CMS Proposes Direct Patient Access to Lab Results
On September 14, 2011, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rules to give patients (and the patient's representatives) direct access to the patient’s own clinical laboratory test result reports. Specifically, the rule would provide that, upon a patient’s request, the laboratory would be required to provide access to completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient. By amending the Privacy Rule, CMS would also preempt contrary state laws governing a patient’s direct access to lab result reports. Comments will be accepted through November 14, 2011, and CMS expects to publish a final rule responding to comments later this year.
