Caveats Abound on Patient Access

The recent proposal from CMS to allow patients electronic access to test results via laboratories is another step in the inexorable march toward information transparency.  The agency is also trying to expand patient access rights to data disclosures (though the jury’s still out there) and has consistently chipped away at the long-standing tenet that medical data should stay in the hands of medical practitioners.

Patients should have full rights to the data generated and used to understand their health condition and develop treatments in response. But lifting the veil, while seemingly inevitable, is just as inevitably going to cause confusion and rachet up the tension between medical practitioners and those they serve.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) that a new proposed rule would amend currently limits  the disclosure of laboratory test results to three categories of individuals: the ‘‘authorized person,’’ the person responsible for using the test results in the treatment context, and, in the case of reference laboratories, the referring lab. “Authorized person” is defined in as the individual authorized under state law to order or receive test

results, or both. In states that do not provide for individual access to the individual’s test results, the individual must receive his or her results through the ordering provider.

 The proposed rule states that “While individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts (for example, individualized medicine and an individual’s active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.”

The issues with test results, as with any other data distribution, are context and interpretation. We’ve reported frequently on the development of personal health records, and a huge sticking point faced by patient-facing PHRs is providing meaningful information and context to those who don’t understand the languages spoken in health care. How many patients can interpret claims data and derive any insights from diagnosis codes and test results without plain English (or other languages, but that’s another point in an increasingly multi-linguistic society) explanations of what they mean. There’s value, and more value is being added as PHRs become more sophisticated, but without a medical editor, misinterpretation occurs pretty easily.

The dangers of misinterpretations are magnified in the arena of unfettered access to lab results. Providers are the current middleman in this data exchange, and they take pains to build context into results reporting, even if they’re doing it in an automated fashion.

While some patients with chronic conditions, who are undergoing regular testing, might understand the context of their results (or more to the point, understand they need a physician to put the info in proper context) the vast majority of patients getting test results via the originating lab are going to see information that might either unnecessarily frighten OR unnecessarily reassure them. 

Physicians on a daily basis have to talk patients through information they found via the Internet, some of it valuable but much of it patently false and/or medically unsound. Managing the conversation around test results is a pretty critical juncture for treatment and the physician/patient relationship.

I ask you, will it serve the greater clinical good to remove the middleman here? I fear that taking a living, thinking clinician out this loop is going to create all kinds of unintended consequences that won’t further the cause or practice of individualized medicine or patient “empowerment” and participation in their own health care.

So yes, unfettered access is a fundamental right for patients, many of whom have no consistent interaction with the medical community, or have interactions with multiple providers and need to ensure their information can follow them to different care settings. But conversely, it’s fundamentally dangerous to provide direct access to information that requires the expertise of a reputable caregiver to explain. Patient empowerment  shouldn’t be construed as a movement that will result in patients becoming medical experts. The move to make test results accessible should be seen for what it is, an excellent way for patients to get one more piece of data to fit into their health care “story,” a story which should be read to them by an expert.