Fraud and Corruption Risks Tied to
Domestic and Foreign HCP Interactions -
Enforcement Trends and Key Risk Indicators

Recent enforcement actions under U.S. health care fraud and abuse laws and the U.S. Foreign Corrupt Practices Act (FCPA) underscore that interactions with health care providers (HCPs) can result in significant legal exposure for life sciences and health care companies.  In this webcast, the presenters will address particular types of HCP interactions that the U.S. Department of Justice (DOJ), the U.S. Securities and Exchange Commission (SEC), and private whistleblowers have targeted in recent investigations, enforcement actions, and litigation.  Among other HCP interactions, this webcast will focus on speaker bureaus, roundtable meetings, sponsorships, post-marketing observational studies, product support programs, clinical decision support activities, and the provision of free goods and samples.  In light of the COVID-19 pandemic, the presenters will analyze how virtual meetings and telemedicine/telehealth activities are likely to impact the risk profile of many of these activities.  This webcast also will address methodologies for identifying key risks associated with these types of interactions through risk assessment and data analysis activities.  The presenters will cover particular steps that companies with nascent or mature compliance programs can incorporate data analysis to mitigate fraud and abuse and international anti-corruption risks.

Top Ten Benefits

  1. The ways in which DOJ, the SEC, and whistleblowers apply the False Claims Act, Anti-Kickback Statute, and FCPA to routine interactions between HCPs and life sciences/health care companies;
  2. Key areas of focus for DOJ, the SEC, and whistleblowers in False Claims Act, Anti-Kickback Statute, and FCPA enforcement actions and cases;
  3. Novel DOJ, SEC, and whistleblower theories tied to historically accepted HCP interactions under the False Claims Act, Anti-Kickback Statute, and FCPA;
  4. Exacerbating circumstances in enforcement actions based on HCP interactions (e.g., DOJ’s so-called “badges of fraud” in speakers fee and product support cases);
  5. The evidence that DOJ and the SEC martial in pursuing enforcement actions tied to HCP interactions;
  6. Defenses that companies can assert in defending legitimate HCP interactions;
  7. The likely impact of the pandemic on HCP interactions and associated risks;
  8. Supplemental compliance controls to mitigate new types of interactions resulting from work-from-home and pandemic-related restrictions;
  9. Methodologies to identify fraud and abuse and anti-corruption risks in audits, monitoring, and data analytics; and
  10. Practical data analysis strategies to mitigate risk.

SPEAKERS

Winston Y. Chan

PARTNER, GIBSON DUNN


Winston Y. Chan is a former federal prosecutor and litigation partner in Gibson, Dunn & Crutcher’s San Francisco office.  He has particular expertise leading matters involving government enforcement defense, internal investigations, compliance counseling, and civil trial litigation for life sciences clients.  Mr. Chan is a LMG Life Sciences “Star” and a Chambers-ranked attorney in the category of White Collar Crime and Government Investigations, and Benchmark Litigation recognizes him as a Litigation Star for being “recommended consistently as a reputable and effective litigator by clients and peers.”  Global Investigations Review ranks Mr. Chan in its annual Global Guide of Recommended Investigations Counsel, including in their inaugural ranking of “the most eminent lawyers in the field under 45.”  Mr. Chan previously served as an Assistant U.S. Attorney in the Eastern District of New York, where he held a number of supervisory positions, including as Health Care Fraud Coordinator.  In that capacity, he oversaw all qui tam and whistleblower investigations involving allegations of False Claims Act violations, kickbacks, misbranding and off-label promotion by pharmaceutical, biotechnology, and medical diagnostic companies, among others.

Michele Wiener

PARTNER, CONTROL RISKS


Michele Wiener is a Partner within Control Risks’ Compliance, Investigations and Technology practice, and head of its Regulatory Risk and Life Science groups in the Americas region. She has significant experience in fraud and corporate compliance matters in the US and abroad. Working on behalf of legal counsel, boards of directors, and senior management of public and private corporations, Michele specializes in conducting complex corporate investigations and forensic accounting engagements involving allegations of corruption, financial reporting fraud, internal controls and books and record-keeping violations under both the Foreign Corrupt Practices Act (FCPA) and UK Bribery Act. She has led engagements in more than 30 countries, including the US, Latin America, Europe, the Middle East, Africa, and Asia. Michele has also helped companies design, evaluate, and improve anti-corruption and anti-fraud compliance programs. In 2019, Control Risks’ Regulatory Risks and Investigations Team in the Americas, led by Michele Wiener, was named Compliance Consulting Team of the Year at the C5 Women in Compliance Awards.

John Partridge

PARTNER, GIBSON DUNN


John Partridge is a Chambers-ranked litigation partner in Gibson, Dunn & Crutcher’s Denver office and a Co-Chair of the firm’s FDA and Health Care Practice Group. His practice focuses on government and internal investigations, white collar defense, and complex litigation for clients in the life sciences and health care industries. Mr. Partridge, whom LMG has ranked as a rising star in life sciences, has particular experience with the False Claims Act, the Foreign Corrupt Practices Act, and the Federal Food, Drug, and Cosmetic Act, including defending major corporations in investigations pursued by the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange Commission (SEC). Mr. Partridge has represented clients in criminal and civil enforcement actions relating to alleged health care fraud and abuse, including actions conducted by DOJ, the U.S. Food and Drug Administration’s Office of Criminal Investigations, the Department of Health and Human Services Office of Inspector General, and State Attorneys General.  His substantive experience includes cases involving allegations relating to, among other things, clinical trials, off-label promotion, sampling practices, importation of regulated products, and anti-kickback issues.  Among other publications, Mr. Partridge and his colleagues wrote the criminal enforcement and pharmaceutical sampling chapters of PLI’s Pharmaceutical Compliance and Enforcement Answer Book.

Reid F. Rector

ASSOCIATE ATTORNEY, GIBSON DUNN


Reid F. Rector is a senior litigation associate in Gibson, Dunn & Crutcher’s Denver office.  His practice focuses on litigation and government investigations for companies in the health care and life sciences industries, including health care and FDA compliance, enforcement, and related litigation.  Mr. Rector has substantial experience representing health care, pharmaceutical, and medical device clients during investigations by the Department of Justice, the Food and Drug Administration, the Department of Health and Human Services Office of Inspector General, and State Attorneys General, including in-depth experience with the False Claims Act and Anti-Kickback Statute.  He also regularly advises clients on FDA regulatory issues under the Federal Food, Drug, and Cosmetic Act.