Rebecca Simone, Esq.
Rebecca Simone represents for-profit and nonprofit health care 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 and a focus on fraud and abuse and Stark law compliance.
What do you focus on?
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 health care law which are all continuously evolving, particularly in the era of COVID-19.
Health Care Transactions
I’ve acted as health care regulatory counsel on mergers and acquisitions of both public and private health care 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 health care providers and health care management companies and investment entities on such transactions and advise clients on underlying licensure, fraud and abuse 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.
Fraud and Abuse
I regularly counsel our health care 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.
Health Information Privacy/HIPAA
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.