CMS Soon Ending COVID Flexibilities for Clinical Labs

During and after the COVID-19 Public Health Emergency, the Centers for Medicare & Medicaid Services (CMS) provided certain flexibilities and exercised enforcement discretion with respect to regulations affecting CLIA-certified laboratories, but has since ended several flexibilities and resumed enforcing certain regulations. In CMS’ latest memo released on Sept. 23, 2025, it announced that additional flexibilities will end as of March 23, 2026.

For example, CMS previously allowed remote review of digital cytology slides by laboratory personnel without obtaining a separate CLIA license for the remote testing site, provided that (i) the primary site was CLIA-certified, and (ii) the work performed at the remote site fell within the specialties/subspecialties of the primary site certificate. CMS considered a private residence as a remote testing site covered by that guidance and acknowledged that digital slides or other data reviewed remotely via a VPN or other secure connection do not require equipment such as a microscope, so the review did not require equipment essential to the operation of a separate laboratory. However, CMS announced that after March 23, 2026, remote review of cytology digital slides or data from laboratory personnel will need to be conducted at a location that is CLIA-certified in the subspecialty of cytology. After that date, laboratories allowing remote review of digital cytology slides or data would need to obtain a separate CLIA certification to continue that work.

The existing guidelines regarding the remote review of slides or data, listed below, remain in place:

• The primary, home site laboratory must have a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for Provider-Performed Microscopy procedures or certificate of accreditation issued by the United States Department of Health and Human Services (HHS) applicable to the category of examinations or procedures performed by the laboratory (42 C.F.R. § 493.3(a)(1))
• The primary laboratory must comply with applicable federal laws, including HIPAA
• The laboratory director of the primary site CLIA number is responsible for all testing performed under its CLIA certificate, including testing and reporting performed remotely
• Survey findings will be cited under the primary laboratory’s CLIA certificate. Enforcement actions, if taken, will affect the primary laboratory’s CLIA certificate
• The primary laboratory’s test reports must indicate the remote site location where the testing is performed. The laboratory may use a coding system rather than the remote site address (e.g., personnel residence) on the final report. This coding system must be available upon request
• The primary laboratory must provide CMS with a list of all staff working remotely, upon request
• The primary location is responsible for retaining all documentation, including testing, performed by remote staff
• The individual performing remote review must be on the primary laboratory’s Form CMS-209, Laboratory Personnel Report
• The primary laboratory must be certified in the specialties and/or subspecialties of the work performed at the remote site

Relatedly, cytology proficiency testing must be performed in accordance with the proficiency testing program and as approved by HHS, and all cytology proficiency testing slide review must occur at a CLIA-certified laboratory. 

Laboratories that allow remote review of cytology digital slides and data should ensure that each location where remote reviews take place are compliant with the updated CMS guidance by the March 23, 2026, deadline.