November 2002
Karen Southwick

New York has become the latest state to give consumers direct access to certain laboratory tests without a physician’s order. Gov. George Pataki signed the legislation into law in September.

The New York law specifies that clinical laboratories "may perform" services upon the request of the consumer and provide a report directly to that person without a physician’s intervention. Allowable tests are limited to those approved by the Food and Drug Administration for sale to the public on a direct or over-the-counter basis without a prescription.

New York thus joins California and many other states in allowing laboratories to perform directly for consumers certain over-the-counter tests ranging from glucose, cholesterol, and glycosylated hemoglobin to urine, stool, and semen analyses. California’s law encompasses a similar range of OTC tests.

The New York statute prohibits the laboratory, which must be a licensed facility, from reporting results to anyone except the consumer. The law specifies that the laboratory should "identify results indicating the need for referral to a physician or other qualified health care practitioner," but following up on that referral is left up to the consumer, who pays for the test.

Mandatory reporting of test results to physicians was not included in the legislation, which was largely backed by the New York State Clinical Laboratory Association. Medical groups objected to that reporting, says Thomas Rafalsky, a health care lawyer who is president of the association, because physicians feared becoming responsible for patients they did not know and might not be able to contact.

"We have made it very clear to the physician community that we’re not trying to replace them in ordering necessary tests," Rafalsky says. "These are just tests approved as OTC. We’re making no effort to do any other tests."

Rafalsky believes the new law can benefit both consumers and laboratories. "Lab tests will be more accurate than consumers doing it at home, and this allows labs to take advantage of another revenue stream," he says. "Labs will compete for that business."

Pathologists’ reactions to the law are mixed. Some express reservations, while others say anything that encourages consumers to be more responsible for their own health is good. The CAP’s official policy holds that patients are best served when laboratory tests are ordered by a qualified physician. The College also leaves it up to individual pathologists and groups, however, to decide whether to offer direct access to testing. The CAP and the New York State Society of Pathologists took no position on the bill.

"There will be problems with this," predicts Vernon A. Pilon, MD, president of the New York State Society of Pathologists and director of pathology at Albany Memorial Hospital. He says the question of liability arises when false-positives or false-negatives are reported and patients act on that information.

"Somebody’s going to sue somebody based on these reports," he says. "People will either think they have something or don’t know they have something."

Because the law stipulates complete privacy, participating laboratories will have to have separate categories within their lab information system for physician-ordered and patient-ordered tests, Dr. Pilon says. "I see a lot of potential pitfalls for the lab. Our system of health care is based on people having a primary physician who coordinates care."

On the other hand, he acknowledges, "the cat’s already out of the bag" as far as OTC and now direct access testing. His hospital administration "will meet to determine whether our lab wants to offer direct access testing. If we do decide to enter this market, I would be in favor of integrating direct access testing with the hospital wellness program," Dr. Pilon says. "I am glad the law says ’may.’"

James Terzian, MD, vice president of New York’s pathology society, takes a different view. "I felt once that labs should not get between the patient and physician," he says. "Today I’m more in favor of letting patients be empowered and have some choices. When you go to the grocery store or the auto dealer, they give you what you want. They don’t tell you that you need someone else’s recommendation."

Dr. Terzian, president of Twin Tier Pathology Associates and medical director of pathology and laboratory medicine at Lourdes Hospital in Binghamton, NY, says consumers "are smart enough not to abuse the privilege" of having direct access to lab testing. "We as physicians shouldn’t be so egocentric as to think we have all the answers."

Besides, he adds, anything that lets people take more interest in their own health care should be encouraged. "The patient should be counseled about the possibility of false-positives and -negatives in a disclaimer," Dr. Terzian says. "We should be available to help them interpret the test upon request."

He agrees with Dr. Pilon that the law does raise the "liability specter" for laboratories. "We haven’t really discussed this at our lab. I myself would be in favor of offering these tests," he says. "Home testing will happen more and more, and potentially there’s a benefit to offering these tests. There’s also some downside, but that’s part of life."

Quite a bit of downside, says Anne Saldanha, MD, director of labs at Kenmore-Mercy Hospital in western New York and CAP state legislative coordinator.

Relying on a laboratory test without further context could cause consumers to make mistaken health decisions, she notes. For example, after a negative pregnancy test, a woman "might go out drinking or engage in risky behavior and there’s a miscarriage." But if a physician had been consulted, the patient’s medical history and other factors would have been taken into account. "It’s better health care when there’s a physician involved," Dr. Saldanha says.

All the extra tests will raise health care costs, she continues. The primary care physician "is supposed to be a gatekeeper," helping curb unnecessary tests. By offering direct access to tests, labs provide poorer quality service at a possibly higher price. Consumers, lulled into a false sense of security by the laboratory results, might not bother to get the care they need, Dr. Saldanha says. "The test result has to be interpreted in light of everything else known about the patient," she adds. "We’ve never done this in a vacuum."

The issue has surfaced in Texas as well. Direct access testing "is not prohibited here, but there’s nothing in the law addressing it, either," says David Henkes, MD, director of pathology and laboratory medicine at Christus Santa Rosa Health Care in San Antonio.

Recently, he says, he has noticed small laboratories springing up in grocery stores and pharmacies offering direct access to tests. The Texas Medical Association, of which he is a member, is investigating the extent of the practice and plans to develop a policy for future legislation. "If it’s already an OTC test, that might be acceptable," Dr. Henkes says. "But consumers have no idea who did the test and how reliable it is."

The American Clinical Laboratory Association estimates that more than half the states permit direct access. "It’s hard to argue against consumer advocacy," says president David Sundwall, MD. "It’s silly today to say that people can’t take responsibility for their health."

That said, he notes, it’s important for patients and physicians to be "partners in health care," and he hopes that laws such as New York’s will emphasize the need to "share information with qualified clinicians."

Paul Bachner, MD, professor and chairman of pathology and laboratory medicine at the University of Kentucky Chandler Medical Center in Lexington and immediate past president of the CAP, says he’s on the fence about direct access testing. "It’s an uncomfortable topic," he says. "It’s not the worst thing taking place in health care, but I am not personally in favor of it, either."

On one hand, by arguing against it, "one could be accused of medical paternalism," Dr. Bachner says. But, he adds, "patients are better served by quality health care, not isolated lab tests. You need the clinical context and history to determine the likelihood of illness."

So far, there’s a lot of opinion and virtually no evidence, Dr. Bachner says. "As far as we know, it’s unclear whether people are brought into the system by direct access or suffer unintended ill effects."

Karen Southwick is a writer in San Francisco.