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Agenda

Ensure Program Integrity and Navigate Industry Uncertainty in a Highly Complex Market

August 20-21, 2019
  • Alexandria, VA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, AUGUST 20, 2019

7:30

Main Conference Registration and Continental Breakfast

8:30

CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

A 340B Boot Camp —
A 101 Primer on Program Intricacies and Regulatory Guidance

Workshop Objective:

As the 340B program continues to grow and reform, it is critical for manufacturers to establish a firm understanding of the principles and complexities within the program itself. This workshop invites those who are new to the 340B program along with those who are looking for a refresher to dive into all of the core concepts and lay a foundation for understanding this complex government program.

Workshop Outline:

I. A Timeline of 340B and Regulatory Guidance

II. Key Concepts and Calculations

III. Manufacturers’ Challenges and Best Practices

Workshop Leader:

Brandon Gagliardo
Consultant, Pricing,
Contracting and Market Access
HighPoint Solutions,
an IQVIA Company

 
B Senior-Level Think Tank — Best Practices to Improve Compliance and Prevent Revenue Leakage

Workshop Objective:

In this advanced session, participants engage in discussion to identify the top challenges faced by pharmaceutical manufacturers. Collaborate with industry counterparts to align and brainstorm strategic solutions to key initiatives.

Workshop Outline:

I. Align with State Practices When Validating Duplicate Discounts

II. Leverage Data Analytics to Detect Diversion

III. Discuss 340B in the Real World

IV. Navigate the Future of 340B

Workshop Leaders:

Jeremy Docken
CEO
Kalderos

Cathy Burton-Meza
Manager, Contract Compliance
Gilead

Charles Washington
Director, Fraud Investigation Group
Pfizer Inc

Trevor L. Wear
Partner
Sidley Austin LLP

10:00

Networking and Refreshment Break

10:30

Chairperson’s Welcome and Opening Remarks

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

The Current and Future State of the
Industry Amidst Changing Dynamics

10:45

KEYNOTE ADDRESS Critical Updates on Government Initiatives Within 340B

Jeff Lucas
Health Policy Advisor
United States Senate

11:30

Drug Pricing Reform — An Analysis of Proposals in the Pipeline

Jeremy Docken
CEO
Kalderos

12:15

Networking Luncheon

1:15

PANEL DISCUSSION Manage Refunds of 340B Overcharges and Mitigate Compliance Risks

Moderator:

Mike Benedict
Vice President, Operations
Apexus

Panelists:

Marcy Imada
Principal
Deloitte & Touche LLP

Christopher Schott
Partner
Hogan Lovells LLP

2:00

340B Limited Distribution Plans — Opportunities and Considerations

John Shakow
Partner
King & Spalding LLP

2:45

Networking and Refreshment Break

3:15

Assess and Address Duplicate Commercial Discount Risk

Aaron Vandervelde
Managing Director
Berkeley Research Group, LLC

Kevin Erb
Consultant
Berkeley Research Group, LLC

4:00

Spotlight on HRSA Audits — How to Prepare and Take Corrective Action

Cathy Burton-Meza
Manager, Contract Compliance
Gilead

Program Integrity and Compliance from the
Covered Entity Perspective

4:45

MULTI-STAKEHOLDER DISCUSSION Maximize the Entity-Manufacturer Partnership

Katy Lees
340B Business Manager
URMC Rochester

Mujeeb Rafiuddin
340B National Account Executive
Genentech

5:30

Close of Day One

Networking, Wine & Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, AUGUST 21, 2019

7:30

Manufacturer-Only Breakfast Discussion*

This interactive session provides an opportunity for manufacturers to convene in a closed-door 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. This session utilizes live polling to allow attendees to anonymously share experiences and benchmark with industry counterparts.

Facilitator:

Amanda Tucker
Senior Government Analyst
UCB

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

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

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

8:45

Technology at Work — Operationalize the Requirements and Prohibitions

Lisa Scholz
Head of Industry Relations
Senty Data Systems

Kenny Yu, Pharm. D., MBA
Apexus Certified Expert, Director of Pharmacy, 340B Program
NYU Langone Hospitals

9:30

COMMUNITY EXCHANGE — CHOOSE TWO OF THREE TOPICS High-Impact Topics Transforming the 340B Landscape

Ask questions, take notes and share proactive approaches to managing key areas of uncertainty. After Round I, switch tables for a new topic. Table hosts welcome newcomers to their tables and brief them on the group’s conversation so far.

Round I: 9:30-9:55
Round II: 10:00-10:30

A Continuing the Conversation on the Impact of
the CMP Rule on Manufacturers

Facilitator:

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

B Understanding and Resolution of Duplicate Discounts —
How Manufacturers Can Work in Good Faith with Covered Entities

Facilitator:

Amanda Tucker
Manager, Government Programs Reimbursement
UCB

C Explore the Potential Use of Technology to Account for
Drug Discounts and the Role of Data

Facilitator:

Steve Zielinski
Director, Industry Relations
Kalderos

10:30

Networking and Refreshment Break

Strategic Planning and Operational Best Practices

11:00

EXTENDED SESSION

Elevate Compliance in Contract Pharmacy Arrangements

Ensure Program Integrity and the Future of 340B

Daryl Schiller, PharmD, FASHP, BCPS-AQ ID
Pharmacy Director
Montefiore Nyack Health System

12:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, AUGUST 20, 2019

7:30

Main Conference Registration and Continental Breakfast

8:30

CHOOSE BETWEEN TWO IN-CONFERENCE WORKSHOPS (A-B)

A 340B Boot Camp —
A 101 Primer on Program Intricacies and Regulatory Guidance

Workshop Objective:

As the 340B program continues to grow and reform, it is critical for manufacturers to establish a firm understanding of the principles and complexities within the program itself. This workshop invites those who are new to the 340B program along with those who are looking for a refresher to dive into all of the core concepts and lay a foundation for understanding this complex government program.

Workshop Outline:

I. A Timeline of 340B and Regulatory Guidance

II. Key Concepts and Calculations

III. Manufacturers’ Challenges and Best Practices

Workshop Leader:

Brandon Gagliardo
Consultant, Pricing,
Contracting and Market Access
HighPoint Solutions,
an IQVIA Company

 
B Senior-Level Think Tank — Best Practices to Improve Compliance and Prevent Revenue Leakage

Workshop Objective:

In this advanced session, participants engage in discussion to identify the top challenges faced by pharmaceutical manufacturers. Collaborate with industry counterparts to align and brainstorm strategic solutions to key initiatives.

Workshop Outline:

I. Align with State Practices When Validating Duplicate Discounts

II. Leverage Data Analytics to Detect Diversion

III. Discuss 340B in the Real World

IV. Navigate the Future of 340B

Workshop Leaders:

Jeremy Docken
CEO
Kalderos

Cathy Burton-Meza
Manager, Contract Compliance
Gilead

Charles Washington
Director, Fraud Investigation Group
Pfizer Inc

Trevor L. Wear
Partner
Sidley Austin LLP

10:00

Networking and Refreshment Break

10:30

Chairperson’s Welcome and Opening Remarks

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

The Current and Future State of the
Industry Amidst Changing Dynamics

10:45

KEYNOTE ADDRESS Critical Updates on Government Initiatives Within 340B

Jeff Lucas
Health Policy Advisor
United States Senate

11:30

Drug Pricing Reform — An Analysis of Proposals in the Pipeline

Jeremy Docken
CEO
Kalderos

12:15

Networking Luncheon

1:15

PANEL DISCUSSION Manage Refunds of 340B Overcharges and Mitigate Compliance Risks

Moderator:

Mike Benedict
Vice President, Operations
Apexus

Panelists:

Marcy Imada
Principal
Deloitte & Touche LLP

Christopher Schott
Partner
Hogan Lovells LLP

2:00

340B Limited Distribution Plans — Opportunities and Considerations

John Shakow
Partner
King & Spalding LLP

2:45

Networking and Refreshment Break

3:15

Assess and Address Duplicate Commercial Discount Risk

Aaron Vandervelde
Managing Director
Berkeley Research Group, LLC

Kevin Erb
Consultant
Berkeley Research Group, LLC

4:00

Spotlight on HRSA Audits — How to Prepare and Take Corrective Action

Cathy Burton-Meza
Manager, Contract Compliance
Gilead

Program Integrity and Compliance from the
Covered Entity Perspective

4:45

MULTI-STAKEHOLDER DISCUSSION Maximize the Entity-Manufacturer Partnership

Katy Lees
340B Business Manager
URMC Rochester

Mujeeb Rafiuddin
340B National Account Executive
Genentech

5:30

Close of Day One

Networking, Wine & Cheese Reception immediately following the final session on day one

DAY TWO WEDNESDAY, AUGUST 21, 2019

7:30

Manufacturer-Only Breakfast Discussion*

This interactive session provides an opportunity for manufacturers to convene in a closed-door 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. This session utilizes live polling to allow attendees to anonymously share experiences and benchmark with industry counterparts.

Facilitator:

Amanda Tucker
Senior Government Analyst
UCB

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

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

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

8:45

Technology at Work — Operationalize the Requirements and Prohibitions

Lisa Scholz
Head of Industry Relations
Senty Data Systems

Kenny Yu, Pharm. D., MBA
Apexus Certified Expert, Director of Pharmacy, 340B Program
NYU Langone Hospitals

9:30

COMMUNITY EXCHANGE — CHOOSE TWO OF THREE TOPICS High-Impact Topics Transforming the 340B Landscape

Ask questions, take notes and share proactive approaches to managing key areas of uncertainty. After Round I, switch tables for a new topic. Table hosts welcome newcomers to their tables and brief them on the group’s conversation so far.

Round I: 9:30-9:55
Round II: 10:00-10:30

A Continuing the Conversation on the Impact of
the CMP Rule on Manufacturers

Facilitator:

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

B Understanding and Resolution of Duplicate Discounts —
How Manufacturers Can Work in Good Faith with Covered Entities

Facilitator:

Amanda Tucker
Manager, Government Programs Reimbursement
UCB

C Explore the Potential Use of Technology to Account for
Drug Discounts and the Role of Data

Facilitator:

Steve Zielinski
Director, Industry Relations
Kalderos

10:30

Networking and Refreshment Break

Strategic Planning and Operational Best Practices

11:00

EXTENDED SESSION

Elevate Compliance in Contract Pharmacy Arrangements

Ensure Program Integrity and the Future of 340B

Daryl Schiller, PharmD, FASHP, BCPS-AQ ID
Pharmacy Director
Montefiore Nyack Health System

12:15

Close of Conference