On March 18, 2020, the FDA issued recommendations for clinical trials conducted during the COVID-19 pandemic. Their guidelines acknowledged the challenges of operating during quarantine. The FDA suggested modifications that encourage the prioritization of public safety.
Researchers have been focusing on decentralized (or virtual) clinical trials. This relies on telehealth to complete clinical trials while following public health recommendations.
This may have seemed difficult in prior years. But changes to telehealth legislation may make this adoption a reality. Let’s first talk about telehealth regulations during the Coronavirus outbreak.
Telehealth before COVID-19
Before the onset of COVID-19, telehealth suffered some key limitations. There were only a few services covered by Medicare. Virtual check-ins and e-visits were among the most common. But coverage varied by state.
Virtual check-ins were generally 5- to 10-minute conversations with a practitioner. They were performed through an approved telehealth service. The e-visits were short communications performed only through a provider’s patient portal.
These services were only offered to patients with a pre-existing provider relationship. Patients between care providers would not have the option for telemedicine.
How telehealth evolved to meet pandemic demands
Quickly, the U.S. realized the severity of the COVID pandemic. Telehealth regulations received updates to better allow for socially distanced healthcare.
The first major change allowed for telehealth payment parity across all procedures. All telehealth billings would receive reimbursement equal to a typical in-office visit. Previous reimbursement rates were not high enough to incentivize telehealth use for providers. Patients can also receive telehealth treatments without an existing physician relationship.
Additionally, limitations for which specialties could use telehealth were adjusted. This allowed for an even broader range of practitioners to leverage telemedicine services. Practitioners were also allowed to work across state lines.
Another important change involves telehealth technologies. Any non-public-facing or audio-only service can be considered telehealth. Platforms like Zoom or Skype qualify as telehealth when used with appropriate intention. Practitioners can also prescribe controlled medications via these remote services.
The future of telehealth
The telehealth regulatory updates offered during the pandemic have been beneficial. Policymakers are considering how best to maintain telehealth use after the pandemic. This has led to two major pieces of legislation so far.
The Protecting Access to Post-COVID-19 Telehealth Act
This act makes several permanent changes to improve telehealth access. As of July 2020, a patient’s home can be considered a distant site. This removes geographic restrictions on what can be billed as telehealth.
Executive Order on Improving Rural and Telehealth Access
The rural regions of America have struggled with hospital access for some time now. On August 3, 2020, the President passed an executive order to improve rural healthcare with accessible telehealth.
Some key contributions of this order include:
The permanent addition of certain telehealth services, and
The temporary extension of other services, like emergency department visits
The major additions are home visits for evaluation and management and home visits for patients with cognitive impairments. The temporary additions are currently under a trial period. If time proves the temporary additions are beneficial, they will likely become permanent.
How do changes to telehealth legislation affect current and future clinical trials?
Each new legislation will make virtual clinical trials more practical. This applies to in and outside of a public health crisis.
Before, conductors of clinical trials ran into issues when working across state lines. This problem was exacerbated by the need for remote communications. Working across state lines could lead to licensure issues.
Another roadblock for virtual clinical trials was the ‘pre-existing patient/clinician relationship’ stipulation. This rule was temporarily adjusted during the pandemic. This led to a larger pool of candidates for clinical testing.
It is still unclear which telehealth regulations will remain permanent. Most important could be the removal of the ‘pre-existing patient/clinician relationship’ rule. It would make virtual clinical trials a continued viable option for the long-term.