Do physicians’ offices need a CLIA certificate to provide home PT/INR monitoring services?
The home PT/INR monitoring coverage decision does not address CLIA certificates or other requirements that Medicare generally requires for laboratory tests. The physician does not need to obtain a CLIA certificate to provide services if the patient uses the equipment at home to perform the tests and reports the results to the physician (or IDTF). However, physician providers do need a CLIA certificate if they are performing prothrombin time tests in their office/facility.
