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Putting New Laboratory Tests into Practice

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Gaining Acceptance from Health Care Providers

Putting Laboratory Tests into Practice: Part I II III IV V

There is no assurance that once a test is developed, approved, and available for use it will ever be adopted for use by doctors. A new test must gain acceptance by doctors, a process that can take years. A crucial element in this process is publication of study findings and other reporting on the new test in the peer-reviewed medical literature. Over time, exposure to the test and data supporting its clinical usefulness from these sources will increase doctors' confidence and comfort with the new test and the interpretation of test results.

Adoption rates are highest among doctors who keep up with the medical literature. These doctors may read about a particular new test in a medical journal and then ask the laboratory if the test is available.

Because doctors regard the scientific literature as the gold standard for information about new tests, researchers seek to have their findings about a newly approved test published in one of the leading journals, as the test is ready for regulatory review or for commercial distribution.

But not all doctors are "early adopters." Some are slower to change their practice patterns. While publication is bound to generate interest, educational seminars offered by professional societies or the manufacturers also provide important information to health care professionals. For these doctors, education and information is essential in their decision-making process whether to use the new test.

Manufacturers of commercial tests provide educational programs for doctors, insurance companies, and opinion leaders. However, professional societies like AACC also play an important role in educating doctors by hosting conferences and seminars, publishing articles in member publications, distributing pamphlets, sending email updates, and other mechanisms that can bring a new test to their members' attention. The laboratories themselves are also involved in promoting newly available tests by providing doctors with educational materials in bulletins or newsletters.

Gaining Acceptance from Insurers

Another factor that affects use by doctors is whether the new test will be paid for by insurers. Coverage determinations are made by insurers, such as private insurance companies as well as Medicare and Medicaid, indicating whether and to what extent a particular test will be paid for by that company. Doctors try to order tests that are covered by insurance, recognizing that most patients cannot afford to pay out-of-pocket for these tests.

As a general rule, tests or the process a test performs are assigned a current procedural terminology (CPT) code by the American Medical Association (AMA). Government payers (Medicare and Medicaid) and private insurance companies have adopted CPT codes to identify the service provided for a patient. The AMA publishes a list of such codes annually in the CPT Manual, which is used by health insurers to determine reimbursement for medical technology and practices.

The next step is a coverage determination by private and government insurers. Private insurers include those used by companies for their employee health insurance plans and policies that individuals can purchase for themselves or their families. Government insurers include Medicare, the federal health insurance program for 39 million elderly and disabled Americans, and Medicaid, which are administered by the Centers for Medicare and Medicaid Services (CMS). Coverage by Medicare is critical for determining whether and at what level a test will be paid, inasmuch as private insurers often follow Medicare's standards. However, many tests are covered by private payers that are not recognized by Medicare; tests for which Medicare coverage precedes private payment are typically those that impact elderly populations.

The criteria that insurers use in coverage decisions vary. For example, Medicare uses a different standard than the FDA for evaluating new technologies. While the FDA uses a "safe and effective" standard, Congress requires that Medicare employ "reasonable and necessary" criteria in deciding whether the program will pay for a treatment, drug, procedure, or device. In addition, the process can vary in cases where local insurance carriers differ in how – or whether – a device meets the "reasonable and necessary" criteria.

So even though a new laboratory test has traveled the long road from research and development through validation of its safety and efficacy, there is still the issue of getting the test reimbursed by insurers so that when it is ordered by a doctor, the patient's health insurance will pay the laboratory performing the test. Acceptance by insurers can be one final, important step in putting a new test into practice.

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