Rule would remove barrier between lab, patient
All patients may someday be able to receive copies of their lab test results directly from labs rather than from being forced to receive the results only from their physicians or other providers who ordered the tests.
The CMS proposed a rule last week that would amend the patient privacy provisions of the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and the Health Insurance Portability and Accountability Act of 1996.
The rule also would create a new fork in the growing electronic stream of what’s been estimated by the CMS at 6.1 billion lab test results a year, although rule makers also estimate as few as one in 2,000 patients will eventually want to receive their test results directly from labs.
The CMS said the change would address provisions in state and federal laws while paving the way for individualized medicine and “an individual’s active involvement in his or her own healthcare.”
The complaining stakeholders include large and medium-sized laboratories, some public health laboratories, electronic health-record system vendors, health policy experts, health information exchange organizations and healthcare providers “who believe that the individual’s access to his or her own records is impeded, preventing patients from a more active role in their personal healthcare decisions,” the CMS said in the rule.
Under current regulations, CLIA limits a laboratory’s disclosure of test results to: the socalled “authorized person,” the person responsible for using the test results for treatment and referring labs. CLIA defines an authorized person as “the individual authorized under state law to order or receive test results, or both.”
The HIPAA privacy rule generally grants patients a right of access to their medical records, but it carves out an exception to honor a state’s right to restrict lab results reporting. The proposed rule would eliminate that. The test results would continue to flow to the ordering clinician under the proposal, but a patient might see test results first, before the doctor.
Laws in 13 states restrict the direct flow of lab results only to providers. Seven states permit direct connections with patients, but only with their provider’s approval, and 23 states and three territories default to the current CLIA and HIPAA restrictions, which, in effect, ban direct patient connections. Just seven states, plus Puerto Rico and the District of Columbia, have laws that permit a patient to receive test results directly from a lab. Thus the proposed rule would federally preempt state laws and de facto disclosure limits in 46 states and territories.
The Federation of American Hospitals declined to comment on the rule. The American Hospital Association was unable to respond to a request for comment by deadline.