In addition to her work on complex transactional matters, Kate delivers comprehensive support across the entire FDA-regulated product lifecycle, guiding clients through product development, clinical trials, product classification, manufacturing, sales and marketing strategies, and recalls with precision. Kate also advises on a broad spectrum of health care regulatory issues, including pharmacy compliance, corporate practice of medicine and dentistry, and fraud and abuse concerns. She guides clients through critical regulations such as the Anti-Kickback Statute, the Stark Law and other legal frameworks. Her proactive, client-focused approach ensures seamless navigation through even the most complex regulatory challenges.
A strategic partner with industry experience
Kate’s distinctive background, rooted in hands-on industry experience, distinguishes her as an exceptional advisor. Her tenure as legal counsel within a large hospital system gives her unparalleled insight into hospital board dynamics and leadership teams and allows hospitals to benefit from her hands-on familiarity with physician contracting, medical staff compliance, pharmacy operations, patient privacy and patient care issues. Kate’s time managing a physician practice and serving as an emergency department administrator at a top-tier academic medical center further enhances her ability to understand and assess clients’ needs. From billing and coding compliance to managed care contracting, financial and strategic planning, emergency preparedness and Emergency Medical Treatment and Labor Act (EMTALA) compliance, Kate’s comprehensive knowledge ensures her clients stay ahead of regulatory and operational challenges.
As former senior regulatory counsel for a prominent middle-market health care lender, Kate developed a sophisticated understanding of the regulatory risks associated with transactions involving pharmaceutical, medical device, technology and health care provider entities. She enables lenders to efficiently and effectively navigate complex lending transactions by identifying and mitigating regulatory risks, ensuring streamlined due diligence and facilitating effective lender documentation.
