Do-it-themselves diagnosis: Patients pick their tests

Direct-access testing allows patients to choose and administer health tests that once required a physician's order. Is it the wave of the future?

By Stephanie Stapleton, amednews staff. May 5, 2003.

You walk down the hallway toward the exam room where your next patient waits. You grab the chart, give it the usual review, knock twice on the door and enter. But something is different. The patient inside has brought lab results from tests she ordered herself. The findings show that one value falls beyond the normal range. She's worried, and that's why she scheduled this appointment.

What do you do now?

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If some in the forecasting business are correct, that's a scene that primary care physicians will confront more and more often. These forecasters see momentum building for direct-access testing -- a service in which consumers pay out of pocket to have a variety of screening tests without ever having to speak to a physician. It's a development driven by state regulatory changes, market forces and the advent of empowered health care consumers.

And it is triggering debate within the medical community.

Proponents of direct-access testing say the service is an important part of personal wellness. It is designed not to supersede the doctor-patient relationship but to enhance it, making it possible for people to actively monitor chronic conditions or particular health concerns.

But some physicians worry that it may cause harm. Whose responsibility is it if a lab result is abnormal? Who is there to put the findings in the overall context of the patient's medical history? Who steers the follow-up decisions? Some doctors say it casts them to the sidelines.

Direct-access tests cost $40 to $175 and must be paid out of pocket.

"In the days of Marcus Welby, we wouldn't have seen this happen," said Clifford M. Teich, MD, an internist in Bloomingburg, N.Y.

Still, it is happening. And here's how. Depending on where the consumer lives, he or she may be able to pop by a local pharmacy or even log on to an Internet site to select from a list of simple tests -- cholesterol, diabetes screening, chemistry panels. Prices range from $40 to $175 or more and must be paid out of pocket. Consumers then submit to a blood draw, usually at a commercial lab. Within a day or two, they receive the results, sometimes online. Often, reference materials are provided to help the lay consumer understand what the numbers mean.

The fact that the process occurs outside the doctor-patient context is a sticking point.

The College of American Pathology, for instance, takes the position that patients are best served "when laboratory tests are ordered by qualified physicians and such a physician directs the course of a patient's diagnostic and therapeutic care; and a physician determines which clinical and anatomic laboratory services are appropriate." Still, the college also leaves room for its members to opt to provide these services based on "an assessment of the interest of the patient, potential legal exposure of the laboratory, applicable state law, medical staff bylaws and other relevant considerations."

The interest of major industry players such as New Jersey-based Quest Diagnostics, one of the nation's largest providers of laboratory and diagnostic services, makes direct-access tests a more likely option. Several years ago, the company tuned into the growing popularity of health fairs. "A light bulb went on," a company spokesman said. Quest now offers the QuesTest in seven states and plans to add more soon. Meanwhile, some hospital and community labs are also beginning to view DAT as a potential source of new revenue. Still, much depends on state law.

State restrictions

Direct consumer access to lab testing is allowed in some form in more than half of all states, though legal specifics vary widely. Some states take a restrictive approach. In New York, narrow legislation was enacted last year allowing clinical laboratories to perform at a consumer's request only those tests that are also approved by the Food and Drug Administration for sale to the public on an over-the-counter basis. California's law is similar, while regulations in states such as Ohio and Nevada are more open-ended. Eighteen states ban it outright.

Still, DAT already has demonstrated appeal among certain consumers. First are the worried well -- educated baby boomers who want to be involved in managing and monitoring their own health. There are also the privacy seekers. They don't want particular tests recorded in their medical record or avoid asking their family doctor for certain tests because of self-consciousness. Finally, there are the hassle avoiders. They want a specific piece of information, such as a PSA result, but don't want to deal with the rigmarole of making appointments, getting referrals or sitting in a doctor's office waiting room.

Direct consumer access to lab testing is allowed in some form in more than 50% of states.

Some doctors acknowledge that each of these mindsets might be a manifestation of patients' changing perceptions of how the health care system works.

"People used to have more real connection with their doctors," said Paul Bachner, MD, immediate past president of CAP and a professor of pathology and laboratory medicine at the University of Kentucky in Lexington. Now, in the managed care era, time and services sometimes seem limited, even withheld. "It undermines trust. But I don't think DAT is the right solution to that problem."

The difficulty, Dr. Bachner and others said, is that DAT ultimately could cause patients' health to be compromised. "By and large, appropriate medical care should be based on more than a lab result," he said. "It should be based on the context of the total patient."

With DAT, consumers are in control, not only by ordering tests but also by asking physicians for follow-up exams. This bothers Dr. Bachner. He has a problem with "random curiosity" driving decisions by health care consumers who are not patients.

"I spend half the day reviewing patients' lab results to say if it is good or bad. It took years to learn this stuff," agreed New York internist Dr. Teich.

Of course, some physicians point to the potential for good. "The glass is half-full rather than half-empty," said Bruce Friedman, MD, a professor of pathology at the University of Michigan Medical School in Ann Arbor. "It's an opportunity to monitor health, an early detection opportunity." Some people will discover things. Maybe they'll do a test on their own, get a funny number and be drawn back into the medical system.

Among physician concerns about DAT are false-negatives and false-positives.

Skeptics question that logic. "If that person is going to need to see a doctor for a treatment anyway, why not start there?" asked Richard G. Roberts, MD, a professor of family medicine at the University of Wisconsin, Madison.

Many see the potential downsides, mostly in the form of more anxiety, more costs, more doctor visits and more downstream follow-up. These scenarios play out because consumers are given raw data with only minimal explanation.

"DAT is an extreme example of a belief in knowing more is doing better," Dr. Roberts said. "In truth, the result of DAT may be that patients may actually not end up knowing more, and they may end up doing worse." Many people believe that a diagnosis is based solely on test results. "It's not black and white. It's shades of gray."

Then, of course, there are the concerns about the impact of false-negatives or false-positives.

The false-negatives could lead to a false sense of security. And because direct tests are done without a physician's direct involvement, there's no physician's suspicious eye comparing the result to patient symptoms or history to know if the question should be revisited.

False-positives trigger the opposite response. "We could end up chasing ghosts," said Gabriel Guardarramas, MD, MPH, a family physician in New York City.

Still evolving

The DAT concept is still in its early stages of evolution. In most cases, the service is costly because availability and competition are limited. Also, it is still somewhat of an experiment. One thing is for certain: The trend is being driven by a profit motive. "That doesn't necessarily mean it is bad for patients. How it is done can make it better or worse," Dr. Bachner said.

One need only read certain Internet advertisements to see reason for trepidation. One claims that "Blood tests make managing your personal health easier!" Another advises consumers, "Practice prevention. Think wellness. A simple blood test without a doctor's appointment could save your life."

More mainstream DAT pioneers, however, are positioning themselves as a part of the health care continuum, an adjunct to physician care, not a quick health fix. In some locations, for instance, Quest is partnering with pharmacies or supermarkets to sell lab test "smart cards."

The cards can be presented at a Quest lab where the work is actually done. Offerings include general wellness and well-known screening tests. Results can be obtained confidentially online and findings are characterized as an informational resource, not a substitute for medical advice. A network of physicians reviews results, and consumers are contacted immediately if a critical medical condition is detected.

Another example is Results Direct, a direct-access testing product created in a joint venture by the Spokane, Wash.-based Pathology Associates Medical Laboratories and the Sacred Heart Medical Center in Spokane. Launched in September 2002, Results Direct offers a range of basic blood and screening tests. HIV and STD tests are not among them because of the need for associated counseling. A medical director calls any patient whose lab numbers require urgent attention. Otherwise, a brief interpretation and a recommendation to contact a physician about a positive result comes with the printed report.

Consumer interest in Results Direct has exceeded expectations, said Lawrence Killingsworth, PhD, the chief science and technology officer at Sacred Heart and PAML. "It has not been a tidal wave, but the tide is definitely turning." Physician response has been interesting, too. In advance of the service's debut, PAML and Sacred Heart sent 2,000 letters to its existing physician clients explaining the addition of direct-access testing to its lab services. Though some doctors expressed worries about overutilization and related issues, many were quite supportive, even encouraging patients to take advantage of the direct testing option.

In general, though, the discussion of direct-access testing's pros and cons, harms and benefits, continues as more experience with it is gained.

Some industry watchers consider the concept to be on the fast track to becoming a regular part of the health care system. After all, they say, it's fueled not only by market demand but also by emerging information technology, which makes it easier for consumers to access the service and directly receive their results via the Internet. Physicians, too, are becoming more comfortable with such connections.

"Ultimately, the debate is going to be mute," Dr. Friedman said. He predicted that in three to five years, the service would be a health benefit offered in most health plans and results will be sent to primary care physicians for efficiency.

ADDITIONAL INFORMATION:

Direct targets

Who among your patients may be interested in direct-access testing? Market research indicates the following consumers are the most likely to seek the service:
The worried well: Affluent, well-educated baby boomers who are generally healthy and want to stay that way. They view direct-access testing as a way to be more empowered regarding their health care.
Privacy seekers: These consumers wish to avoid having certain tests and test results recorded in their medical record. They may also feel uncomfortable or self-conscious asking their primary care physician for certain tests.
Hassle avoiders: They seek specific information about their health, but do not want to take the time to access the health care system if no treatment is necessary.