By Ankita Rao, Kaiser Health News
The regulation was announced Monday by the Department of Health and Human Services. It amends privacy rules under the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that required patients to get their lab results from their physician, according to the announcement.
The final rule notes that some labs and physicians had raised concerns about the move when the administration issued a preliminary rule in June 2011. “Commenters expressed concern that patients might receive and act upon results that appear to be abnormal (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 said the rule helps ensure patients have full access to their health information and can be proactive in their choices for care. The rule also notes that studies have found “physician practices failed to inform patients of abnormal test results about seven percent of the time, resulting in a substantial number of patients not being informed by their providers of clinically significant tests results.”
Dr. Jon Cohen, senior vice president and chief medical officer at Quest Diagnostics, welcomed the change. “I think more physicians are comfortable with having their patients access this information – the conversations between patients and doctors will be more substantive,” he said.
He said Quest, the largest diagnostic laboratory system in the country, believes the rule will help reduce medical errors and duplicate tests, since patients will have quicker access to this part of their medical history.
Jessie Gruman, president of nonprofit patient advocacy organization Center for Advancing Health, said the rule eliminates only one small part of a larger barrier to patients receiving information they need to make better decisions about their health and treatment. She said there is a need for more transparency about drugs and medical device costs.
“It’s certainly welcome,” she said, “but this is not a big, heroic change in policy.”
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