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

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Special Briefing on

FRAUD & ABUSE

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

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

UNITED THERAPEUTICS

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

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

” Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES

Thursday, March 18, 2021 1:00

2:45

4:15

Opening Remarks from the Co-Chairs

The Real-Life Lessons from the Novartis, Gilead, and Biogen Settlements: Key Liability Risks Relating to Speaker and Patient Assistance Programs

Keeping up with Evolving Regulatory Requirements and Staying Compliant in the COVID Context and Beyond

1:15

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

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

2:00

Prosecutorial Perspectives on Recent Settlements, OIG’s Guidance, and Enforcement Priorities for 2021

1:1 Peer-to-Peer Networking 4:00 Break

• 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 | #Fraud&Abuse

• 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 In late 2020, OIG finalized a series of safe harbors to the AKS. This session will analyze their implications and ambiguities:

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

IN-HOUSE COUNSEL ROUNDTABLE

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• 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 5:45

Closing Remarks & Briefing Adjourns

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