Verified profile

John E. Kelly

Partner, Healthcare Ind. Prac. Chair at Barnes and Thornburg

John E. Kelly's profile photo
LocationWashington | New YorkDistrict of Columbia, United States
Current roleAdjunct Law School Professor American University Washington College of Law · since Jan 2024
Government service12yrsU.S. Department of Justice (DOJ) · U.S. Attorney’s Office · U.S. District Court

About

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. 

Roles

Jan 2024–Present
Current role

Adjunct Law School Professor

American University Washington College of Law

Washington, District of Columbia

Professor

The False Claims Act in the Healthcare Industry

May 2022–Present
Current role

Barnes & Thornburg LLP Partner | Chair of the Healthcare Department and Healthcare Industry Practice Group

Barnes & Thornburg LLP

Washington | New York, District of Columbia

Foreign Corrupt Practices Act (FCPA)Civil LitigationHealth LawWhite Collar CrimeComplianceGovernment

Partner; Chair of Barnes & Thornburg's Healthcare Industry Practice / Former DOJ Healthcare Fraud Prosecutor / Compliance, government investigations, and False Claims Act litigation) in healthcare & life sciences.

Jan 2012–May 2022
Former role

Member and Managing Partner of the Washington, D.C. Office

Bass, Berry & Sims PLC

Washington, District of Columbia

Foreign Corrupt Practices Act (FCPA)InvestigationsHealth LawWhite Collar Crime

Managing partner of the firm's Washington, D.C. office and Member of the firm’s Compliance and Government Investigations practice. Law practice focuses on healthcare litigation, regulatory, and compliance issues, government investigations, healthcare fraud and abuse, and foreign anti-corruption compliance and investigations. Clients span across many industries with a particular involvement in life sciences and healthcare. This includes providers, clinical laboratories, and pharmaceutical and medical device companies.

Jan 2011–Jan 2012
Former role

Partner

Fulbright & Jaworski

Washington, District of Columbia

Foreign Corrupt Practices Act (FCPA)Civil LitigationHealth LawWhite Collar Crime

Member of Fulbright's Health Care and White Collar and Government Investigations practice groups. Focus on matters involving health care (criminal and civil), the Foreign Corrupt Practices Act (FCPA) and other anti-corruption laws, government and corporate internal investigations, and regulatory and compliance issues. Extensive trial experience at the state and federal levels.

Sep 2008–Dec 2010
Former role

Senior Counsel

Fulbright & Jaworski

Washington, District of Columbia

Foreign Corrupt Practices Act (FCPA)Health LawWhite Collar Crime

Member of Fulbright's Health Care and White Collar and Government Investigations practice groups. Focused on matters involving health care (criminal and civil), the Foreign Corrupt Practices Act (FCPA) and other anti-corruption laws, government and corporate internal investigations, and regulatory and compliance issues. Extensive trial experience at the state and federal levels.

Jan 2006–Jan 2008
Former role

Assistant Chief for Health Care Fraud

U.S. Department of Justice (DOJ), Criminal Division, Fraud Section

(appointed)District of Columbia

Civil LitigationFederal GovernmentEnforcementHealth Law

Supervised attorneys and specialized in investigating and prosecuting health care fraud matters nationwide. Trials and investigations involved violations of the Anti-Kickback Statute, the False Claims Act, and anti-money laundering prohibitions.

Jan 2004–Jan 2006
Former role

Chief of Staff and Deputy Director

U.S. Department of Justice (DOJ), Executive Office for United States Attorneys

(appointed)District of Columbia

Federal GovernmentChief of StaffLegal Officers and Practitioners

Managed the operational oversight of all 94 United States Attorneys' Offices worldwide. Worked closely with senior leadership within the United States Attorneys' Offices, the Department of Justice, HHS-OIG, the FBI, and other federal and state agencies.

Jan 1999–Jan 2004
Former role

Assistant United States Attorney

U.S. Attorney’s Office, United States Attorneys'​ Offices

(appointed)New York Western District

Federal GovernmentLegal Officers and PractitionersCriminal Law

Obtained extensive trial and investigation experience as an Assistant United States Attorney in the Northern and Western Districts of New York.

Jan 1996–Jan 1999
Former role

Assistant District Attorney

U.S. District Court, Monroe County District Attorney's Office

(appointed)New York

Legal Officers and Practitioners

Obtained extensive trial and investigation experience as an Assistant District Attorney in Rochester, New York.

Representative matters

Experience

April 2025

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.

Recognition

Honors

Patricia Meador Leadership Award

American Health Law Association

January 2024

The Best Lawyers in America

April 2025

The Best Lawyers in America, 2024-2025

Patricia Meador Leadership Award

January 2024

Fellow of the Health Ethics Trust

January 2024

Chambers USA

January 2024

Chambers USA, Healthcare, 2020-2024; Litigation: White-Collar Crime & Government Investigations, 2019

Super Lawyers

Washington, D.C. | April 2025

Washington, D.C., Super Lawyers, 2013-2024

LMG Life Sciences Life Science Star

January 2024

Cooperative Achievement Award

Department of Health and Human Services Office of Inspector General

April 2025

Director’s Award for Superior Performance in Public Service

Executive Office for United States Attorneys

April 2025

Publications & speeches

United States Defends Falsity Theory, Use of Debatable Sub-Regulatory Guidance in Medicare Advantage False Claims Act Suit Against Kaiser Permanente

AmericUnited an Health Law Associate newsletter

September 2022

Co-author

American Health Law Associate newsletter

Chief Executive

March 2021

Co-author

Medicare Advantage Enforcement Trends and Compliance Risks

Health Ethics Trust Virtual Certification Intensive Course

August 2023

Health Ethics Trust Virtual Certification Intensive Course

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

2023 Pharmaceutical Compliance Congress

April 2023

Panelist

Private Equity – Be Careful, It Ain’t Private Anymore

American Health Law Association (AHLA) Health Care Transactions Conference

April 2023

Presenter

Medicare Advantage Enforcement Trends and Compliance Risks

Health Ethics Trust Virtual Certification Intensive Course

February 2023

Co-presenter

Managed Care Enforcement: Are You Ready for the Next Wave of Audits, Investigations, and Litigation?

HCCA Virtual Managed Care Compliance Conference

February 2023

Presenter

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

January 2023

Panel moderator

Healthcare Enforcement Trends: What to Do if the Government Comes Knocking

March 2025

Link

Health Ethics Trust Compliance Certification Intensive Course: Compliance Trends and Enforcement/Managed Care

February 2025

Link