Patient-directed testing isn’t new—it’s been around for decades in the U.S. Over-the-counter glucose testing kits have been available since the early 1980s, and pharmacies sell at-home tests for pregnancy, illicit drug use and other biomarkers.
Then in the late 2010s, diagnostic companies started offering a variety of blood-based direct-access test (DATs), including hormone panels, electrolytes, heavy metal screening, metabolic panels and prostate-specific antigen.
Such direct-access tests, defined as those accessed by patients without a physician order, might be appealing to patients but they remove the primary care physician from the clinical care decision-making, according to an AMA Council on Science and Public Health report presented at the 2023 AMA Annual Meeting in Chicago.
“In a system of complex insurance reimbursement and high out-of-pocket plans, DATs may appear appealing for patients. However, current DAT practices appear to skirt regulatory requirements, could easily be misinterpreted by patients, and lack appropriate diagnostic and counseling practices by a physician,” says the report. “Potential utilization of DAT may be warranted in the realm of infectious disease when immediate testing would be beneficial for public health.
“However, test results should still be carefully communicated to the patient and monitored by a physician who is responsible for the patient’s care,” the report adds.
Labs should be CLIA-certified
To address direct-access tests, the AMA House of Delegates adopted policy stating that “direct-access testing, in which patients may order a diagnostic laboratory test on demand, should only be provided by teams which are physician-led, and performed in facilities” that are certified by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvements Amendment.
Delegates also adopted policy saying that health professionals who perform direct-access testing on request and without a physician referral should recognize that doing so establishes a patient relationship, with all the ethical and professional obligations such a relationship entails.
“Health care professionals are responsible for relevant clinical evaluation, including pre- and post-test counseling about the test, its results and indicated follow up,” the policy states further. “While they may choose to refer the patient for post-test counseling to an appropriate provider who accepts the patient, they also maintain ethical and professional responsibility until the patient has been seen by that provider. Additionally, health care professionals shall report all required findings to relevant oversight entities such as state public health agencies, even if the patient and the laboratory are not co-localized in the same jurisdiction.”
Delegates also reaffirmed AMA policy calling for regulation of direct-to-consumer testing and education of patients about the risks and benefits.
Read about the other highlights from the 2023 AMA Annual Meeting.
