CMS Proposes Changes to CLIA Personnel and Virtual Access Rules

The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) issued a proposed rule on Oct. 8 that would revise the Clinical Laboratory Improvement Amendments (CLIA) regulations. The changes address personnel qualifications, remote review of laboratory data and images, proficiency testing, and other laboratory requirements. Comments are due Dec. 7.

The proposal would roll back parts of the personnel requirements in the 2023 CLIA final rule, which took effect Dec. 28, 2024. For many laboratory director candidates, the proposed changes would allow qualification through either one year of supervisory laboratory experience or 20 continuing education credit hours covering laboratory director responsibilities, rather than requiring both. Physicians could also qualify through one year of laboratory training during residency or fellowship. The proposal would remove the requirement for laboratory directors of moderate- and high-complexity laboratories to conduct on-site visits at least every six months. It would also eliminate the requirement for certain doctoral degree holders to have board certification approved by HHS.

CMS began exercising enforcement discretion on several of these requirements in June 2025.

Other changes would codify the use of virtual access to review digital laboratory data, results and images under the primary testing laboratory’s CLIA certificate, provided secure connections and other requirements are met. Cytology would be excluded from this flexibility.

The proposal would also eliminate the mandatory six-month waiting period for reinstatement following certain proficiency-testing failures, provided laboratories meet reinstatement requirements. CMS noted that this change could help maintain access to immunohematology testing, particularly in rural hospitals where referral testing may delay critical transfusion care. Additional changes would require test reports to include the laboratory’s CLIA number and the name listed on its certificate. The proposed rule also removes obsolete reporting requirements related to COVID-19.

CMS estimates annual cost savings ranging from approximately $2.8 million to $149.8 million, with most savings attributed to the proposed personnel qualification changes.