What does this mean? In a nutshell, patients in all 50 states are now guaranteed the right to access the results of tests conducted by freestanding labs. (The right to test results from labs within hospitals, other health care facilities and physician offices has already been in place under HIPAA, and a handful of states have already guaranteed direct patient access to freestanding lab test results.) The compliance date for the rule is eight months out, in early October, in order to give labs time to put necessary processes into place.
What exact changes were made to the regs? This was a surgical strike. The Clinical Laboratory Improvement Amendments (CLIA) regulations were revised to permit labs to provide results to patients, and the HIPAA regulations were revised to eliminate lab test results from the (very short) list of records not covered by HIPAA's patient access rule. Thus, if a patient asks, CLIA permits and HIPAA requires that a lab provide the results.
Is this significant? Yes, it is. This is a notable development because it was prompted not by legislation (the usual culprit when it comes to regulatory revisions) but by persistence on the part of patient advocacy groups and evolution in thinking within government. The final regulation has been a long time coming. It was originally published as a proposed rule more than two years ago. While it has been supported by many interested parties, including the Society for Participatory Medicine, there was significant opposition to the rule from organized medicine on the grounds that unmediated information could be misinterpreted by patients and could otherwise be problematic. The rule was held up in the final stage of review — at OMB, which reviews the projected cost burden of proposed regulations — for five months (that's at least 2-3 months longer than expected).
Under HIPAA, health care providers have up to 30 days to respond to patient requests for health care records, and freestanding labs will now join imaging centers, physician offices, hospitals, clinics and other providers in complying with this requirement. Labs, like other providers, may charge patients for the cost of providing records. Given the 30-day response period, there should be plenty of time for physicians to contact patients directly about potentially worrisome test results. Since most, if not all, of the data at issue here will be stored and transmitted electronically, it is possible — and perhaps even likely — that many test results will be transmitted to patients in less than 30 days.
Some of the health care organizations that already facilitate delivery of this sort of information do it automatically and electronically. That's the vision of the future for the engaged patient: frictionless sharing of information. Coming soon to a lab near you.