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CMS Issues Final Rule on Patient Access to Laboratory Test Results

February 7, 2014—The Centers for Medicare and Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), and Department of Health and Human Services (HHS) Office of Civil Rights (OCR) Feb. 6 jointly published a final rule titled CLIA Program and HIPAA Privacy Rule; Patients’ Access to Test Reports.  Although HIPAA provides individuals with a right to access their protected health information including test reports, this rule provides a similar right to receive test reports directly from laboratories. The rule is effective April 7, 2014.

Under the final rule, laboratories subject to the Clinical Laboratory Improvements Amendments (CLIA) will now be able to provide access to completed test reports once they receive a request from a patient or a patient’s personal representative. The rule also removes the HIPAA exception related to laboratories that would otherwise be an impediment to this rule and incorporates the HIPAA 30-day timeframe for providing access to the results.

According to the three agencies, the 30-day delay “is generally sufficient time to allow a treating provider to receive a test report in advance of the patient’s receipt of the report and to communicate the result to and counsel the patient as necessary with regard to the result.”

If the test result is not available in 30 days, the lab may delay providing the results for no more than an additional 30 days. In that case, it must inform the individual in writing of the reason for the delay and the date by which there will be access to the results.


Ivy Baer, J.D., M.P.H.
Senior Director and Regulatory Counsel
Telephone: 202-828-0499


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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806