On lab results, it's "Show me—first"

The CMS this week published what it described as a proposed rule that I'm calling the "Me First" Lab Rule.

Today, patients can obtain their laboratory test results from their healthcare providers under guarantees in the Heath Insurance Portability and Accountability Act of 1996. In a few more years, the CMS' own electronic health-record incentive programs should spur widespread provider adoption of interoperable EHRs, and that should speed up patient access to lab results considerably. By then, the torrent of an estimated 6.1 billion test results per year will pour automatically into those provider EHRs. From there, lab results should flow automatically to patients by way of personal health record systems "tethered" to providers' EHRs.

The CMS' proposed rule, however, reinterprets both the flow-controlling Clinical Laboratory Improvement Amendments of 1988 and the HIPAA privacy rule in a way that pre-empts many state lab-access laws and procedures. It changes who gets to see test results first, the physician or the patient.

Both CLIA and HIPAA now support a states'-rights approach to test results reporting. They look first to state law, and then, if none is applicable, to federal law. Thus, in 39 states and U.S. territories, lab test results must flow first to the ordering or using provider.

Only nine states have laws that permit a patient to receive test results directly from a lab. Seven states permit direct connections with the provider's permission.

It's a doc-centric system in most states, but one from which patients derive benefits. To give docs their due, sending lab results to them first supports the doc's role as the first interpreter of lab results' clinical meaning, the first counselor of bad news, and the first planner, with the patient, of a course of treatment. The CMS rule-writers didn't mention these important roles or analyze the potential impact the loss of the docs being first in line to receive lab values might have on patients.

Under the CMS' proposal, the flood of data still would flow to the ordering providers, but it also would create a second, simultaneous stream from the labs—most likely passing through some data-handling intermediary—to the patients, who may see their results before their physicians do.

Why change?

One reason rule-makers cite is that various "stakeholders" say the status quo imposes "barriers to the exchange of health information." (Coincidentally, when "stakeholders" stump for federal pre-emption of more-stringent state privacy laws, those laws are denounced as "barriers to information exchange" as if that's all that needs to be said, with no mention of the benefits the more-stringent privacy protections might provide.)

And who are these stakeholders? According to the rule-writers, they are policymakers, providers, EHR vendors, HIOs, and "large and medium-sized laboratories."

As luck would have it, a public relations firm working for lab giant Quest Diagnostics sent out a press release this week lauding the CMS' proposed rule and highlighting the ability to view and use lab data in Quest's new smartphone application.

Follow Joseph Conn on Twitter: @MHJConn.