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, 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, other life sciences entities, and payors as they grapple with rapidly changing healthcare industry regulations, technology, and expansion.
John also serves as outside compliance and investigations counsel for a number of healthcare companies including some that are 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 additional 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 and overpayments from 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.
Articles in the National Law Review database by John E. Kelly