Direct-access testing: Issues and opportunities

Dec. 1, 2008

DNA and allow you to identify genetically related family members whom you

Steve A. McClain, MD, Associate Professor of Dermatology,
State University of New York-Stony Brook; Founder, McClain Laboratories:
In some hospitals in the east, they are hitting people up for $2,000 or
$2,500 in tests as soon as babies are born. They want to DNA-type everyone.

Dr. Friedman: There is legislation pending in
Congress and at the state level to control some of this Web-based DNA
testing because it is such a lucrative market that there are a number of
charlatans in the business. Healthcare consumers often do not want their
genetic testing performed in hospitals because they do not want it to appear
in their medical records if they have some predisposition to a chronic
disease or cancer.

Davies: It seems that more and more physicians are
sending patients out to places to have blood drawn before they come in for
their appointments, and the doctor has the results in hand when the patient
comes in. Do doctors make enough money out of blood draws, or might they
consider it a relief to tell patients to get their own bloods? Then they do
not have to write a prescription — and it may relieve them of potential
liability for any test results.

Dr. Friedman: I have been asking this question for a
long time. Physicians these days are so besieged by various problems that
DAT testing is only a low-level concern. They do not get terribly exercised
about this because, as you said, it really does not hit them in the
pocketbook. It is not a large profit item for them.

Davies: As for the volume of testing going up so much
that it becomes a problem, I would guess that LabCorp thinks this is the
kind of problem that they would love to have. And companies in the
diagnostic area might see opportunity in the expanding number of tests that
are being done. It could be an opportunity for instrument providers to sell
more equipment into the marketplace.

Dr. Friedman: There are also walk-in clinics in
big-box stores like Wal-Mart, Walgreens, and CVS, and they are fulfilling an
important need. I predict that an important new initiative for these walk-in
clinics, particularly those in retail pharmacies, will be to provide some
basic lab testing, some of which will be point-of-care testing. The question
is who provides quality-control oversight for this testing?

Davies: I received an e-mail this morning from one of
the market-survey companies with the title “Retail clinics: the re-emerging
market for convenience and in-store healthcare.” These convenience clinics
represent a disruptive innovation in U.S. healthcare. Wal-Mart has announced
it is opening up 400 of these clinics inside its stores over the next few

Dr. Friedman: There is no question that consumers
love laboratory tests because they provide a quantitative measure of their
health status that they can assess with relative ease. Everyone knows their
cholesterol value. These walk-in clinics could be an exploding new market.
The companies will outsource maintenance, support, and quality oversight to
an outside party, and a nurse or technician will draw the blood and
essentially run the tests on a just-in-time basis in these clinics.

Davies: This is primarily an out-of-pocket type
business right now. Have the insurance companies weighed in as to their
thoughts on how this could impact what they do and how they cover?

Dr. Friedman: I do not think it is on their radar
screens. They generally are in favor of having consumers pay for services
out of pocket; I suspect that they are going to sit back and see how this
evolves. The clinics run on a very lean basis, so somehow they are going to
find some way to integrate low-cost testing into many of the visits. Lab
testing could also enhance walk-in traffic for the stores. The
retail-pharmacy chains are interested in expanding the scope of practice for
their pharmacists, so this is a perfect type of new business for Walgreens
and CVS. They can hire additional pharmacists to provide health and drug
counseling, and integrate such services with these walk-in clinics. Retail
pharmacies can be an important healthcare-delivery venue on a relatively
cost-effective basis.

Davies: What is the upside, and what is the downside
for laboratories and also for public health?

Dr. McClain: On the one side, we are talking about
lab testing in a fundamentally healthy population, so the risks are not so
complex. Many of your positives are probably going to even be false
positives in that scenario. The sicker the patients you bring in, the more
problems that come in with this kind of testing. As long as the physician is
somehow kept in the loop, it is probably going to work. But the physicians
and other administrators do not like surprises. They do not particularly
like hearing about a patient's abnormal “porcelain” from the patient. It
puts the physician in a somewhat defensive mode.

On the other hand, there is a movement to elevate the
status of pharmacists. Every year, that hits the political agenda. I do not
have any particular axe to grind; I do not care one way or another who does
the testing, as long as it is done logically. The way these clinics are
going to do best is if they are following a specific problem — diabetes,
Coumadin follow ups, and so on.

Dr. Friedman: I do not believe you can consider DAT
in isolation. It is a component of overall consumer-directed testing. The
vast majority of home testing consists of pregnancy tests and diabetics
monitoring their own blood-glucose levels. Right now, the majority of
consumer-driven testing would meet the test that Dr. McClain just discussed,
which is under a physician's supervision.

Dr. McClain: If we fragment patient care too much,
then it becomes difficult for the patient to do the right thing. This sounds
like a win-win for both patients and physicians.

Dr. Friedman: That is why I raised this issue of PHRs
before. The next big e-health phenomenon will be so-called patient portals
offered by physicians' offices, multispecialty clinics, and hospitals, that
will enable patients to set up appointments with their physicians, view test
results via the physicians' electronic medical record (EMR), ask questions
of nurses and physicians (e-visits), and request prescription refills.
Ultimately, this is going to happen; and you will have patient PHRs
tethered, in some cases, to hospital EMRs so that clinical information can
be exchanged among them. Then glucometer data will get captured by this PHR
and will be reviewable by the physician caring for the patients.

Dr. Cobb: This kind of testing is on a relatively
small scale now, and most people do not know much about it. But once these
changes happen, the dynamics of the whole system — the tests that are
ordered, and the physician's involvement — may change drastically. This is
great for patients who have chronic diseases and who do not know when
something is probably normal or when they should be concerned. Sometimes,
patients could theoretically get that lab test ordered even when away from
home, and the doctor could consult remotely. I can see that as one really
useful role for all of this, although it is probably just a tiny percentage
of how it is being utilized right now.

Dr. McClain: Many patients take better care of
themselves as a result of self-monitoring; but, inevitably, there is
potential for catastrophic error when the patient is put in the position of
being the decision maker. Patients can get into trouble with potassium,
Coumadin, and insulin — all medications in need of frequent self-monitoring.

Dr. Cobb: I do have patients who self medicate —
people with autoimmune diseases — and they will up their prednisone because
they think they are not feeling well. Many times patients come to see the
doctor to get labs ordered, and come back to get the results and have
treatment. For chronic patients, some of this could happen electronically,
and they would not have to come in so often. I do see some concerns though,
like patients not following up on abnormal results. Physicians are
accountable when patients do not always come back for their follow-up
appointment to get important information. You are still held responsible in
the eyes of a jury. You should have known better; you should have made every
effort to make sure this patient got the proper care and follow up. So,
there is going to be that potential.

Dr. McClain: We have focused almost exclusively on
clinical-lab tests, but tissue analysis, anatomic pathology, and
microscopic-lab applications should be considered as well. Direct-access
testing can mean walk-in melanoma screening to identify melanomas at an
early stage, far smaller than most pathologists are accustomed to seeing
presently. Just as clinical dermatologists are using improved tools for
clinical analysis, so must pathologists. The idea is that patients can walk
in and be scanned in a few minutes for cutaneous melanoma, mainly by
computer modeling of growth and involution over time. In other words, lesion
growth or regression is tracked; and the changing lesions, whether growing
or involuting, are ranked — given a score — and examined more carefully.
There is also a CPT code for billing. Patients with hundreds of nevi or a
family history of melanoma can be screened and followed more closely, with
the assurance the nevi are being tracked to the nearest 0.01 millimeter.
Relative to anatomic or microscopic pathology — if I may be permitted to
stretch my imagination a bit — digital-microscope workstations of the future
will be far better than the simple camera attached to a microscope presently
in use. Automating morphometry tools and point-by-point mapping of
pathologic lesions make the pathologists' work substantially more precise.

Davies: Having come from Canada, my final comment
is that this whole world is vastly different than the healthcare
experiences that I had up north. This is very interesting and gives me
an enormous amount to think about. I get asked routinely about the
difference in the healthcare between the United States and Canada, and
it is apparent that there are several differences, even at first blush.

Dr. Friedman: In Brazil, the system in place regarding lab
testing is that the physician writes an order for lab testing, gives it
to the patient, and the patient picks the lab of his choice. The test
results are given back to the patient, and the patient carries them back
to the physician for interpretation. As a result, the laboratories in
Brazil are much more service oriented and hospitable; they brew coffee,
they have soft music playing. They have to provide better service
because they are competing directly for the consumer business. Having
patients pick their clinical labs is not a radical model in other