The Centers for Medicare & Medicaid Services and the Centers for Disease Control and Prevention proposed a rule, published October 8, that would let laboratory staff review most test data and images from outside the building under the certificate of the laboratory that generated it. One subspecialty is carved out: cytology.
Where the line sits
The proposal would define "virtual access" in the CLIA regulations to cover digital laboratory data, digital results, live imaging and digital images reviewed away from the primary testing laboratory's premises, over a secure connection to that laboratory's systems, and still treated as work done under its own certificate. The proposed definition carves cytology out by name: "Virtual access is not permitted in the subspecialty of cytology." Anyone examining a cytology slide, digital image or digital data at a location other than the primary CLIA-certified laboratory would still have to obtain a separate CLIA certificate carrying the cytology subspecialty for that location. CMS says it is codifying enforcement discretion it has exercised since the pandemic.
Cytology's own digital carve-in
Separately, the rule would let gynecologic cytology proficiency testing — the annual testing event each screener must take — use digital images of glass slides, not only the slides themselves. CMS says that reflects the FDA's authorization for marketing, in 2024, of the first digital cytology screening system, which creates digital images of glass slides. Because cytology proficiency testing evaluates an individual rather than the laboratory as a whole, CMS would also require that programs approved by HHS "must have a system in place to monitor the integrity of the testing" — the role proctors play in the College of American Pathologists and American Society for Clinical Pathology glass-slide programs.
Who can hold which lab job
The rule would also revise personnel-qualification requirements set by a 2023 CLIA final rule whose updated qualifications took effect December 28, 2024. CMS says interested parties raised concerns after the rules were in force, most of them about laboratory director qualifications, and warned that stricter requirements could shrink the pool of eligible directors and affect access to care in rural areas and at laboratories that perform Mohs testing. CMS announced enforcement discretion for some of those requirements in a memo on June 23, 2025. It ties the proposed changes to "current workforce shortages," citing surveys of laboratory vacancy rates that rose during the pandemic and, it says, remain above pre-pandemic levels.
The SARS-CoV-2 rule it would remove
One proposed change takes something away rather than adding it. Under section 18115 of the CARES Act, CMS required laboratories to report SARS-CoV-2 test results to the Secretary of Health and Human Services. CMS says that authority ran only until the end of the federal public health emergency declaration, so the reporting requirements expired when the emergency terminated on May 11, 2023 — while the regulatory text stayed on the books. The rule proposes to rescind it at 42 CFR 493.41, 493.555(c)(6), 493.1100(a), 493.1100(b) and 493.1834(d)(2)(iii), and to revise the definitions section, 493.2, to drop a cross-reference to one of them. The document calls the requirement obsolete.
What to do
This is a proposal, not a final rule; none of these changes are in effect. CMS says comments must come one of three ways — through regulations.gov, by regular mail, or by express or overnight mail — and must refer to file code CMS-3478-P. The deadline printed in the document is December 7, 2026.