On September 12, the Centers for Medicare and Medicaid Services (CMS) proposed amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule regulations to permit laboratory results to be sent directly to the patient and/or their personal representative at the patient’s request. Prior to implementation of the proposed changes, laboratory test results in states that did not provide for an individual’s access to his or her own laboratory test results could only be sent to an "authorized person" (generally the treating physician, but defined as the individual authorized under state law to order or receive test results), the person responsible for using the test results for treatment and, in the case of reference laboratories, the referring lab. Patients in these states generally were required to receive laboratory results through the ordering provider.
The proposed HIPAA changes generally would preempt state laws that prohibit HIPAA-covered laboratories from providing laboratory test results directly to patients.
If the proposals are finalized, many of the affected laboratories will be required to develop procedures to provide direct patient access to test reports for approximately 6.1 billion tests annually.