The primary means of ensuring EMTALA compliance while implementing emergency telemedicine programs include incorporating critical clinical details into the services contracts and implementing robust written policies that anticipate division of labor issues, the need for backup coverage, triaging, patient transfer protocols, and credentialing issues. With adequate up-front due diligence and meaningful contracting, hospitals and telemedicine providers can avoid common EMTALA liability pitfalls.
The expansion of health care services delivered through telehealth is impacted by numerous legal, regulatory, and reimbursement frameworks. Standard medical practices for consent, privacy, credentialing, and licensing apply to telehealth; however, the opportunity for cross-state practice complicates their application. Hospital-specific rules for credentialing and emergency stabilization must also be considered. Delivery of medical services is often driven by reimbursement, which for telehealth is governed by a complicated web of rules that vary by service, payer, and location. Temporary changes to these rules in association with the public health emergency (PHE) declared in response to the COVID-19 pandemic has rapidly reshaped the telemedicine regulatory landscape. Advocacy for smart legislation that improves and simplifies access to care is important to ensure equity of telehealth services.
Improving Direct-to-Consumer Medical TestingTo the Editor Dr Rockwell called for changes to the direct-toconsumer (DTC) medical testing industry. 1 We agree but also recognize that patient access to tools such as home thermometers, blood pressure monitors, glucometers, pregnancy tests, and HIV tests have allowed for improvement in the diagnosis and monitoring of disease. We believe that there can be value in empowering consumers to monitor specific aspects of their health. We suggest 5 actions to improve the reliability and utilization of DTC medical tests.First, more information is needed about which tests are being ordered and why and what consumers do with the results. New studies should provide data about whether DTC testing drives patients to their physicians unnecessarily or whether it provides important diagnostic information.Second, certain laboratory tests have very low utility and should rarely (if ever) be ordered. Many hospitals and insurance companies have formularies of allowable laboratory tests. Likewise, DTC testing should be limited to a menu of tests with clear clinical value and for which unbiased interpretive guidance is available.Third, people may select DTC testing because of the uncertainty of out-of-pocket costs when a physician orders a test. Improved transparency in the cost of laboratory tests would help address this issue. Studies of DTC testing should specifically address the extent to which consumers may choose to obtain physician-ordered testing through a DTC vendor because the cost is less expensive and more apparent.Fourth, DTC testing that is not waived by the Clinical Laboratory Improvement Amendments (CLIA) should be restricted to CLIA-certified laboratories. Some testing facilities have claimed exemption from regulatory oversight asserting they provide "health information" and not diagnostic test results. We also suggest that DTC testing should generally be limited to testing that is approved by the US Food and Drug Administration.Fifth, the consumer-driven health care market is growing rapidly and is expected to exceed $350 million by 2020. National restrictions on DTC services may drive people to seek it from other countries, just as they seek less expensive prescription drugs. Patients need easier access to highquality, affordable health care and reliable options for obtaining DTC testing. If health care professionals are concerned about the types and quality of DTC tests, then DTC testing should be offered at appropriately accredited hospitals and laboratories with engaged directors who practice laboratory test stewardship.We believe that the quality and value of health care can improve if these actions are undertaken.
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