Sunny J. Levine is a health care lawyer with Foley & Lardner LLP, and member of the firm’s Telemedicine & Digital Health and Health Care Industry Teams working with hospitals and health systems, physician practice groups and technology companies across the country. Sunny’s practice focuses on federal and state regulatory compliance and business issues in the health care industry. She also works with companies offering highly regulated consumer products, such as medical marijuana and alcohol beverages.
“Foley’s Telemedicine & Digital Health Industry Team has been recognized by Chambers USA: America’s Leading Business Lawyers, which states: “Commentators describe the firm as ‘a market leader in telemedicine issues.’ ‘This is the Dream Team.’ ” (Florida, 2020).
Sunny’s practice includes regulatory compliance issues associated with telemedicine, digital health and health innovation. She helps emerging companies and entrepreneurs navigate state and federal laws governing virtual care offerings across multi-state footprints. Her work involves the intersection of medical practice rules, business structures and the corporate practice of medicine, professional licensure, telemedicine prescribing and informed consent.
Selected, representative matters include:
- Telehealth-Based Opioid Use Disorder Treatment. Assisted an opioid use disorder treatment company in adding telehealth to their model. The work included determining substance use disorder licensing requirements, controlled substance prescribing limitations, opioid treatment prescribing requirements, and analyzing the interplay between telehealth and substance use disorder treatment in multiple states. The guidance helped the company determine potential strategic market entry points for a successful launch and subsequent expansion.
- Telehealth-Based Substance Use Disorder Treatment. Helped with emerging direct to consumer telehealth company involved in the treatment of substance use disorder, and specifically, alcohol use disorder. The work included determining substance use disorder licensing requirements, analyzing the ability to provide substance use disorder treatment via telehealth in multiple states, and assisting with building out the corporate structure, to facilitate the company’s entry into new states.
- Remote Patient Monitoring and Clinical Staff. Worked with digital health company offering remote patient monitoring services, advising on the development of their corporate structure across multiple states. The work included reimbursement and billing considerations along with nurse practitioner, clinical staff, and auxiliary personnel scope of practice and supervision requirements. Through these efforts, the company was able to comply with regulatory requirements while launching a scalable, affordable staffing model for RPM.
- Asynch Direct to Consumer Men’s Health. Advised a start-up company providing nationwide telehealth-based men’s health services through a direct-to-consumer, asynchronous (store & forward) telemedicine platform. Drafted suite of operational contracts and documents for company, including professional service agreements, privacy agreements, technology agreements, and patient-facing materials. Provided guidance on state-specific laws and regulations on prescribing weight loss and erectile dysfunction medications via telemedicine.
- Digital Ocular Health. Advised ophthalmology and optometry groups on federal and state vision laws, including co-location requirements and fraud abuse issues. The work included reviewing state tele-ophthalmology laws and regulations to help determine which states to target when expanding into new states for a multi-state footprint.
- Telehealth and COVID-19 Public Health Emergency Waivers. Advised various telehealth companies on navigating federal and state changes in provider licensure and telehealth modalities during the COVID-19 public health emergency. The work allowed the companies to immediately take action and expand their platforms to provide services across multiple states.
- Telemedicine Legislative Analysis. Advised a leading academic medical center on pending or newly enacted telemedicine laws, regulations, and regulating board policies throughout the U.S., and U.S. territories (Guam, Puerto Rico).
- “Telemedicine: Reimbursement Challenges and Opportunities,” AHLA Telemedicine Webinar Series (March 18, 2021)
- Co-author, “50-State Survey of Telehealth Commercial Insurance Laws,” Health Care Law Today (February 9, 2021)
- Co-author, “Top Ten Issues in Health Law 2021,” American Health Law Association’s Health Law Connections (January 1, 2021)
- Co-author, “Georgia Finalizes New Telemedicine Practice Rules,” Health Care Law Today (October 21, 2020)
- Co-author, “Telehealth and Substance Use Disorder Treatment: State Law Issues,” Health Care Law Today (August 6, 2020)
- "The Building Blocks to Telehealth Success: How to Structure a Compliant Telehealth Offering," California Telehealth Resource Center’s Telehealth Summit Webinar Series (August 5, 2020)
- Co-author, “Telehealth and Substance Use Disorder Treatment: Regulatory Barriers to Entry Can Mean Opportunity for Innovative Companies,” Health Care Law Today (August 3, 2020)
- Co-author, “Patient Records: Part 2 Final Rule Reduces Substance Use Disorder Record Sharing Barriers,” Health Care Law Today (July 15, 2020)
- “Telehealth: Where We Were, Where We Are, and Where We Are Headed,” Celesq AttorneysEd Center Webinar (June 2, 2020)
- Author, “COVID-19: DEA and SAMHSA Guidance for Treating Opioid Use Disorders via Telehealth,” Health Care Law Today (April 9, 2020)
- Co-author, “COVID-19: New Florida Executive Order on Telehealth and Immunization Coverage for State Employees During Public Health Emergency,” Health Care Law Today (April 6, 2020)
- Co-author, “Florida Issues New Emergency Order Further Relaxing Licensure, Telehealth, and Practice Standards to Combat COVID-19,” Health Care Law Today (March 24, 2020)
- Co-author, “Managing the Commercial Impact of Coronavirus: Emergency Order Relaxes Florida Licensure, Telehealth, and Practice Standards to Combat COVID-19,” Health Care Law Today (March 20, 2020)
- Co-author, “COVID-19: Florida Obtains First Medicaid 1135 Waivers Related to COVID-19 – 5 Key Takeaways,” Health Care Law Today (March 20, 2020)
- Co-author, “COVID-19: DEA Confirms Public Health Emergency Exception for Telemedicine Prescribing of Controlled Substances,” Health Care Law Today (March 18, 2020)
- Co-author, “Telehealth: 5 Key Takeaways from the Coronavirus Spending Bill,” Health Care Law Today (March 12, 2020)
- Co-author, “Telehealth is Here to Stay: New 50 State Survey of Commercial Insurance Laws Reveals Progress,” Health Care Law Today (December 2, 2019)
- Co-author, “Fact or Fallacy: Is Telehealth Here to Stay?” HealthTech (August 2019)
- Author, “Direct Primary Care: Not insurance,” Hillsborough County Bar Association Lawyer Magazine (March - April, 2019)
- “Florida Medical Marijuana System for Physicians,” University of South Florida, Morsani College of Public Health, Law and Medicine Scholarly Concentration (April 9, 2018)
- “Medical Marijuana 101 for Florida’s Healthcare System,” The Florida Bar, Health Law Section (March 13, 2018)
- “Medical Marijuana 101 for Florida’s Healthcare System,” Hillsborough County Bar Association, Health Care Law Section (December 6, 2017)
- Stetson University College of Law (J.D., cum laude)
- Notes & comments editor, Stetson Law Review
- Served on the Philip C. Jessup International Moot Court Competition team
- Florida International University (B.A., magna cum laude)