Gaining Acceptance from Healthcare Practitioners
There is no assurance that once a test is developed, approved, and available that it will be immediately used by a healthcare practitioner. A new test generally gains acceptance by the practitioner through various continuing educational venues. This is often accomplished through peer-reviewed medical publications, continuing medical education programs, and other reporting media that tout the advantages of the new test. Over time, exposure to the test and data supporting its clinical usefulness will increase the practitioner's confidence and comfort in ordering the new test and the interpretation of the results.
Adoption rates are highest among healthcare practitioners who keep up with the medical literature. They may read about a particular new test in a medical journal and then ask the laboratory if the test is available. Because healthcare practitioners regard the scientific literature as the gold standard for information about new tests, researchers seek to have their findings published in one of the leading journals as the test is prepared for regulatory review or for commercial distribution.
It is commonplace for manufacturers of commercial tests to provide educational programs for healthcare practitioners, insurance companies, and laboratory leaders. However, professional societies like AACC also play an important role in educating healthcare practitioners 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 practitioners with educational materials through in-service education programs, in bulletins, or newsletters.
Gaining Acceptance from Insurers
Another factor that may affect how and when a new test will be ordered is dependent on healthcare 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. Healthcare practitioners do their best to try to order tests that are covered by most insurance plans, recognizing that some patients may have to pay out-of-pocket for these tests. Non-FDA approved tests are often denied payment by the insurance company, with payment responsibility falling on the patient. This is particularly true for many of the newer genetic tests and should be discussed with your healthcare provider.
All laboratory tests 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(s) provided for a patient. The AMA publishes a list of such codes, which are annually updated in the CPT Manual. Each laboratory test performed must have a CPT code submitted to the insurance company to identify the test performed and to determine what reimbursement will be made.
The next step is a coverage determination policy, developed independently by private and government insurers. Most employers offer health insurance plans for their employees through private insurers. In addition, private insurers offer policies that individuals can purchase for themselves or their families.
Coverage determinations can vary greatly between different insurance companies. They can also vary within the same insurance company based on negotiated agreements between the private insurer and the employer. Some tests, like many of the newly developed genetic tests, may be covered under one employer's plan but not be covered under another employer's health plan, even though both plans are sponsored by the same insurance provider. Payment then becomes the responsibility of the patient.
Government insurers include Medicare, which is the federal health insurance program for over 55 million elderly and disabled Americans, and Medicaid, which covers another 72 million people, including the Children's Health Insurance Program (CHIP). Both 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.
Some tests may be covered by private payers that are not recognized by Medicare. For those individuals who qualify for Medicare, Medicare becomes their primary insurer. Many individuals have a secondary, private insurer; thus for those tests not covered by Medicare, charges for that test would be resubmitted to a secondary private insurer for potential payment. Because many private insurers follow Medicare rules, there is no guarantee that reimbursement will be made and payment becomes the responsibility of the patient.
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 medical device (lab tests are considered medical devices). 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 healthcare practitioner, 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.