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.
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