Proposed rules that were published on September 14, 2011 in the Federal Register would allow individuals to receive lab test results directly from the lab.  If such rules are finalized, they will mark a significant change for patients, labs and providers in Tennessee. 

Currently, in states such as Tennessee that do not allow for individual access to test results, the patient generally must receive his or her lab test results through the ordering physician.  The proposed rules would preempt state law and allow patients to bypass the ordering physician and to receive their test results directly from the lab. 

Under current federal regulations, the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) limit a lab’s disclosure of test results to three categories of individuals: (1) the person authorized under state law to order or receive test results; (2) the health care provider responsible for using the test results for treatment; and (3) in the case of reference labs, the referring laboratory.  

Under the current federal HIPAA privacy rules, individuals generally have a right to obtain a copy their protected health information from covered entities.  The current HIPAA privacy rules, however, carve out exceptions for CLIA labs and CLIA-exempt labs.  Tennessee state law specifies that lab test results may only be reported directly to the health care professional who requested the test, to the person responsible for using the test, or to the lab initially requesting the test.  Unlike many other states, Tennessee does not allow direct patient access to lab test results. 

The proposed rules explain that although individuals can obtain test results through the ordering provider, it is believed that “the advent of certain health reform concepts” would be best served by increasing patients’ direct access rights.  In order to accomplish this change, the Secretary of HHS and the CMS Administrator are proposing to amend HIPAA by deleting the CLIA and CLIA-exempt lab exceptions from the HIPAA privacy rule’s individual right of access provision and by adding a new subsection to CLIA providing that upon a patient’s request, a lab may provide an individual with access to his or her completed test reports. 

By making direct disclosure of the test results permissible under CLIA and by eliminating the CLIA and CLIA-exempt lab exceptions from HIPAA, if the rules are finalized, then all CLIA and CLIA-exempt labs that are subject to HIPAA would be required to disclose an individual’s completed test results directly to such individual upon request.  Labs may charge a reasonable, cost-based fee to provide individuals with copies of test reports under the proposed rules.  The fee may include copying costs and postage, but may not include costs associated with searching for and retrieving the information. 

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