Lab Results on Demand: CLIA/HIPAA Amendment Increases Patient Access

A new final rule (the “Final Rule”) from the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights (collectively, the “Agencies”) gives patients and their personal representatives the right to request and be granted access to test results directly from laboratory companies. The change comes by way of the Agencies’ amendment of the regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and amendment of the regulations implementing the Health Insurance and Portability Act (“HIPAA”). Laboratories subject to CLIA can now give patients and their personal representatives copies of completed test reports. The FInal Rule also does away with the exception under HIPAA that insulated CLIA-certified laboratories and CLIA-exempted laboratories from provisions of HIPAA that provide individuals with the right of access to their protected health information. This marks a shift from past practice where results would go to the doctor, who would then pass them on to the patient or the patient’s personal representative (defined generally as a person authorized to act on behalf of the patient in making health care decisions). The Final Rule allows laboratories to give direct access to test results under CLIA and does away with the exception under HIPAA.

What does this mean for patients and their personal representatives? According to the Agencies, the Final Rule provides “individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and health care.” Secretary of the Department of Health and Human Services (“HHS”) Kathleen Sebelius stated, “[i]nformation like lab results can empower patients to track their health progress, make decisions with their health care professionals, and adhere to important treatment plans.” According to an HHS press release, once a patient or a personal representative makes a request for laboratory results, copies of the results must be given to the patient or representative within 30 days. Additionally, “the patient or the personal representative may have to put their request in writing and pay for the cost of copying, mailing, or electronic media on which the information is provided, such as a CD or flash drive.” 

During the comment period preceding publication of the Final Rule, many commenters voiced concerns that providing unfettered access to laboratory results to patients and their personal representatives would lead to confusion. Without the aid of explanation from their health care providers, patients and their personal representatives might be provided with results that they would misinterpret or not be able to interpret at all. The Agencies responded that the Final Rule “will further encourage ordering and treating providers to more proactively discuss with patients the range of possible test results and what the results may mean for the particular patient before or at the time the test is ordered.” The Agencies have also indicated that 30 day period in which to provide the results to patients or their representatives will be sufficient for the “ordering or treating provider to receive the test report in advance of the patient’s receipt of the report, and to communicate the result to the patient, and counsel the patient as necessary with regard to the result.”

The Final Rule follows the trend of ensuring more patient access to records and participation in the management of the patient’s own health care—a trend that has largely been facilitated by the rise of electronic health records and new health care technologies.

The Health Law Gurus™ will continue to follow issues regarding individuals’ rights to access their medical records and participate in their own health care decisions.

We encourage you to share your experiences and thoughts about patient access to medical records with us and our readers in the comments section below.

To view the HHS Press Release, click here.

To view the Final Rules, click here.