Tag archives: pandemic

COVID-19 Update: FDA Inspections Signal Resumption of Government Enforcement Efforts

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20.  Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.”   To … Continue reading

COVID-19 Update: World Health Organization Warns of Dangerous Phase

During a press conference on June 19, 2020, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus stated that “[t]he pandemic is accelerating” and that we are now in a “dangerous phase” where the virus is “spreading fast.”   June 22, 2020 saw the largest single day spike in cases, with 183,020 new cases worldwide.   In the … Continue reading

Arbitrating disputes in the pharmaceutical, life sciences and healthcare sector in the era of the COVID-19 pandemic

Introduction A signature feature of the last several months has been the scramble for masks, shields and gowns – personal protective equipment (PPE) – for doctors, nurses and other care workers. Governments have been focused on ensuring that health authorities, both public and private, have a sufficient supply of essential medical equipment (such as PPE … Continue reading

COVID-19 Update: CDC Releases Guidance for Reopening

On May 14, 2020, the U.S. Centers for Disease Control (“CDC”) published voluntary guidance that provides checklists for reopening certain workplaces and activities.  The decision tools state that “[i]t is important to check with state and local health officials and other partners to determine the most appropriate actions while adjusting to meet the unique needs … Continue reading

COVID-19 Update: CMS Issues Additional Waivers to Assist Providers

The Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules to boost frontline medical staff at healthcare facilities during the COVID-19 pandemic.  The new waivers expand on the workforce flexibilities announced by CMS on March 30, 2020 (previously covered by the HL Pulse here).  The new waivers include: Physicians in Critical … Continue reading

COVID-19 update: CMS publishes fact sheet describing process for providers and suppliers seeking CARES Act Medicare accelerated and advance payments

On March 28, 2020, CMS released guidance related to the expanded accelerated and advance payments provided under the Coronavirus Aid, Relief, and Economic Security (CARES) Act signed into law by President Trump on March 27. These payments are typically available when there is a disruption in claims submission or claims processing, and are offered in … Continue reading

Update to Prior CMS Action: CMS Approves 11 New Medicaid Section 1135 Waivers; 13 States Total

On March 13, 2020, following President Trump’s declaration of a national emergency in response to the COVID-19 pandemic, CMS announced its approval of the first Section 1135 Waiver aimed at addressing the spread of COVID-19 (Coronavirus) in Florida. On March 19, CMS granted a Section 1135 Waiver to deal with the COVID-19 outbreak in Washington … Continue reading

COVID-19 Update: Coronavirus Designated a Pandemic by WHO

On Wednesday the World Health Organization declared COVID-19 a pandemic.  WHO Director-General Tedros Adhanom Ghebreyesus stated that “In the days and weeks ahead, we expect to see the number of cases, the number of deaths and the number of affected countries climb even higher.”  In a hearing before the House Oversight and Reform Committee Dr. … Continue reading

COVID-19 Update: CDC says Spread of Coronavirus Virus “Inevitable”

On Tuesday February 25, 2020, Nancy Messonnier, director of the U.S. Center for Disease Control’s National Center for Immunization and Respiratory Disease warned in a call with reporters that “[u]ltimately we expect we will see community spread in the United States. It’s not a question of if this will happen, but when this will happen, … Continue reading
LexBlog