What’s happening: CMS has responded to the CAP’s request for clarification on remote cytology practices following recent federal policy updates, including requirements related to CLIA certification for laboratories.
What CMS said:
- CMS officials stated that remote Rapid Adequacy Assessments, also known as rapid on-site evaluation (ROSE), require a separate CLIA certificate for the off-site location where the pathologist performs the review, including virtual slide review.
- They noted that adequacy assessment does not count as a separate examination for workload limit purposes.
- For surgical pathology cell blocks, CMS indicated that remote review by a pathologist may be performed without a separate CLIA certificate if directed by the laboratory director.
The impact: Many laboratories rely on remote workflows to support patient access and timely diagnosis. CMS’s interpretation may affect how labs structure remote adequacy assessments and manage CLIA certification compliance.