Rule Gives Patients Access to Lab Reports

Patients no longer have to call their physicians to get the results of a lab test under a new federal rule that gives them direct access to the reports. 

The Department of Health and Human Services (HHS) action amends earlier federal requirements that patients access their lab tests through their physicians. Patients can continue to do so, but the new flexibility "gives patients a new option to obtain their test reports directly from the laboratory, while maintaining strong protections for patients' privacy," HHS announced in February. 

Under certain circumstances, individuals designated by or personally representing the patient also can see or obtain a copy of the patient's protected health information, including an electronic copy. 

The final regulation acknowledges concerns that a number of physicians and laboratories expressed during rulemaking about giving patients a way to receive laboratory test reports "without the benefit of provider interpretation and without contextual knowledge that may be necessary to properly read and understand the reports." 

For example, physicians and labs cautioned that patients might receive and act upon results that appear to be abnormal — such as showing false positives or false negatives — or results that are out of the normal range for the general population but may be normal for that particular patient due to his or her medical conditions.

But HHS Secretary Kathleen Sebelius said "information like lab results can empower patients to track their health progress, make decisions with their health care professionals, and adhere to important treatment plans." Supporters, such as consumer advocacy groups, agreed the change would give patients the chance to play a more active role in their health care and have more informed conversations with their health care professionals, resulting in better health outcomes.

HHS officials pointed to studies showing physician practices sometimes fail to inform patients of abnormal test results, "resulting in a substantial number of patients not being informed by their providers of clinically significant tests results." But those studies show that happens only about 7 percent of the time.

Action, March 14, 2014