CLIA in 2025: What dermatology practices need to know now about the updated laboratory requirements

By Faiza Wasif, MPH, Associate Director, Practice Management, August 1, 2025

Each month, DermWorld tackles issues “in practice” for dermatologists. This month, practice management staff discuss what dermatology practices need to know about the updated laboratory requirements.

Whether your office does potassium hydroxide (KOH) preps, slide stains, patch testing, or runs a full Mohs lab, in-office testing plays a central role in dermatology practice. Most of these services are regulated under the Clinical Laboratory Improvement Amendments (CLIA), which are overseen by the Centers for Medicare & Medicaid Services (CMS). As of June 23, 2025, updated federal requirements are in effect for laboratory directors and testing personnel.

For many dermatology practices, these updates will not require operational changes —but they do call for a close look at your current CLIA certificate, staff designations, and documentation to ensure qualifications align with new federal standards.

Understanding CLIA and its role in your practice

CLIA sets quality standards for all laboratory testing done on humans in the U.S., including in-office labs. It classifies tests into three levels of complexity:

• Waived tests — simple, low-risk tests

• Moderate complexity — tests that require more training and equipment

• High complexity — advanced testing, such as dermatopathology or immunofluorescence

Depending on the type of testing your lab does, you must have a specific CLIA certificate and meet education and training standards for both lab directors and testing personnel.

Key updates in the revised CLIA rule & subsequent CMS enforcement discretion

Following sustained advocacy by the AADA, CMS has suspended enforcement of a controversial CLIA policy that would have excluded board-certified dermatologists from serving as lab directors for moderate- and high-complexity labs. Under this suspension, CMS:

• Allows individuals qualified as technical supervisors to qualify as high-complexity laboratory directors for testing in dermatopathology.

• Clarifies that high-complexity laboratory directors have a total of two years of laboratory training or experience and laboratory experience directing or supervising high-complexity testing. This includes training completed during residency or fellowship, so board-certified dermatologists, dermatopathologists, and Mohs surgeons meet the requirements and do not need additional training.

• Permits laboratory directors to have either at least one year of experience directing or supervising nonwaived laboratory testing or 20 continuing education (CE) credit hours in laboratory director responsibilities.

• Eliminates the requirement for an additional 20 CE credit hours, so anyone previously qualified as a clinical consultant continues to qualify without taking additional 20 CE credits.

Lab director qualifications as of June 23, 2025

The updated rules specify two primary qualification pathways depending on board certification status:

For MDs and DOs with board certification

Physicians certified by the American Board of Pathology (ABP) or the American Osteopathic Board of Pathology (AOBP) in anatomic or clinical pathology remain eligible to direct labs. Under CMS’s updated enforcement discretion, dermatologists who are board-certified by the American Board of Dermatology (ABD) or the American Osteopathic Board of Dermatology (AOBD) now also qualify for lab director roles in both moderate- and high-complexity settings.

For MDs and DOs without dermatology or pathology board certification

Physicians without relevant board certification can still qualify by meeting experience and education thresholds:

• High-complexity labs: Require a minimum of two years of hands-on experience supervising or directing non-waived testing.

• Moderate-complexity labs: Require at least one year of equivalent supervisory experience.

Continuing education: In both cases, 20 CE hours focused on lab director duties are required. These CE credits can typically be obtained through accredited organizations such as the College of American Pathologists (CAP).

Transition policy for existing laboratory directors

Lab directors of moderate- or high-complexity labs in place before Dec. 28, 2024, may continue under the previous qualifications as part of a grandfathering provision, as long as they remain in their current role without a break in service or change in certificate. This exception does not apply to testing personnel.

Additional important notes

• The updated rules focus on lab personnel qualifications, not test types, but non-compliance can lead to loss of certification, billing issues, or denied reimbursement.

• State or local regulations may be stricter and must also be followed.

• Any changes to testing complexity, equipment, or staff may require updating your CLIA certificate — report changes to CMS or your accrediting agency.

Steps your practice should take now

• Confirm that your current or prospective lab directors are credentialed appropriately for the complexity of testing performed, and that they meet the updated rules and CMS enforcement discretion.

• Ensure documentation of continuing education is complete and current, especially for directors qualifying through experience rather than board certification.

• Align director qualifications with lab complexity and testing scope, especially for practices overseeing more than one lab (e.g., Mohs and dermatopathology).

CLIA communications go paperless in 2026

Effective March 1, 2026, all laboratories must switch to email notifications to receive electronic CLIA fee coupons and certificates. Paper versions will no longer be issued after March 1, 2026. To prepare, visit the CMS CLIA website.

How the Academy is supporting you

The Academy remains committed to protecting the interests of dermatologists by proactively engaging with federal agencies, including CMS, to address evolving regulatory challenges. Whether responding to changes in CLIA requirements, scope-of-practice policies, or reimbursement rules, the Academy works to ensure that dermatology practices can continue to deliver high-quality care without unnecessary administrative or regulatory burdens. This includes securing clarifications, pushing back on restrictive interpretations, and providing members with individualized support when compliance issues arise. AAD members are encouraged to contact regulatory@aad.org to report issues or for support.

Training and tools to stay informed and compliant

Stay prepared with the Academy’s updated online CLIA training and comprehensive dermatology-specific manual, covering key lab procedures and inspection essentials. Both resources help ensure your practice stays compliant and inspection-ready.

See the latest CLIA updates, resources, and guidance in the Practice Management Center.

Additional DermWorld Resources