CLIA Proposed Rule 2026 (CMS-3478-P): What Would Change

The CLIA proposed rule published October 8, 2026 (CMS-3478-P) would let lab directors qualify with 1 year of supervisory experience or 20 CE hours, drop doctoral board certification, end the 6-month director onsite visit, codify virtual access except for cytology, and allow digital gyn cytology PT. It is proposed only. Comments are due December 7, 2026.

Last reviewed Oct 2026 · By Sound Lab Consultants CLIA team · Source: CMS-3478-P, 91 FR 64480 (Oct 8, 2026), FR Doc. 2026-20613. General information, not legal advice.

Status: PROPOSED RULE. Nothing on this page is in effect. Until CMS publishes a final rule, the current 42 CFR Part 493 and current CMS memos apply.

Key facts and official sources

• Published October 8, 2026, as 91 FR 64480 (FR Doc. 2026-20613, file code CMS-3478-P). Source: Federal Register

• Comments must be received by December 7, 2026. Online docket: CMS-2026-3235

• Current director rules: 42 CFR 493.1405 (moderate) and 42 CFR 493.1443 (high)

• Current PT reinstatement rule: 42 CFR 493.807

What does the CLIA proposed rule 2026 cover?

The Federal Register notice groups the changes into four areas:

1. Virtual access: remote review of digital data, results, live imaging and digital images under the primary testing lab's CLIA certificate. Cytology is excluded.

2. Gynecologic cytology PT: PT using digital images of glass slides.

3. Personnel qualifications: revising or rescinding several requirements that took effect December 28, 2024.

4. Other changes: removing SARS-CoV-2 reporting, certificate and test-report updates, enforcement changes, and technical corrections.

How would lab director qualifications change?

CMS and CDC propose that directors qualify with 1 year of supervisory experience or 20 CE credit hours. Physicians could also qualify through 1 year of laboratory training during residency or fellowship. Board-certified pathologists are unchanged. The table summarizes Table 1 of the proposed rule:

• Physician, moderate: Current rule: 1 yr supervisory experience and 20 CE; Proposed: 1 yr residency/fellowship lab training or 1 yr supervisory or 20 CE

• Physician, high: Current rule: 2 yrs supervisory experience and 20 CE; Proposed: Same three options

• Doctoral, moderate: Current rule: Board certification and 1 yr and 20 CE; Proposed: 1 yr supervisory or 20 CE

• Doctoral, high: Current rule: Board certification and 2 yrs and 20 CE; Proposed: 1 yr supervisory or 20 CE

• Master's or bachelor's, moderate: Current rule: Lab experience and supervisory experience and 20 CE; Proposed: 1 yr supervisory or 20 CE

The proposal would remove the HHS-approved doctoral board certification requirement at §493.1405(b)(3) and §493.1443(b)(3).

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).

What happens to director onsite visits and PPM competency?

• Onsite visits: §493.1407(c) and §493.1445(c) would return to requiring that the director be "accessible to the laboratory as needed." The current requirement for an onsite visit at least every 6 months, with at least 4 months between visits, would be rescinded.

• PPM competency: the PPM director competency requirements in §493.1359 would be rescinded.

CMS notes in the proposal that "laboratory director citations remain among the top ten condition-level deficiencies cited by laboratory surveyors."

What would change for PT sanctions?

• Rescind the mandatory waiting period in §493.807(b). Today it is at least six months before a lab sanctioned for unsuccessful PT can be reinstated.

• Remove "one of which may be on site" from §493.807(a). Labs could use on-site PT or order off-cycle PT for the two reinstatement events.

See what to do after a failed PT event.

What would virtual access and digital cytology PT allow?

• Virtual access would be a new defined term. It would allow qualified staff to review digital data, results, live imaging and digital images under the CLIA certificate of the lab that generated the data. Cytology is excluded because the statute requires cytology slides to be evaluated on a certified lab's premises.

• Gyn cytology PT could use digital images of glass slides.

What other changes are proposed?

• Remove SARS-CoV-2 reporting requirements.

• Test reports would add the lab's CLIA number and its name as it appears on the CLIA certificate.

• The multiple-site exception would let labs on the same campus under the same director file one application.

• Define "doctoral degree" as one defined by the academic institution's doctoral program, and define science degrees using 2020 NCES CIP codes.

How do I submit a comment on CMS-3478-P?

Comments must be received by December 7, 2026, citing file code CMS-3478-P. Use one method only:

1. Online: regulations.gov docket CMS-2026-3235, then "Submit a comment"

2. Regular mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3478-P, P.O. Box 8016, Baltimore, MD 21244-8016

3. Express or overnight mail: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3478-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850

Tips for an effective comment: name the section (for example, §493.1407(c)) and say whether you support or oppose the change. Explain the effect on your lab using your own facts, and suggest alternative wording if you have it. Comments are public, so leave out patient or confidential information.

What should labs do now?

1. Keep following the current rules.

2. Keep documenting director onsite visits.

3. Audit personnel files against current Subpart M.

4. List any remote review and confirm no cytology is reviewed off-site without its own certificate.

5. Check that your report template would meet the proposed CLIA-number requirement.

6. Comment by December 7.

Frequently asked questions

Is the 2026 CLIA proposed rule in effect?

No. It takes effect only if CMS publishes a final rule, and that final rule would set its own effective date.

Does it remove board certification for lab directors?

It would remove the HHS-approved board certification requirement for doctoral-degree directors. Pathologist board certification is unchanged.

Would the 6-month director onsite visit go away?

It is proposed for removal. Until a final rule says otherwise, keep meeting and documenting the current requirement.

When are comments due?

They must be received by December 7, 2026.

Can cytology be reviewed remotely under virtual access?

No. Cytology is excluded from the proposed virtual access provisions.

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