CLIA

Thanks to persistent 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 laboratory directors for testing in dermatopathology.

• Clarifies that high-complexity laboratory directors need to have a total of 2 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 1 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 will continue to qualify without taking further 20 CE credits.

CMS is committed to working with individual dermatologists experiencing issues in applying as CLIA Lab Directors. AAD members are encouraged to report issues to regulatory@aad.org The Academy will coordinate with CMS to help facilitate review and support resolution of any issues.

Below are some brief FAQs about the impact of the new enforcement discretion on dermatologists, followed by a more thorough review of lab director requirements.

FAQs on CMS CLIA enforcement discretion on lab director requirements

The below information is based on the June 23, 2025, CMS memorandum regarding enforcement discretion of personnel regulations and AAD/A communication with CMS as of July 16, 2025. As this situation continues to evolve, the AAD/A remains in active communication with CMS and will update guidance and member announcements as needed.

Are dermatologists certified by the American Board of Dermatology (ABD) or the American Osteopathic Board of Dermatology (AOBD) able to become lab directors for testing in dermatopathology under the new CLIA requirements?

Yes, CMS clarified that it would recognize board certification by the ABD and AOBD. A dermatologist who is licensed and board certified by the ABD or AOBD is qualified to serve as a laboratory director for testing in dermatopathology.

Is there additional training needed to be a high-complexity laboratory director for testing in dermatopathology?

No. Licensed dermatologists who have completed dermatology residency training and received ABD or AOBD board certification do not need additional training.

Are recently graduated dermatologists, dermatopathologists, and Mohs surgeons able to become CLIA lab directors for testing in dermatopathology?

Yes, CMS confirmed that individuals qualified as technical supervisors qualify as laboratory directors for testing in dermatopathology and clarified that residency training in dermatology qualifies as supervision experience. This will allow a recent graduate, who is licensed and board certified in dermatology or dermatopathology, to serve as a laboratory director for testing in dermatopathology, without requiring any additional training or experience.

Do qualifying lab directors need to have both 1 year of experience and 20 continuing education (CE) hours to serve as a laboratory director of a moderate complexity laboratory?

Under the enforcement discretion, CMS stated that laboratory directors can qualify with either one year of supervision experience or 20 CE credit hours to serve as a laboratory director of a moderate complexity laboratory — both are not needed. CMS has clarified that residency training in dermatology qualifies as supervision experience and training.

Would training received by dermatologists during residency and fellowships count toward the training requirements as CLIA lab directors for testing in dermatopathology?

Yes, laboratory training in residencies and fellowships satisfy the training requirements for both high-complexity and moderate-complexity laboratories. Therefore, board-certified dermatologists, dermatopathologists, and Mohs surgeons meet the requirements due to experience acquired in residency; no further training is required as a CLIA lab director.

I am a practicing dermatologist and work as a lab director. What do I have to do?

If you have been a lab director since Dec. 28, 2024, board-certified dermatologists are grandfathered as qualifying under the regulation, so no further action is needed.

As a dermatologist/dermatopathologist, I am currently technical supervisor of a high-complexity laboratory. Do I still qualify under the enforcement discretion?

If you were qualified and serving as a technical supervisor for high complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since that time, then you are grandfathered as qualifying to be a technical supervisor under the regulation. Licensed and board-certified dermatologists/dermatopathologists also qualify as laboratory directors for testing in dermatopathology.

What do I do if I have issues with my CLIA lab director application?

CMS has committed to assisting individual dermatologists to address any issues related to their CLIA applications. Should you experience any issues, please report them to regulatory@aad.org. The Academy will coordinate directly with CMS to assist in resolving any issues.

CLIA requirements for lab operations

To operate a CLIA-certified laboratory, staff must meet the minimum requirements set by CLIA, which vary depending on the complexity of the laboratory tests being performed. Updated requirements were set to be effective Dec. 28, 2024, but following AADA advocacy, CMS issued enforcement discretion on June 23, 2025 as outlined in CMS Memo # QSO-25-21-CLIA.

General requirements

• Waived Testing: Laboratories that only perform waived tests have no specific personnel requirements regarding education or certification. However, it is important to consult state scope of practice laws to ensure the correct personnel are conducting the tests.

• PPMP Laboratories: For laboratories performing Provider Performed Microscopy Procedures (PPMP), both the lab director and testing personnel must have an MD, DO, DPM, NP, or PA degree.

• Moderate-Complexity Laboratories: The lab director must meet CLIA qualifications under federal regulations, which may include holding an MD, DO, PhD, MS, or BS degree. Testing personnel in this setting must have at least a high school diploma.

• High-Complexity Laboratories (e.g., dermatopathology, immunodermatology, and Mohs surgery labs): The lab director must meet high-complexity CLIA qualifications. Under CMS’s current enforcement discretion, board-certified dermatologists (ABD/AOBD), dermatopathologists (ABD/ABP), or anatomic pathologists (ABP/American Osteopathic Board of Pathology [AOBP]) may qualify, provided they are licensed physicians in the lab’s state. Testing personnel in high-complexity labs must have at least an associate degree in a scientific field.

Updated requirements for lab directors (effective June 23, 2025)

The new regulations update the personnel qualifications for laboratory directors in moderate and high-complexity laboratories.

For physicians with an MD or DO degree

The lab director must be board-certified in anatomic pathology or clinical pathology (or both) by the American Board of Pathology (ABP) or the American Osteopathic Board of Pathology (AOBP). Under the June 23, 2025, enforcement discretion, board certification in dermatology by the American Board of Dermatology (ABD) or the American Osteopathic Board of Dermatology (AOBD) are also included.

For physicians without certification in pathology or dermatology

If a physician does not hold board certification in pathology or dermatology, they must meet the following qualifications to be eligible to direct a CLIA laboratory:

• For high-complexity laboratories (e.g., dermatopathology, immunodermatology, Mohs), at least two years of experience directing or supervising non-waived laboratory testing.

• For moderate-complexity laboratories, at least one year of experience directing or supervising non-waived laboratory testing.

• At least 20 continuing education (CE) credit hours covering laboratory director responsibilities, which can be earned through programs offered by organizations like the College of American Pathologists (CAP).

Residency-based qualification clarified

CMS has clarified that residency training in dermatology qualifies as supervision experience and training, in addition to the CMS enforcement discretion described below.

CMS enforcement discretion: Dermatology-specific clarification

Effective June 23, 2025, CMS is exercising enforcement discretion for certain dermatologists serving as laboratory directors, including those performing Mohs surgery. These individuals may now qualify if they:

• Hold a valid MD or DO license in the state where the lab is located, and

Are certified by any of the following boards:

• Anatomic Pathology by ABP or AOBP

• Dermatopathology by ABD and ABP

• Dermatology by ABD and AOBD

Grandfather provision for current lab directors

• Grandfather clause: If a lab director has been continuously employed in their role since Dec. 28, 2024, they will not need to meet the new educational requirements, as long as their employment remains uninterrupted. This provision is designed to allow existing lab directors to maintain their positions without meeting the new qualification requirements.

• For new lab directors: Any new lab directors who started on or after Dec. 28, 2024, must meet the updated qualifications as outlined above.

Additional information on CLIA regulations

• Impact on testing types: The recent changes to the CLIA regulations primarily focus on the qualifications required for laboratory directors, and the additional clarifications provided by CMS pertain to dermatologists as lab directors of testing in dermatopathology. However, labs may need to adjust their staffing or training procedures to ensure compliance with the new director qualifications, or they may risk losing their ability to perform certain tests.

• Compliance and penalties: Laboratories that do not meet the new requirements by the effective date of Dec. 28, 2024, may face loss of CLIA certification or accreditation, depending on the level of non-compliance. This could result in the laboratory being unable to perform certain tests or facing penalties.

• State and local regulations: In addition to CLIA and CAP requirements, laboratories must comply with any more stringent state or local regulations, including licensing requirements.

How to ensure compliance

• Review lab director credentials: Dermatology practices should ensure that their lab directors meet the updated qualifications, qualify under the enforcement discretion, or fall under the grandfather provision if applicable.

• Continuing education: Lab directors must ensure they complete the required continuing education (CE) to meet the new director responsibilities, particularly if they are not board-certified in pathology.

• Multiple laboratories: If a dermatology practice operates multiple types of labs (e.g., Mohs surgery and dermatopathology), the lab director must meet the qualifications for each lab type.

CLIA paperless transition (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 or use:

• Partner toolkit for transition to paperless

• CLIA fees and certificates fact sheet

• CLIA poster

Related Academy resources