New Arizona Law Expands Number of laboratory tests Consumers Can Order on their Own, Fuels Debate

In April, the governor of Arizona signed a law that allows consumers in that state to request any medical lab test from clinical laboratories without a doctor's order. The new law takes effect in July and builds on a previous one that allowed Arizonans to order just a few tests, such as blood cholesterol tests. This new law adds to an ongoing debate on patient autonomy versus oversight by health practitioners.

Allowing consumers to order their own medical tests, called direct access testing or direct to consumer tests, is not new. Arizona joins 28 other states and the District of Columbia that already have laws that allow patients to order any test they wish without an order from a doctor. Thirteen states require a physician's pre-authorization, while nine other states allow individuals to order only a limited number of tests.

In 2002, a New York Times article reported on lab companies testing the waters of direct access testing. According to that report, tests that are popular among people who opt for direct access testing include thyroid hormone levels and tests for liver and kidney function, prostate cancer, allergies, STDs, HIV and Lyme disease, to name a few. Having direct access to these types of tests, say some advocates, encourages people to be more engaged with their healthcare and more likely to take steps, such as lifestyle changes, to improve their health.

Among the most common reasons that patients give for being interested in direct access testing, according to a 2012 position paper from the American Society for Clinical Laboratory Science (ASCLS), a partner organization of lab tests, are convenience, cost savings, privacy, getting tests results faster than going through their doctors, and being more prepared for doctors' visits. Getting tests that insurance doesn't cover is another reason, though direct-access tests are not covered by Medicare, Medicaid, or most insurance providers and patients pay for them out-of-pocket.

Along with the freedom to order their own tests, patients aren't required to review the results with physicians and that is cause for concern, says the ASCLS position paper and a policy statement from the American Society for Clinical Pathology, another laboratory tests partner.

Other issues raised include whether tests requested by patients would be appropriate for their situations and whether they would be able to reliably interpret test results on their own, including possible false positives or false negatives. Patients who order their own tests might also miss the benefits of physical exams and medical history questions from healthcare providers, which are key factors in health assessments. And there is "the potential for unscrupulous fear tactics in advertising" to consider as well, says ASCLS.

In their statements, the professional lab societies acknowledge the convenience and other benefits of direct access tests but remain cautious about their use. To ensure quality testing and appropriate use, ASCLS and ASCP recommend that patients make sure that any lab they use for direct access testing is certified under the Clinical Laboratory Improvement Amendments (CLIA), which sets standards for U.S. medical laboratories. Patients should review all test results with their healthcare provider and follow up with any recommendations for further testing or treatment.

Direct access testing is poised to expand and grow. Patients who choose to order their own tests can use reliable resources like laboratory tests to better understand their laboratory tests and the implications of results. However, these resources do not replace visits to health practitioners. Patients are strongly encouraged to discuss any health concerns with their providers and to consider making appointments to follow up on lab test results.