Putting a Test into Practice
There is no assurance, however, that once a test is developed, approved, and put on the market it will ever be adopted for use by physicians. A new test must gain acceptance by physicians, a process that can take years. A crucial element is publication of study findings and other reporting on the new test in the peer-reviewed medical literature. Over time, exposure to the test from these sources will increase their confidence and comfort with the new test.
Adoption rates are highest among physicians who keep up with the medical literature, according to Dr. Murray. “Doctors read about a new test in the literature, and ask if the laboratory can [do it] for them,” he said.
Because physicians regard the scientific literature as the gold standard for information about new tests and procedures, researchers seek to have their findings about a newly approved test published in one of the leading journals, as the test is ready for review or for commercial distribution.
But not all doctors are “early adopters.” Some are slower to change their practice patterns, noted Dr. Sue Evans, Vice President of Product Development for Caliper Technologies Corporation. And while publication is bound to generate interest, additional educational seminars provided by professional societies or the manufacturers are also very important. For these physicians, education and information is essential in their decision-making process whether to utilize the new test.
Manufacturers provide educational programs for doctors, third-party payers, and opinion leaders, according to Dr. Evans. However, also important is the role of professional associations in educating physicians, such as through holding conferences and seminars, distributing pamphlets, sending email updates, and other campaigns to bring a new test to their members’ attention. Also involved in promoting newly available tests are the laboratories themselves, who educate physicians through bulletins or newsletters.
Another factor that effects uptake by physicians is whether the new test will be reimbursed by insurers so that when it is ordered, the patient’s health insurance will pay the laboratory performing the test. Coverage determinations are made by insurers, such as private insurance companies as well Medicare and Medicaid, indicating whether and to what extent a particular test will be paid for by that company. Doctors may only order tests for which coverage decisions have been made, recognizing that most patients cannot afford to pay out-of-pocket for these tests. For more information on coverage issues, see the
sidebar.
If a test is to become a commonly used clinical tool, it will proceed from concept through development and safety and efficacy evaluations to FDA approval and favorable coverage decisions to acceptance and use by physicians. While the process has many steps and does take time, it ensures that the tests we as consumers rely on for accurate information about our health are effective and have earned the confidence of regulators and our health care providers.
