Once limited to use in rural or remote communities, telehealth technology and the provision of telemedicine services are increasingly being used, both domestically and outside the United States, to expand the geographic reach of health care services, to improve access to health care, and to enhance the health care consumer experience by making access more efficient and convenient. Telehealth and telemedicine providers offer a wide range of practices and access points, including interactions among providers and patients through email, telephone, Internet, video-conference, mobile apps, and remote devices.
Many factors continue to drive growth and innovation in telehealth and telemedicine. Through the use of smartphones, laptops, tablet computers, and other mobile devices, health care consumers often are only a click away from platforms that can link them to physicians and other health care professionals who can potentially diagnose, treat, monitor, and provide consultations on a diverse and growing number of health conditions. Along with such improvements in technology, telehealth and telemedicine are also increasingly being seen as effective technological tools for improving access to basic care and, often as a result, health outcomes, especially in underserved areas. For example, many hospitals and health systems are using telehealth and telemedicine to expand their service offerings by collaborating with other hospitals and health systems, both domestically and internationally, in the development of programs such as tele-ICU, tele-stroke, and telepathology. Telehealth- and telemedicine-driven solutions are being integrated into health care settings, such as clinics and emergency departments, not only to provide support related to volume but also to fill gaps or shortages in the care continuum (e.g., telebehavioral health). Health care providers also are increasingly using telehealth and telemedicine to better track and more frequently interact with their patients.
Services/Scope of Practice
Epstein Becker Green (EBG) helps a diverse spectrum of health care companies navigate the many legal and regulatory challenges affecting the provision of telehealth and telemedicine services. EBG helps to assess and manage the risks that can arise in a telehealth and telemedicine setting. We counsel our clients on all aspects of the law and the developing regulatory landscape as they relate to telehealth and telemedicine, including:
- Compliance with federal and state laws affecting the practice of telehealth and telemedicine
- Considerations regarding corporate structures
- Strategy regarding potential pathways for third-party reimbursement under federal and state health care programs and within the private payer market
- Contract negotiations with providers, payers, and technology companies
- Compliance with health care fraud and abuse laws
- Professional liability risk management
- Coordination with professional and trade associations regarding client challenges and priorities
- Tracking of federal and state legislation and regulations, and understanding the impact on client operations
- Development of coalitions supporting policy issues
EBG attorneys have an in-depth focus on the regulation of telehealth and telemedicine, mobile health, health information technology, and other software and remote monitoring applications used in the health care context. We have been at the forefront of the development of global regulatory policy for health information technology and integrally involved in the regulatory challenges facing the telehealth and telemedicine market.
We counsel companies involved in all aspects of telehealth and telemedicine, including hospitals and health systems, physicians and health care professionals, medical groups, clinics, device manufacturers, information technology companies, web-service providers, and investors. We have assisted clients in a diverse array of matters, including the following:
- EBG represented a client that provides personalized second opinions to primary care and attending physicians from specialists at some of the most respected hospitals in the country. The firm provides continuing counseling on a range of regulatory issues impacting the company’s business model, marketing, and physician arrangements.
- EBG counseled one of the largest providers of telehealth medical consultations in the United States. The company provides access to U.S. board-certified doctors and pediatricians via phone or online video consultations and is expected to perform almost 250,000 virtual consults in 2014. In addition to health care regulatory matters, our services included advising on ERISA and a number of state policy and advocacy matters.
- EBG has advised multiple clients that provide video consults via smartphone/tablet apps between a network of available physicians and patients all across the United States. One client-involved network of U.S. licensed physicians is affiliated with independent physician-owned medical practices throughout the United States. EBG has provided continuing counsel and advice on a number of regulatory matters, including scope of practice, licensure, prescribing, privacy and security, corporate practice of medicine, and fraud and abuse.
- EBG has advised a clinic in Washington, D.C., providing primary care services to Latino residents of Washington, D.C. The clinic won a half-million dollar grant from a large insurer to implement a regional telepsychiatry program. EBG is currently advising the clinic on a number of regulatory issues regarding implementation of the telepsychiatry program.
- EBG is providing regulatory counsel to a large insurer regarding the various telehealth initiatives that the company is launching around the country.
- EBG has advised a client that has initiated a national genetic counseling testing program provided via a telehealth platform. EBG provided counsel and advice on a number of state regulatory matters.
- EBG has counseled one of Montana’s largest comprehensive hospitals, serving the health care needs of more than 400,000 people in a four-state area, focused on being a technology leader in the health care industry. EBG advised on transactional matters and prepared a number of agreements between the health system and the participating telehealth sites.
- EBG has advised a legal and regulatory telehealth organization delivering vital support to the community on topics such as physician and nurse licensure, credentialing and privileging, Medicare and Medicaid reimbursement, and private insurance payment policies. EBG provides regulatory and reimbursement counseling.
EBG has extensive experience working with telehealth and telemedicine, peer-to-peer, and similar virtual care businesses to develop business models and arrangements that navigate various federal and state laws and regulations to achieve organizational goals. We also regularly advise clients on data privacy and security and other legal issues arising in the context of a technology-based and virtual health care model.
In keeping with the firm's commitment to telehealth, EBG has developed TechHealth Perspectives—a popular blog dedicated to legal and regulatory issues relating to telehealth and telemedicine, which has addressed such issues as telehealth reimbursement, privacy and security, FDA-related issues, corporate-related issues, and other issues affecting telehealth.
The practice has also published the 50-State Survey of Telemental/Telebehavioral Health (2016), a groundbreaking, comprehensive survey on the laws, regulations, and regulatory policies impacting telemental health in all 50 states and the District of Columbia.
EBG attorneys have co-authored “Navigating the Telehealth Landscape: Legal and Regulatory Issues,” published by Bloomberg BNA’s Portfolio Series. EBG attorneys also write and speak frequently regarding issues related to telehealth and telemedicine.
For more information on Epstein Becker Green and its telehealth and telemedicine-related services, please contact one of our Telehealth & Telemedicine lawyers.