On October 8, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), under the Department of Health and Human Services (HHS), published a significant proposed rule in the Federal Register. This rule outlines substantial amendments to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, codified at 42 CFR Part 493. The proposed changes are designed to modernize federal oversight of clinical laboratories, ensuring the continued accuracy and reliability of patient test results while simultaneously adapting to advancements in technology and addressing critical industry needs, such as workforce shortages. Comments on the proposed rule are due by December 7, 2026.
Codifying Virtual Access for Laboratory Operations
A central component of this proposed rule is the formal codification of "virtual access," which would allow pathologists and other qualified laboratory personnel to remotely review digital laboratory data, digital results, live imaging, and digital images. This move acknowledges the widespread adoption of digital technologies in diagnostics and represents a shift from previous regulatory frameworks that did not account for such remote capabilities. Prior to this proposed rule, CMS had exercised enforcement discretion, initially during the SARS-CoV-2 public health emergency (PHE) and subsequently post-PHE, to permit remote review under specific conditions. CMS memo QSO-23-15-CLIA, issued May 11, 2023, continued this flexibility, citing no concerning citation trends related to remote review in the subsequent period.
However, a critical carve-out exists within this proposed flexibility: the subspecialty of cytology. While other digital data review would fall under the primary laboratory's CLIA certificate, section 353(f)(4)(B)(vi) of the Public Health Service Act (PHSA) and existing regulations at 42 CFR 493.1274(a) mandate that cytology screening and slide preparations must be evaluated on the premises of a CLIA-certified laboratory. Consequently, CMS revised its guidance in QSO-23-15-CLIA-REVISED on September 23, 2025, to discontinue the temporary enforcement discretion for remote review of cytology digital images of slides as of March 23, 2026. This means any laboratory wishing to conduct remote cytology slide image review must obtain a separate CLIA certificate for that remote location. The proposed rule explicitly adheres to this distinction, excluding cytology from the broader virtual access provisions under a single primary certificate for screening purposes.
Modernizing Gynecologic Cytology Proficiency Testing
In a move towards technological alignment, the proposed rule would permit the use of digital images of glass slides for gynecologic cytology proficiency testing (PT). This change aims to bring CLIA regulations in line with advancements in diagnostic tools, specifically the Food and Drug Administration (FDA)-authorized digital cytology screening systems. By allowing digital images in PT, CMS and CDC seek to ensure that proficiency testing accurately reflects contemporary laboratory practices and technologies utilized in actual patient care, thereby enhancing the relevance and effectiveness of the testing process.
Adjustments to Personnel Qualification Requirements
The proposed rule also seeks to address ongoing concerns regarding the burden associated with personnel qualification requirements, particularly those that took effect on December 28, 2024. Key changes include removing limitations related to "human-only" laboratory science, which could broaden the pool of qualified personnel. Additionally, the rule proposes adding specific qualifications for histopathology gross tissue examination personnel and Mohs dermatology laboratory directors. These adjustments are intended to alleviate workforce shortages, streamline qualification processes, and ensure appropriately trained staff are available for specialized laboratory functions, all while maintaining quality standards.
Broader Regulatory Updates and Streamlining Efforts
Beyond virtual access, cytology PT, and personnel qualifications, the proposed rule encompasses several other significant changes. It seeks to remove SARS-CoV-2 (COVID-19) reporting requirements, reflecting the evolving phase of the pandemic. Updates to certificate requirements are also proposed, alongside revisions to the regulatory text concerning the establishment of the Clinical Laboratory Improvement Advisory Committee (CLIAC). Test reporting requirements and enforcement protocols would also see revisions aimed at enhancing clarity and efficiency. Finally, the rule includes various editorial and technical corrections to ensure the CLIA regulations are current and consistent. These collective updates underscore a comprehensive effort by CMS and CDC to adapt CLIA regulations to the current landscape of clinical laboratory science and practice.
