The Lab Director Rule CMS Never Made You Follow
CMS and the CDC proposed a 51-page CLIA rewrite this morning that undoes most of what the 2023 personnel rule did to laboratory directors. The qualification it unwinds has been law for 649 days, was enforced for 177 of them, and the relief that followed went to state surveyors rather than to the practices holding the certificate. For dermatology, where a fifth of all Certificate of Compliance labs sit, the median Mohs surgeon bills $215,230 a year through the certificate in question.
On June 23, 2025, CMS sent a memo to state survey agency directors telling them to stop enforcing a rule CMS had written.
The memo is QSO-25-21-CLIA. It runs three pages, it is addressed to the surveyors and not to the laboratories, and it quietly suspends a stack of personnel qualification requirements that had taken effect six months earlier.
This morning CMS and the CDC proposed to make that suspension permanent.
CMS-3478-P published at 91 FR 64480, 51 pages, RIN 0938-AV89, comments due December 7, 2026. The trade will lead on virtual access, which is fair, since letting pathologists read digital slides under the primary lab's certificate is the headline. The part that touches your certificate today is buried in section II.C.
What Broke on December 28, 2024
The 2023 CLIA final rule (88 FR 89976, published December 28, 2023) rewrote 42 CFR part 493, subpart M. Its personnel provisions took effect a year later to the day.
On that date, a board-certified dermatologist stopped qualifying as a high complexity laboratory director on residency training alone.
CMS describes the new bar in its own words: §493.1443 "now requires both 2 years of supervisory lab experience and 20 CE credit hours in laboratory director responsibilities," where "[u]nder the previous regulations, dermatologists qualified as high complexity laboratory directors based solely on their residency training."
So a Mohs surgeon who finished fellowship in 2024 and opened a practice with its own lab needed two years of documented supervisory experience they had no way to have accumulated.
CMS also records, without apparent discomfort, that the industry did not see it coming: several interested parties "later stated that they did not realize the impact the regulatory changes could have on their laboratories until after the rule went into effect."
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