Regulations/Legal

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April 2020
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Joint Commission issues statement on face masks from home

Editor's Note The Joint Commission on March 31 issued a statement saying it supports letting healthcare staff bring their own standard face masks or respirators from home when their facilities cannot provide access to protective equipment that is equivalent to their exposure risk, during the COVID-19 pandemic. In taking this…

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By: Judy Mathias
April 2, 2020
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HHS: FDA issues emergency authorization of anti-malaria drugs for COVID-19 treatment

Editor's Note The Department of Health and Human Services (HHS) announced on March 29 that the Food & Drug Administration (FDA) had issued an emergency use authorization for hydroxychloroquine and chloroquine in the treatment of COVID-19. The FDA allowed for the drugs to be “donated to the Strategic National Stockpile…

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By: Judy Mathias
March 30, 2020
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FDA acts to increase COVID-19 supplies with instructions for manufacturers importing PPE, devices

Editor's Note The Food & Drug Administration (FDA) on March 24 took action to increase US supplies in response to the COVID-19 pandemic by providing instructions to manufacturers importing personal protective equipment (PPE) and other devices. The instructions to manufacturers clarify the types of PPE and devices they can import…

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By: Judy Mathias
March 26, 2020
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FDA announces actions taken in response to COVID-19 pandemic

Editor's Note: The Food & Drug Administration (FDA) on March 25 announced several actions it has taken in its response to the COVID-19 pandemic. These include: In response to the demand for hand sanitizers and their active ingredient, alcohol, the FDA issued guidance to alcohol manufacturers on how to incorporate…

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By: Judy Mathias
March 26, 2020
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COVID-19 case-fatality rate, patient characteristics in Italy

Editor's Note In the first half of February only three cases of COVID-19 were identified in Italy, and all had recently traveled to China. On February 20, a case of pneumonia due to SARS-CoV-2 was diagnosed in northern Italy’s Lombardy region. Within 14 days, many other cases of COVID-19 were diagnosed in…

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By: Judy Mathias
March 25, 2020
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FDA: Safety Alert on transmission risk of SARS-CoV-2 virus in fecal microbiota

Editor's Note The Food & Drug Administration on March 23 issued a Safety Alert to inform healthcare providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT), and that the agency has determined that additional safety protections are needed.…

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By: Judy Mathias
March 24, 2020
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CDC updates strategies for optimizing the supply of facemasks

Editor's Note The Centers for Disease Control & Prevention on March 17 updated its strategies for optimizing personal protective equipment (PPE) supplies, including facemasks. The strategies are based on surge capacity and include: *Conventional capacity: Patient care is provided without any change in daily practices. Use facemasks according to product…

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By: Judy Mathias
March 23, 2020
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CMS announces regulatory relief for VBC programs in response to COVID-19

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on March 22 extended the deadlines for quality reporting and applications for providers, clinicians, and facilities in value-based care (VBC) programs as they face a growing number of COVID-19 patients. CMS also announced that it will not use any data…

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By: Judy Mathias
March 23, 2020
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CDC: First preliminary description of outcomes in US patients with COVID-19

Editor's Note This first preliminary description of outcomes in COVID-19 patients in the US between February 12 and March 16, 2020, indicates that fatalities were: 10% to 27% in patients aged 85 or more 3% to 11% in patients aged 65-84 years 1% to 3% in patients aged 55-64 years…

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By: Judy Mathias
March 19, 2020
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CMS releases recommendations on adult elective surgeries, procedures

Editor's Note The Centers for Medicare & Medicaid Services (CMS) on March 18 released recommendations that all elective surgeries and nonessential medical, surgical, and dental procedures be delayed during the COVID-19 outbreak. As more healthcare providers are asked to assist with the COVID-19 response, it is important that they consider…

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By: Judy Mathias
March 19, 2020
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