A consortium of over 70 medical directors from pathology labs across the country is asking the federal government to continue a COVID-era exemption that helped to streamlines the process for remote diagnostics.
The exemption to the federal Clinical Laboratory Improvement Amendments (CLIA), which was enacted in the spring of 2020, temporarily eliminated the need for pathologists to obtain and maintain a separate state license from the Department of Public Health (DPH) to perform diagnostic work outside of the lab.
“We don’t want to undermine the value of having a CLIA license and a review by the Department of Public Health,” says Jochern Lennerz, MD, PhD, the senior author of the correspondence and director of the Center for Integrated Diagnostics at Massachusetts General Hospital. “It is justified, relevant, and necessary. However, during the pandemic CMS has removed the necessity to have our home offices licensed as a medical laboratory – red tape that ultimately has little to no effect on diagnostic quality. “
In their open letter, the group calls for two things: an immediate action item and a long-term goal.
The call to action by the laboratory directors is directed to the Center for Medicare and Medicare Services (CMS) and the Clinical Laboratory Improvement Advisory Committee to work together with the Center for Clinical Standards and Quality (CCSQ) to ensure that the regulatory exemptions implemented during the pandemic remain in place until Congress can amend the Public Health Service Act by updating the 34-year old CLIA statutes to account for non-traditional diagnostic modalities and the last three decades of medical progress.
In a recent correspondence to Nature Medicine, the authors write that the exemption has led to significant patient benefits, including faster diagnostic times, more workplace flexibility and improved patient care.
“Remote work has already improved the lives of patients and physicians, by enabling access to an expanded workforce that is not bound to the physical laboratory.” they write. “We, the laboratory leadership, strongly believe that continuing the implemented enforcement discretion for remote work enables laboratories and the field of diagnostics the continued realization of highest standards.”
Lennerz explains that all the rules that apply to lab-based diagnostics continue to apply to remote diagnostics, and it is the responsibility of each lab’s medical director to ensure that the processes and workflows are validated and documented.
“The machines, scanners, and sequencers are all running within an appropriately accredited facility,” he adds. “Then the review of the data can be done remotely.”
With many of the COVID-era exemptions for medical care now coming to an end as the country recovers from the 30-month public health crisis, the authors are hoping this exemption can continue as part of a longer plan to update regulatory guidelines for pathologists.
“Failure to make remote work a permanent change would be an oversight that could undermine our legacy of laboratory management and continued innovation in medicine – innovation that has continued despite governing statutes that are over 34 years old.”
The authors also express their willingness to work with lawmakers on a long-term update of CLIA that will incorporate remote work as well as the recent influx of new technologies into the field of pathology.
“CLIA was amazing for its time, but it was created in the 1960s and last updated in 1988,” explains Lennerz. “We wanted to raise awareness that disciplines like cytopathology, molecular diagnostics, genomics, but also more recent innovations like artificial intelligence — are not accounted for in these CLIA statutes.”