CMS, CDC, and HHS Seek Public Input on Potential CLIA Updates
Centers for Medicare & Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and the Department of Health and Human Services...
1 min read
The U.S. Centers for Medicare & Medicaid Services (CMS) revised the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Post-Public Health Emergency Guidance to discontinue the temporary enforcement discretion allowing for remote review of cytology digital slides.
On Sept. 23, CMS announced it will end the enforcement discretion for remote review of cytology digital slides outside of their primary CLIA-certified cytology laboratory. Any laboratories currently remotely reviewing digital images of cytology slides must obtain a CLIA certificate for that location by March 23, 2026.
In a memo, CMS explains that this enforcement discretion, enacted in response to the COVID-19 pandemic, is no longer necessary. However, CMS will continue to exercise enforcement discretion for laboratory personnel to remotely review digital laboratory data, digital results, and digital images without a separate CLIA certificate for the remote testing site. CMS considers digital materials accessed via a virtual private network to be an extension of the primary laboratory, provided that no microscope or other laboratory equipment is necessary for the review.
Source:
https://www.cms.gov/files/document/qso-23-15-clia-revised-2025-09-23.pdf
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