Rebecca Simone represents healthcare providers, healthcare companies, and healthcare investment and management firms in connection with their regulatory and transaction needs. Rebecca has particular experience in telehealth, dialysis, pharmacy/pharmaceuticals, behavioral health, 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.
As the public health emergency has come to an end, transitioning from COVID-19 waivers and flexibilities has presented both opportunities and challenges for my clients. I expect to see continued innovation from healthcare technology companies and healthcare providers to continue to adapt to the changing environment. However, as is often the case in healthcare, technology moves faster than regulation. I am currently counseling several clients on expanding their telehealth and other digital health solutions 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.
Long Island Healthcare partner Rebecca Simone is quoted in this article discussing the importance for telehealth providers to create comprehensive compliance plans. Rebecca identifies beneficial qualities for compliance officers within organizations and discusses why startup telehealth employees are wary of taking on these roles. Rebecca was quoted from a panel discussion she participated in at the American Telemedicine Association Conference & Expo in March.
This article, which covers the dismissal of a lawsuit against medical device maker Bracco USA Inc. and several healthcare providers over an alleged scheme involving free medical equipment, mentions NP for representing one of the providers in the case (NYU Langone Health System Inc.). The NP team includes Long Island Healthcare partners Lindsay Maleson and Rebecca Simone, and Government Investigations & White-Collar Defense partner Adam Tarosky and associate Bobby McManigal, both of the Washington, DC office.
Hofstra University School of Law, J.D., cum laude
University of Delaware, B.S., cum laude
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