Published October 8, 2026 as 91 FR 64480, FR Doc. 2026-20613, file code CMS-3478-P. Source: Federal Register
Director qualifications are in §493.1405 (moderate) and §493.1443 (high). Source: 42 CFR 493.1405
Gyn cytology PT rules are in §493.855 and §493.945. Source: 42 CFR 493.945
Current enforcement discretion on personnel: QSO-25-21-CLIA (June 23, 2025). Source: CMS QSO-25-21-CLIA
Remote cytology needs its own certificate: QSO-23-15-CLIA-REVISED. Source: CMS memo
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The Federal Register notice groups the changes into four areas:
Virtual access. Codify remote review of digital data, results, live imaging and digital images under the primary lab's CLIA certificate. Cytology is excluded.
Gynecologic cytology PT. Allow PT using digital images of glass slides.
Personnel qualifications. Roll back several requirements that took effect December 28, 2024, under the 2023 final rule (CMS-3326-F).
Other changes. SARS-CoV-2 reporting, certificates, test reports, enforcement, CLIAC and technical corrections.
CMS proposes one standard for moderate and high complexity directors: at least 1 year directing or supervising laboratory testing, or 20 CE credit hours covering director responsibilities. Physicians gain a third route: 1 year of laboratory training during residency or fellowship. Board-certified pathologists are unchanged.
Comparison (current rule since Dec 28, 2024 vs proposed):
Physician, moderate (§493.1405(b)(2)). Current: 1 yr supervisory experience and 20 CE. Proposed: 1 yr experience or 20 CE or 1 yr lab training in residency/fellowship.
Physician, high (§493.1443(b)(2)). Current: 2 yrs supervisory experience and 20 CE. Proposed: same three options as moderate.
Doctoral, moderate (§493.1405(b)(3)). Current: HHS-approved board certification and 1 yr and 20 CE. Proposed: 1 yr experience or 20 CE; no board certification.
Doctoral, high (§493.1443(b)(3)). Current: board certification and 2 yrs and 20 CE. Proposed: 1 yr experience or 20 CE; no board certification.
Master's / bachelor's, moderate. Current: lab experience and supervisory experience and 20 CE. Proposed: 1 yr supervisory experience or 20 CE.
Source: Table 1 of the proposed rule. Current HHS-approved doctoral board certifications listed in SOM Appendix C would still be accepted as documentation of the 1 year of experience.
Mohs and dermatopathology. A new §493.1443(b)(6) would let a licensed MD/DO qualify as a high complexity director for dermatopathology with certification in anatomic pathology, dermatopathology, or dermatology (ABD, AOBD or ABPS).
Onsite visits: §493.1407(c) and §493.1445(c) would return to "accessible to the laboratory as needed." The every-6-months onsite visit with 4 months between visits would be removed.
PPM competency: the PPM director competency provisions at §493.1359(c)(1)-(5) and (d) would be rescinded.
Doctoral degree would mean "an earned doctoral degree as defined by the academic institution's doctoral program."
Biological, chemical and clinical/medical laboratory science degrees would be defined by 2020 NCES CIP codes (for example CIP 26, 40.05, and listed 51.10 codes). Animal and veterinary sciences are included.
Thesis/research language limiting research to human health would be removed, so animal-model research can count.
The definitions of "experience directing or supervising" and "laboratory training or experience" (limited to CLIA-certified labs) would be rescinded.
Other fixes include grandfathering for moderate complexity clinical consultants (§493.1417(c)) and gross tissue examination by high complexity testing personnel (§493.1489(b)(7)).
A new §493.2 definition of virtual access: review of digital laboratory data, digital results, live imaging and digital images under the CLIA certificate of the primary testing laboratory that generated the data. It codifies the flexibility in memo QSO-23-15-CLIA. Cytology is excluded. Remote cytology review still needs a separate CLIA certificate for that location, as stated in QSO-23-15-CLIA-REVISED (effective March 23, 2026).
§493.855 and §493.945 would allow 10- and 20-slide test sets or digital images of the test slides. HHS-approved PT programs would need a system to monitor the integrity of testing, similar to proctoring for glass-slide events.
Remove SARS-CoV-2 reporting requirements.
Multiple-site exception: labs on the same campus under the same director could file one application, not only hospital labs.
Test reports (§493.1291(c)(2)) would add the CLIA number and the lab name as it appears on the CLIA certificate.
Rescind the mandatory 6-month reinstatement wait after PT failure; alternative sanctions would continue until revocation.
Update §493.2001(a) on CLIAC, which was terminated on March 31, 2025.
Comments must be received by December 7, 2026. Refer to file code CMS-3478-P and use only one method:
Online: regulations.gov docket CMS-2026-3235. Select "Submit a comment."
Regular mail: CMS, Department of Health and Human Services, Attention: CMS-3478-P, P.O. Box 8016, Baltimore, MD 21244-8016.
Express or overnight mail: CMS, Department of Health and Human Services, Attention: CMS-3478-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
Comments are posted publicly. Do not include patient or confidential information.
Keep complying with current rules. Proposed changes have no legal effect. QSO-25-21-CLIA enforcement discretion (June 23, 2025) still applies to the items it lists.
Audit personnel files against current Subpart M and note who would qualify under the proposal.
Keep documenting director onsite visits until a final rule removes the requirement.
Inventory remote review. Confirm remote staff are on Form CMS-209 and that no cytology is reviewed off-site without its own certificate.
Check your report template for the CLIA number and certificate name.
Comment by December 7, 2026 on the items that affect your lab.
Is the 2026 CLIA proposed rule in effect?
Does the proposed rule remove board certification for lab directors?
No. It is a proposed rule published October 8, 2026. It takes effect only if CMS publishes a final rule, which would state its own effective date.
It would remove the HHS-approved board certification requirement for doctoral-degree directors under §493.1405(b)(3) and §493.1443(b)(3). Pathologist board certification is unchanged.
When are comments due?
Would the 6-month director onsite visit go away?
Comments must be received by December 7, 2026, citing file code CMS-3478-P.
It is proposed for removal. Until a final rule says otherwise, document onsite visits as §493.1407(c) and §493.1445(c) currently require.
Can cytology be reviewed remotely under virtual access?
No. Cytology is excluded. Remote cytology review needs a separate CLIA certificate for that location.
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