Federal Government Gives Patients a New “Right”: Access to Lab Results



14712500_SMany patients groups and their allies understandably cheered a new regulation that just came about as a result of many years of advocacy: Nationwide, patients now have a “right” to access their lab results directly. The “right” to receive test results directly from labs now ranks equally with the “right” to get our medical records.

Clinical labs had been treated differently than healthcare providers because they have their own federal law: the Clinical Laboratory Improvements Amendments of 1988 (CLIA), which delegates regulatory power to the U.S. Department of Health & Human Services (HHS).

Previously, CLIA regulations had allowed only “authorized persons,” as defined by state law, to receive test results. Thirteen states had excluded patients themselves from the definition of authorized persons. Patients have long expressed concern that giving physicians monopoly control over lab results risks their being lost in the busyness of physicians’ practices.

I certainly applaud the outcome. Nevertheless, I question whether the means fully justify the end. I have three major concerns, in increasing order of importance.

First, I am always wary of the federal government pre-empting state laws, which it has in this case. I know many libertarians subscribe to a theory of competitive federalism, in which the federal government can override state laws that are not in the interest of liberty. However, only thirteen states had laws preventing labs from disclosing results directly to patients. One writer celebrated that the new rule rendered those laws “obsolete.”

I lived in one of them – California – for many years. I always received a copy of my test results from LabCorp in the mail. I suppose I had requested it through my doctor’s office, and he approved it. If my doctor had not gone along, I had the right to switch doctors.

I also wonder why the advocates who succeeded in ensuring that patients in thirty-seven states had direct access to their lab results decided to focus their energies on the federal government instead of continuing to work on the holdouts. 160 groups lobbied HHS on the new regulation, of which most were in favor of the change. It is a worrying sign that too many people accept that the federal government has such power. If they had lobbied the thirteen remaining states until victory, the resulting policy would have been much more robust and deeply rooted.

Second, the regulation is a result of an effort in HHS to grant patients “new rights.” There are a number of Obama appointees in HHS who are passionate about patients’ access to their medical data. They even frame it as a civil-rights issue. However, perhaps because they are not well grounded in the founding principles of liberty, they frame the issue in a disturbing way.

I participated in a meeting at HHS last September, in which Dr. Farzad Mostashari, the National Coordinator for Health Information Technology, repeatedly announced that he and his colleagues had (gulp) “created” (not even “discovered” or “defined”) a “new right” for patients to access their data. The notion that government agencies “create” rights should obviously be anathema in our country’s regulatory regime.

Third, allowing patients direct access to test results shirks another big question: Which tests are available to patients at all? That question is answered by FDA, which does not appear to have the same commitment to patients that is emerging from HHS. Last year, the FDA ordered 23AndMe, a genetic-testing company, to stop making claims about the diagnostic value of its services. The company now markets its direct-to-consumer tests only as ways to determine ancestry.

So, the government has “created” a right for you to get your test results directly. But it denies you the right to choose which tests you want.

Well, I suppose it is a (very limited) step in the right direction.

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For the pivotal alternative to Obamacare, please see the Independent Institute’s widely acclaimed book: Priceless: Curing the Healthcare Crisis, by John C. Goodman.

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