The lab test result data access rule is finally final.
See the HHS presser and the final rule, which is scheduled to be published today.
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.
David Harlow
The Harlow Group LLC
Health Care Law and Consulting
A version of this post first appeared on e-patients.net, the blog of the Society for Participatory Medicine. David Harlow chairs the Society's Public Policy Committee.