Whose Blood Is It Anyway
Many patients’ group 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. Many free-marketers 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 which 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 only markets its direct-to-consumer tests 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.
“The notion that government agencies “create” rights should obviously be anathema in our country’s regulatory regime.”
Eek, indeed!
“Nationwide, patients now have a “right” to access their lab results directly.”
Well color me uninformed, but I had no idea that 13 states kept people from seeing their lab results directly. It seems like an unnecessary measure, and patients should have the right to see their own results as soon as possible.
“…the government has “created” a right for you to get your test results directly.”
Because we aren’t granted rights? We are only given rights created by the government? I think defined may be a little more appropriate.
“The notion that government agencies “create” rights should obviously be anathema in our country’s regulatory regime.”
I think John said it best!
“Patients have long expressed concern that giving physicians monopoly control over lab results risks their being lost in the busyness of physicians’ practices.”
This is a valid argument, as it is more important for patients to have their own medical information, than to get lost or hear misinformation from their doctor.
Yes, but there are still restrictions. Until you are not denied the right to choose your type of test, then patients will be free with their “created rights.”
“I always received a copy of my test results from LabCorp in the mail.”
It sounds as if you were one of the lucky ones.
Why is it a step in the right direction? There are things that should only be disclosed with a physician. There are some test results that might seem disturbing to a common individual but normal or not worrying to a doctor. And there is the flip side, a more dangerous scenario, in which a common individual think the test results are positive and normal, while the doctor might believe it to be a concerning matter. What is the goal of giving a patient their test results if they don’t have the expertise to read them? You said it; the HHS “created” a new right, but is it beneficial?
Think also about the privacy issues. Doctors have to pledge patient doctor confidentiality, they are held liable if they misplace a pertinent document about a patient, including test results. If physicians are held at this high standard, why distribute test results to patients? They are not going to safeguard them as they are in a doctor’s office, they probably read it (not understand it), store it in a drawer (where they will never be seen again) or throw them out. If you are not a doctor, having their test results or no will not any difference. If the patient has the test results, there is no case for the confidentiality agreement.
So, government is now granting rights. And about your medical care. Mmmmm? Once all your information is government record, all the doctors are employees or otherwise beholden to government, will government rescind that right when it becomes a nuisance that those pesky citizens are calling for explanations of results?
Let there be more “freedom” in the system. As John said, if you and your doc don’t see eye to eye on things get another doc! Of course that would mean a “free market” system. That is not American!!!
There is a reason why they lobbied the federal government instead than the states senates. The lobbyist knew that those thirteen states would be reluctant to change their laws. It would be harder to convince them because every state has its own interest; they have different systems and different ideologies. So, for the lobbyist it was much easier to lobby a government that has been prone to “sell” its postures to the highest bidder, than others that might be reluctant to do so.