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An opinion article in the Journal of the American Medical Association (JAMA) calls for several actions to rein in direct-to-consumer (DTC) testing before it gets out of control, including more state regulations and state medical board sanctions against providers who work for DTC companies.
The healthcare industry has been under increasing pressure to contain costs and reduce unnecessary tests, procedures and treatments, and improve quality of care. The Affordable Care Act and other laws and policies have spurred providers to move further away from the high volume, fee-for-service system that has long led to out-of-control costs and toward a system that promotes high value care.
“Apparently eluding these efforts to transform healthcare delivery and control costs is a growing direct-to-consumer (DTC) medical marketplace, which offers low-value medical testing directly to consumers,” wrote Kimberly Lovett Rockwell, MD, JD, an associate with Jones Day in Detroit. She authored the JAMA opinion piece while at Honigman, Miller, Schwartz & Cohn in Bloomfield Hills, Michigan.
With a projected value of $350 million by 2020, the DTC testing industry offers individuals the convenience of taking things into their own hands, self-testing their blood, urine, and saliva samples to see if they’re at risk for certain diseases, including cardiac disease and cancer. These tests don’t require a doctor’s examination or prescription or record of a consumer’s medical history. The lawless nature of these tests, not to mention their tendency to generate fear mongering, is cause for concern, Rockwell emphasized.
“Most companies also offer these tests widely to the public without any reference to evidence-based guidelines or the appropriateness of testing in their advertisements. Moreover, advertisements tend to entice consumers by appealing to fears of contracting common disorders such as cardiac disease, stroke, and various cancers,” she observed.
Despite their minimal value, DTC tests continue to grow and expand, due to regulatory loopholes at both state and national levels, and the overall drive toward consumer-driven care, Rockwell observed. States in their definitions of the practice of medicine typically don’t view DTC testing as unlawful, provided that DTC companies steer away from giving medical advice or analyzing results. Just nine states definitively require that consumers get an order from a licensed medical professional for a medical test, she noted.
Several federal entities regulate the validity of DTC testing: They must get clearance from U.S. Food and Drug Administration and CLIA certification. The Federal Trade Commission also has the power to regulate DTC advertising to ensure that ads are truthful. None of these federal entities, however, “have any role in setting limits on who should receive various types of medical testing in accordance with evidence-based guidelines,” Rockwell observed.
DTC tests also drive up costs. Low-risk populations are most likely to invest in a DTC test, putting them at greater risk for false positive results. Consumers, anxious over results but unable to seek guidance from the DTC companies, lean upon their physicians to review the results. This ultimately leads to a series of “downstream interventions,” in which the doctor, unfamiliar with a DTC test, sends the patient to a specialist for additional and sometimes unnecessary testing. Insurers are left to pay for all of these additional interventions.
To curb this cycle of follow up-testing, Rockwell suggested that states implement requirements for licensed healthcare professionals to sign off on laboratory tests. She also proposed state medical boards sanction practitioners employed by DTC companies who order tests without any qualifiers, such as a patient’s medical history or an exam. Healthcare professionals also need to educate consumers on the risks of DTC testing and not give in to additional referrals and tests when patients confront them with DTC test results, according to Rockwell.
“If physicians, healthcare industry stakeholders, and policymakers are serious about reining in healthcare spending and promoting high-value healthcare, then the DTC medical marketplace cannot be ignored because it exploits the same lack of accountability for high-volume, low-value medical testing that provoked the regulatory environment governing physicians and hospitals today,” she wrote.
Rockwell concluded that state-level interventions would “increase accountability for preserving scarce healthcare resources and also protect patients from untoward downstream consequences of follow-up testing and procedures.”