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A division ofUBM Americas

R E G I S T E R B Y J U N E 1 6 , 2 0 1 7 A N D S A V E $ 3 0 0 !CLE and CPE

Credits Available! Pending Approval

Supporting Media Partners:

August 22-23, 2017Hilton Alexandria Old TownAlexandria, VAS UMM I T

Strengthen Program Compliance and Integrity in an Evolving Regulatory Landscape

CBI’s Annual

Customize Your Conference Experience — Choose Between Two In-Conference Workshops:

101 Summit — 340B Boot Camp 340B Duplicate Discounts

Develop proactive techniques to improve new policy adoption and program compliance

Determine impact of the Mega-Guidance withdrawal on diversion risk

Review manufacturer comments on HRSA’s Final Rule regarding manufacturer ceiling prices and civil monetary penalties

Reduce duplicate discount loss potential by working with intermediaries to conduct good faith dispute resolution

Evaluate the evolving specialty bio/pharma landscape and discuss changes in decision-making autonomy, payment methodology and delivery system structure

Discuss options to increase visibility into contract pharmacies and understand how claims adjudication has occurred

Uncover best practices to respond to covered entities and initiate good faith financial remediation

LEGAL SPOTLIGHT

John Shakow, Partner,

King & Spalding

CO

MPLIANCE SPOTLIGHT

Chris Hatwig, President,

Apexus

MAN

UF

ACTURER-ONLY DISCUSSION

Hae Won Min Liao, Assistant General Counsel, Gilead Sciences

COVERED ENTITY INSIGHTS

Jeff Davis, Legislative and Policy Counsel,

340B Health

CONFERENCE CHAIR

Sabrina Aery, Director, 340B Compliance and State Policy,

Bristol-Myers Squibb

A B

Hear Insights from the Industry’s First 340B Closed-Door Collaboration ForumPLUS!

Premier Media Partner:

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A Great Place to Meet Your Market!Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while

demonstrating thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact Kelsey Maloney at 339-298-2257 or email kelsey.maloney@cbinet.com.

With evolving regulations impacting 340B programs, pharmaceutical companies are faced with uncertainty on how to strengthen program compliance and integrity. CBI’s 340B Manufacturer Summit breaks down and clarifies recent and impending regulations, provides strategies to develop comprehensive self-disclosure response and auditing processes and establishes best practices to collaborate with covered entities and contract pharmacies within an evolving healthcare landscape.

WHO SHOULD ATTEND:

You will benefit from attending this event if you are from a pharmaceutical/biotech manufacturer with responsibilities or involvement in the following areas:

• Government Pricing

• Contracting

• Legal

• Compliance

• Pricing

• Government Accounts

• Finance

• Reporting

• Reimbursements

• Rebates

This conference will also benefit consultants, outside counsel and software vendors providing services in the above areas of Medicaid rebates, government pricing, contracting or revenue management.

BENCHMARK WITH LEADING 340B PERSPECTIVES, INCLUDING:

Mike Benedict, Vice President, Apexus

Cathy Burton-Meza, Manager, Contract Compliance, Gilead Sciences

Marcus Farbstein, RPH, Director, Public Policy and Government Markets, Medivation

Jason Hardaway, Managing Partner, CiiTA, LLC

Colleen Menges, Director, Government Contracts, Johnson & Johnson

Shrujal Patel, Co-Founder and Managing Partner, The Alinea Group, LLC

Frank Prybeck, Director, Government Pricing and Contract Administrator, Celgene

Charles Washington, Director, Global Security, Pfizer Inc

And More!Conference Sponsors Include:

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DAY ONE TUESDAY, AUGUST 22, 2017 12:00 Main Conference Registration

1:00 Chairperson’s Welcome & Opening RemarksSabrina Aery, Director, 340B Compliance and State Policy, Bristol-Myers Squibb

Regulatory Spotlight — Gain Insight from Program Pioneers on the Future of 340B

APEXUS KEYNOTE ADDRESS1:15 Compliance Spotlight — Best Practices to

Ensure 340B Program IntegrityManufacturers and covered entities face unique compliance challenges when implementing 340B program initiatives within their organizations. This address delivers updates on key topics, including GPO prohibition, program integrity, orphan drugs and refund services while discussing tools and resources available to manufacturers to ensure program compliance.

Chris Hatwig, MS, RPh, President, Apexus

Mr. Hatwig, MS, RPh, is President of Apexus, the nation’s leader in creating reliable health care solutions by enhancing access to medications and improving patient care. One key function of Apexus is its role as the HRSA-designated Prime Vendor for the 340B Drug Pricing Program. The Prime Vendor collaborates with manufacturers to provide strategic contracting opportunities for key 340B purchasers such as academic medical centers, community health centers, and other grantees. Apexus supports integrity and compliance for all program stakeholders through education at 340B University and technical assistance through the Apexus Answers Call Center.

340B HEALTH KEYNOTE ADDRESS 2:00 Covered Entity Operational Insights and

Case Study ExamplesThe 340B program affects all stakeholders working within government pricing programs, especially health care organization covered by this program. This session provides attendees the opportunity to hear directly from 340B Health, a membership organization of over 1,200 public and nonprofit hospitals and health systems

participating in the 340B drug pricing program, discuss covered entity operations as well as key challenges these organizations face related to 340B implementation.

Jeff Davis, Legislative and Policy Counsel, 340B Health

Jeff Davis is the Legislative and Policy Counsel for 340B Health, a nonprofit organization of more than 1,300 hospitals and health systems participating in the federal 340B drug pricing program. Mr. Davis works closely with 340B Health’s Senior Vice President and General Counsel and government relations staff on legislative and regulatory advocacy in the areas of health policy and drug pricing. He provides technical assistance to 340B Health members on matters relating to the 340B program and offers legal support to 340B Health staff’s advocacy efforts. Mr. Davis also keeps 340B Health members informed of issues and developments relevant to the 340B and Medicaid drug rebate programs. Before joining 340B Health, Mr. Davis served as health policy advisor for a member of the U.S House of Representatives.

Assess the Impact of Recent and Impending 340B Guidance to Maintain Program Compliance

2:45 Legal Spotlight — Ensure Program Compliance and Prepare for Future Guidance 2017 has been a year of 340B guidance withdrawals and delays, keeping manufacturers in limbo regarding guidance implementation and shifting effective dates. Gain a comprehensive understanding of the latest guidance implications and statuses to ensure you are properly positioned for successful implementation and program compliance. • Review manufacturer comments and discuss

HRSA’s New Final Rule on Ceiling Prices and Civil Monetary Penalties

• Ensure compliance by relying on language of the CMP statute, pre-existing regulations and reasonable assumptions while Final Rule implementation is pending

• Diagnose what is outstanding, what has been pushed and challenges that remain

John Shakow, Partner, King & Spalding

3:30 Networking and Refreshment Break

“The program was beyond a value-add. The mix of knowledge with the presenters provided something for every participant.”

— Manager, Strategic Contracting, Johnson & Johnson

101 Summit —Interpret the AMP Final Rule for Successful Implementation

AWorkshop Objective: As the 340B program continues to expand, it is even more critical for government pricing and federal reporting functions to establish a firm understanding of program complexities and nuances. This workshop invites individuals who are new to the 340B program, or seeking a refresher on core concepts, to compare and explore AMP and 340B to identify the impact on program compliance. The 2016 AMP Final Rule impacts facets of the 340B drug pricing program and understanding these updates is vital to manufacturer compliance. This workshop hones in on relevant changes and provides best practices that can be implemented to achieve success. Ask questions, benchmark, gain perspective and lay the foundation for understanding intricacies and facets of AMP and 340B.

Key Questions to Be Addressed:• How do I calculate Average Manufacturer Price (AMP)?• How do I calculate best price?• What is the AMP Final Rule and how does it impact 340B?• What is the impact of RCP AMP calculations on 340B?

Workshop Outline:

I. 340B Legislation — Key Components of AMP Final Rule • Determine impact of AMP Final Rule on

the 340B drug pricing program, including implications on AMP, Best Price and PHS ceiling price calculations

• Highlight financial and operational challenges of the AMP Final Rule

• Discuss manufacturer perspectives on implementing new AMP final rule requirements

II. 340B Pricing and Calculations• Gain insight on 340B ceiling prices based on

the Medicaid Drug Rebate Program (MDRP) pricing metrics

• Assess financial impact of AMP Final Rule with respect to the 340B Drug Pricing Program

• Explore assumptions that can be made for calculating AMP and determining Best Price which impact ceiling price

• Discuss best price exclusion and RCP AMP calculation

340B Duplicate DiscountsBWorkshop Objective:Duplicate discount volume continues to increase as a key area of risk for 340B manufacturers. Contributing factors including a surge in eligible claims attributed to Medicaid rebate expansion, proliferation of Medicaid MCOs managing pharmacy claims with limited 340B understanding and rapid growth in 340B contract pharmacy volumes have created a “perfect storm” of financial exposure.

This workshop deep dives into duplicate discount risks for manufacturers and best practices to monitor and prevent these infractions from occurring.

Engage with manufacturer counterparts in this interactive workshop to gain a true understanding of the duplicate discount landscape and develop an action plan to limit their occurrence.

Key Questions to Be Addressed:• How often do duplicate discounts occur and how can

I track when and where they occur?

• How do I investigate duplicate discounts?

• How can I prevent duplicate discounts from occurring in the future?

Workshop Outline:

I. Current Duplicate Discount Landscape and Future Projections• Break down compliance obligations for

covered entities versus manufacturers

• Consider duplicate discount efforts in relation to evolving trends in State Medicaid requirements

• Explore HRSA and CMS initiatives to make Medicaid MCOs responsible for 340B duplicate discount prevention

II. Impact of Scrutiny on Duplicate Discounts• Review HRSA audits of covered entities

findings to better understand duplicate discounts volume

• Gain insight on manufacturer inquiries information of duplicate discounts

• Discuss challenges of reviewing your customers and discuss best practices for preserving relationships while ensuring compliance

4:00 C H O O S E B E T W E E N T W O I N - C O N F E R E N C E W O R K S H O P S ( A - B )

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DAY TWO WEDNESDAY, AUGUST 23, 2017

8:00 Manufacturer-Only Breakfast Discussion* This interactive session provides an opportunity for manufacturers to convene in a private session and discuss best practices to ensure 340B program compliance. Participants are encouraged to bring questions to this session and benefit from gaining multiple perspectives from manufacturers of various sizes and specialties. While this session will cater specifically to participants’ key questions, topics of discussion to be expected include:

• Good faith dispute resolution

• Diversion risk

• New HRSA Final Rule

• Impact of withdrawn Mega-Guidance

• Contract pharmacies

• Future of the 340B Program

*This session is open to all manufacturers attending CBI’s 340B Manufacturer Summit. CBI reserves the right to qualify participants.

Hae Won Min Liao, Assistant General Counsel, Gilead Sciences

Kristin Hicks, Partner, Arnold & Porter Kaye Scholer LLP

9:00 Chairperson’s Review of Day OneSabrina Aery, Director, 340B Compliance and State Policy, Bristol-Myers Squibb

9:15 Update on State Efforts to Exclude 340B Drugs from Medicaid Managed Care Rebates• Gain insight on the OIG’s recent work reviewing

the 340B program• Break down the OIG study on duplicate

discounts for 340B-purchased drugs and assess impact on drugs paid through Medicaid MCOs

• Explore States’ efforts to prevent duplicate discounts and discuss manufacturer best practices to reduce risk

Adam Freeman, Team Leader, U.S. Department of Health and Human Services, Office of Inspector General

10:00 Networking and Refreshment Break

10:30 PREMIER PANEL 340B Closed-Door Collaboration Forum ReportGain insight on the industry’s first 340B Closed-Door Collaboration Forum as it convened manufacturers and covered entities to discuss innovative methods to work together under the 340B program. In this panel session, participating manufacturers discuss key learnings from this Forum and share best practices to improve communication and collaboration with covered entities.

MODERATOR: Shrujal Patel, Co-Founder and Managing Partner, The Alinea Group, LLC MANUFACTURER PARTICIPANTS: Sabrina Aery, Director, 340B Compliance and State Policy, Bristol-Myers Squibb Cathy Burton-Meza, Manager, Contract Compliance, Gilead Sciences Colleen Menges, Director, Government Contracts, Johnson & Johnson Frank Prybeck, Director, Government Pricing and Contract Administrator, Celgene Charles Washington, Director, Global Security, Pfizer Inc

NETWORKING, WINE AND CHEESE RECEPTIONimmediately following the final session on day one

III. Key Considerations for Manufacturers to Comply and Effectively Work within the 340B Program• Explore possible impact on 340B prices of line

extension drugs and authorized generics

• Gain insight on manufacturer pain points that addressed within the AMP Final Rule

• Recognize the impact of noncompliance as it relates to government pricing program participation and financial penalties

5:30 Close of Workshop A

Workshop Leaders:Meenakshi Datta, Partner, Sidley Austin LLP

III. Best Practices for Preventing Duplicate Discounts• Work with state Medicaid agencies to

ensure duplicate discount prevention• Consider internal analytical best practices

to explore duplicate discounts• Reduce duplicate discount loss potential

by working with intermediaries to conduct good faith dispute resolution to maintain positive relationships between pharmaceutical manufacturers and covered entities and increase successful resolutions

5:30 Close of Workshop B

Workshop Leaders:Jason Hardaway, Managing Partner, CiiTA, LLC Marcus Farbstein, RPH, Director, Public Policy and Government Markets, Medivation

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Collaborate with 340B Stakeholders to Optimize Compliance

11:30 Manufacturer Role in Ensuring Compliance within Contract Pharmacy ArrangementsWith the expansion of multi-contract pharmacy arrangements, pharmaceutical manufacturers are faced with additional roadblocks when navigating the complex 340B regulatory landscape. Discuss best practices for manufacturers to prevent revenue leakage within contract pharmacy arrangements.• Gain insight on best practices to avoid

diversions in an environment that challenges transparency between the contract pharmacy and manufacturer

• Discuss options to increase visibility into contract pharmacies and understand how claims adjudication has occurred

• Discover billing procedures to collaborate with covered entities and wholesalers to improve efficiency and ensure compliance

Cathy Burton-Meza, Manager, Contract Compliance, Gilead Sciences

12:15 Networking Luncheon

1:30 Respond to and Resolve 340B Related IssuesAs HRSA continues to encourage transparency

between covered entities and manufacturers,

the volume of self-disclosure letters, Medicaid

rebate disputes, and refund payments from MFRs

regarding overpayment, and from CEs regarding

non-compliance, continues to increase. Walk

through the main components of these issues

and hear updates on each.

• Discuss self-disclosure letters and dissect

core elements to better comprehend these

documents

• Describe state trends in Medicaid 340B policy

and the impact on duplicate discounts

• Resolve MFR refund challenges and

understand payments from covered entities

regarding non-compliance

Mike Benedict, Vice President, Apexus

2:15 Close of Conference

“As always, CBI delivered a conference filled with quality content and subject matter experts in the government

programs field.” — Director, Contracts and Pricing, Acorda Therapeutics, Inc.

“The CBI Conference was outstanding — Very informative and timely topics covering the hot industry

trends. Very worthwhile event to attend.” — Executive Director, Finance, Customer Contract Management and Government Pricing, Merck

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“Everyone had a lot of good information to provide. The different perspectives were extremely valuable. This was a well put together

program and I found it very informative.” — Corporate Counsel, Pfizer

“The topics are timely as manufacturers consider emerging 340B policy and its impact on operations.”

— President, Apexus

UPCOMING GOVERNMENT PRICING MEETINGS:

FEDERAL PRICING and REPORTING

9TH ANNUAL

20th ANNUAL

GTN 2017NOVEMBER 15-16 2017

PHILADELPHIA, PA

MAY 8-10, 2018 ORLANDO, FL

FEBRUARY 27-28, 2018 PHILADELPHIA, PA

NOVEMBER 29-30, 2017 PHILADELPHIA, PA

To learn more or to register for any of the below events, please call 800-817-8601

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REIMBURSEMENT and CONTRACTING

WEBwww.cbinet.com/340B

EMAILcbireg@cbinet.com

PHONE800-817-8601339-298-2100 outside the U.S.

LIVE CHATwww.cbinet.com/340B

WAYS TO REGISTER NOW!

SCAN HERE

CBI 70 Blanchard Road Burlington, MA 01803

A division ofUBM Americas

340B MANUFACTURER SUMMIT PC17378

VENUE: Hilton Alexandria Old Town 1767 King Street Alexandria, VA 22314 Phone Reservations: (800) 445-8667 Hotel Direct Line: (703) 837-0440

ACCOMMODATIONS: To receive CBI’s special discounted hotel rate online or by phone, please go to:

• Online: www.cbinet.com/340B• Phone reservations: (800) 445-8667 and mention CBI’s 340B Summit

Book Now! The Hilton Alexandria Old Town 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. CBI does not use Housing Bureaus and none are authorized to call on our behalf.

REGISTRATION FEE: ADVANTAGE PRICING Standard Onsite Conference $1799 $2099 $2199

Register by June 16, 2017 and SAVE $300. 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 full, Standard Rate.

GROUP RATE: Looking to bring your team? Contact Information Services to learn about potential group savings. Call 800-817-8601 or email cbireg@cbinet.com.

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

SATISFACTION GUARANTEED: 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 CBI conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for CBI conferences is not required.

SUBSTITUTION AND 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 $399 administrative charge. No refunds will be made after this date; however, the registration fee less the $399 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, 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 $399 administrative charge should you or a colleague be unable to attend the rescheduled date. CBI 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 CBI.

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

August 22-23, 2017Hilton Alexandria Old TownAlexandria, VAS UMM I T

Strengthen Program Compliance and Integrity in an Evolving Regulatory Landscape

CBI’s Annual

R E G I S T E R B Y J U N E 1 6 , 2 0 1 7 A N D S A V E $ 3 0 0 !CLE and CPE

Credits Available! Pending Approval

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ANY QUESTIONS OR TO REGISTERCONTACT: Christian Alongi

phone 339-298-2131 email christian.alongi@cbinet.com