Rebecca Simone represents for-profit and nonprofit healthcare companies and health care investment and management firms in connection with their regulatory and transaction needs. Rebecca has particular expertise in telehealth, COVID-19, dialysis, pharmacy/pharmaceuticals, cosmetic dermatology/MedSpa, and a focus on fraud and abuse and Stark law compliance.
My practice covers various areas of regulatory compliance and transactional work. I work closely with clients on growth strategies, including mergers, acquisitions and joint ventures at every level from startup to publicly traded company, providing counsel on related regulatory issues and structure. I also spend much of my time providing compliance guidance in areas such as telehealth, reimbursement, licensing, fraud and abuse and state healthcare law which are all continuously evolving, particularly in the era of COVID-19.
I’ve acted as healthcare regulatory counsel on mergers and acquisitions of both public and private healthcare entities and regularly work on joint ventures and other contractual arrangements such as employment agreements, professional services agreements and license/lease arrangements. I work closely with both healthcare providers and health care management companies and investment entities on such transactions and advise clients on underlying licensure, fraud and abuse, corporate practice of medicine, and other regulatory issues. I am currently working with several clients that are involved in the world-wide response to the COVID-19 pandemic, including COVID-testing companies, laboratories and physician practices.
I regularly counsel our healthcare clients on navigating their practices/businesses within the confines of the federal Anti-Kickback Statute, the federal Stark law and state law equivalents. I have successfully obtained advisory opinions from the Department of Health and Human Services Inspector General regarding compliance with the Anti-Kickback Statute. I also work with clients that are responding to inquiries, such as subpoenas and civil investigative demands, from regulatory agencies. I have significant experience with pharmacy/pharmaceutical manufacturer issues and patient assistance programs.
I work with clients that have experienced data breaches or are undergoing HIPAA investigations. Additionally, I help clients bring their policies and practices into compliance with HIPAA.
COVID-19 is arguably the top healthcare priority in the United States and has impacted all entities and individuals in the healthcare space in some way. I expect to see innovation from healthcare technology companies and health care providers to continue to adapt to this changing environment. However, as is often the case in healthcare, technology moves faster than regulation. I am currently counseling several clients on operating their COVID-19-related services and businesses in a compliant manner. I expect to see increased enforcement activity and government investigations related to allegations of companies/providers fraudulently taking advantage during the pandemic.
Hofstra University School of Law, J.D., cum laude
University of Delaware, B.S., cum laude
Subscribe to stay informed of the latest legal news, alerts, and business trends.Subscribe