CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports

The Department of Health and Human Services (HHS) has taken action to give patients or a person designated by the patient a means of direct access to the patient’s completed laboratory test reports. This final rule accomplishes the following: revises the CLIA regulations to allow laboratories to report results directly to patients; removes an exception from HIPAA regulations that prevented laboratories from reporting results directly to patients; and preempts all applicable state laws that restrict a patient’s access to their laboratory results. When the final rule becomes effective, all laboratories in all states and territories must report lab results to the patient if: the patient requests the results; and the laboratory can authenticate that the results belong to the requesting patient. The compliance date of these provisions is not until October 6, 2014. The biggest change most laboratories must make is to create, adopt, and implement policies and procedures concerning how the laboratory will accommodate patient requests for test results. The HIPAA Privacy Rule requires providers to respond to patient requests within 30 days and allows a laboratory to offset the costs by charging the patient a “reasonable, cost-based fee,” that represents the labor, supplies, and postage of fulfilling the patient’s request to access lab results. Most laboratories will need to amend their NPP to incorporate whatever policies and procedures they create to fulfill patient’s requests for test results.

Source: https://www.federalregister.gov/articles/2014/02/06/2014-02280/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports