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John Kelly
OVERVIEW

John E. Kelly
Partner, Healthcare Department and Healthcare Industry Practice Chair

Washington, D.C.

1717 Pennsylvania Avenue N.W.
Suite 500
Washington, D.C. 20006-4623

P 202-831-6731

F 202-289-1330

OVERVIEW

John E. Kelly
Partner, Healthcare Department and Healthcare Industry Practice Chair

Washington, D.C.

1717 Pennsylvania Avenue N.W.
Suite 500
Washington, D.C. 20006-4623

P 202-831-6731

F 202-289-1330

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.

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.

OVERVIEW

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 a number 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. 

Professional and Community Involvement

Member, District of Columbia Bar Association

Member, New York State Bar Association

Member, American Health Law Association (AHLA) Fraud and Abuse Group 

Co-chair, AHLA Fraud and Compliance Conference

Former co-chair, AHLA Fraud and Abuse Practice Group 

Member, Health Care Compliance Association (HCCA)

Former vice chair, American Bar Association (ABA) Health Law Section

Former vice chair, ABA Emerging Issues in Healthcare Law Conference

Former liaison, ABA Health Law Section’s Health Law and Policy Committee 

Honors

Chambers USA, Healthcare, 2020-2022; Litigation: White-Collar Crime & Government Investigations, 2019

Washington, D.C., Super Lawyers, 2013-2022

LMG Life Sciences Life Science Star, 2022

Cooperative Achievement Award, Department of Health and Human Services Office of Inspector General 

Director’s Award for Superior Performance in Public Service, Executive Office for United States Attorneys

Experience

Represented a Fortune 50 healthcare company in a FCA/qui tam action. The case involved novel allegations about the relationship between a payor, pharmacy benefit manager, and pharmaceutical manufacturer in the Medicare Advantage space. After advocacy by our litigation team, the DOJ declined to intervene in the lawsuit. The whistleblower proceeded and the case was favorably resolved while dispositive motions were pending.  

Obtained dismissal of a FCA/qui tam matter alleging that a Fortune 50 pharmaceutical company caused, through the sale and marketing of its product, the submission of false claims based on insufficient labeling that failed to adequately warn about certain side effects.

Negotiated a favorable settlement with DOJ and HHS-OIG for a vascular surgical center in a FCA/qui tam action alleging the submission of false claims from unnecessary medical procedures.

Obtained a complete victory against DOJ for the former vice president of a national transportation company who, along with three others, was accused of trying to defraud customers. Case involved a three-month federal criminal trial and an appeal before the Sixth Circuit Court of Appeals.

Represented a large hospital system and negotiated a favorable settlement with HHS-OIG utilizing the OIG’s Self-Disclosure Protocol after conducting an internal investigation into possible compliance issues.

Represented a global healthcare company in a qui tam action alleging violations of the FCA, which concerned how negative pressure wound therapy devices were being marketed and distributed as durable medical equipment. Negotiated a favorable settlement with DOJ, HHS-OIG, and relator.

Represented a global medical device company in a five-year DOJ investigation into allegations of healthcare and securities fraud resulting in a Deferred Prosecution Agreement and no post-settlement monitoring

Represented a group of diagnostic imaging centers in a DOJ and HHS-OIG investigation alleging FCA violations; negotiated resolution with no post-investigation monitoring or corporate integrity agreement

Represented a global healthcare company in a drug diversion matter concerning how controlled substances were ordered, secured and dispensed by the company under state and federal law; following an internal investigation and meeting with the DEA, the government declined to pursue further action.

Represented a hospital system in its appeals of RAC denials in Administrative Law Judge and Medicare Appeals Council proceedings

Conducted global FCPA compliance risk assessment for a publicly traded international medical device company

EXPERIENCE
Presentations
  • Panel moderator, "Cross-Industry in-House Counsel Think Tank: Implementing Internal Due Diligence Measures and Compliance Strategies to Mitigate FCA Risk,” Advanced Forum on False Claims and Qui Tam Enforcement, New York City, New York, Jan. 23-24, 2023
  • Presenter, "Anti-Corruption Settlements," Seton Hall Law Middle East Healthcare Compliance Program (HCCP), Dubai, UAE, Jan. 16-19, 2023
  • Presenter, "Enforcement, Compliance Officer, and General Counsel," HCCA Virtual Healthcare Enforcement Compliance Conference, Nov. 8, 2022 
  • Co-presenter, “Managed Care Enforcement Trends and Compliance Risks,” Health Ethics Trust 27th Annual Best Compliance Practices Forum, Oct. 20-21, 2022
  •  Presenter, "US Healthcare Compliance Certification Program," Seton Hall Law Center for Health & Pharma Law, Oct. 13, 2022
  • Co-presenter, “The Future is Now: Managed Care Enforcement Trends and Risk Areas,” AHLA 2022 Health Plan Law and Compliance Institute, Chicago, Illinois, May 9-10, 2022
  • Co-presenter, “Managed Care Enforcement Trends and Compliance Risks,” Health Ethics Trust Washington Executive Course Virtual Conference, May 4-6, 2022
  • Panel moderator, “The Aftermath of an Organizational Crisis: Stumbling Blocks and Lessons Learned,” 2022 Consero Healthcare General Counsel Forum, Pasadena, California, May 2, 2022
  • Panelist, “Managed Care Enforcement Trends and Compliance Risks,” Health Ethics Trust’s Compliance Certification Intensive Course, Feb. 23, 2022
Publications
  • Co-author, “United States Defends Falsity Theory, Use of Debatable Sub-Regulatory Guidance in Medicare Advantage False Claims Act Suit Against Kaiser Permanente,” American Health Law Associate newsletter, September 2022 
  • Co-author, “What’s Next for Corporate America Under Garland,” Chief Executive, March 25, 2021
INSIGHTS AND EVENTS
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