • Evaluate the Importance of Cross-Functional Collaboration of GP, Finance and Compliance


10:45 Using Analytics to Drive Gross-to-Net Assumptions in Government Programs

7 PRICING, CONTRACTING AND REIMBURSEMENT 8

LEGAL AND COMPLIANCE 9

FINANCE OPERATIONS


1:00 Legal and Compliance Closing Fireside Chat

2:15 Chairman’s Closing Remarks

2:30 Close of Congress

AGENDA-AT-A-GLANCE

3

Sabrina Aery, Director, Federal Executive Branch Strategy, Bristol-Myers Squibb

Rafael Angulo, Director, Government Pricing, Novartis

Steve Benz, Partner, Arnold & Porter

Brian Bohnenkamp, Partner, King & Spalding

Mike Borgia, Group Director, Government Channel, Johnson & Johnson

Larry Breen, Director, Financial Planning and Analysis, Sunovion Pharmaceuticals

Tara Brodo, NEW!

Director, Contract Operations, Daiichi Sankyo

Lynn Buhl, Director, KPMG

JoAnn Bute, Director, Government Pricing and Compliance, Amneal Pharmaceuticals

Chris Callahan, NEW!

Manager, KPMG

Jason Carter, NEW!

Director, Government Pricing, Gilead

David Chan, Co-Founder and CEO, Riparian

Rebecca Chan, NEW!

Senior Director, Government Programs and Pricing, Gilead

Lisa Clayton, Director, Government Reporting, Granard Pharmaceuticals

Philip Coburn, NEW!

Director, U.S. Government Pricing Compliance, Pfizer Inc

John Coster Ph.D., R.Ph., Director, Division of Pharmacy, Center for Medicaid and CHIP Services, CMS

Shane Daniels, NEW!

Manager, Government Contract Services, EY

Meena Datta, Partner, Sidley Austin LLP

Rujul Desai, Of Counsel, Covington & Burling LLP

Rajeev Devgan, Director, Government Rebate Operations, Johnson & Johnson Health Care Systems

Jennifer English, Senior Director, Market Access, Pricing and Gross-to-Net Financial Operations, Insmed Corporation

Megan Falkowski, NEW!

Director, Government Pricing and Government Contracting Policy, Pfizer Inc

Kelly Guntrum, NEW!

Head, Value Based Contracts and Innovation, UCB

Stacey Hale, Manager, Drug Rebate, Oklahoma Health Care Authority

Josephine Hawkins, Associate Director, Medicaid, AstraZeneca

Doug Helling, Associate General Counsel, UCB

Glen Huttar, Director, Government Pricing, Johnson & Johnson Health Care Systems

Lisa Kiniklis, NEW!

Director, Government Pricing and Reporting, Alnylam Pharmaceuticals

Stephanie Kupski, Director, U.S. Pricing and Government Reporting, CSL Behring

Richard Lane, NEW!

Associate Director, Finance, Jazz Pharmaceuticals

Rob LaPorte, Senior Director, Government Pricing, Sun Pharmaceutical Industries, Inc.

Miree Lee, M.S., MBA, Bio/Pharma Pricing, Contracts and Compliance Consultant, M. Lee Consulting

Erika Lightbourne, NEW!

Advisor, Government Price Reporting Operations, Lilly USA

Elizabeth Lindquist, Partner, King & Spalding

Felecia Manning, NEW!

Associate Director, Market Access, Pricing and Reimbursement, Theravance Biopharma US

Jay McKinley, NEW!

Director, Government Pricing Compliance, Sandoz Inc.

Ed McAdam, Director, Government Pricing, Contracting Operations and Analytics, Indivior plc

Lisa McNair, Senior Manager, Compliance – Government Programs, Alvogen

Jesse Mendelsohn, Vice President, Centers of Excellence, Model N

Mark Myers, Director, Healthcare Resources Division, VA Office of Inspector General, Office of Contract Review

Tiffany Nowell, NEW!

Assistant General Counsel, Pfizer Inc

Jill Page, Director, Government Programs and Price Reporting, AMAG Pharmaceuticals

Jeff Park, NEW!

Director, Pricing and Contracting, Aimmune

Kelly Pitt, NEW!

Senior Counsel, North America, Sobi, Inc

Jennifer Plitsch, Partner, Covington & Burling LLP

Dorine Rascoe, Fiscal Program Manager, Drug Rebates, Maryland Department of Health

William Sarraille, Partner, Sidley Austin LLP

John Shakow, Partner, King & Spalding

David Tawes, Regional Inspector General, Department of Health and Human Services, OIG

Kevin Tran, NEW!

Manager, Government Contract Services, EY

Stephanie Trunk, Partner, Arent Fox

Darnell Turner, NEW!

Executive Director, Government Price Reporting, Exelixis

Nicholas Uehlecke, NEW!

Advisor, U.S. Department of Health and Human Services (HHS) (Invited)

Aaron Vandervelde, Managing Director, BRG

Raquel Villanueva, Senior Manager, Contract Operations, Jazz Pharmaceuticals

Debbie Walters-Francique, Vice President and Assistant General Counsel, Pfizer Inc

Trevor Wear, Partner, Sidley Austin

Donna White, Vice President, Contracts and Compliance, Chiesi USA Inc.

Joseph Wieseler, NEW!

Medicaid Drug Rebate Manager, South Dakota Department of Social Services

DISTINGUISHED SPEAKERS

4

For newcomers and seasoned professionals with responsibilities including government pricing, contracting, reporting and compliance, this 101 Boot Camp is designed to lay the groundwork and instill a fundamental understanding on key components to be discussed throughout the remainder of the Congress. The session will conclude with an interactive monthly/quarterly mock calculation.

• Fundamentals of the Medicaid Drug Rebate Program (MDRP)• Insight into additional government programs, including Medicare,

340B and FSS• Intersection between MDRP and 340B• Deep dive into basic calculations for certain price types including

AMP, BP and URA • Systems and technology to facilitate government pricing

and reporting• Considerations for class of trade inclusion and exclusion• Mock calculation scenario planning

Miree Lee, M.S., MBA, Bio/Pharma Pricing, Contracts and Compliance Consultant, M. Lee Consulting

Stephanie Kupski, Director, U.S. Pricing and Government Reporting, CSL Behring

Erika Lightbourne, Advisor, Government Price Reporting Operations, Lilly USA

This senior-level Tthink Tank serves as a great starting point to ignite the conversation. During this working group, meet fellow esteemed colleagues to share experiences and brainstorm solutions to common challenges. Participants are surveyed prior to the meeting to help the facilitators prepare key topics of discussion. Take part in this knowledge-exchange and meeting of the minds to connect on key issues facing government pricing and reporting professionals working in the life sciences industry. The discussion points will be summarized and distributed after the conference concludes. Potential topics for discussion include:• Operational impacts of policy and pricing reform• Pricing transparency requirements• Innovative bundling and contracting• Machine learning, A.I. and automation • Class of trade monitoring • Rebate stacking

*This Think Tank is targeted for management-level and above professionals with pricing, reporting and contracting responsibilities.

MODERATOR:

KPMG

PANELISTS:

Rebecca Chan, Senior Director, Government Programs and Pricing, Gilead

Sabrina Aery, Director, Federal Executive Branch Strategy, Bristol-Myers Squibb

PRE-CONFERENCE SYMPOSIA — TUESDAY, MAY 19, 20208:00 Pre-Conference Symposia Registration and Networking Breakfast

A GOVERNMENT PRICING AND REPORTING 101 BOOT CAMP

9:00 CHOOSE BETWEEN TWO SYMPOSIA BASED ON LEVEL OF EXPERTISE (A-B)


B SENIOR-LEVEL THINK TANK

Small and Emerging Biotech1 Mid-Large Pharma2 Generic

Manufacturers31:00 Track Chair’s Welcome

Jennifer English, Senior Director, Market Access, Pricing and Gross-to-Net Financial Operations, Insmed Corporation

1:05 PANEL DISCUSSION Product Launch Roadmap — Best Practices to Establish a GP Strategy • Evaluate key concepts to

factor into your government pricing objectives during new product planning

• Discuss strategies to establish your new product within federal programs

• Assess policies and procedures for loading pricing with compendia

• Strategize how to form a team of legal counsel, consultants, internal staff, software, etc.

• Communicate the value of the GP cost/function to management

1:00 CHOOSE BETWEEN THREE TRACKS BASED ON COMPANY TYPE (1-3)

5


Glen Huttar, Director, Government Pricing, Johnson & Johnson Health Care Systems

1:05 Technology and Automation Driving GP Efficiencies• Gain insight into how A.I.,

machine learning and robotics are being integrated into government pricing and contracting

• Leverage actionable insights to streamline GP calculations and analytics

1:45 Keeping Compliant — Strategies to Support Infrastructure and Processes to Enable Commercial, GP and Drug Pricing Teams • Considerations when building

teams to scale the business• Organizational structure

and responsibilities


JoAnn Bute, Director, Government Pricing and Compliance, Amneal Pharmaceuticals

1:05 CPIU Penalty Impact to Manufacturers • Address how to overcome

challenges if CPIU penalty is triggered due to loss of business vs. price increase

• Navigate the effects of price increases

• Discuss drug shortages and CPIU

• Assess the volatility of generic AMPs

• Examine CPIU and penny pricing in PHS

Lisa Clayton, Director, Government Reporting, Granard Pharmaceuticals

Mike Borgia, Group Director, Government Channel, Johnson & Johnson

10:30 - 11:00 Networking and Refreshment Break

6

PANELISTS:

Lisa McNair, Senior Manager, Compliance – Government Programs, Alvogen

Jeff Park, Director, Pricing and Contracting, Aimmune

Associate Director, Market Access, Pricing and Reimbursement, Theravance Biopharma US

1:45 2020 Industry Update — Emerging Biotech/New Launch• Tailoring best practices to

small company needs • Industry benchmarking • Hot topic polling — Real-

time illustration of pressing problems and solutions

• Interactive Q&A dialogue

David Chan, Co-Founder and CEO, Riparian

2:25 Align Operational Practices Around COT Assignments• Explore the challenges

of Class of Trade (COT) assignments

• Evaluate industry best practices for COT assignments

• Discuss the downstream impact of COT assignments on calculations

• Identify risks and implications of inaccurate payments on government pricing (GP)

• Gain insight into real world examples of efficiencies when departments are aligned

GP Advisor, The Activus Group

• Impact of drug pricing on teams, infrastructure and operations to ensure compliance

Debbie Walters-Francique, Vice President and Assistant General Counsel, Pfizer Inc

Tiffany Nowell, Assistant General Counsel, Pfizer Inc

2:25 PANEL DISCUSSION Considerations and Approaches to Support Product and Business Success • Best practices to collaborate

with cross-functional teams• System design and

implementation• Process design and

third-party oversight• Balance the increasing demands

of government price reporting• Interaction between GP, states

and government affairs

MODERATOR:


PANELISTS:

Rob LaPorte, Senior Director, Government Pricing, Sun Pharmaceutical Industries, Inc.

Rafael Angulo, Director, Government Pricing, Novartis

1:45 GP Considerations for Sourcing Programs• Understand the players

involved in sourcing • Discuss unbundling and

allocations• Learn about methods for

innovative factoring

Lynn Buhl, Director, KPMG

Chris Callahan, Manager, KPMG

2:25 Generic Product Launch Approaches and Considerations • Assess market drivers, market

share and competition• Discuss WAC considerations

and how price changes impact government pricing

• Identify key considerations for discounting and rebate arrangements

• Explore provisional 340B prices

• Hear approaches to voluntarily sell generics to the VA



3:35 CHOOSE BETWEEN THREE TRACKS (4-6)

Federal Contracting and Reporting 5 340B Program Oversight

and Compliance 63:35 Track Chair’s Welcome

3:40 Voluntary Contracting and Claims • Key considerations when

negotiating for supplemental rebates and programs

• Discuss best practices, bid types, PDLs and how to review for compliance

• Assess how to manage MCOs inclusion in supplementals

• Identify what SPAPs are, why to participate and qualified vs. non-qualified

• Look ahead at what to expect with voluntary contracting and claims

Josephine Hawkins, Associate Director, Medicaid, AstraZeneca


3:40 Country of Origin and Trade Agreement Act Compliance• Sourcing obligations for all

Federal Supply Schedule (FSS) and other government sales

• Certification requirements and best practices

• Recent developments and outstanding issues

• Impacts for both generic and branded manufacturers

Jennifer Plitsch, Partner, Covington & Burling LLP


Megan Falkowski, Director, Government Pricing and Government Contracting Policy, Pfizer Inc

3:40 340B Update — Policy Proposals, Regulatory Oversight and Compliance• Gain insight into the current

state of OPA/HRSA guidance• Evaluate experiences with the

OPAIS reporting system• Navigate reasonable

assumptions and implementation hurdles

• Discuss results of HRSA audits of manufacturers and covered entities

Medicaid Claims and Contract Operations4

7

4:20 Improve the Efficiency of Medicaid Claims Validation • Invoices and PPAs• Variance tests for your

product portfolio• What to look for in claim-level

detail and how to get it• Considerations for duplicates

and 340B• Bracing for increased

volume with the growth of your manufacturer

Deloitte

5:00 PANEL DISCUSSION State Invoicing and Dispute Resolution Think Tank • Gain insights into the state’s data

flow and invoicing processes• Hear manufacturers highlight

common disputes• Discuss challenges with

340B claims• Processing state invoices for

Medicaid and supplemental programs

• Learn from states as they discuss reasons behind claim issues

• Discover best practices, including the benefits of leveraging a standardized validation tool

PANELISTS:

Dorine Rascoe, Fiscal Program Manager, Drug Rebates, Maryland Department of Health

Stacey Hale, Manager, Drug Rebate, Oklahoma Health Care Authority

Joseph Wieseler, Medicaid Drug Rebate Manager, South Dakota Department of Social Services

4:20 Prepare, Negotiate and Implement FSS Contracts• Discuss key elements of

getting on the FSS schedule• Hear strategies to approach

contract negotiations• Learn about FSS program

intricacies, non-FAMP and FCP calculations

Mark Myers, Director, Healthcare Resources Division, VA Office of Inspector General, Office of Contract Review

5:00 Understand the Subcontractor Flow Down Requirements and Strategies for Compliance• Examine manufacturer

requirements to flow down certain provisions to its subcontractors and the substantive requirements of the particular clauses

• Discuss what qualifies as a “subcontract” in the context of the flow down requirements

• Learn the flow down requirements enforced by the Department of Labor’s Office of Federal Contracts Compliance Programs

• Gain strategies for compliance with the flow down requirements in your VA FSS Schedule 65 I B contract

• Hear ways to flow down the required clauses in your agreements with subcontractors

Elizabeth Lindquist, Partner, King & Spalding

4:20 340B Duplicate Discounts — What Happens When the Free Lunch is No Longer Available?• Understand the financial

impact of duplicate discounts on all stakeholders in the 340B program

• Learn how eliminating duplicate discounts impacts unexpected beneficiaries of the 340B program

• Discuss recent developments in how state Medicaid programs, PBMs and covered entities are managing the impact of duplicate discounts

• Review options for how manufacturers can better address duplicate discounts in a sustainable manner

Aaron Vandervelde, Managing Director, BRG

5:00 PANEL DISCUSSION 340B Refund Processing for New Products and Restatements • Strategies to operationalize

refunds and reconciliation processes

• Streamline refund overpayments to 340B covered entities

• Calculate the estimated ceiling price in accordance with the CMP Final Rule

• Discuss working within the OPAIS pricing system for new drugs and quarterly reconciliations

PANELISTS:

Philip Coburn, Director, U.S. Government Pricing Compliance, Pfizer Inc

Jill Page, Director, Government Programs and Price Reporting, AMAG Pharmaceuticals

Cathy Burton Meza, Senior Manager, Audits and Compliance, Gilead

5:45 CLOSE OF TRACKS AND PRE- CONGRESS

W EL C O M E R E C EP T I O N

MAIN CONFERENCE DAY ONE — WEDNESDAY, MAY 20, 20207:30 Networking Breakfast

8:30 Chairman’s Welcome and Opening Remarks Rajeev Devgan, Director, Government Rebate Operations, Johnson & Johnson Health Care Systems

8:45 KEYNOTE ADDRESS State of the Industry — Political and Legislative Trends • Updates to the Prescription Drug Pricing Reduction Act

(PDPRA) of 2019 and impacts to manufacturers • Initiatives to implement International Pricing Index (IPI)

and favored nations clause• Impact of the IPI model on best price (BP) and price

reporting methodology• Part D pricing threshold for new drug issuants• 2020 elections and pending reform proposals

Nicholas Uehlecke, Advisor, U.S. Department of Health and Human Services (HHS) (Invited)

9:30 PANEL DISCUSSION Navigate Complexities of State Price Transparency and Reporting Requirements • Overview of the current landscape and evolving universe

of state pricing transparency laws• Operationalize challenges from the continuously evolving

pricing transparency legislation• Best practices to effectively monitor changes to pricing

transparency requirements • Insight into departmental organization and where the

ownership of price transparency requirements liesMODERATOR:

Trevor Wear, Partner, Sidley Austin

PANELISTS:

Jay McKinley, Director, Government Pricing Compliance, Sandoz Inc.

Lisa Kiniklis, Director, Government Pricing and Reporting, Alnylam Pharmaceuticals

Doug Helling, Associate General Counsel, UCB

Tiffany Nowell, Assistant General Counsel, Pfizer Inc

8


10:45 Evaluate Impacts of Price Reporting on Government Program Liability

John Shakow, Partner, King & Spalding

11:30 Cross-Functional Impact of Industry Trends and Hot Topics — Operational, Financial, Technological and Compliance Considerations• Explore the impact of current drug pricing legislation on

business models, workforce and compliance• Discuss technology implications of systems integration

and interoperable data• Hear financial implications and compliance considerations

if bringing another company’s drug into your portfolio• Learn leading practices for team structure and bringing

systems on board

Deloitte


1:30 Operational Excellence and Process Efficiency Strategies for Government Pricing• Hear updates in advancements to government pricing

and reporting• Discuss key concepts to gain efficiencies amid a landscape

of uncertainty• Leverage actionable insights to streamline government

pricing calculations and analytics

Jesse Mendelsohn, Vice President, Centers of Excellence, Model N

2:15 OIG UPDATE OIG Work Plan and 2020 Initiatives • Learn the latest program integrity initiatives and

oversight activities• Hear how the OIG develops its work plan and

strategic goals• Gain insight into findings and policy recommendations

from recent studies• Discuss initiatives to ensure manufacturer compliance with

MDRP price reporting requirements

David Tawes, Regional Inspector General, Department of Health and Human Services, OIG


3:30 CMS REMOTE ADDRESS MDRP Policy Initiatives and Operational Updates• Status update on changes to the Medicaid Drug

Rebate Program • Insight into implementation of covered outpatient

drug regulation • Address issues relating to value-based purchasing

John Coster Ph.D., R.Ph., Director, Division of Pharmacy, Center for Medicaid and CHIP Services, CMS

4:15 State Spotlight — Prevailing Trends and Key Factors Impacting State Policy • State activity, nuances and obstacles to overcome • Insight on waivers and the transition to universal PDLs • Updates on where various states are with value-based

contracting • Reactions related to changes in reimbursement

methodology

5:00 Close of Day One

NETWORKING COCKTAIL RECEPTION

DAY TWO — THURSDAY, MAY 21, 20208:00 Networking Breakfast

Pricing, Contracting and Reimbursement7 Legal and Compliance8 Finance Operations9


Jason Carter, Director, Government Pricing, Gilead

8:40 Understand and Integrate Government Pricing with Broader Market Access Trends • Discuss how market access

trends, including PBM driven initiatives, are evolving and implicating government pricing obligations

• Employ strategies to align government pricing and gathering of data from new sources such as EHRs

8:30 CHOOSE BETWEEN 3 TRACKS BASED ON FUNCTION (7-9)


Donna White, Vice President, Contracts and Compliance, Chiesi USA Inc.

8:40 Ensuring Compliance with State Price Transparency Reporting • Discuss considerations

to effectively manage compliance requirements

• Navigate the impact and penalties associated with non-compliance

• Understand what triggers a reporting event for your organization


8:40 GTN Models and Best Practices for Forecasts, Estimates and Accruals• Discuss how states are invoicing

and coming up with accruals• Understand how much needs to

be accrued• Evaluate what to expect in

terms of utilization given delays that may occur between states and managed Medicaid

• Delve into processes involved for accruals

Larry Breen, Director, Financial Planning and Analysis, Sunovion Pharmaceuticals

9

1:00 FIRESIDE CHAT Legal and Compliance Closing Fireside ChatAn interactive discussion featuring a panel of experienced attorneys providing insight into the most pressing issues. Discussion topics are decided the day of, however, question submission in advance of the discussion is encouraged.


MODERATOR:

KPMG LLP

PANELISTS:

John Shakow, Partner,

King & Spalding




• Consider the intersection of government pricing and growing HTA reporting across U.S. and global markets


9:25 Innovative Contracting and Bundling

Kelly Guntrum, Head, Value Based Contracts and Innovation, UCB


10:45 Navigate Evolving Value-Based Contracting Models and Overcome GP Implications• Evaluate what is in the market

today in terms of value and outcomes-based arrangements

• Discuss how the existing value-based frameworks are working

• Identify implications to government pricing and discuss strategies to overcome


• Build internal infrastructure to ensure compliance with the laws

• Evaluate the intersection with Sunshine reporting requirements

Brian Bohnenkamp, Partner, King & Spalding

9:25 Bona Fide Service Fees and Fair Market Value Determination• Key considerations to overcome

challenges with FMV and streamline the determination of fees for service Medicaid price reporting

• Approaches to FMV issues, including what they value, how they're valued and how they document their analysis

• New PBM and other changes in the marketplace present FMV and FFS service issues

William Sarraille, Partner, Sidley Austin LLP


10:45 Surviving a Government Pricing and Contracting Audit• Discuss various types of audits

that can occur (year-end financial, 340B, OIG, CMS, internal, etc.)

• Highlight common audit findings and implications

• Share leading practices to avoid, prepare for and manage various audits

Shane Daniels, Manager, Government Contract Services, EY

Kevin Tran, Manager, Government Contract Services, EY

9:25 PANEL DISCUSSION Evaluate the Importance of Cross-Functional Collaboration of GP, Finance and Compliance/Legal• Discuss best practices to gain

enhanced business decisions related to gross-to-net

• Navigate challenges with delayed invoicing and gain best practices to tackle accruals

• Understand the size of the 340B business to assist with accrual estimates

• Explore perspectives on the evaluation of discounts vs bona fide service fees and FMV

MODERATOR:


PANELISTS:

Ed McAdam, Director, Government Pricing, Contracting Operations and Analytics, Indivior plc

Kelly Pitt, Senior Counsel, North America, Sobi, Inc

Tara Brodo, Director, Contract Operations, Daiichi Sankyo

Darnell Turner, Executive Director, Government Price Reporting, Exelixis


10:45 Using Analytics to Drive Gross-to-Net Assumptions in Government Programs• Discuss how to collaborate with finance

and other cross-functional partners in order to enrich GTN insights

• Delve into analyses that help drive GTN assumptions for government programs

• Understand and troubleshoot some of the challenges associated with GTN analytics and data

Raquel Villanueva, Senior Manager, Contract Operations, Jazz Pharmaceuticals

Richard Lane, Associate Director, Finance, Jazz Pharmaceuticals

2:15 Chairman’s Closing Remarks

Rajeev Devgan, Director, Government Rebate Operations, Johnson & Johnson Health Care Systems

2:30 Close of Conference

“This conference is amazing!! Extremely knowledgeable speakers providing a wealth of information. This conference is a must for anyone involved in any part of the GP space.”

SP O NS O R S & E X HIB I T O R S

A GREAT PLACE TO MEET YOUR MARKET!

Maximize your access to decision-makers and align your brand with the life sciences industry’s premier thought-leaders and industry innovators. Informa Connect-CBI’s custom sponsorship programs are designed to support your organization’s overall

business development and marketing initiatives through meaningful prospect and customer interactions, brand assertion campaigns and content-rich thought-leadership opportunities. Capitalize on the life sciences community’s premier platform for peer-to-peer exchange, solution driven content and first-in-class networking opportunities. For additional information on sponsorship or exhibit opportunities, please call Derek Tagliarino at (339) 298-2206 or email [email protected].

10

Media Partners:

W W W. M E D I C A I D D R U G R E B AT E S .C O M

JOIN US AGAIN IN SEPTEMBER FOR YOUR FALL MEDICAID UPDATE!

Medicaid Drug Rebate Program September 15-17, 2020

Marriott Marquis | Chicago, IL

Tuesday, May 19, 2020

9:00AM A B 1:00PM 1 2 3 3:35PM 4 5 6

Thursday, May 21, 2020

8:30AM 7 8 9

Disney’s Contemporary Resort4600 North World DriveLake Buena Vista, FL 32830Phone Reservations: (407) 939-1936Hotel Direct Line: (407) 824-1000

ACCOMMODATIONS:To receive Informa Connect-CBI’s discounted hotel rate, visit www.cbinet.com/medicaid

BOOK NOW! The Disney’s Contemporary Resort is accepting reservations on a space and rate availability basis. Rooms are limited so please book early. All travel arrangements subject to availability.

PLEASE NOTE: All hotel reservations for this conference should be booked directly with the hotel. Informa Connect-CBI does not use Housing Bureaus and none are authorized to call on our behalf.

VENUE

PRICING CHOOSE FROM

Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Credit Card (Visa, MC, AMEX, Discover) or checks accepted. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.)

PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate.

GROUP RATE

Looking to bring your team? Contact Christian Alongi to learn about potential group savings. Call 339-298-2131 or email [email protected].

* Advantage pricing rates do apply when applicable. Offer may not be combined with any other special pricing promotions. Offer may be used at Informa Connect-CBI co-located events.

SUBSTITUTION & CANCELLATION

Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. All cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $499 administrative charge. No refunds will be made after this date; however, the registration fee less the applicable administrative charge can be credited to another Informa Connect-CBI conference if you register within 30 days from the date of this conference to an alternative Informa Connect-CBI conference scheduled within the next six months. In case of conference cancellation, Informa Connect-CBI's liability is limited to refund of the conference registration fee only. Cancellation of a conference due to events beyond our control* are subject to a $499 administrative charge, should you or a colleague be unable to attend the rescheduled date. Informa Connect reserves the right to alter this program without prior notice.

PLEASE NOTE: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or Informa Connect-CBI.

*Events beyond our control include: severe weather conditions, natural and man-made disasters and any other similar events.

SATISFACTION GUARANTEED:

Informa Connect-CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable Informa Connect-CBI conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for Informa Connect-CBI conferences is not required.

ADDITIONAL DETAILS

11

REGISTRATION INFORMATION

Advantage Rate Register by 1/24/20

Standard Rate Register by 5/18/20

Onsite Rate

Life Sciences Companies $2699 $3199 $3299

Solution Providers/ Consultants/Law Firms $3099 $3599 $3699

SAVE

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Informa Connect-CBI 70 Blanchard Road Burlington, MA 01803

W W W . C B I N E T . C O M / M E D I C A I D

May 19-21, 2020 • Disney’s Contemporary Resort • Orlando, FL

REGISTER BY JANUARY 24, 2020 AND SAVE $500!

ANY QUESTIONS OR TO REGISTER CONTACT:

Christian Alongi phone 339-298-2131 email [email protected]

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critical policy updates and approaches to effectively ... · report and comply with state and...

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