Rebecca Simone

Healthcare

Healthcare Transactions

Private Equity & Investment Funds

Medicare, Medicaid, and Other Government Payors

Life Sciences

Cybersecurity & Privacy

Managed Care Contracts & Network Development

Accountable Care Organizations & Physician Hospital Alignment Strategies

Dental Services Organizations

Digital Health & Telemedicine

Health Information - Privacy, Security & Data Sharing

Behavioral Health

Healthcare Regulatory & Compliance

Fertility, Reproductive Medicine, Sexual Health & Wellness

Rebecca Simone represents healthcare providers, companies, and investment and management firms in connection with their regulatory and transaction needs. Rebecca has particular experience in telehealth, hospital matters, pharmacy/pharmaceuticals, behavioral health, and billing compliance issues, as well as a focus on fraud and abuse and Stark Law compliance.

/My focus

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 startups to publicly traded companies, providing counsel on related regulatory issues and structure. I also spend much of my time providing compliance guidance in telehealth, reimbursement, licensing, fraud and abuse, and state healthcare law, which are all continuously evolving, particularly in the post-public health emergency era.

HEALTHCARE TRANSACTIONS

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 healthcare providers (including hospitals, surgical centers, pharmacies, physician groups, and telehealth practices) and healthcare management companies and investment entities on such transactions and advise clients about underlying licensure, fraud and abuse, corporate practice of medicine, and other regulatory issues. I have extensive expertise in providing guidance on PC/MSO models and working with clients to establish and maintain such models in a compliant manner.

FRAUD AND ABUSE

I regularly counsel our healthcare clients about navigating their practices/businesses within the confines of the federal Anti-Kickback Statute, the federal Stark Law, and state law equivalents. I have 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, including those in the digital healthcare and device spaces, responding to inquiries, such as subpoenas and civil investigative demands, from regulatory agencies and assist them with self-disclosures and repayments to relevant regulatory agencies, as needed. I have significant experience with pharmacy/pharmaceutical manufacturer issues and patient assistance programs.

HEALTH INFORMATION PRIVACY/HIPAA

I work with clients who have experienced data breaches or are undergoing HIPAA investigations. I also help clients bring their policies and practices into compliance with HIPAA.

/Looking ahead

I expect continued innovation from healthcare technology companies and providers in areas such as artificial intelligence (AI) and telehealth. However, as is often the case in healthcare, technology moves faster than regulation. I am currently counseling several clients on expanding their digital health solutions in a compliant manner. I expect to see increased enforcement activity and government investigations in these areas.

New York State Bar Association

American Bar Association

Nassau County Bar Association

American Health Lawyers Association

American Telemedicine Association