AADA Advocacy Win: CMS suspends CLIA lab director enforcement policy

June 23, 2025

Advocacy News Alert

As a direct result of advocacy by the AADA, CMS will exercise enforcement discretion on several provisions of its revised CLIA laboratory director policy that had excluded board-certified dermatologists from directing moderate- and high-complexity laboratories. Specifically, CMS will:

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

• Require high-complexity laboratory directors to have a total of 2, not 4, years of laboratory training or experience and laboratory experience directing or supervising high-complexity testing.

• Permit 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.

• Waive the requirement for an additional 20 CE credit hours. As such, any individual previously qualified as a clinical consultant will be able to continue to qualify without taking an additional 20 CE credits.

The Academy led multiple high-level meetings with CMS staff to raise concerns about the policy’s impact, emphasizing that the changes failed to recognize the full scope of board-certified dermatologists’ training and their longstanding involvement in clinical laboratory services.

Under the revised CLIA rule, which took effect on Dec. 28, 2024, only physicians certified in anatomic or clinical pathology were recognized as qualified to serve as lab directors based solely on board certification. This removed a longstanding pathway that acknowledged dermatology expertise in laboratory oversight.

CMS’s decision to pause enforcement and address these changes in future notice-and-comment rulemaking reflects the strength of AADA’s advocacy efforts and reinforces the importance of the long-standing recognition of board-certified dermatologists’ qualifications and clinical expertise in laboratory oversight. For questions, please contact regulatory@aad.org.