Elaine C. Naughton
Elaine Naughton provides healthcare regulatory counsel as it relates to compliance, operational and transactional matters. She works with a wide range of clients in the healthcare and life science industries, including physician practices, hospitals, clinical laboratories, pharmacies, biotechnology companies and private equity firms, among others. Relying on her strong foundational knowledge of the regulatory landscape, her practice involves:
- Compliance, Regulatory and Operational Matters – Counseling healthcare providers and suppliers on federal and state regulatory requirements affecting day-to-day operations, including contract drafting and negotiations; licensure, certification and reimbursement; clinical trials and human subjects research; and compliance inquiries related to fraud and abuse concerns.
- Mergers, Acquisitions and Dispositions – Assisting with the buying and selling of healthcare providers and suppliers; structuring transactions; navigating complex licensure issues; conducting due diligence analyses; and facilitating self-disclosures.
Prior to joining Bass, Berry & Sims, Elaine served as a law clerk to the Honorable David J. Hale of the U.S. District Court for the Western District of Kentucky. Elaine earned her law degree from the University of Kentucky College of Law and a B.A. in history from the University of Chicago.
Memberships
American Health Law Association (AHLA)
Representative Experience
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Representation of Parthenon Capital, a growth-oriented private equity firm, as healthcare regulatory counsel in its investment in RxSense, a high-growth healthcare technology company that utilizes its proprietary technology platform to provide innovative prescription savings solutions to consumers and pharmacy benefits administration and analytics to enterprise customers
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Assisted a prominent children’s hospital with a range of industry-sponsored and investigator-initiated research agreements
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Counseled a major research university with all regulatory and contracting aspects of a multi-national investigator-initiated clinical trial
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Representation of Kinderhook Industries, LLC in its investment in AbsoluteCARE, value-based primary care provided headquartered in Baltimore, Maryland, for $105 million. Kinderhook Industries, LLC is a private investment firm that manages over $3.3 billion of committed capital.
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Advised research institutions and laboratory companies on Medicare billing for clinical trials, observational studies and other research
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Representation of the University of Pittsburgh Medical Center (UPMC) in the spinoff and sale of the management services organization responsible for the operational and strategic management of Chartwell to CarepathRx, a platform company formed by Nautic Partners that offers pharmacy solutions to patients undergoing complicated medication therapies. Nautic will manage the UPMC pharmacy moving forward. Terms of the transaction were not disclosed.
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Representation of OptionOne, a specialty pharmacy providing home and alternate-site infusion therapies through a comprehensive clinical approach to patient care, in its sale to Amerita, Inc., a specialty infusion company focused on providing complex pharmaceutical products and clinical services to patients outside of the hospital. Terms of the transaction were not disclosed.
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Representation of J. Knipper and Company, Inc. – one of the largest suppliers of end-to-end pharmaceutical samples management services and a Court Square portfolio company – and its affiliates, including KnippeRx, in its acquisition of Eagle Pharmacy – a Florida-based full-service, direct-to-patient (DTP) pharmacy. This strategic transaction for KnippeRx will expand the company’s pharmacy programs, scale and automation capabilities.
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Publications
Past Events
Media Mentions & Firm News
Accolades
Kentucky Law Journal — Production Editor
CALI Awards — Healthcare Organizations & Finance; Federal Criminal Law; Criminal Law; Criminal Procedure; Conflict of Laws; Products Liability; and Torts