If you have a relative who has cancer, ask them about the dreadful time they spent waiting for their diagnosis. Tumors continue growing while hospitals are running tests, and these delays are at least in part due to antiquated regulation. Here, we aim to raise public awareness of the desirability of a short-term fix for remote diagnostics and the longer-term need for improved statutes.
As physicians rendering diagnoses every day, pathologists provide critical contributions to the health of patients. As laboratory directors, we the authors lend our voices to the important discussions regarding advancing regulatory frameworks. During the COVID-19 pandemic of the past 30 months, one of the early regulatory exemptions enabled the (optional) use of remote work in clinical laboratories and pathology1. This has allowed pathologists to continue to provide care for our patients in a safe environment — for example, by enabling remote review of microscopic slides, which is essential for cancer diagnostics.
Remote diagnostic work has been conducted in the USA for decades2,3. The regulatory exemptions during COVID-19 included one key catalyst: they removed the need to obtain and maintain a separate home license for remote review of diagnostic materials as long as certain conditions are met. These conditions ensure all other requirements of the Clinical Laboratory Improvement Amendments (CLIA) are maintained. The regulatory exemptions facilitate timeliness of diagnosis and assure quality of patient care via appropriate compliance for those who have opted to establish remote work procedures.
The study and use of nontraditional diagnostic modalities have demonstrated non-inferiority to traditional workflows. It is well established that technological advancements have led to transformative breakthroughs in the practice of pathology that hold great promise for continued advancements. Examples include genomics and molecular diagnostics, digital and computational pathology, and most recently the inclusion of artificial intelligence solutions. Unfortunately, these new and nontraditional diagnostic workflows are not yet accounted for in the CLIA, which was last amended in 1988. The pathology laboratory leadership community welcomed the President’s Fiscal Year 2023 budget request4, which emphasized the importance of amending the CLIA statute. Health care touches the lives of all Americans, and CLIA is an integral part it; therefore, we are pleased that Congress now has the opportunity to amend CLIA. But until that happens, remote diagnostics should be continued.
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. We, the laboratory leadership, strongly believe that continuing the implemented enforcement discretion for remote work enables for laboratories, and the field of diagnostics, the continued realization of the highest standards. 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.
We urge the Center for Medicare & Medicare Services5, and specifically the Clinical Laboratory Improvement Advisory Committee6 (which is managed by the Centers for Disease Control and Prevention6 and provides guidance to the Department of Health & Human Services)7,8, to work together with the Center for Clinical Standards and Quality7 to ensure that the regulatory exemptions implemented during the pandemic1 remain in place. This is until Congress can amend the Public Health Service Act by updating the 34-year-old CLIA statutes9 to account for non-traditional diagnostic modalities and the last three decades of medical progress.
US Department of Health & Human Services (HHS), Center for Clinical Standards and Quality/Survey & Certification Group Ref: QSO-20-21-CLIA. Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency (March 26, 2020); https://www.cms.gov/files/document/qso-20-21-clia.pdf-0 (accessed 7 September 2022).
Furness, P. N. & Bamford, W. M. Curr. Diagn. Pathol. 7, 281–291 (2001).
Dietz, R. L. et al. Am. J. Clin. Pathol. 153, 198–209 (2020).
HHS. Fiscal Year 2023: Budget in Brief; https://www.hhs.gov/sites/default/files/fy-2023-budget-in-brief.pdf (accessed 7 September 2022).
US Centers for Medicare & Medicaid Services (CMS). Strategic Plan; https://www.cms.gov/ (accessed 7 September 2022).
US Clinical Laboratory Improvement Advisory Committee (CLIAC); https://www.cdc.gov/cliac/index.html (accessed 7 September 2022).
US Center for Clinical Standards and Quality, CMS. Functional Statement; https://www.cms.gov/About-CMS/Agency-Information/CMSLeadership/Office_CCSQ (accessed 7 September 2022).
US Centers for Disease Control. Clinical Laboratory Improvement Amendments (CLIA): CLIA Law and Regulations; https://www.cdc.gov/clia/law-regulations.html (accessed 7 September 2022).
US Statute at Large. 102 Stat. 2903 - Public Law 100-578, 100th Congress; https://www.congress.gov/public-laws/100th-congress (31 October 1988).
All authors are members of the Association of Directors of Anatomic and Surgical Pathology. Affiliations and professional organizations are listed for identification purposes. The views expressed in this letter are those of the individual signatories and do not necessarily reflect the views of the affiliated institutions or organizations. L.P. is on the medical advisory board for Ibex, a consultant for Hamamatsu, and equity owner of LeanAP Innovators; G.G.B. completed contracted research for Hamamatsu; J.H. is a consultant for Aadi Bioscience and Tracon Pharmaceuticals; all other authors have no relevant conflicts of interest.
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Lennerz, J.K., Pantanowitz, L., Amin, M.B. et al. Ensuring remote diagnostics for pathologists: an open letter to the US Congress. Nat Med (2022). https://doi.org/10.1038/s41591-022-02040-6