In October 2013, a final action amended the CLIA regulations. This CMS-CDC-OCR rule specifies that, upon a patient's request, the laboratory may provide access to completed test reports that, using the laboratory's authentication process, can be identified as belonging to that patient. The rule retains the existing provisions that provide for release of test reports to authorized persons and, if applicable, the individuals (or their personal representative) responsible for using the test reports. The rule also continues to retain the existing provision that provides release of test reports from reference laboratories to the laboratory that initially requested the test.
In addition, this rule also amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to provide individuals the right to receive their test reports directly from laboratories by removing the exceptions for CLIA-certified laboratories and CLIA-exempt laboratories from the provision that provides individuals with the right of access to their protected health information.
The final rule, will be officially published in the Federal Register February 6, 2014 and becomes effective April 7, 2014. Laboratories must comply with this HIPAA requirement by October 6, 2014.