Elizabeth H. Bernauer

Telehealth has become the “it factor” when it comes to communication between health care professionals and patients, especially during the COVID-19 pandemic.

“Health care providers can provide telehealth services across state lines during the COVID-19 emergency regardless of state and local prohibitions,” the US Department of Health & Human Services (HHS) has stated.

This action is an attempt to counteract barriers created by the pandemic and, of course, help patients get the care they need during this time. The idea behind this expansion in telehealth is to “ease access and expand the range of services paid for through insurance,” according to HHS.

HHS issued this interpretation or ruling because of a traditional legal barrier to the use of services delivered via telehealth. The predominant legal rule traditionally has been that the provider must be licensed to practice in the state where the patient is located. That is not a challenge when the patient and provider are in the same state, but it served as a substantial hurdle for consulting with specialists. The HHS ruling eliminated that challenge.

Telehealth encompasses a wide variety of concepts, from legislation to the structure of the system, and is very complex in its manner, practice, and implementation. Legislation plays a complicated role in telehealth and is typically viewed as a barrier to diffusion.

 It has a role in state-to-state access and understanding, as well as the guidelines and standards that go with telehealth. As the use of telehealth becomes more popular, the need to understand legal and regulatory approaches grows more critical.

A few years ago, the FDA collaborated with the HHS Office of the National Coordinator for Health Information Technology to develop “strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical apps, that promotes innovation, protects patient safety, and avoids regulatory duplication.”

A main concern is, of course, confidentiality of patient information, which would be held within a mobile application or website. The initiative attempted to address this by using passwords, special identifiers, and even secure forms of communication between patients and providers. However, this can be even more difficult to control and track when there are conflicting state regulations regarding telehealth activities.

On the federal level, “the government is investigating the expansion of telehealth to address access as well as quality and cost of care,” according to a recent article in Pharmacy and Therapeutics.

Telehealth was initially directed at serving individuals with chronic conditions, but it has now become a matter of general access to ensure patients are seen appropriately. Recently, legislation was reintroduced, such as the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act and the Telehealth Innovation and Improvement Act.

 Overall, these bills strive to enhance the quality of care for remote patients.

“Licensing for telehealth remains a multilayered effort with state-by-state inconsistencies that have restricted the wide application of telemedicine or telepharmacy. Standard legal and/or regulatory frameworks remain elusive. Reimbursement typically follows a clear legal framework using strategies to support appropriate use of telehealth in delivering care. The lack of clarity in the law creates inconsistent reimbursement by payers to care providers. Ultimately, a clear legal framework is required if reimbursement dilemmas are to be solved,” wrote Marcoux et al in the Pharmacy and Therapeutics article.

It seems that telehealth and telepharmacy will be long-lasting programs that increase access to health care for all.

A widespread implementation will hopefully lead to “enhancing patient experience, improving population health, reducing costs, and improving the work life of health care providers,” according to an article in the Journal of the American Medical Informatics Association.

The largest barrier appears to be regulation across state lines. It is possible for health care providers to provide telehealth services across state lines, although that is not always the case.

Telehealth will need further regulation to maintain the momentum.

Debate has been going on for years regarding whether this sort of legislation should be put in place and what must be done to ensure patient care and the safety and security of information.

Telehealth continues to evolve and pose issues. Leaders in the field are working to get telehealth regulated in a way that is easy to view and accessible across all regions. The legislative background and regulations are changing as the environment of health care changes. Overall, telehealth is a very helpful and practical tool, but some of its aspects need tweaking to ensure safe, secure access. 

is a PharmD candidate at the University of Kentucky College of Pharmacy in Lexington.

Joseph L. Fink III, JD, BSPharm, DSc (Hon), FAPhA, 

is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.

Brown C. Telehealth services across states OKed under HHS declaration. Bloomberg Law. December 3, 2020. Accessed July 14, 2021. https://news.bloomberglaw.com/tech-and-telecom-law/telehealth-services-across-states-oked-under-hhs-declaration

van Dyk L. A review of telehealth service implementation frameworks. Int J Environ Res Public Health. 2014;11(2):1279-1298. doi:10.3390/ijerph110201279

Marcoux RM, Vogenberg FR. Telehealth: applications from a legal and regulatory perspective. P T. 2016;41(9):567-570.

Bakken S. Telehealth: simply a pandemic response or here to stay? J Am Med Inform Assoc. 2020;27(7):989-990. doi:10.1093/jamia/ocaa132

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But state-to-state communications and inconsistencies related to licensing present legal issues.