Medical-necessity determinations begin in the lab
Medical Laboratory Observer, Jan, 2005 by Barbara Harty-Golder

Q What role should the laboratory play in the determination of medical
necessity?

A Because all test orders eventually pass through it, the laboratory is in a
unique position to contribute to the discussion of medical necessity, both
from a test-volume standpoint and from the scientific aspects of test design
and applicability. Because the determination of medical necessity also
relies on medical history and clinical follow-up, however, laboratory data
must be integrated in some meaningful way with information from physicians
and from allied healthcare personnel if it is to be practical. Thus, any
discussion of "medical necessity" must begin with a formal definition, in
the clinical setting, of just what the term means. The definition will often
include not only the utility of a specific test in a particular clinical
setting, but also how often it should be used and when follow-up is needed.

The laboratory can provide a starting point for medical-necessity
determinations by providing the medical staff with an analysis of the
ordering patterns of physicians and of overall test volumes. Increases in
test volumes for a particular test, for example, may indicate an increased
staff awareness of new and useful testing procedures, may be purely
defensive medicine, or may be the result of a misunderstanding of the
utility of the test in question. The laboratory can start the discussion by
bringing to the attention of the appropriate medical staff committee a
change in ordering patterns or a discrepancy among physicians in the way
tests are being used.

Once the discussion is initiated, the laboratory can provide valuable
assistance to the medical staff members by educating them about the limits
and utility of the tests under consideration so that a reasonable analysis
of necessity and propriety of ordering patterns can be made. The presence of
a well-informed pathologist or technologist at the table when discussions of
tests are underway can facilitate the process by eliciting questions,
uncovering problems, and providing answers.

Once a determination of a general standard of medical necessity has been
made, the laboratory is in the best position to monitor compliance with that
standard on an individual-patient or ordering-physician basis. Such
monitoring should only be performed under the direction of the medical staff
itself and should be conducted with the intent of education rather than
punishment. The laboratory should never be put in the position of
"policeman" regulating the ordering patterns of physicians, but rather that
of colleague assisting physicians in the best and most efficient management
of patient care.

Remember that even well-implemented programs can take time to produce
results, because they invariably involve refining practice patterns that
have been established over many years. One laboratory struggled with daily
ordering of international normalized ratios (INRs) on patients whose
anticoagulant had been so recently re-adjusted that no change in INR could
reasonably be expected, leading to a cycle of multiple adjustments of
medication on the heels of too many tests. In this situation, the pharmacy
actually identified the problem, the lab collected the data, and the two
jointly presented information to the medical staff regarding optimum timing
of INR testing and dose adjustment. After several months of discussion with
the medical staff and several different presentations, an "anticoagulant
team" eventually was established to assist physicians. Dosage adjustments
decreased, patients had fewer venipunctures, and INR management improved
dramatically with fewer patients over- and under-coagulated: a near-perfect
example of how the laboratory can coordinate with its other partners in
healt hcare to improve patient care under the banner of "medical necessity."

By Barbara Harty-Golder, MD, JD

Barbara Harty-Golder is a pathologist-attorney consultant in Chattanooga,
TN. She maintains a law practice with a special interest in medical law. She
writes and lectures extensively on healthcare law, risk management, and
human resource management.

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MLO's "Liability and the Lab" is intended to provide risk management and
human resource management education; it is not intended to provide specific
legal advice. If you require legal advice, the services of an attorney
should be sought. Dr. Harty-Golder welcomes your questions, which can be
sent to her at toadehall@....


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