Public acceptance of virtual health care services, commonly referred to as “telehealth” or “telemedicine,” has been on a steep upward trajectory in recent years, with telehealth appointments booming during the COVID-19 pandemic.
Our Telehealth group regularly works with clients to conceptualize, roll out, grow, and sustain their telehealth services and platforms, often on a national basis.
In the absence of a streamlined regulatory framework across states—which has yet to develop—we help our clients understand the relevant state and federal telehealth laws that do exist, evaluate potential ambiguities with respect to business risk, and make business and operational decisions about how best to comply, all while anticipating how the regulatory environment will continue to evolve.
Entering the Market
Increased demand for telehealth services is creating a simultaneous explosion in new technologies and in the sheer number of health care specialties and licensed professionals who are seeking entry into the virtual health care delivery market. Entry into this market, however, is complicated by a tangled web of regulatory requirements, many of which are at the state level and can differ by profession. Considerations include creating the appropriate corporate structure, ensuring that professional licensure requirements are met, creating a business model through which the appropriate standard of care is offered, and evaluating and addressing potential compliance issues. Clients rely on us for step-by-step guidance and support in the often arduous and time-consuming process of getting their virtual businesses off the ground.
Putting the Right Structure in Place
Many of our telehealth clients launch businesses with little or no previous experience in the health care field, or with telehealth laws and regulations, and often are largely unaware of the legal and regulatory hurdles before them. For example, telehealth companies must establish corporate structures that meet the regulatory conditions of each of the states in which they operate, each of which has distinct corporate structure and ownership requirements. Our substantial experience—both in setting up national platforms and in advising clients more generally about related regulatory requirements—makes us the logical choice to help clients plan for and establish the right foundation and framework.
Navigating the Regulatory Waters: There’s an App for That
Having helped launch dozens of national telehealth platforms, Epstein Becker Green maintains a comprehensive collection of state regulatory requirements for all 50 states plus the District of Columbia and Puerto Rico, and we have assembled all of this information in a free app, available to anyone. Our Telemental Health Laws app provides users with state-specific content relating to the regulatory requirements for professional mental / behavioral health practitioners and stakeholders seeking to provide telehealth-focused services. App users can educate themselves with the rules in each state, ask more targeted questions, and get better prepared for the strategic rollout of their telehealth network.
- Provided a rapidly expanding telehealth company focused on women’s health, with strategic and regulatory advice as the company has expanded beyond its original footprint in two states. Each new phase of this state expansion has involved our providing advice on state laws regarding telemedicine and corporate structure.
- Provided a virtual cardiovascular care provider with strategic and regulatory advice on various strategic partnerships, compliance and fraud and abuse questions, payor contracting, and data privacy and security considerations.
- Supported expansion plans for a provider of virtual speech-language pathology services, advising on issues relating to corporate practice / structure as well as strategic partnerships.
- Advised a provider of telecounseling services on corporate, strategic, and regulatory considerations relating to provision of their services to college and university students.
- Counseled a pharmaceutical manufacturer regarding involvement in virtual-based health care models.
- Advised a physical therapy provider on various strategic and regulatory considerations as the company has expanded to include virtual PT services.
- June 12-14, 2023