Laboratory test results are key to patients getting the care they need, and in the past, state laws limited the ordering of these tests to physicians. However, as people have become more engaged in managing their own healthcare, this model has begun to change. Currently, 37 states and the District of Columbia permit consumers to order some or all of their laboratory tests without the involvement of a physician. Individuals can also buy over-the-counter test kits or get laboratory services from non-traditional settings such as retail centers. These direct-to-consumer lab tests can provide invaluable information to individuals about their health status in a timely and convenient manner. However, many healthcare providers and policymakers are concerned that some of these tests may be of questionable quality and value, or that consumers might not have enough background knowledge to make sound decisions based on their test results.
To enhance patient benefit from direct-to-consumer testing, AACC urges the Centers for Medicare and Medicaid Services and the Food and Drug Administration to require that direct-to-consumer testing providers disclose sufficient information about their products and services, enabling consumers to make fully informed health decisions. These providers should employ user-friendly descriptions of risks, benefits, and limitations of all tests offered; clear and understandable reports of test results, with enough information to assist in decision-making; prominent instructions to contact a qualified healthcare provider with any questions or concerns; and a comprehensive, public listing of tests offered and prices charged, according to AACC’s position statement.
Laboratory medicine professionals are integral to all aspects of this consumer-driven process. AACC encourages lab professionals to collaborate with federal agencies to inform the public about the costs, benefits, interpretation, and limitations of direct-to-consumer tests. Likewise, consumers should consult qualified healthcare professionals about test results and when making decisions about their healthcare.
“Direct-to-consumer laboratory testing is a key element of ongoing efforts to empower people in decisions affecting their healthcare,” said AACC CEO Janet B. Kreizman. “AACC supports expanding consumer access to high-quality direct-to-consumer testing services, and urges policymakers to ensure that these services have demonstrated clinical validity and utility and make a positive impact on patient outcomes.”
For more information on the position statement click here.