CMS Proposes CLIA Changes That Would Allow Remote Lab Review. Comments Are Due Dec. 7.
A proposed rule published Oct. 8 would permit virtual access under a lab's certificate, ease director qualifications and let dermatologists direct Mohs labs by board certification. Cytology is excluded from remote review.
The Centers for Medicare and Medicaid Services proposed on Oct. 8 to rewrite parts of the Clinical Laboratory Improvement Amendments (CLIA) rules, which govern every laboratory that tests human specimens, including those in physician offices. The proposed rule would allow remote review of digital laboratory data, loosen laboratory director qualifications and drop expired SARS-CoV-2 reporting requirements. Comments are due Dec. 7.
The rule is a proposal, not a final rule. Offices that run moderate complexity testing or provider-performed microscopy, or that employ a dermatologist who performs Mohs surgery, should read the sections that apply to them.
Virtual access
The rule would define virtual access as review of digital laboratory data, digital results, live imaging and digital images through a secure connection to the primary laboratory's systems. That work would be treated as performed under the primary laboratory's CLIA certificate wherever the reviewer sits, and remote staff would have to be listed on the laboratory's Form CMS-209 personnel report. Virtual access would not apply to provider-performed microscopy certificates, since those procedures happen during the patient visit.
Cytology is excluded: “Virtual access is not permitted in the subspecialty of cytology.” Laboratories using virtual access would have to keep records of who performed the testing, the software version and the device used. CMS says it reviewed survey citations from March 2023 to July 2024 and “identified no concerning citation trends related to the remote review of digital data, results, or images.”
Gynecologic cytology proficiency testing
Proficiency testing could use digital images of glass slides. Because cytology testing evaluates individuals rather than the laboratory as a whole, the rule would require that approved programs “must have a system in place to monitor the integrity of the testing,” the role a proctor plays with glass slides today.
Director qualifications and duties
Physicians could qualify as moderate complexity laboratory directors through relevant experience, 20 continuing education credit hours or at least one year of laboratory training during residency or fellowship. For high complexity directors, CMS would cut the required experience directing or supervising high complexity testing from two years to one and add the same residency or fellowship training route.
Dermatologists could qualify as high complexity laboratory directors for dermatopathology, including Mohs testing, through dermatology board certification instead of documenting their training. CMS says about 20 percent of all laboratories with a certificate of compliance are in dermatology offices. The rule would also drop the requirement that moderate and high complexity directors be on site at least every six months, leaving a duty to be accessible to the laboratory as needed. For provider-performed microscopy, it would rescind the director's duty to evaluate and document the competency of testing personnel, including semiannual reviews in the first year.
Most of these changes loosen requirements. The cost is a new set of documentation and security duties for any office that adopts remote review.
The other changes
The rule would remove the SARS-CoV-2 test reporting requirements, which expired with the end of the public health emergency on May 11, 2023. It would let any laboratories on the same campus under the same director file a single certificate application, not only hospital laboratories, and would define a campus as the area within 250 yards of the main building. All certificate holders would have to report a change of email address within 30 days.
Test reports would have to show the laboratory's CLIA number and its name as it appears on the CLIA certificate, not only a trade name. On enforcement, CMS would rescind the mandatory six-month waiting period before a laboratory can resume testing after proficiency testing failures, citing access problems in rural areas.
What to do now
Ask your laboratory director or medical director which provisions touch your office, then decide whether to comment through regulations.gov under docket CMS-2026-3235 (file code CMS-3478-P) before Dec. 7.
Reported, fact-checked and edited by The Script Pad's editorial staff.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
