CMS Proposes CLIA Updates With Direct Implications for Mohs Laboratories

On October 8, 2026, the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) published a proposed update to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The proposal, CMS-3478-P, includes provisions specifically addressing laboratory directors for Mohs testing, as well as broader changes involving virtual access and onsite responsibilities.

The proposal is not a final rule. Current CLIA requirements remain in effect unless and until CMS and CDC complete rulemaking and announce an effective date. Public comments are due December 7, 2026.

A Proposed Qualification Pathway for Mohs Laboratory Directors

The proposal would add a specific high-complexity laboratory-director pathway for a licensed physician who directs a dermatopathology laboratory in a dermatology office where Mohs procedures are performed. The proposed pathway recognizes certification in anatomic pathology, dermatopathology or dermatology by specified boards.

For Mohs surgeons, the most notable element is the proposed recognition of dermatology board certification. CMS and CDC state that this would simplify and standardize documentation rather than requiring dermatologists to demonstrate the experience pathway introduced by the 2023 CLIA final rule.

The agencies developed the proposal after receiving concerns that the current combination of supervisory-experience and continuing-education requirements could reduce the number of eligible laboratory directors, particularly in rural areas and practices that perform Mohs testing.

Because the rule is still proposed, practices should not change laboratory-director assignments or qualification files based on the proposal alone.

Onsite Visits Could Be Replaced by an “Accessible as Needed” Standard

Current regulations require moderate- and high-complexity laboratory directors to be onsite at least once every six months, with at least four months between the two minimum visits. CMS and CDC propose removing that fixed schedule and returning to language requiring the director to be accessible to the laboratory as needed.

If finalized, this change could reduce a prescriptive federal documentation burden. It would not remove the director’s responsibility for the laboratory’s overall operation, qualified personnel, quality systems or regulatory compliance. State law, accreditation requirements and a laboratory’s own validated procedures could still impose additional expectations.

Virtual Access Is Broader Than Remote Mohs Diagnosis

The proposal would define “virtual access” as the remote review of digital laboratory data, digital results, live imaging and digital images through a secure connection to the primary testing laboratory. The work would remain under the CLIA certificate of the laboratory that generated the data. Cytology would be excluded.

The proposed definition includes quality-control and quality-assurance data, test results and real-time viewing of microscope slides in areas such as histopathology. It also calls for qualified personnel, secure connections, recordkeeping, confidentiality protections and quality controls for work performed through virtual access.

This provision should not be described as blanket authorization for remote Mohs diagnosis. The proposal does not by itself validate a scanner, software platform, network, display or diagnostic workflow. Laboratories considering digital processes would still need to evaluate applicable CLIA provisions, state requirements, accreditation standards, cybersecurity, validation and the intended use of each technology.

Why This Matters for Mohs Practices

Mohs surgery integrates surgical removal, tissue processing, microscopic evaluation and immediate clinical decision-making. Laboratory-director qualifications and oversight therefore affect both compliance and day-to-day operations.

The proposal gives practices an opportunity to review how personnel credentials, director responsibilities, quality records and digital-access policies are documented. It also gives laboratory teams a chance to identify operational concerns that may be useful in a formal public comment.

Comments must reference file code CMS-3478-P and be received by December 7, 2026. Electronic comments may be submitted through the federal docket identified in the proposed rule.

Three Key Takeaways

1. The rule is proposed, not final. Existing CLIA obligations remain in place.
2. Mohs laboratory leadership is addressed directly. The proposal would recognize a defined dermatology board-certification pathway for certain high-complexity laboratory directors.
3. Virtual access would carry safeguards. Qualified personnel, secure systems, records, confidentiality and quality controls would still be required.

Tips for Histotechnologists

Mohs Workflow

1. Maintain complete case-to-map traceability for every stage, block and slide, regardless of whether records are reviewed onsite or through an approved digital workflow.
2. Document incomplete sections, folds, chatter, missing epidermis or other technical limitations and escalate them promptly to the Mohs surgeon or laboratory director.
3. Keep quality-control, maintenance, reagent and temperature records current; proposed director-qualification changes do not suspend daily quality-system responsibilities.

Histopathology Workflow

1. Follow the laboratory’s validated orientation, embedding, sectioning and staining procedures, and document any deviation.
2. Verify stain and control acceptability before slides enter the interpretive workflow, escalating unacceptable results according to laboratory policy.
3. Record recuts, additional levels and special-stain requests with clear specimen identity and chain-of-custody documentation.

Educational Disclaimer

This article is for educational and operational awareness only. It is not legal, regulatory or medical advice. Laboratories should consult the final rule, CMS guidance, applicable state requirements, their accrediting organization and qualified counsel before changing policies or personnel assignments.

Sources

• Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention. Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing, Personnel Qualifications, and Other Changes. Proposed rule CMS-3478-P. Published October 8, 2026.
• Centers for Medicare & Medicaid Services. MLN Connects Newsletter for October 15, 2026. Comment reminder published October 15, 2026.
• Centers for Medicare & Medicaid Services. For Laboratory Directors. Accessed October 16, 2026.
• AABB. CMS Proposes Changes to CLIA Personnel and Virtual Access Rules. Published October 14, 2026.
• Federal docket. CMS-2026-3235. Comments due December 7, 2026.

Media and Designer Notes

• Hero-image concept: A clean, non-graphic editorial scene showing a Mohs laboratory workstation, labeled slide trays, a microscope and a secure digital review screen. Do not depict fabricated tissue findings or identifiable patient information.
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• Caption: A federal CLIA proposal addresses Mohs laboratory-director qualifications, onsite responsibilities and secure virtual access to laboratory information.
• Alt text: Mohs laboratory workstation with microscope, labeled slide trays and a secure digital review screen.
• Credit/rights: Original AI-generated editorial artwork produced for this MohsPro publication; approved for use with this article.
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• Video option: 45-second explainer using the three takeaways; production plan pending.