The 101-page final regulation amends the Clinical Laboratory Improvement Act, which regulates 239,000 healthcare testing labs.
Some patient advocates and healthcare organizations, particularly laboratories and health-record system vendors, have long seen the laboratory regulations, known as CLIA, as unnecessarily preventing patients from playing a more active role in healthcare decisions.
Those concerns, advances in personalized medicine and patient involvement, and the federal efforts to promote the use of electronic health records “call for revisiting barriers or challenges to individuals' gaining access to their health information,” federal officials note in the new rule.
Before the revisions, CLIA stipulated that labs could release test results to three types of individuals: the person authorized under state law to order or receive results, typically a physician; the person responsible for using the test results for treatment; and a referring lab that requested the test.
The new policy also eliminates an exemption for CLIA-covered labs to HIPAA, which generally requires healthcare providers to give patients a copy of their medical records on request.
Under the new rule, labs will be required to provide patients copies of their lab test results within 30 days of a request. HIPAA-covered labs will have 180 days from the effective date of the rule to comply.
“The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule,” HHS Secretary Kathleen Sebelius said in a news release. “Information like lab results can empower patients to track their health progress, make decisions with their healthcare professionals, and adhere to important treatment plans.”
Lab services giant Quest Diagnostics promptly praised the change.
"HHS' final rule means millions of Americans who previously could not access their laboratory and other healthcare data from clinical laboratory companies like Quest can now do so without first requiring the approval of their healthcare provider,” said Dr. Jon Cohen, its senior vice president and chief medical officer. Quest also sells an electronic health-record system that accesses lab results.
According to the rule, compliance will cost labs an aggregate of $59 million a year for the first five years to comply, money they can make offset with “a reasonable, cost-based fee” they can charge patients for copies of their lab results.
The regulation modifies a draft rule issued in 2011. It was a joint effort of the CMS, the Centers for Disease Control and Prevention, the Office for Civil Rights and the Office of the National Coordinator for Health Information Technology. The final rule is effective 60 days after publication in the Federal Register, which is expected Thursday.
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