An amendment to the Clinical Laboratory Improvement Amendments of 1988 regulations announced today by the U.S. Department of Health & Human Services boosts access to completed lab test results for patients and designated patient representatives.
The final rule, to be officially published in the Federal Register Feb. 6, also eliminates an exception under HIPAA that kept patients from accessing their own protected health information when it was held by a CLIA-certified or CLIA-exempt lab.
"These changes to the CLIA regulations and the HIPAA Privacy Rule provide individuals with a greater ability to access their health information, empowering them to take a more active role in managing their health and healthcare," the final rule reads. Under HIPAA, in most cases, according to the rule, labs will be required to enable individuals to access their lab test reports within 30 days of request.
Reference labs that are not subject to HIPAA, however, will not be under any obligation federally to grant access to such results, although the rule specifies that they "will be permitted to do so under federal law."
"We expect significant benefits to flow to patients as a result of increased access to their laboratory test results," the rule reads. "Commenters to this final rule describe these benefits as including increased patient participation in treatment programs, such as those that involve monitoring of chronic diseases, and the ability of patients to identify and treat health risks sooner and more effectively."
HHS estimates that such access will cost labs, at minimum, more than $932,000 in 2014, and nearly $56 million maximum. By 2017, HHS estimates that access will cost a minimum of more than $1 million for the year, and close to $61 million maximum. Such costs were estimated for 2013 at between $3 million and $63 million.
The cost estimates were based on "assumptions from internal discussions and consultations with two laboratories" that currently provide test results directly to patients.
The final rule was issued jointly by the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention and the Office for Civil Rights.
The rule originally was proposed in September 2011.
Research published last fall in the Journal of Participatory Medicine found that patients able to view their lab results online overwhelmingly reacted positively to being able to do so. After reviewing results on line, the most common actions taken by patients were discussion of results with family and friends, looking up information online or making a graph of results over time.