Commercial healthcare laboratories are seeking parity with other healthcare providers under privacy provisions of the Health Insurance Portability and Accountability Act of 1996.
Labs press for federal preemption on state data laws
They are asking for federal preemption of those portions of state laws that interfere with the ability of laboratories to exchange patient data in bulk. Without such a change they say the effort to move healthcare records into the electronic age will be hindered.
According to testimony at a hearing before a federal information technology advisory panel—the Health IT Policy Committee—laboratories want out from under certain data-exchange restrictions that they see as unfairly singling them out and impeding their large-scale data-sharing arrangements with other healthcare organizations. The restrictions are imposed by HIPAA, the federal Clinical Laboratory Improvement Act of 1988, or CLIA, and state privacy and medical and laboratory licensing laws.
Panelist Joy Pritts, a privacy lawyer and an assistant research professor at the Health Policy Institute at Georgetown University, explained that typically privacy issues involving electronic health information are governed at the federal level by HIPAA, which also gives patients a right of access to their own medical records—a right that was strengthened by the health IT privacy provisions of the American Recovery and Reinvestment Act of 2009. However, Pritts said, HIPAA includes a “carve out” for certain test orders and results from labs covered by CLIA, including thousands of hospital labs as well as thousands more commercial reference labs.
In contrast to HIPAA, many states take a far more paternalistic view regarding whether patients should have unfettered access to their own laboratory test results, Pritts said. Legislators in multiple states crafted their lab laws in such a way that physicians would be able to receive and interpret laboratory test results before their patients see them.
In general, CLIA says laboratory results should be protected, but it allows the release of patient test results in a couple of ways. One way permits a laboratory to release test results to the “individual responsible for using the test.” The phrase is undefined under federal law, Pritts said, but is “generally understood to include the person who ordered the test.”
CLIA also allows a laboratory to release patient test results to an “authorized person,” which is defined in the law as an “individual authorized under state law to order tests or receive tests, or both.” So, in effect, HIPAA hands off protection of lab data to CLIA, which defers in many cases to the states, according to Pritts.
According to Donald Horton, vice president, public policy and advocacy for Laboratory Corporation of America, the CLIA provision that end users of lab test results must authorize their release makes life for labs “far more difficult in the context of making millions of historical test results available for health information networks,” Horton said.
Those would include health plans, he said, that “need lab data for quality improvement, disease or case management, patient safety or pay-for-performance initiatives.”
Labs have tried to address the issue through contractual representations and warranties, he said, “but this ‘workaround’ is extremely inefficient and is not always effective.”
Horton said the lab industry’s trade group, the American Clinical Laboratory Association has developed proposed amendments of both the CLIA statute and regulations. These lab-desired regulatory changes would expand the list of “authorized persons” to whom labs can send test results. The expanded list would include “covered entities” and their “business associates” as defined under HIPAA.
“Our proposal would operate as a targeted pre-emption of state authorized person laws,” he said. “States would continue to be permitted to define ‘authorized person,’ so long as they do not exclude covered entities and business associates.”
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