Registration and Continental Breakfast

Co-Chairs’ Welcoming Remarks and Introduction of Keynote Speaker

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

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

• 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?

Morning Coffee Break

Patient Assistance Programs: How to Structure and Manage Them without Running Afoul of Evolving Regulatory Enforcement Theories

• 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

Networking Lunch

Not So Safe: Exploring the Boundaries of the Discount Safe Harbor in Light of Recent Court Decisions

• 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

The Yates Memorandum a Year Later

• 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

Afternoon Refreshment Break

Developments with the False Claims Act and Qui Tam Enforcement in Light of the Escobar Decision

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.

Pricing Considerations for the Compliance Agenda in an Evolving Environment

• 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

Conference Adjourns to Day 2

Registration and Continental Breakfast

Co-Chairs’ Welcoming Remarks

The Enforcers Speak: US Attorney’s Office Roundtable

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?

Morning Refreshment Break

Lessons Learned from Recent FCPA and Anti- Corruption Enforcement Actions

• 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

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

• 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

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

• 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?

Conference Ends

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