Proposed Rule Applies to Labs under CLIA Regulation Patients Would Get Direct Access to Lab Test Results

Proposed Rule Applies to Labs under CLIA Regulation

 

Patients Would Get Direct Access to Lab Test Results

 

CMS this month proposed a rule change to give patients of labs operating under CLIA regulations (as well as their authorized patient representatives) direct access to their test result reports.

 

At the present time, laboratory test patients in many states do not have direct access to their results because of a CLIA rule permitting direct release of test results only if (1) the ordering provider expressly authorizes the laboratory to do so at the time the test is ordered, or (2) state law expressly allows for it. 

 

Even though the HIPPA Privacy Rule generally permits direct release of health information to a patient or authorized representative, it defers to the CLIA regulation limitations.  There are 26 states without laws authorizing direct disclosure of test results to patients and 13 states that expressly prohibit it. Patients of CLIA regulated labs in these states cannot obtain their lab results directly.

 

The proposed rule would amend CLIA regulations to allow labs to give patients their test result reports on request.  

 

The proposed rule would eliminate the Privacy Rule exception for an individual’s access to laboratory test result reports.   The amended Privacy Rule would preempt contrary state laws governing a patient’s direct access to lab result reports.

 

CMS reimburses laboratory service providers under Medicare and other federal healthcare programs, CDC is responsible for lab regulation under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and OCR is responsible for administering the Privacy Rule that under the Health Insurance Portability and Accountability Act of 1986 (HIPAA).