Caroline Reignley provides strategic legal, regulatory and compliance counsel to for-profit and nonprofit hospitals, health systems, other healthcare providers, life sciences and technology companies.
Fraud and Abuse
Caroline counsels clients on interpretation and risk mitigation under the Anti-Kickback Statute, Stark Law and EKRA. She also advises on internal and government investigations related to the False Claims Act, Stark Law and Anti-Kickback Statue. Her extensive experience navigating civil and criminal investigations within the healthcare space informs her strategic approach to risk management in transactions and the development of robust compliance programs.
Caroline advises clients involved in digital health—the intersection of health software applications, analytical tools, medical technology and electronic data assets enabled by the internet and mobile devices—on the applicable legal and regulatory infrastructure, with a particular focus on remote patient monitoring programs. She offers nuanced insights into fraud and abuse issues that arise in novel partnerships and other relationships between digital health companies and established healthcare providers. Her broad experience allows her to deliver practical, forward-thinking compliance and revenue strategies that help her clients thrive in today’s complex and still-evolving digital health regulatory landscape.
Medicare Reimbursement and Healthcare Compliance Matters
Caroline advises Medicare providers, consultants and vendors on a wide range of business, legal and regulatory issues. Caroline has extensive experience advising clients on Medicare and Medicaid fee-for-service reimbursement, billing and coding. She also advises clients on professional licensure, scope of practice, physician and health care professional clinician relationships and supervision, together with overall corporate compliance.
Prior to joining the Firm, Caroline served as a health law fellow for a regional nonprofit health system and as a law clerk at the US Department of Health and Human Services. Her background gives her a deep understanding of legal issues from both the regulator and provider perspectives.
- Successfully defended multiple health systems in government investigations and related False Claims Act cases.
- Represented health systems, hospitals and physician practices that submitted Stark Law self-disclosures.
- Reviewed compensation arrangements between a large hospital and its independent and employed physicians to ascertain whether historical compensation methodologies or actual compensation were likely to cause legal risk under applicable law.
- Represented a digital health start-up in the establishment of its business model, including negotiating multimillion-dollar service agreements with large health systems and providing advice on fraud and abuse, reimbursement, licensure, scope of practice and other compliance matters.
- The Best Lawyers, Ones to Watch, Health Care Law, 2021 – 2023
Georgetown University Law Center, JD, 2015
Clemson University, BS, magna cum laude, 2011
District of Columbia