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Statement of Need: The current CLIA regulations and related laws of the states and territories pose potential barriers to the laboratory exchange of test reports directly with the patient. This rule implements changes that support of the Secretary's efforts of achieving patient-centered and health IT-enabled health care and allow patients direct access to their test reports from a laboratory

Summary of the Legal Basis: The final rule removes the exceptions to an individual's right of access related to CLIA and CLIA-exempt laboratories. HIPAA-covered laboratories will be required to provide an individual (or the individual's personal representative) with access, upon request, to the individual's completed test reports (and other information maintained in a designated record set) in accordance with the provisions of section 164.524 of the Privacy regulations.

Alternatives: Several alternatives were considered before selecting the approach in this final rule to provide access to laboratory test reports upon a patient's request. One alternative would have been to leave the regulations as written without making any changes. However, this option would leave in place the restrictions on patients' direct access to their laboratory test results and would therefore impede the goal of promoting patient-centered health care. Another alternative would have been to revise the definition of "authorized person" under CLIA to specifically include a patient as an authorized person. This alternative was not considered feasible because the definition of "authorized person" in the CLIA regulations also permits individuals to order tests, and it defers to state law for authorization. A last alternative considered would have been to require the laboratory to automatically provide each test report directly to each patient rather than the permissive approach to provide patients access to their reports upon request. However, this alternative would have had the potential of significantly increasing the cost for laboratories since 100 percent of the 350 million to 703 million test reports issued annually would need to be provided to the patients.

Anticipated Costs and Benefits: We estimate that this rule will not have an economically significant impact on laboratories. It will facilitate the ability of patients to compare test results over time and to share this information with future physicians or multiple physicians. This improved information sharing is likely to improve health care, especially for patients and providers who do not have access to electronic health records in the near term.

Risks: None. This rule will allow laboratories to use existing processes for patient access or develop new procedures that are appropriate for their facility. It expands an individual's right of access to include receiving test reports directly from laboratories. This rule does not alter the role of the ordering or treating provider in reporting and explaining test results to patients.