JAIME L.M. JONES is global co-leader of the firm’s Healthcare practice, a member of the Global Life Sciences Leadership Council, and serves on the firm’s COVID-19 Task Force. Jaime draws on her extensive experience defending healthcare and life sciences companies in government investigations and enforcement actions to provide legal and compliance organizations and Boards of Directors with strategic, practical advice to manage enforcement actions, litigation, and regulatory risk.
Enforcement Defense and Strategy. Jaime has led the defense and successful resolution of high-profile, high stakes government enforcement actions. Jaime has helped the world’s leading pharmaceutical and device manufacturers and healthcare providers to navigate and successfully defend against civil and criminal enforcement actions at the cutting edge of government enforcement theories. While she has negotiated many high-profile public settlements she has brought many more matters to an efficient close without negotiated resolutions or litigation. Among other issues, she has deep experience defending enforcement matters based on allegations of:
- Violations of the False Claims Act
- Violations of the Anti-Kickback Statute, Stark Law, Beneficiary Inducement Statute, and other healthcare fraud and abuse laws
- Billing and coding improprieties, including as to inpatient, behavioral health, Medicare Advantage and pharmacy providers
- Off-label promotion, pre-approval promotion, risk minimization, and other allegations of improper promotion of drugs and medical devices in violation of the Food, Drug, and Cosmetic Act
- Violations of cGMP and Quality System regulations
- The U.S. Foreign Corrupt Practices Act and other anti-corruption and anti-bribery laws
Practical Regulatory Counseling. Recognized in Chambers 2020 as “a true expert in healthcare fraud and abuse,” Jaime provides strategic counseling advice on healthcare fraud and abuse and regulatory issues to help companies achieve their objectives and minimize risk. Informed by her extensive enforcement experience, her advice is practical, measured, and informed by a deep understanding of industry standard practices and how regulators and enforcers view the issues. She routinely counsels clients on pricing, coding and billing, and reimbursement issues, arrangements between healthcare professionals/organizations and life sciences manufacturers, joint venture arrangements, patient access programs, and promotional activities of FDA-regulated entities.
Advisor to PE and Other Investors. Jaime brings these same skills to bear to counsel private equity and other investors exploring and executing on opportunities in the healthcare and life sciences industries.
Structuring Effective Compliance Programs. She has negotiated significant Corporate Integrity Agreements with HHS-OIG and assists her clients to build global corporate compliance programs that are effective at identifying and addressing real areas of risk and are right-sized for their business. She regularly assists her clients in performing compliance audits.
Jaime leads teams to conduct discrete and efficient internal investigations and helps healthcare and life sciences companies to remediate identified issues.
False Claims Act Litigation. When necessary, Jaime leads litigation in both state and federal courts, with an emphasis on False Claims Act cases and whistleblower retaliation claims. She has successfully defended qui tam claims brought against pharmaceutical and device manufacturers and institutional healthcare providers in courts across the country.
Recognized Expertise. Jaime is among the top healthcare lawyers in the United States and is consistently ranked in Chambers as a leading lawyer. In Chambers 2021, she was recognized as being “steeped in both regulatory and legal knowledge” and “prepared to share her experience and make practical recommendations. In Chambers 2020, Jaime was identified for her “extensive contentious practice, which includes FCA litigation, DOJ investigations and enforcement actions for an array of healthcare providers and drug manufacturers” and “advocacy and presentation skills.” One of Jaime’s healthcare clients named her a BTI Client Service All-Star for 2020. Earlier, she was recognized on Law360’s list of top life sciences attorneys under 40 and was named a Rising Star in the Euromoney LMG 2015 Guide.
Prior to joining the firm, Jaime clerked for the Hon. Gerald B. Tjoflat, United States Court of Appeals for the Eleventh Circuit, from 2001–2002. Jaime received her J.D. in 2001 with high honors from Duke University School of Law, and her B.A., cum laude, from the University of Notre Dame.