Day 1 - Monday, March 6, 2017

8:00
Registration and Continental Breakfast
8:45
Co-Chairs’ Welcoming Remarks and Introduction of Keynote Speaker
9:00
Keynote Address: Trends in FDCA Enforcement and Best Practices for Keeping You and Your Company in the Clear
9:30
Off Label Promotion Update: Legalities, Practicalities, and Current Realities
10:45
Morning Coffee Break
11:00
Patient Assistance Programs: How to Structure and Manage Them without Running Afoul of Evolving Regulatory Enforcement Theories
12:00
Networking Lunch
1:00
Not So Safe: Exploring the Boundaries of the Discount Safe Harbor in Light of Recent Court Decisions
2:15
The Yates Memorandum a Year Later
3:15
Afternoon Refreshment Break
3:30
Developments with the False Claims Act and Qui Tam Enforcement in Light of the Escobar Decision
4:30
Pricing Considerations for the Compliance Agenda in an Evolving Environment
5:15
Conference Adjourns to Day 2

Day 2 - Tuesday, March 7, 2017

7:45
Registration and Continental Breakfast
8:15
Co-Chairs’ Welcoming Remarks
8:30
The Enforcers Speak: US Attorney’s Office Roundtable
10:00
Morning Refreshment Break
10:15
Lessons Learned from Recent FCPA and Anti- Corruption Enforcement Actions
11:15
Evaluating Potential Fraud and Abuse Risks When Working with New Technologies, Including Diagnostics, Combination Products, and LDTs
12:00
Regulatory and Legal Considerations When Using Social Media to Promote Drugs and Medical Devices
12:45
Conference Ends

Post-Conference Workshop

Compliance Risk Assessment Masterclass: Ensuring that You Have a First-Class Compliance Program by Benchmarking at the Most Interactive Level

Mar 7, 2017 2:00pm – 5:00pm

Speakers

Elizabeth C. Hanks
Compliance Counsel
E.C. Hanks Law, LLC

Seth H. Lundy
Partner
King & Spalding LLP

William “Butch” Hulse
Chief Compliance Officer and SVP, Enterprise Risk Management, Quality and Regulatory
Acelity

Post-Conference Workshop

Sunshine Act Compliance Working Group: Deciphering the Latest Developments and How Open Payments Data Is Being Used in Government Investigations

Mar 8, 2017 9:00am – 12:00pm

Speakers

Avi (Abraham) Spira
Vice President, Chief Compliance Officer
Cantel Medical Corp.

Kevin M. Henley
Senior Compliance Counsel
Otsuka Pharmaceutical Development & Commercialization, Inc.

Sheva Sanders
Partner
Stinson Leonard Street LLP

Day 1 - Monday, March 6, 2017

8:00
Registration and Continental Breakfast
8:45
Co-Chairs’ Welcoming Remarks and Introduction of Keynote Speaker

Katherine DeKam
Chief Compliance Officer, Director of Compliance
Acumed

Margaret D. Price
Senior Director Corporate Compliance/Chief Compliance Officer
Upsher-Smith Laboratories, Inc.

9:00
Keynote Address: Trends in FDCA Enforcement and Best Practices for Keeping You and Your Company in the Clear

Beth P. Weinman
Associate Chief Counsel for Enforcement
Food & Drug Division, OGC

9:30
Off Label Promotion Update: Legalities, Practicalities, and Current Realities

Joel Kurtzberg
Partner
Cahill Gordon & Reindel LLP

Tracy Palmer Berns
Vice President, Ethics & Compliance
Medtronic

Sara Miron Bloom
Assistant United States Attorney
U.S. Attorney’s Office, District of Massachusetts

Averi Price
Chief Compliance Officer
Radius Health, Inc.

  • What is FDA’s current position on truthful and non-misleading communication following the November hearing?
  • Updates on Congressional action
  • What is the standard for what is considered to be truthful and nonmisleading – who determines what is truthful and non-misleading?
  • Latest guidance on off label promotion – What do/should companies do in the interim? What are they already choosing to do?
    • Acclarent
    • Vascular Solutions
    • Amarin and Pacira fall out
  • Is government changing/likely to change its practices on off label enforcement based on recent developments?
  • What are some specific examples of problematic behaviors that the DOJ is looking for?
  • Identifying specific challenges that smaller companies face when promoting their products
  • Preapproval communication: How to frame discussions around clinical trial information?

10:45
Morning Coffee Break
11:00
Patient Assistance Programs: How to Structure and Manage Them without Running Afoul of Evolving Regulatory Enforcement Theories

Joshua S. Levy
Partner
Ropes & Gray

Richard S. Liner
Senior Compliance Counsel
Bayer Corporation

Lisa A. Shrayer
Vice President Legal, Chief Compliance Officer
Keryx Biopharmaceuticals, Inc.

Clorinda Walley
Executive Director
Good Days

  • OIG HHS new guidance on PAPs
  • Reexamining the criteria PAPs employ in defining disease funds or when determining patient eligibility
  • Identifying potentially abusive PAP structures
  • What are the characteristics and safeguards necessary to ensure compliant PAP arrangements?
  • Managing and maintaining compliant PAP arrangements

12:00
Networking Lunch
1:00
Not So Safe: Exploring the Boundaries of the Discount Safe Harbor in Light of Recent Court Decisions

Jeffrey S. Baird
Chairman of Health Care Group
Brown & Fortunato, P.C.

Andrew Dahlinghaus
Vice President, Chief Compliance Officer
ConvaTec

Margaret D. Price
Senior Director Corporate Compliance/Chief Compliance Officer
Upsher-Smith Laboratories, Inc.

Carrie Valiant
Board of Directors, Member
Epstein Becker and Green

Kriss Basil
Assistant U.S. Attorney
U.S. Attorney’s Office, District of Massachusetts (Boston, MA)

Clorinda Walley
Executive Director
Good Days

  • Meaning of the discount safe harbor under the anti-kickback statute
  • How does the discount safe harbor get applied to common discounting behavior?
  • Effects so far of an erosion of discount safe harbor – how do recent settlements affect industry’s interpretation of the discount safe harbor and where does that leave medical device companies?
  • What types of arrangements are being protected under the discount safe harbor at this time?
  • Some predictions as to what the future may hold

2:15
The Yates Memorandum a Year Later

Richard Hayes
Deputy Chief, Civil Division
United States Attorney’s Office, Eastern District of New York

Jennifer McGee
Chief Compliance Officer
Otsuka Pharmaceutical Development & Commercialization

Jennifer M. Spalding
Senior Vice President, General Counsel Medical Segment
Cardinal Health

  • The Yates Memorandum and Individual Accountability
    • Main points and directives
    • How is it being implemented?
    • How is it impacting continued matters?
  • What are the DOJ’s gravest concerns and investigation triggers for individual culpability?
  • Recent developments in enforcement
    • Cases and lessons learned thus far
  • What should this mean for a company’s compliance program?
    • What documentation is the DOJ looking for and do companies currently record it?
    • Measures that need to be taken to prepare more vulnerable individuals in an organization
    • Upgrading protocols to detect fraud and abuse that could seemingly implicate those who in reality lack knowledge or involvement
    • Checks and balances to safeguard oversight on all levels of the corporate hierarchy

3:15
Afternoon Refreshment Break
3:30
Developments with the False Claims Act and Qui Tam Enforcement in Light of the Escobar Decision

John M. Falzone III
Assistant Attorney General, Affirmative Civil Enforcement Practice Group
New Jersey Division of Law

Jack W. Pirozzolo
Partner
Sidley Austin LLP

Jay Speers
Counsel, Medicaid Fraud Control Unit
Office of the Attorney General, State of New York

Laura M. Kidd Cordova
Partner
Crowell & Moring LLP

Given the recent developments concerning implied certification theory and materiality requirement in the Escobar decision, it is imperative that companies understand the scope and interpretation of the FCA. This session will focus on developments thus far in qui tam enforcement and provide attendees with best practices on how they should update their compliance programs accordingly and respond to investigations.

4:30
Pricing Considerations for the Compliance Agenda in an Evolving Environment

Wendy Goldstein
Partner
Cooley LLP

David Ralston
Senior Director, Associate General Counsel, Business Conduct
Gilead Sciences

  • Update on industry activity
  • Better practices to manage pricing, reimbursement support, copay mitigation, and charitable foundation relationships
  • Trends in state law pricing transparency
  • Developing a relevant oversight agenda for your organization on key relationships that impact pricing

5:15
Conference Adjourns to Day 2

Day 2 - Tuesday, March 7, 2017

7:45
Registration and Continental Breakfast
8:15
Co-Chairs’ Welcoming Remarks

Katherine DeKam
Chief Compliance Officer, Director of Compliance
Acumed

Margaret D. Price
Senior Director Corporate Compliance/Chief Compliance Officer
Upsher-Smith Laboratories, Inc.

8:30
The Enforcers Speak: US Attorney’s Office Roundtable

Zachary Cunha
Assistant U.S. Attorney, District of Rhode Island
U.S. Department of Justice

Charlene Keller Fullmer
Assistant United States Attorneys
U.S. Attorney's Office, Eastern District of Pennsylvania

John Vagelatos
Assistant United States Attorney, Affirmative Civil Enforcement Chief
United States Attorney’s Office, Eastern District of New York

R. David Walk Jr.
Assistant U.S. Attorney, Health Care and Government Fraud Unit
United States Attorney's Office, District of New Jersey

Moderator:

Brien T. O’Connor
Partner
Ropes & Gray LLP

With the DOJ’s continued pursuit of fraud and abuse and with new government regulations and guidance for enforcement priorities, don’t miss this unique opportunity to hear directly from the enforcers as they share their insights and touch on:

  • What they are interested in prosecuting?
  • Update on prosecution of off label promotion – how do enforcers see recent court decisions involving off label promotion?
  • What are some of the other theories of liability beyond off label promotion?
  • What specific behaviors on the part of companies do prosecutors see as problematic that can cumulatively lead to investigations?

10:00
Morning Refreshment Break
10:15
Lessons Learned from Recent FCPA and Anti- Corruption Enforcement Actions

Jennifer Santos
Sr. Corporate Counsel
Vertex Pharmaceuticals

Ilana Shulman
Chief Compliance Officer
Hill-Rom

Katherine DeKam
Chief Compliance Officer, Director of Compliance
Acumed

  • The status of enforcement activities against pharma and device companies on the theory that foreign state-owned healthcare system or an employee constitute a foreign official under FCPA
  • What does the US government consider to be sufficient internal controls?
    • Using technology to detect cross-reference relationships that may indicate wrongdoing
    • Having automated gift controls in place
    • Making sure that subsidiaries are on board
    • Performing employee training on a regular basis
    • Auditing and monitoring of distribution networks
  • How does the Yates memo impact the healthcare industry with regards to these investigation?
  • Country-specific anti-corruption efforts – things that are common practice in the US but potentially violate laws of countries such as China and Brazil

11:15
Evaluating Potential Fraud and Abuse Risks When Working with New Technologies, Including Diagnostics, Combination Products, and LDTs

Barry Boise
Partner
Pepper Hamilton LLP

Ralph W. Carmichael
Chairman & Chief Executive Officer
BÕNWRx Ltd

  • Potential fraud and abuse challenges that arise with diagnostics, combination products, and LDTs
  • Recommendations for avoiding some common pitfalls
  • Staying current in the evolving new technologies space
  • Case studies – exploring scenarios and solutions

12:00
Regulatory and Legal Considerations When Using Social Media to Promote Drugs and Medical Devices

Amy K. Dow
Member
Epstein Becker and Green

Jessica Parker-Battle
Director, Compliance
Biogen

  • FDA guidance on using social media to promote products
  • What can be learned from FDA’s warning letters to companies? What repercussions have been seen as a result of FDA’s finding issues with companies’ promotion of their products on social media?
  • Best practices for engaging in product promotion on social media that minimize the risk of accusations of preapproval promotion or off label marketing?
  • What lessons can be learned from celebrity endorsement letters?

12:45
Conference Ends

Networking Lunch will be served immediately following the conference for Post-Conference Workshop Attendees only

Compliance Risk Assessment Masterclass: Ensuring that You Have a First-Class Compliance Program by Benchmarking at the Most Interactive Level

Mar 7, 2017 2:00pm – 5:00pm

Elizabeth C. Hanks
Compliance Counsel
E.C. Hanks Law, LLC

Seth H. Lundy
Partner
King & Spalding LLP

William “Butch” Hulse
Chief Compliance Officer and SVP, Enterprise Risk Management, Quality and Regulatory
Acelity

What is it about?

Workshop A | 2:00 pm – 5:00 pm (registration at 1:45)   With the pharmaceutical industry’s remaining to be the focus of government inquiry and with the increased scrutiny of the medical device companies, sharpen your new tools with this interactive session of best practices for both small and large medical device and pharmaceutical organizations. Take this rare opportunity to ask any unanswered questions on how the knowledge from earlier panels can be tailored to your company’s specific needs in this interactive forum focused on best practices and practical knowledge.
  • Healthcare compliance
    • Industry codes, standards, and benchmarks – what are they, why do they matter and why should you care about them?
    • What is the difference between industry codes, standards, detailed guidance, and laws/regulations?
    • How are industry standards and other benchmarks used during government investigations and prosecutions?
    • Key industry codes
      • PhRMA Code of Interactions with Healthcare Professionals
      • AdvaMed Code of Ethics on Interactions with Healthcare Professionals
        • Industry standard during medical device prosecutions
        • Understanding the distinctions between the Code’s detailed guidance and regulations
        • What role whether a company has been certified or not plays in an enforcement?
      • Accreditation Council for Continuing Medical Education (ACCME)
      • Code of Conduct adopted by Healthcare Supply Chain Association (HSCA)
      • Other critical sources for guidance, best practices, and keeping current with trends
        • OIG Compliance Guidance and OIG Advisory Opinions
        • Corporate Integrity Agreements (CIA)
  • Measuring the effectiveness of the compliance program and conducting internal investigations
    • What indicators should be used to measure a compliance program’s value and effectiveness?
    • How small and mid-size organizations can adapt their compliance protocols to fit their resources?
    • How to conduct internal investigations while maintaining the attorney – client privilege?
  • Best practices for persuading a company’s marketing team and sales force that effective compliance doesn’t mean restricting selling capabilities but rather protects their interests as well as the interests of their customers
    • Making compliance a priority for management and embedding compliance into a company’s business processes
    • Using compliance data to help business
    • Beware of scientific exchange trouble areas
    • Managing vendors
  • M&A Concerns
    • Transitioning: Incorporating a company’s culture of compliance with that of the newly acquired one
    • Smaller and mid-size companies: How having a well-established compliance program in place can make a company a better candidate to be acquired?
  • Evaluation of training of sales representatives and medical science liaisons
    • What should the training content look like?
    • Best practices in assisting a company’s sales force in how to remain compliant without causing stagnation in its sales quotas
    • Translating FDA guidance to a company’s sales reps’ pitch
    • Creating checks and balances to oversee outside reps and consultants, domestically and abroad
    • What are the risks associated with using MSLs?
    • Where should the divide between MSLs and sales teams be? How to make sure that MSLs don’t become an extension of the sales force?

Sunshine Act Compliance Working Group: Deciphering the Latest Developments and How Open Payments Data Is Being Used in Government Investigations

Mar 8, 2017 9:00am – 12:00pm

Avi (Abraham) Spira
Vice President, Chief Compliance Officer
Cantel Medical Corp.

Kevin M. Henley
Senior Compliance Counsel
Otsuka Pharmaceutical Development & Commercialization, Inc.

Sheva Sanders
Partner
Stinson Leonard Street LLP

What is it about?

Workshop B | 9:00 a.m.-12:00 p.m. (Registration begins at 8:30 a.m.)   Now that the three reporting cycles are in the books and the Sunshine Act implementation has been ongoing for two years, benchmark with your peers and ensure that your compliance program is robust enough to overcome all of the challenges that are arising from Sunshine reporting. Managing and maximizing the utility of the data collected has never been more important now that the government, competitors, and whistleblowers/relators are able to access the reported data. The question is no longer how to compile and report but how is this data being used. This interactive session will give you just that, information on how this huge amount of data can be utilized by the companies themselves to give compliance departments some leverage in their business as well as on how this data is used by the government enforcers.
  • Recent developments with the Sunshine Act – three years later, are there any changes to the Sunshine Act regulation?
  • Reviewing the kinks in, nuts and bolts of, and patches for reporting challenges and identifying best practices to ensure systems are as effective as possible
  • Lessons learned from the dispute reporting process: what works and what needs work?
  • Mitigating exposure to liability that stems from the Sunshine Act: fair market value, transfers of value, contracting
  • Reducing the pain-points associated with grants and clinical trials: overcoming lacking CMS guidance and creating a unified system
  • Extracting the most value out of Sunshine data through a robust internal monitoring, investigation, and auditing system
    • How can open payments data be used from a compliance perspective for auditing and monitoring in internal investigations?
    • How is this data useful for something other than transparency reporting?
  • Anticipating and addressing media inquiries: defending a company at a reputational level
  • Multi-state survey – adjusting compliance programs to address both federal and state disclosure mandates
  • How is Sunshine data being used by the government?
    • Insys Therapeutics indictment of a sales representative and a manger
    • How can open payments data be used proactively to prepare in order to avoid government investigations?

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