Bringing Everyone to the Table: Rapid Evidence Assessments Facilitate Meaningful Dialogue Across the Stakeholder Spectrum

In the last two decades, the number of commercially available genetic tests is thought to have increased by more than 5,000%—from approximately 1,500 to an estimated 100,000 or more. This number only increases daily as US-based, Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories commercialize new tests through the laboratory-developed test (LDT) pathway. LDTs are specialized tests performed only by certain labs and are regulated by Medicare through CLIA. This pathway, which is largely exempt from FDA premarket review, permits tests to come to market quickly and with little regulatory oversight. 

The LDT pathway can be problematic because it does not require evidence from laboratories to support test claims. FDA previously identified problems with high-risk LDTs, ranging from a lack of appropriate controls yielding erroneous results to outright falsification of data. This makes it difficult for payers to know which tests to cover and for clinicians to know which tests are likely to help patients.  

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Topics: Evidence-based decision making

Increased Payer Support for Telemedicine May Improve Maternal Health Outcomes and Lower Costs

When compared to ten other developed nations, the United States has the highest maternal death rate. Yet, according to a recent maternal mortality review committee report by the Centers for Disease Control and Prevention, 84% of pregnancy-related deaths are preventable. This maternal health crisis has been shaped, in part, by socioeconomic inequities and inconsistent insurance coverage policies, which limit healthcare access by underserved populations. So what tools are available now to help reduce preventable harm among childbearing women? Clinical evidence suggests that telehealth could be one solution. 

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Topics: Evidence-based decision making

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