Overview

Kate Hardey is a corporate healthcare partner in the Washington, D.C., office of Kirkland & Ellis LLP. Kate is an experienced attorney with a focus in a broad range of healthcare transactions and regulatory matters. With her extensive law firm, in-house and healthcare industry experience, Kate has a deep understanding of the complex regulatory landscape affecting companies in the healthcare provider and life science space including physician groups, hospital systems, home health, hospice, laboratory, pharmacy and pharmaceutical and medical device manufacturers.

Kate routinely advises clients on a broad range of healthcare-related issues including corporate practice of medicine and dentistry, pharmacy compliance and general fraud and abuse matters, such as the Anti-Kickback Statute and the Stark Law and other related regulatory matters. In addition, Kate has extensive experience with U.S. Food and Drug Administration (FDA) compliance matters including pharmaceutical and medical device manufacturing, drug and device development and clinical trials, drug and device product sales and marketing, and over-the counter (OTC) and dietary supplement product compliance and enforcement.

Kate's in-house experience includes serving as Senior Regulatory Counsel at a leading middle-market healthcare lender where she advised on healthcare regulatory risks for a wide range of healthcare provider and facility transactions, in addition to transactions involving pharmaceutical and medical device manufacturers in all stages of product development. Kate also served as in-house legal counsel in a large health system, where she served on hospital boards and leadership teams. In this role, Kate counseled hospital clients on a wide range of legal issues including physician contracting, medical staff compliance, pharmacy compliance, patient privacy and patient care matters.

Kate's healthcare industry experience includes managing physician practices where she oversaw all aspects of the practice's billing and coding compliance and managed care contracting. In addition to her physician practice management experience, Kate served as the emergency department administrator at a major academic medical center where she was responsible for the department's EMTALA compliance, physician contracting, financial and strategic planning and hospital emergency preparedness.

Kate was recognized in the 2023 Southeastern Legal Awards as one of the Most-Effective Deal-Makers. In September 2022, she received the M&A Advisor award for Healthcare/Life Sciences Deal of the Year. Kate is regularly called upon to advise on large corporate transactions in connection with major acquisitions and mergers undertaken by private equity and strategic acquirers in the healthcare provider, healthcare services, and life sciences platforms.

More

Recognition

Recognized in American Lawyer Media as a “Most Effective Deal-Maker,” June 2023 

Recognized in North Carolina Lawyers Weekly as “Leaders in the Law,” November 2020

Credentials

Admissions & Qualifications

  • 2004District of Columbia
  • 2018North Carolina
  • 2003Virginia

Education

  • Catholic University of AmericaJ.D.cum laude
  • Marymount UniversityM.S., Healthcare Administration
  • George Mason UniversityB.A., English