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PCC 2023 — Pharmaceutical Compliance Congress


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Delivered as a Hybrid Event
April 25 - 27, 2023The Ritz-Carlton, Tysons Corner | McLean, VA

John Kelly
Chair, Healthcare Industry Practice at Barnes & Thornburg LLP


John Kelly is a former federal prosecutor and an experienced trial attorney who focuses on guiding and defending clients across all areas of business, with a primary focus in the healthcare and life sciences industries. A knowledgeable, creative and thoughtful practitioner who is as comfortable in the boardroom as he is in a courtroom, John is driven to do what is right for his clients.

As Chair of Barnes & Thornburg’s Healthcare Department and Industry Practice, John advises and defends companies and individuals in criminal prosecutions and civil litigation involving health care fraud and abuse issues, including the False Claims Act (FCA), Anti-Kickback Statute and Stark Law, the Food, Drug and Cosmetic Act (FDCA), the Controlled Substances Act (CSA), the Foreign Corrupt Practices Act (FCPA), and other regulatory and compliance issues. He is well versed in the needs of providers, hospitals, health systems, clinical labs, pharmacies, pharmacy benefit managers, drug distributors, pharmaceutical manufacturers, medical device companies, and payors as they grapple with rapidly changing healthcare industry regulations and expanding government enforcement initiatives.

John serves as outside compliance and investigations counsel for a number of healthcare companies including those subject to the requirements of a corporate integrity agreement. He leads internal investigations and works with the client and reportable events committee to determine if reporting is necessary.

Additionally, John has extensive experience in managed care and with Medicare Advantage risk adjustment providing compliance guidance, best practices, and assisting with disclosures to federal and state regulatory agencies. And John has a robust white collar defense practice representing companies and individuals in matters against the U.S. Department of Justice (DOJ), U.S. Department of Health and Human Services - Office of Inspector General (HHS-OIG), Food and Drug Administration (FDA), Federal Bureau of Investigations (FBI), Drug Enforcement Administration (DEA), and other federal and state regulatory agencies.

Prior to joining Barnes & Thornburg, John was a partner in another national firm where he served on its executive committee, as managing partner of that firm’s D.C. office, and as co-chair of its Compliance & Government Investigations Practice Group.

Before entering private practice, John had a distinguished career as a federal prosecutor where he investigated and prosecuted healthcare fraud cases nationwide while directing and supervising agents and prosecutors. He held | 2number of leadership positions at the DOJ including: assistant chief for the Healthcare Fraud in the Criminal Division’s Fraud Section, lead prosecutor for the Medicare Fraud Strike Force in Los Angeles, and chief of staff and deputy director of the Executive Office for U.S. Attorneys. In these roles, he worked closely with leadership at various federal agencies, including DOJ, HHS-OIG, CMS, FBI, and DEA.

John is a frequent speaker and writer on topics related to healthcare fraud and abuse, the FCPA, the FDCA, and compliance programs. He is invited to speak at conferences and seminars across the country and overseas, and was a regular instructor at the DOJ’s national training center where he lectured on trial advocacy, criminal procedure, evidence, ethics and healthcare fraud.

John is often quoted by national media outlets on compliance and government enforcement. His insights have been published in articles by The Wall Street Journal, Reuters, Bloomberg News, Modern Healthcare, and Law360, among others.

Agenda Sessions

  • Former Prosecutor Panel — Answers and Insights from Industry’s Trusted Advisors