CMS Clarifies Waived Occult Blood Testing

Only non-automated fecal occult blood (FOB) testing devices will remain on the Centers For Disease Control (CDC) waived tests list, and the hemoglobin by copper sulfate method will be removed depending on comments CMS receives from stakeholders on a proposed rule in the Nov. 7 Federal Register. CMS believes that the hemoglobin by the copper sulfate method is no longer being used in clinical labs and if that belief is confirmed by stakeholders, it will be removed from the waived test list. Hospitals that own provider based testing sites such as physician offices or STAT labs operating under a CLIA certificate of waiver (COW) should check any FOB testing to ensure compliance with this change. Any COW laboratory that is performing copper sulfate hemoglobin testing should comment on the rule or find an alternative testing method. The proposed rule does not specify an effective date. Comments are due by Jan. 6, 2015.