By Helen Hughes and Mark Sulkowski
As physicians who have dedicated our careers to clinical research and to the advancement of telemedicine respectively, we’ve witnessed first-hand the transformative power of technology in health care. However, despite our progress over the last four years, there remains a glaring barrier to the potential of telehealth in the United States: the complex, state-based system of health care licensure. This system significantly restricts patient access to specialized care, especially for those who could benefit from participating in clinical trials. It’s time for Congress to enact legislation allowing for federal reciprocity of medical licensure, a move that could revolutionize clinical research in this country.
Telemedicine has the potential to transcend geographic and economic barriers, offering patients access to the best medical experts, regardless of location. This is especially crucial for participants with rare or life-threatening conditions who want to enroll in clinical trials. Trials are usually conducted at a limited number of quaternary academic medical systems, limiting who can participate.
Implementing federal reciprocity for clinicians delivering care through clinical trials would have several profound benefits. Firstly, it would enable patients from across the country to access the newest, most advanced treatments and expertise, regardless of geographic location. This is particularly vital for patients with very rare or complex conditions, who often cannot enroll in clinical trials within their home state. Telemedicine participation would decrease the economic burden that is be placed on patients and families in traveling for in-person clinical trial participation. Additionally, by facilitating the participation of a more diverse patient population, this new model would enhance the quality and relevance of clinical trials, leading to more generalizable and impactful research findings.
The concept of federal reciprocity of health care licensure is not without precedent. The Veterans Affairs (VA) system operates under a model where any VA physician can treat any VA patient in any state, if the physician is licensed in at least one state. This model has significantly improved access to care for veterans, allowing them to receive specialized services that might not be available locally. Similarly, the Sports Medical Licensure Clarity Act ensures national legal protection to athletic sports medicine professionals who are required to travel outside their primary licensed state while caring for athletes. As part of this law, health care services provided by a sports medicine professional to an athlete outside of his or her licensing state are deemed to have occurred in the professional’s primary state of licensure.
Critics may argue that such a policy could undermine state medical boards and compromise patient safety. However, this concern overlooks the rigorous quality assurance checks already in place for clinical trials and the additional oversight required from Institutional Review Boards. Clinical trial licensure reciprocity could be narrowed to trials subject to United States federal human subjects protection regulations. This would limit interstate clinical trial care delivery to research that already has multiple layers of participant protection in place. Legislation could also include a carve-out for health care treatment that has high state-to-state variability (e.g. reproductive health) to ensure that such a model does not conflict with varying state approaches to these issues.
Congress has the opportunity to make a significant impact on the future of health care and medical research by passing legislation for federal reciprocity of health care licensure for clinicians delivering care through clinical trials. Such a move would align with the national interest in promoting health, advancing science, and ensuring that all Americans have access to the best possible care. It’s time to embrace the full potential of telemedicine and remove the barriers that prevent patients from accessing life-changing clinical trials. Let’s make cutting-edge health care access as borderless as the technology that supports it, for the benefit of patients, researchers, and the future of medicine itself.
Helen Hughes, MD MPH is Assistant Professor of Pediatrics, The Johns Hopkins University School of Medicine and Medical Director, Office of Telemedicine, Johns Hopkins Medicine.
Mark Sulkowski, MD is Professor of Medicine and Director of the Division of Infectious Diseases at Johns Hopkins Bayview Medical Center and Senior Associate Dean for Clinical Trials at The Johns Hopkins University School of Medicine.
