Editor's Note The Food & Drug Administration on May 11 took new actions to accelerate the development of novel prevention and treatment options for COVID-19. The agency is providing guidance documents to make the process for submitting applications to initiate studies for new drugs and biological products more efficient. The…

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Editor's Note The Centers for Medicare & Medicaid Services (CMS) on May 11 released a proposed rule that increases Medicare inpatient prospective payment system (IPPS) rates by a net of 3.1% in FY 2021, compared to 2020, for acute care hospitals participating in the Hospital Inpatient Quality Reporting Program that…

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Elective surgical procedures that were temporarily suspended in mid-March are now on the table—or soon will be—at some US facilities. The ban, announced on March 18 by the Centers for Medicare & Medicaid Services (CMS), was enacted to free up resources for facilities overwhelmed by surges of COVID-19 patients. On…

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Editor's Note: The Centers for Disease Control and Prevention on May 8 updated it weekly surveillance summary of COVID-19 activity in the US for week 18. Among the updates: The percentage of specimens testing positive for SARS-CoV-2 decreased at public health, commercial, and clinical laboratories. Labs have confirmed 832,238 positive…

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Editor's Note The Food & Drug Administration (FDA) on May 6 issued a guidance to implement section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) as it relates to shortages and potential shortages of medical devices occurring during the COVID-19 pandemic. Manufacturers are required to notify…

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Editor's Note The Centers for Disease Control and Prevention (CDC) on May 1 announced the launch of the “SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES)” consortium. This network of laboratories will speed the release of SARS-CoV-2 sequence data into the public domain for use by public…

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Editor's Note The Centers for Disease Control and Prevention on May 1 updated its weekly surveillance summary of COVID-19 activity in the US ending April 25. Among the updates: The percentage of specimens testing positive for SARS-CoV-2 decreased at public health and commercial laboratories and remained similar at clinical labs.…

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Editor's Note European regulators have approved Siemens Healthineers’ molecular Fast Track Diagnostics SARS-CoV-2 Assay, which has 100% specificity and sensitivity. The new assay uses real-time polymerase chain reaction (PCR) to detect ribonucleic acid (RNA) from this virus. The company plans to ship more than 1.3 million tests per month worldwide…

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Editor's Note The Occupational Safety and Health Administration (OSHA) on April 24 issued interim guidance on the reuse and decontamination of N95 and other filtering-facepiece respirators during the COVID-19 pandemic. OSHA notes that the National Institute for Occupational Safety and Health (NIOSH) has identified research that suggests the following methods…

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Editor's Note The Joint Commission on April 23 announced that it supports the Centers for Disease Control and Prevention’s new recommendations that healthcare facilities “. . . implement source control for everyone entering a healthcare facility (eg, healthcare personnel, patients, visitors), regardless of symptoms . . .” Source control involves…

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