Direct Patient Access to Laboratory Test Reports: 10 Things a Lab Should Know About the Final Rule, in G2 Compliance Advisor

Mark Armstrong, a Member of the Firm in the Health Care and Life Science practice, in the Houston office, and Ali Lakhani, an Associate in the Health Care and Life Science practice, in the Washington, DC, office, co-wrote an article titled "Direct Patient Access to Laboratory Test Reports: 10 Things a Lab Should Know About the Final Rule."

Following is an excerpt:

On Feb. 6, 2014, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office for Civil Rights finalized the Patients' Access to Test Reports final rule (79 FR 7290). 

The rule amends provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to require clinical laboratories covered under CLIA to make available to patients, upon request, completed test reports. The rule also amends the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to grant individuals the right to access such reports directly from laboratories without the ordering provider's approval. The rule became effective on April 7, 2014; however, HIPAA-covered entities have until Oct. 6, 2014, to comply. These changes to the CLIA regulations and the HIPAA Privacy Rule provide individuals with a greater ability to access their health information and empower them to take a more active role in managing their health and health care. 

This article discusses key provisions of the rule and highlights 10 things a clinical laboratory should know.

The objective of the rule, which became effective on April 7, 2014, is to formalize an additional mechanism through which individuals may obtain test reports in order to reduce the instances of patients not being informed of test results. Hopefully, greater access to test reports will reduce the number of patients who fail to seek appropriate care and will further reduce unnecessary duplicate testing. To this end, the rule applies "broadly and uniformly" to all HIPAA-covered laboratories, including primary laboratories, reference laboratories, and hospital laboratories.