The proposed rule giving patients (and their authorized representatives) direct access to their own laboratory test results? It was issued in the Sept. 14, 2011, Federal Register to modify regulations under two statutes that restrict such access: the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA). The aim is to further individualize medicine and empower patients to participate in medical care decisions (NIR 11, 17/Sept. 22, p. 1). Currently, the rulemaking is in the clearance process within the Centers for Medicare and Medicaid Services (CMS), with a tentative release date of late summer, an agency spokesperson told NIR. At present, CLIA allows disclosure of lab test results only to “authorized persons” unless state law decrees otherwise. A lab may release test results directly to the patient only if (1) the ordering provider expressly authorizes the lab to do so at the time the test is ordered or (2) state law expressly allows for it. The proposed rule would override release restrictions in 39 states and territories, encompassing some 22,671 labs that provide approximately 6.1 billion tests annually, CMS noted. It also would modify the HIPAA privacy rule to provide individuals the right to receive […]
The proposed rule giving patients (and their authorized representatives) direct access to their own laboratory test results?
It was issued in the Sept. 14, 2011, Federal Register to modify regulations under two statutes that restrict such access: the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA). The aim is to further individualize medicine and empower patients to participate in medical care decisions (NIR 11, 17/Sept. 22, p. 1).
Currently, the rulemaking is in the clearance process within the Centers for Medicare and Medicaid Services (CMS), with a tentative release date of late summer, an agency spokesperson told NIR.
At present, CLIA allows disclosure of lab test results only to “authorized persons” unless state law decrees otherwise. A lab may release test results directly to the patient only if (1) the ordering provider expressly authorizes the lab to do so at the time the test is ordered or (2) state law expressly allows for it.
The proposed rule would override release restrictions in 39 states and territories, encompassing some 22,671 labs that provide approximately 6.1 billion tests annually, CMS noted. It also would modify the HIPAA privacy rule to provide individuals the right to receive their test results directly from the lab by removing the exceptions for labs subject to CLIA.
Labs would have flexibility in how they choose to handle patients’ requests for their test report, but patients would have the right to request results in electronic or paper form. In instances where anonymous testing is performed, the lab is not required to furnish these patients with their test reports.
To help offset compliance costs, labs may charge a reasonable, cost-based fee. If the patient requests that the copy be mailed, the fee may include only the cost of copying (including supplies and labor) and postage. If the patient asks for a summary or explanation of the information, the fee may be charged for preparing it but may not include any costs associated with searching for and retrieving the information requested.
