Special Briefing on Fraud & Abuse in the Sales and Marketing of Drugs & Medical Devices

Page 1

EARN CLE CREDITS

Special Briefing on

FRAUD & ABUSE

in the Sales and Marketing of Drugs & Medical Devices March 18, 2021 (Eastern Daylight Time) • Virtual Conference Hear from Government Speakers:

Jolie Apicella Chief, Health Care Fraud Unit United States Attorney’s Office, Eastern District of New York

Amanda Masselam Strachan Chief, Health Care Fraud Unit United States Attorney’s Office, District of Massachusetts

ACI is my preferred conference given the range of speakers, particularly by government enforcers, in house and law firms.

Associate Sponsors:

UNITED THERAPEUTICS

Broad spectrum of viewpoints and experiences, learned a lot from DOJ. ADAMAS PHARMA

Lee M. Cortes, Jr. Chief, Health Care Fraud Unit United States Attorney’s Office, District of New Jersey

Allan Medina Chief, Health Care Fraud Unit Criminal Division, Fraud Section, Department of Justice

AmericanConference.com/Fraud-and-Abuse • 888 224 2480

Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES


Thursday, March 18, 2021

Amanda Masselam Strachan Chief, Health Care Fraud Unit United States Attorney’s Office, District of Massachusetts

12:45

Opening Remarks from the Co-Chairs Katherine DeKam Chief Compliance Officer Acumed

Seth H. Lundy Partner King & Spalding LLP

Katherine DeKam Chief Compliance Officer Acumed

Seth H. Lundy Partner King & Spalding LLP

Jane H. Yoon Partner Paul Hastings LLP While falling short of declaring speaker programs by pharmaceutical and medical device companies as being in strict violation of the Anti-Kickback Statute (AKS), the Office of Inspector General (OIG)’s recent guidance affirms the agency’s strong reservations about such programs. This guidance outlines several “suspect characteristics” that would give rise to liability under the AKS, leading industry to seriously re-evaluate how it conducts speaking events. This session will address: • OIG’s objections to events held at restaurants and/or a significant period of time after a product is authorized • Points of divergence from industry practices and what companies will need to change • Considerations for resuming in-person speaker programs after the pandemic Be prepared to turn on your audio and video and engage in conversation with our esteemed chairs! 1:45

Prosecutorial Perspectives on Recent Settlements, OIG’s Guidance, and Enforcement Priorities for 2021 Jolie Apicella Chief, Health Care Fraud Unit United States Attorney’s Office, Eastern District of New York

2 | #Fraud&Abuse

Lee M. Cortes, Jr. Chief, Health Care Fraud Unit United States Attorney’s Office, District of New Jersey

4:15

Stephen Chien Global Compliance Lead, Senior Associate General Counsel Gilead Sciences Richard S. Liner Senior Assistant General Counsel Bayer Pharmaceuticals

Join a panel of esteemed prosecutors in discussion of: • What the enforcement activity of the past year reveals about the state of industry compliance with fraud and abuse laws • Insight on how the DOJ is interpreting OIG’s Special Fraud Alert and its anticipated impact on future enforcement • Types of industry practices under ongoing scrutiny • Potential shifts in enforcement priorities under the Biden administration as some of the regulatory infrastructure dismantled under Trump is rebuilt 2:45

The Real-Life Lessons from the Novartis, Gilead, and Biogen Settlements: Key Liability Risks Relating to Speaker and Patient Assistance Programs Sean C. Cenawood Partner Dentons

William A. Sarraille Partner Sidley Austin

In evaluating their own compliance measures, drug manufacturers must be cognizant of the deficiencies that led to recent, big ticket enforcement actions. This session will examine three major settlements from the past year, each relating to violations of both the AKS and the False Claims Act (FCA), with an analysis of important lessons learned: • Novartis’ $678 million settlement with the DOJ and corporate integrity agreement with OIG (in July 2020) over payments to care practitioners who spoke at Novartis events to induce them to prescribe the firm’s drugs • Gilead’s $97 million settlement with the DOJ (in September 2020) resulting from use of a foundation as a conduit to cover the co-pays of Medicare patients taking a Gilead drug • Biogen’s $22 million settlement with the DOJ (in December 2020) over allegations that it paid kickbacks to patient assistance charities in order to induce them to use its drugs 3:45

1:1 Peer-to-Peer Networking 3:55 Break

IN-HOUSE COUNSEL PANEL

Perspectives on Staying Compliant in the Context of the Pandemic, Managing Interactions with HCPs, and Keeping up with Evolving Regulatory Requirements

MODERATOR: David H. Resnicoff Partner Riley Safer Holmes & Cancila LLP

1:00

Practical Analysis of a Game Changer: Interpreting the November 2020 Special Fraud Alert on Speaker Programs

Allan Medina Chief, Health Care Fraud Unit Criminal Division, Fraud Section, Department of Justice

Rebecca L. Orttel Chief Counsel, U.S. Market and Global Health Law COE; Chief of Staff, Americas Region Medtronic MODERATOR

Katie McDermott Partner Morgan, Lewis & Bockius LLP

• Conducting audits of compliance issues that may have gone unnoticed during the pandemic or that relate to measures taken in unusual times • Evaluating when and how manufacturers can assist providers in setting up telemedicine arrangements that would enable patient access to their products, without violating of the AKS • Overcoming compliance challenges as sales efforts resume with greater intensity • Understanding how manufacturers and medical device companies can transition toward value-based contracting arrangements in compliance with the AKS • Evaluating the potential for fraud in interaction with pharmacies – e.g., manufacturer involvement in completing prior authorization forms to ensure drug coverage; contacting pharmacy patients for resale reminders; obtaining data from pharmacies 5:15

What the Newest AKS Safe Harbors Mean for Pharmaceutical and Medical Device Manufacturers Michael K. Loucks Partner Skadden, Arps, Slate, Meagher & Flom LLP James Stansel Executive Vice President & General Counsel PhRMA

Julie Ritchie Wagner Senior Assistant General Counsel PhRMA

In late 2020, OIG finalized a series of safe harbors to the AKS. This session will analyze their implications and ambiguities: • Debating the impact of eliminating the safe harbor for rebates paid by manufacturers to pharmacy benefit managers (PBMs) • Assessing changes to protections for engaging healthcare providers through consulting agreements • Expanded protection for drug and medical device companies for bundled product and service warranties 6:00

Closing Remarks & Briefing Adjourns

twitter: @ACI_Anticorrupt linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals


C5 GROUP’S VIRTUAL EVENTS

Join Us Virtually this March! Our new virtual events continue to be guided by our unifying philosophy: we believe that growth and success occurs when the power of people and the power of information come together. We may not be able to gather in person, but nothing stops connection and innovation. As the current global situation continues to unfold, we understand that it may not be possible to attend our events in person. At the same time, we also understand that collaboration is more vital than ever and for that, you can still rely on CI to bring the industry together but in a different way. We are transforming quickly to ensure you can now connect virtually and continue to gain unparalleled access to market leading intelligence and to the facilitation of a global exchange of expertise.

Click Here to Watch Demo

Participate in Meaningful Networking Enjoy an Easy to Use, Dynamic Online Platform Immerse Yourself in Live Presentations and Panel Discussions Engage with Attendees and Speakers in an Interactive Format Meet 1-on-1 with Your Fellow Attendees

For more information and answers to many of your questions, please visit:

AmericanConference.com/Fraud-and-Abuse


About us:

Join Our Email List to Stay Connected

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

SIGN UP TO RECEIVE EXCLUSIVE DISCOUNTS, OFFERS AND PROGRAM UPDATES

For over 30 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

AmericanConference.com/join-our-email-list/

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

Accreditation will be sought in those jurisdictions requested by

EARN CLE the registrants which have continuing education requirements.

hands-helping BECOME A SPONSOR

CREDITS

With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, The Canadian Institute, and C5 Group, provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board. ACI certifies this activity has been approved for CLE credit by the State Bar of California. ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Don’t miss the opportunity to maximize participation or showcase your organization’s services and talent. For more information please contact us at: SponsorInfo@ AmericanConference.com

Looking to Register?

This course is identified as nontransitional for the purposes of CLE accreditation.

For more information on ACI’s CLE process for virtual events visit: www.americanconference.com/accreditation-instructions-for-virtual-attendance/

Mark Parrish American Conference Institute

Fadumo Omer American Conference Institute

M.Parrish@AmericanConference.com

F.Omer@AmericanConference.com

1 212 352 3220 x7207

1 212 352 3220 x7361

Contact our Customer Service Representatives:

Use Registration Code: B00-999-MPH21

Use Registration Code: B00-999-FOR21

CONFERENCE CODE:

Register & Pay by March 18, 2021

PRICING

876L21-VRT

$595

Virtual Conference

All program participants will receive an online link to access the conference materials as part of their registration fee. Additional copies of the Conference Materials available for $199 per copy. To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/. Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/

© American Conference Institute, 2021

Bringing a Team? 3-4

10% Conference Discount

5+

Call 888-224-2480

Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service.


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.