CLIA Proposed Rule 2026: Virtual Access, Cytology PT and Lab Director Changes
Short answer: On October 8, 2026, CMS and CDC proposed a CLIA rule (CMS-3478-P) that would codify remote "virtual access" to digital lab data, allow digital-image gynecologic cytology proficiency testing, and loosen laboratory director qualifications. Comments are due December 7, 2026. It is a proposal only; current CLIA requirements still apply.
What did CMS and CDC propose on October 8?
The proposed rule, titled "Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes," appeared in the Federal Register on October 8, 2026 (91 FR 64480, RIN 0938-AV89). It amends 42 CFR Part 493 and is issued jointly by CMS and CDC. Comments are accepted through December 7, 2026 on Regulations.gov under docket CMS-2026-3235.
This is the first concrete rulemaking to follow the CLIA modernization Request for Information that CMS opened in July. For background on that RFI, see our coverage of the CMS CLIA regulations RFI. Unlike the RFI, this document contains actual regulatory text that labs can comment on line by line.
How would "virtual access" work?
The rule would add a definition of virtual access: review of digital lab data, digital results, live imaging, and digital images performed under the primary testing laboratory's CLIA certificate while not physically on its premises, through a secure connection. It would codify the flexibility CMS first granted after the COVID-19 public health emergency in memo QSO-23-15-CLIA.
Several guardrails come with it. The laboratory director of the primary lab stays responsible for all testing, including remote work. Testing must be performed by qualified personnel, who must be listed on Form CMS-209 and identified to CMS on request. Labs would need policies requiring confidential use on secure networks rather than public ones. Records would have to capture who performed the testing, the software version, and the device used.
Virtual access would not be allowed for the cytology subspecialty, and it would exclude provider-performed microscopy certificates. The proposal also expands retention duties: cytology and histopathology records would need to keep both the slide and any digital image.
What changes for gynecologic cytology proficiency testing?
CMS proposes to allow proficiency testing that uses digital images of glass slides, citing the FDA's 2024 authorization of a digital cytology screening system. The existing 10-slide and 20-slide scoring and consensus structures would extend to digital images, with 10 points for a correct response and a deduction of 5 points for an incorrect one, as summarized from the proposal text.
HHS-approved PT programs would also need "a system in place to monitor the integrity of the testing." That language matters for any lab that relies on a PT provider to run digital programs. Molecular and genetic labs are less directly affected by the cytology piece, but the integrity requirement signals how CMS is thinking about remote and digital testing generally.
How would laboratory director qualifications change?
This is the part most likely to affect molecular and genetic testing labs. Under the current rules, most director pathways require several elements at once, such as supervisory experience and 20 continuing education hours. The proposal generally converts that "and" into "or," and shortens some experience requirements.
- Physician directors, moderate or high complexity: one year of laboratory training in residency or fellowship, or one year of supervisory experience, or 20 CE hours. High-complexity physicians currently need two years of supervisory experience plus CE.
- Doctoral directors: the HHS-approved board certification requirement would be removed, and one year of supervisory experience or 20 CE hours would suffice. HHS-approved certifications would still count as documentation of experience.
- Master's and bachelor's directors, moderate complexity: one year of supervisory experience or 20 CE hours. Bachelor's-level directors currently need two years of lab and two years of supervisory experience plus CE.
The proposal also drops language requiring doctoral and master's research to relate to testing for human disease, would use the 2020 NCES CIP classification to define qualifying science degrees, removes the six-month on-site requirement for moderate and high complexity directors, and adds a pathway for certain board-certified dermatologists to direct high-complexity Mohs labs. Grandfathering would extend to moderate and high complexity directors qualified before December 28, 2024.
Why is CMS doing this now?
Workforce pressure is a stated driver. The proposal cites an average traditional laboratory vacancy rate that rose from 8.35 percent in 2020 to 13.82 percent in 2022, and describes about 300,000 CLIA-regulated laboratories. Easier virtual access and broader director eligibility are meant to widen the pool of qualified staff.
What else is in the proposal?
The "other changes" bucket removes outdated SARS-CoV-2 reporting requirements, updates certificate requirements, adds the CLIA number and laboratory name to test reports, revises enforcement provisions, and revises public consultation requirements, including CLIAC regulatory text. Labs that generate their own report templates should note the test report change, since template edits and LIS validation take lead time.
The rule does not address laboratory-developed test oversight directly. For that debate, see our explainers on the FDA LDT rule status and the Enhancing CLIA Act. Still, a rule that rewrites director and remote-work requirements shows CLIA is the regulatory channel CMS is actively modernizing.
What should labs and decision-makers do before December 7?
Medical directors should check how their own qualification pathway maps to the proposed "or" structure, and whether any current directors or technical consultants would gain or lose eligibility. Operations leaders should inventory any remote data review already happening, since the rule would require documentation of personnel, software version, and device. Compliance teams should draft comments on secure-network, retention, and report-content provisions.
Reimbursement and revenue cycle teams should note that nothing here changes billing or coverage today. A proposed rule can change before it is finalized, and the final text may differ. For lab-side workflow and documentation support, visit ScreenMyGene.
Frequently asked questions
Is the CLIA proposed rule in effect now?
No. CMS-3478-P is a proposed rule published October 8, 2026. It has no force until CMS publishes a final rule, which may differ from the proposal. Current CLIA regulations in 42 CFR Part 493 continue to apply while the comment period runs through December 7, 2026.
Does virtual access apply to cytology?
No. The proposed definition of virtual access would not be permitted for the cytology subspecialty and excludes provider-performed microscopy certificates. CMS cites that its post-pandemic memo on remote cytology image review ended as of March 23, 2026. Digital images would, however, be allowed for gynecologic cytology proficiency testing.
How would director qualifications change for doctoral directors?
The HHS-approved board certification requirement would be removed for doctoral directors of moderate and high complexity labs. Qualification would rest on one year of supervisory experience or 20 continuing education hours. HHS-approved certifications could still serve as documentation of that experience under the proposal.
What new report content is proposed?
CMS proposes adding the CLIA number and laboratory name to test reports. Labs should review report templates and LIS configurations now, because changes to report formats usually require validation and ordering-provider communication before they go live. The final requirement and any compliance date would be set in a final rule.
How can labs submit comments?
Submit through Regulations.gov under docket CMS-2026-3235, referencing file code CMS-3478-P, by December 7, 2026. Comments can also be mailed to CMS at P.O. Box 8016, Baltimore, MD 21244-8016. CMS asks commenters to use only one submission method.
This article is for educational purposes only and does not constitute legal, regulatory, billing, or clinical advice. Proposed rules may change before finalization; confirm requirements with the Federal Register text and your compliance counsel.
Sources: Federal Register, CMS-3478-P, 91 FR 64480 (October 8, 2026), federalregister.gov; Federal Register public inspection document 2026-20613; MLO Online, "CMS proposes CLIA updates for digital access, personnel qualifications" (October 9, 2026); Global Relay GRIP (October 9, 2026).