American Conference Institute’s 15th Advanced Forum on Fraud & Abuse in the Sales and Marketing of Medical Devices

Best Practices for Updating Your Medical Device Compliance Program by Fortifying Your Protocols, Strengthening Your Team, and Creating a Culture of Living Compliance

In preparation for discussion of the main conference topics, join us for this unique interactive approach to enhancing your medical device compliance program. Benchmark with industry leaders to strengthen your current protocols in this interactive forum. With government enforcers increasingly pursuing fraud and abuse in the medical device industry, don’t miss this unique opportunity to learn best practices and get answers to your company’s specific compliance questions, whether a large or small organization.

• AdvaMed Code of Ethics on Interactions with Healthcare Professionals
• How it’s become the industry standard during medical device prosecutions
• Understanding the distinctions between their codes’ detailed guidance and regulations
• What role that plays in enforcement, whether you have been certified or not
• Recruiting and candidate selection: Avoiding FCA exposure and risk management before the interview
• Making compliance a priority for management
• How to persuade your sales force to invest in the value of compliance
• Translating FDA guidance to your sales reps’ medical device pitch
• Best practices to assist your salesforce on how to remain compliant without stagnating their numbers
• Creating checks and balances to oversee outside reps and consultants, domestically and abroad
• How small and medium size organizations can adapt compliance protocols to fit their resources
• M&A concerns
• Preparing for an opportunity: How having a well-established compliance program in place can make you a better candidate to be acquired
• After the ink dries: How to synchronize your culture of compliance with that of the newly acquired
• Compliance for the C suite: How to organize who serves in what capacity on both a smaller and larger scale
• To sign or not to sign: The ramifications of business association agreements and other documents that have implications you did not foresee
• Drafting contracts that satisfy your HCP’s needs while also protecting your interests
• Transitioning out of old practices to the reality of buying groups: Who is the real target audience now?
• Conducting internal audits and ensuring confidentiality
• HIPPA and global digital privacy: Best practices to remain in compliance and manage security risks
• Considerations for expanding into pharma or combination devices

​9:00 a.m. to 12:00 p.m. (Registration begins at 8:30 a.m.)

Registration for Main Conference

Co-Chairs’ Welcoming Remarks

Insiders’ Roundtable on Recent Enforcement and Compliance Trends

• Lessons learned from recent settlements in Anti-Kickback cases
• Emerging Trends in Compliance Practices
• What’s around the corner: What keeps in-house counsel and law firm practitioners up at night.
• There’s an App for that: the emerging issues of Medical devices involving software

Under the Microscope: Managing, Defending and Curtailing Whistleblowers and Allegations under the False Claims Act

• How to spot a serial whistleblower before you invite them in
• What to look for on a resume, in an interview and what to include in a background check
• Best employment practices in mitigating risks so disgruntled employees will be less likely to use the FCA as a means of voicing their complaints
• How to triage vague or anonymous complaints before they make themselves an emergent priority
• Ascertaining if the doctor or surgeon takes a kickback, will that taint the entire claim and open up the medical device manufacturer to FCA prosecution

Afternoon Refreshment Break

Navigating the Federal Anti-Kickback Statute and Identifying the Specific Risks for Medical Device Companies

• What are the growing enforcement challenges not only facing medical device companies but their consultants and advisory boards?
• Avoiding lavish dinners is not enough: Best practices to ensure your compliance program includes controls for more subtle triggers to Anti-Kickback violations
• Walking the fine between safe harbor protections and violations, new developments
• Who qualifies as a royalty bearing surgeon?
• When do royalties trigger Anti-Kickback violations?

Understanding and Adapting to New Guidance Regarding the Parameters of Conversation and Dissemination of Information Regarding Off- Label Use of Medical Devices

• What the FDA Draft Guidance means for medical device promotion
• Best practices to update your salesforce training program
• Necessary adjustments to be made to your controls for your outside contracted sales team
• When, where, and how you can distribute medical publications
• Does the First Amendment still protect that right to distribute as it was deemed in WLF v. Friedman?
• How does this translate overseas?
• Managing your salesforce and FCA exposure
• What happens when your sales team instructs providers to utilize a device in a context that can lead to overbilling?
• Analyzing the consequences of Medtronic Spine and the kyphoplasty settlements
• Balancing that fine line of medical device sales and playing doctor
• Warranty issues
• What can we expect from promised FDA further guidance?

Conference Adjourns to Day 2

Continental Breakfast

Co-Chairs’ Welcoming Remarks and Introduction of Keynote Speaker

Keynote Address – Lessons Learned from the Most Recent Investigations, How to Modify Corporate Practices to Not Run Afoul of New Enforcement Priorities and Identifying Current Areas of Concern

Lines in the Sand: Extracting Hard Lines from Government Guidance on Social Media

• What are some of the most effective social media tools which carry the least risk
• To Tweet or not to Tweet: Clarifications on FDA guidance and potential loopholes
• Translating “guidance” to best practices
• The legal ramifications for noncompliance: Does the FDA have jurisdiction over Twitter?
• How to employ practices which ensure statements made by third parties on company sponsored sites are not perceived to be endorsed by them
• Keeping track of internet marketing to ensure rules are not violated
• Assigning responsibility for monitoring social media
• Creating parameters for responding to off-label, and other inquiries in chat rooms, message boards, and other media outlets
• Word choices that have previously triggered government scrutiny

Morning Refreshment Break

CIAs: What You Need to Consider Before Signing, During Oversight, and What to Expect After Reaching the Finishing Line

• Determining what’s negotiable and practical considerations of implementation pre-execution
• How to prepare all levels of management before it goes live
• As scrutiny of executive certifications have intensified, ensuring inaccuracies won’t haunt you later
• Establishing protocols to confirm certifications represent facts supported by recorded data
• Impressing upon management the potential consequences of inexact certifications if errors or overstated information surface during an investigation
• How many CIAs will be permissible before more punitive consequences are pursued by the OIG and DOJ?
• M&A: Considerations when acquiring a company under a CIA
• Life after government oversight: How to maintain that structure of compliance

Networking Lunch

Navigating a Global Marketplace: Managing the Manufacturing, Sales and Distribution of Drugs and Medical Devices by Being Vigilant of the Latest Anti-Corruption Pitfalls

• China: Lessons learned from recent anti-corruption enforcement actions
• Overseas Training: Addressing FCPA and global anticorruption standards with your overseas sales force
• Vetting criteria to determine who might be more compliant
• Dealing with 3rd party intermediaries
• Best practices for minimizing risks
• Best practices for due diligence in vetting consultants, manufacturers, and vendors in high risk markets
• Competing against local companies in cultures where gift giving is the norm
• Establishing preventative internal controls measures to prevent and detect corruption

Afternoon Refreshment Break

U.S. Attorney’s Office Roundtable: The Enforcers Speak

DOJ announced it has no intentions on letting up on its pursuit of fraud and abuse in this industry, to the contrary, it has indicated criminal prosecutions will be on the rise. 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:

• Identifying the types of sales and marketing activities that raise red flags for state enforcers and have potential to trigger an investigation
• FCA violations
• Off-label promotion
• Anti-Kickback
• Are the AdvaMed and PhRMA codes considered the industry standard by which your organizations’ actions will be measured?
• What they are looking for in reporting?
• When does the DOJ pursue parallel criminal and civil investigations?
• When does the DOJ pursue prosecution of individuals?
• How does that impact cooperation from corporations?
• When to voluntarily disclose
• What changes should be expected in upcoming consent decrees and Corporate Integrity Agreements?
• cGMP prosecutions and other categories of enforcement actions the enforcers see on the horizon

The Sunshine Act: With Open Payments Now Live, What this Means for Your Compliance Program and Your Relationships with HCPs, Both Here and Abroad

• Six months after Open Payments goes live, how the industry is managing it, and how the public is responding
• Knowing your vulnerabilities and identifying data points and outliners which may signal a broader problem
• Creating QA/QC checks and controls in place at every stage to make sure the data is being categorized and reported correctly
• As more companies expand globally, what are the requirements for reporting and transparency in in Japan, Latin America, Europe, and Slovakia?
• In light of past FCPA cases, is it worth globalizing your domestic transparency systems in anticipation of future domestic demands as well as those imposed by non-U.S. regulators?
• After over a year of reporting, how the Sunshine Act has affected relationships with providers and what lessons can be gleaned to maintain those relationships moving forward

Conference Adjourns