Proposed CLIA Rules Amendment Skirts Doctors

Gienna Shaw, September 13, 2011

A proposed rule drafted by three federal agencies would allow patients to receive their test results directly from labs—with no doctor playing middleman.

The Centers for Medicare & Medicaid Service, the Department of Health and Human Services' Office for Civil Rights, and the Centers for Disease Control and Prevention, would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and HIPAA privacy regulations and is part of a larger effort to strengthen patients' rights to access their own medical records.

The rule was announced Monday at a live HHS event—kicking off a week that's been designated by President Obama as "National Health Information Technology Week."

"Patients have a right to access and use their health information," Farzad Mostashari, MD, the national coordinator for health information technology, said at Monday's first-ever HHS Consumer Health IT Summit. "And we are here today to make it easy for them to exercise that right."

Under the proposed rule, labs would be authorized to release results to patients or their designated representatives upon request after authenticating that the results belong to the patient.

"When it comes to healthcare, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions, and receive better care," HHS Secretary Kathleen Sebelius said at the summit. "In the past you often had to wait days or weeks to get the results from your doctor… Under this rule you'll be able to get your results directly and act quickly if there is a cause for concern."

CLIA covers all phases of laboratory testing, including the reporting of test results. Under the current regulations, CLIA limits a laboratory's disclosure of test results to three categories of individuals: the "authorized person," the person responsible for using the test results in the treatment context, and, in the case of reference laboratories, the referring lab.

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