This piece was submitted to SmartBrief by reader J. William Beakey, L Ac, O.M.D.
Director, Professional Co-op Services
A recent article in the ADLM SmartBrief article discussed direct-to-consumer blood testing, focusing on routine tests available from brick-and-mortar businesses, websites and major labs. While this model can empower individuals to take a more proactive role in managing their health, it does not address a growing regulatory gap: individuals who do not hold clinical licenses, often called “affiliates,” who are now actively marketing and facilitating the sale of laboratory tests to the public.
Ordering lab tests has historically required a licensed clinician’s order for anything beyond CLIA-waved tests. There is now a broadening situation in which licensed physicians provide test orders in exchange for fees paid by third-party affiliates, who are often unlicensed, and commissions may also be added on some platforms. Consultations and remedies, which can be very costly, may also be involved. In practice, this structure allows unlicensed parties to control the commercial and transactional aspects of clinical testing, while relying on nominal physician involvement to satisfy ordering requirements. There is no apparent oversight or regulation of the activity of these affiliates.
Licensed clinicians may offer tests on their websites as a convenience for patients and to potentially expand their practice. In these cases, it is clear that a clinician is involved and has responsibility.
LabCorp and Quest offer a patient-direct test menu limited to routinely ordered tests that are well known to the public. Testing companies with physical locations, such as Any Lab Test Now, offer a more inclusive list of tests while other internet-based companies, for example, Hims & Hers, may offer only testing related to a product or service they provide. In all of these examples, contracted licensed clinicians are involved, but not in the traditional patient/provider relationship. Typically, it is stated that results are not interpreted and the purchaser is advised to consult with their own practitioner. While required notice of critical results is accomplished, there is minimal oversight and regulation.
Busy clinicians may not have time to discuss, order and review all the lab tests patients want beyond those that are urgently needed. The public needs help in both obtaining and interpreting lab work, and expanding who can accomplish these tasks is something that should be considered. Empowering licensed dieticians and nutritionists to help provide needed services has already been done in some states. Evaluating certification programs offered through the internet could be an additional step.
The State of Arizona allows an individual to order any lab test themselves without a physician involved and this could be adopted universally, removing one obstacle.
Now is the time for both professional organizations and oversight agencies to thoroughly review the sale of lab tests and offer clarification to both the public and the business community.
— J. William Beakey, L Ac, O.M.D., Director, Professional Co-op Services
Association for Diagnostics & Laboratory Medicine Position
ADLM supports expanding and encouraging consumers’ ability to access their own health information by allowing individuals to directly order their own laboratory tests. Medical tests can help individuals learn more about their health and become more involved in decisions affecting their well-being when performed appropriately. Only reputable CLIA-certified laboratories should perform direct-to-consumer testing and should provide consumers with sufficient information and/or expert help to assist them in interpreting the results. Consumers should always consult qualified healthcare providers when making decisions that could affect their personal health.