Two years ago tomorrow, Norton Rose Fulbright shared the first of its many blog updates regarding the Coronavirus and the global pandemic that was about to unfold. On January 22, 2020, we shared news from the CDC that confirmed the
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…
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…
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,…
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…
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,…
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…
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…
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…