Overview
The HHS Office of the Inspector General’s (OIG) trend of Anti-Kickback Statute (AKS) enforcement proceedings against medical products companies has continued in the past several years. Yet, some recent OIG advisory opinions have found that OIG would not impose administrative sanctions for certain financial arrangements under the AKS. During this webinar, we will discuss recent trends in AKS enforcement as well as safe harbors. We will cover how to comply with AKS requirements, including government expectations and requirements, investigative best practices, self-disclosure, and privilege issues.
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Speakers
John Bentivoglio, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
Hannah Bornstein, Partner, Nixon Peabody LLP
Lisa Rachlin, Commercial Counsel, Vertex Pharmaceuticals, Inc.
Jennifer Schwartz, Managing Counsel, Office of the General Counsel, Merck & Co., Inc.
JOHN BENTIVOGLIO is a partner at Skadden, Arps, Slate, Meagher & Flom LLP where he represents pharmaceutical, medical device and biotechnology manufacturers in criminal, civil and administrative enforcement actions by the US Department of Justice, state attorneys general and other agencies. He has negotiated successful resolutions of such matters for Allergan, Calloway Laboratories, Jazz Pharmaceuticals, Merck & Co., Otsuka Pharmaceuticals and Serono, among others. He also has counseled more than a dozen companies on the negotiation and implementation of Corporate Integrity Agreements. In addition to assisting companies in enforcement actions, he regularly advises clients on compliance program issues and on federal and state anti-kickback and false claims statutes, FDA advertising and promotional rules, and Medicare and Medicaid regulatory issues. From 1997-2000, he served as associate deputy attorney general and special counsel for health care fraud at the DOJ, where he advised the attorney general and deputy attorney general on national enforcement initiatives, health care investigation and prosecution policies, and interagency coordination. From 1996-1997, he was a special assistant to the assistant attorney general, Criminal Division. Earlier in his career, Mr. Bentivoglio served as a professional staff member to Sen. Joseph R. Biden Jr., chairman, Committee on the Judiciary.
JENNIFER SCHWARTZ is a Managing Counsel in the Office of General Counsel at Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Jennifer joined Merck in 2004 and is a member of Merck’s Commercial Legal group, providing legal support to Merck’s US Marketing and Sales, Account Management, Market Access, and Compliance organizations. She has also provided regulatory legal support for a number of Merck’s pharmaceutical products. Prior to joining Merck, Jennifer was an associate at Covington & Burling LLP and clerked for the Honorable Denny Chin, then a District Judge of the Southern District of New York. Jennifer is a graduate of Dartmouth College and New York University School of Law.
