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Agenda

Strategies and Best Practices to Strengthen Program Compliance, Effectively Communicate with Stakeholders and Prevent Revenue Leakage

August 21-22, 2018
  • Arlington, VA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, AUGUST 21, 2018

7:30

Main Conference Registration

8:30

Chairperson’s Welcome and Opening Remarks

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

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

8:45

KEYNOTE ADDRESS Update on 340B Program Integrity and Process

Mike Benedict
Vice President, Operations
Apexus

9:30

STATE PERSPECTIVE Bridging the Gap between Manufacturers and States to Mitigate Disputes and Promote Program Integrity

MODERATOR:

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

PANELISTS:

John Stancil, R.Ph.
Director of Pharmacy
North Carolina Department of Health and Human Services

Amanda Tucker
Manager, Government Programs Reimbursement
UCB

10:15

Networking and Refreshment Break

10:45

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

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

Workshop Objective:

Perfect for anyone new to 340B or those looking for a refresher course, this introductory level workshop lays the foundation for understanding this complex government program.

Developed specifically based on feedback from last year’s 101 workshop, this session explores core concepts, including definitions of key terms, an overview of calculations, perspectives across multiple stakeholders, top challenges for manufacturers and program regulation and guidance.

Workshop Outline:

I. 340B Program History and Regulatory Guidance

II. Key Terms, Concepts and Calculations

III. Manufacturer Challenges and Best Practices for Program Compliance

12:15

Close of Workshop A

Workshop Leaders:

Mike Benedict
Vice President, Operations
Apexus

Charles Washington, CFE, CPP, CICA
Director, America’s Compliance Division,
Pfizer Inc

 
B Senior-Level Think Tank — Best Practices for Communicating with States and Covered Entities to Prevent Revenue Leakage

Workshop Objective:

In this advanced session, participants engage in discussion to identify issues and best practices related to top 340B challenges including diversions and duplicate discounts. Content and talking points are driven by participants, who are surveyed in advance.

Collaborate with your industry counterparts to align and brainstorm solutions that can be feasibly implemented within your organization.

Workshop Outline:

I. Diversions and Duplicate Discounts

II. Impact of Scrutiny on Duplicate Discounts

III. Audience Driven Discussion

12:15

Close of Workshop B

Workshop Leaders:

Alexis Arroyo
Senior Director, Pricing, Contracting and Market Access
High Point Solutions

Cathy Burton-Meza
Manager, Contract Compliance
Gilead

Jason Hardaway
Managing Director
CiiTA

12:15

Networking Luncheon

1:30

COVERED ENTITY PERSPECTIVE Learning Each Other’s Language — Insights on Covered Entity Processes to Improve Communication and Collaboration

Shrujal Patel
Co-Founder and Managing Partner
The Alinea Group

Katy Lees
340B Manager
University of Rochester Medical Center

2:30

Networking and Refreshment Break

3:00

POINT/COUNTER-POINT Patient Definition — Manufacturer vs Covered Entity Interpretation

Manufacturer Attorney:

Elizabeth Kolbe
Associate
Sidley Austin

Covered Entity Attorney:

Jason Reddish
Partner
Feldesman Tucker Leifer Fidell LLP

4:00

Ask the Experts Panel

4:45

Day One Wrap-Up and Q&A

5:00

Close of Day One

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

DAY TWO WEDNESDAY, AUGUST 22, 2018

7:30

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. This session utilizes live polling to allow attendees to anonymously share experiences and benchmark with industry counterparts.

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

Brian McCartney
Director, Government Pricing and Reporting
AstraZeneca

Natalie Morris
Director, Federal Government Affairs & Policy
AstraZeneca

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

8:45

SPOTLIGHT 340B Reform — Insight on Action to Preserve and Improve 340B

John Shakow
Partner
King & Spalding LLP

9:45

Sifting Through the Stack —
Responding to and Resolving Self-Disclosure Letters

Charles Washington, CFE, CPP, CICA
Director, America’s Compliance Division
Pfizer Inc

Mujeeb Rafiuddin
340B National Account Manager
Genentech, Inc.

10:30

Networking and Refreshment Break

11:00

INTERACTIVE MANUFACTURER PANEL Views from the Trenches —
Perspectives on Implementing Change and Continuous Improvement

MODERATOR:

Steven Benz
Partner
Arnold & Porter

PANELISTS:

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

Cathy Burton-Meza
Manager, Contract Compliance
Gilead

12:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, AUGUST 21, 2018

7:30

Main Conference Registration

8:30

Chairperson’s Welcome and Opening Remarks

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

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

8:45

KEYNOTE ADDRESS Update on 340B Program Integrity and Process

Mike Benedict
Vice President, Operations
Apexus

9:30

STATE PERSPECTIVE Bridging the Gap between Manufacturers and States to Mitigate Disputes and Promote Program Integrity

MODERATOR:

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

PANELISTS:

John Stancil, R.Ph.
Director of Pharmacy
North Carolina Department of Health and Human Services

Amanda Tucker
Manager, Government Programs Reimbursement
UCB

10:15

Networking and Refreshment Break

10:45

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

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

Workshop Objective:

Perfect for anyone new to 340B or those looking for a refresher course, this introductory level workshop lays the foundation for understanding this complex government program.

Developed specifically based on feedback from last year’s 101 workshop, this session explores core concepts, including definitions of key terms, an overview of calculations, perspectives across multiple stakeholders, top challenges for manufacturers and program regulation and guidance.

Workshop Outline:

I. 340B Program History and Regulatory Guidance

II. Key Terms, Concepts and Calculations

III. Manufacturer Challenges and Best Practices for Program Compliance

12:15

Close of Workshop A

Workshop Leaders:

Mike Benedict
Vice President, Operations
Apexus

Charles Washington, CFE, CPP, CICA
Director, America’s Compliance Division,
Pfizer Inc

 
B Senior-Level Think Tank — Best Practices for Communicating with States and Covered Entities to Prevent Revenue Leakage

Workshop Objective:

In this advanced session, participants engage in discussion to identify issues and best practices related to top 340B challenges including diversions and duplicate discounts. Content and talking points are driven by participants, who are surveyed in advance.

Collaborate with your industry counterparts to align and brainstorm solutions that can be feasibly implemented within your organization.

Workshop Outline:

I. Diversions and Duplicate Discounts

II. Impact of Scrutiny on Duplicate Discounts

III. Audience Driven Discussion

12:15

Close of Workshop B

Workshop Leaders:

Alexis Arroyo
Senior Director, Pricing, Contracting and Market Access
High Point Solutions

Cathy Burton-Meza
Manager, Contract Compliance
Gilead

Jason Hardaway
Managing Director
CiiTA

12:15

Networking Luncheon

1:30

COVERED ENTITY PERSPECTIVE Learning Each Other’s Language — Insights on Covered Entity Processes to Improve Communication and Collaboration

Shrujal Patel
Co-Founder and Managing Partner
The Alinea Group

Katy Lees
340B Manager
University of Rochester Medical Center

2:30

Networking and Refreshment Break

3:00

POINT/COUNTER-POINT Patient Definition — Manufacturer vs Covered Entity Interpretation

Manufacturer Attorney:

Elizabeth Kolbe
Associate
Sidley Austin

Covered Entity Attorney:

Jason Reddish
Partner
Feldesman Tucker Leifer Fidell LLP

4:00

Ask the Experts Panel

4:45

Day One Wrap-Up and Q&A

5:00

Close of Day One

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

DAY TWO WEDNESDAY, AUGUST 22, 2018

7:30

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. This session utilizes live polling to allow attendees to anonymously share experiences and benchmark with industry counterparts.

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

Brian McCartney
Director, Government Pricing and Reporting
AstraZeneca

Natalie Morris
Director, Federal Government Affairs & Policy
AstraZeneca

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

8:45

SPOTLIGHT 340B Reform — Insight on Action to Preserve and Improve 340B

John Shakow
Partner
King & Spalding LLP

9:45

Sifting Through the Stack —
Responding to and Resolving Self-Disclosure Letters

Charles Washington, CFE, CPP, CICA
Director, America’s Compliance Division
Pfizer Inc

Mujeeb Rafiuddin
340B National Account Manager
Genentech, Inc.

10:30

Networking and Refreshment Break

11:00

INTERACTIVE MANUFACTURER PANEL Views from the Trenches —
Perspectives on Implementing Change and Continuous Improvement

MODERATOR:

Steven Benz
Partner
Arnold & Porter

PANELISTS:

Sabrina Aery
Director, 340B Compliance and State Policy
Bristol-Myers Squibb

Cathy Burton-Meza
Manager, Contract Compliance
Gilead

12:00

Close of Conference