CMS eases certain CLIA laboratory requirements during COVID-19 emergency

To meet the urgent need to expand laboratory capacity, the Centers for Medicare & Medicaid Services yesterday announced a relaxed enforcement policy under the Clinical Laboratory Improvement Amendments during the COVID-19 public health emergency with respect to review of pathology slides, proficiency testing, alternate collection devices, and requirements for a CLIA certificate. Among other flexibilities, CMS said the policy will enable:

• Pathologists to review pathology slides remotely if certain defined conditions are met;

• U.S. laboratories performing COVID-19 testing that apply for CLIA certification to begin testing as quickly as possible; and

• Laboratories within a hospital/university hospital campus to hold a single CLIA certificate for the laboratory sites within the same physical location or street address