Proposed Rule CMS-3478-P; “Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes”
The Centers for Medicare & Medicaid Services (CMS) is seeking input from interested parties on proposed changes to the rules implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The proposed rule was published in the Federal Register on October 8, 2026.
The proposed rule would modernize CLIA regulations through proposals in four key areas, which we need YOUR input on:
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Virtual Access –Codification of CMS’s prior use of enforcement discretion to permit remote review of digital data, digital results, live imaging, and digital images as part of the primary laboratory’s certificate, except in cytology.
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Gynecologic Cytology Proficiency Testing – Expansion of regulations to allow digital images in gynecologic cytology proficiency testing, aligning with FDA-authorized technologies.
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Personnel Qualification Requirements – Revisions to personnel qualification requirements finalized in prior rulemaking, and expand eligibility to individuals with appropriate education, experience, and training to address workforce shortages.
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Other Changes –Correction of editorial and technical errors, rescission of obsolete SARS-CoV-2 reporting requirements, updated notification requirements for changes to email addresses, test report information, enforcement regulations, and public consultation requirements.
Important Deadline: Comments must be received no later than December 7, 2026.
For more information, visit the CMS CLIA Program website.
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