Communication date: January 19, 2023
NOTE: The information below was current at the time of communication. Subsequent CAP changes, if applicable, are not reflected in this eAlert
The Centers for Medicare and Medicaid Services (CMS) has recently clarified its stance on the reporting of cytogenetic testing results when portions of the analysis or interpretation are performed by personnel at a home testing site with a different CLIA number. The laboratory issuing the final patient report may include the name of the main laboratory and a unique code to indicate the location in lieu of including the home address on the patient report. For example, the patient report with the interpretation could indicate that a portion of the analysis was performed at [Name of Main Laboratory] – Site #5, where “Site #5” is an internal code known by the main laboratory as corresponding to a specific home location.
This change does not impact testing performed under the temporary CMS policy, QSO-20-21-CLIA, issued on March 26, 2020, which allows pathologists and other laboratory professionals (eg, cytogeneticists, cytotechnologists, toxicologists) to remotely review and report patient results from a temporary location (eg, an individual’s home) during the COVID-19 health care emergency. Under this policy, the temporary location is not required to obtain a separate CLIA certificate provided the scope of work performed remotely falls under the primary laboratory’s CLIA certificate. The name and address of temporary testing locations included under a laboratory’s CLIA certificate do not need to be separately listed on the patient report. Please note that the CMS policy is subject to change once the health care emergency is resolved.
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