The Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued three reports: 1) on the United States Food and Drug Administration [FDA] use of emergency use authorizations to deal with novel coronavirus [COVID-19] testing; 2) on FDA work with laboratories to implement COVID-19 diagnostic testing; and 3) on state Medicaid managed care capitation payments where a Medicaid beneficiary was enrolled in two different states. You can read about and access the three complete HHS OIG reports below.
FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing (OEI-01-20-00380)
To address problems with the first authorized COVID-19 test, the Food and Drug Administration (FDA) worked with the Centers for Disease Control and Prevention (CDC), including allowing CDC to modify the terms of its original EUA. In using its Emergency Use Authorization (EUA) authority, FDA also made calculated decisions to increase availability of COVID-19 testing, but these decisions often came at a potential cost to test quality. FDA authorized tests using lower levels of evidence to support developers struggling to access clinical samples. In response, FDA took steps to support developers and ease its workload, which included issuing EUA guidance, updating templates (submission guides for developers requesting EUA), and adjusting its EUA review process, among others. Some developers still reported being frustrated and confused.
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• Visit the COVID-19 Portal
FDA's Work with the Tri-Agency Task Force for Emergency Diagnostics Helped Labs Implement COVID-19 Tests (OEI-01-20-00381)
Prior to the COVID-19 pandemic, FDA worked with the task force to identify gaps in responses to prior emergencies (e.g., the Zika virus outbreak). The task force made two recommendations within FDA's jurisdiction: (1) require test manufacturers to include certain information with tests, and (2) require test manufacturers to provide test verification materials with tests. FDA implemented both recommendations during the COVID-19 pandemic and reported that these were helpful for labs.
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Nearly All States Made Capitation Payments for Beneficiaries Who Were Concurrently Enrolled in a Medicaid Managed Care Program in Two States (A-05-20-00025)
All 47 States reviewed made capitation payments on behalf of Medicaid beneficiaries who were concurrently enrolled in two States. Specifically, capitation payments were made on behalf of 208,254 concurrently enrolled beneficiaries in August 2019 and 327,497 concurrently enrolled beneficiaries in August 2020. The Medicaid program incurred costs of approximately $72.9 million in August 2019 and $117.1 million in August 2020 for capitation payments associated with beneficiaries in one of the two concurrently enrolled States.
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