Coronavirus Stories We’re Following
Even as expanding corridors of the world are sheltering in place to “flatten the curve” of the Coronavirus, many sectors of the international economy continue to operate, albeit differently than ever before. Many sectors of the economy that perhaps did not realize how important they were in years past are now “essential,” while others who perhaps previously thought they were essential are now anything but essential, and must sit and watch as their valuations plummet.
For us, business continues, and we still have deadlines even though most courts are only operating remotely. Similarly, state and federal governments are dramatically shifting regulatory and enforcement priorities to respond to the pandemic, and our clients in regulated industries still seek our advice regarding their short and long term strategies.
Here are some resources we’re finding useful as we make our own go-forward plans:
Ramsey Villalon from Mamone Villalon in Miami has prepared an excellent synopsis of the CARES Act: https://mamonevillalon.com/update-on-passage-of-cares-act-or-phase-iii-legislation/. Ramsey will update his website with further developments, and we will include Ramsey’s updates here as well.
A helpful summary of Federally Guaranteed Forgivable Business Loans is available here.
IRS’s Coronavirus Tax Relief page is available here.
The American Bankers Association has published an extensive list of the relief packages being offered by most major financial institutions in the U.S. The list is available here.
Here are some of the stories we’re watching relevant to our own practice in this unprecedented event:
FDA
FDA is at the epicenter of the universe, tasked by law with the monitoring, study and approval of the drugs, tests, vaccines and other medical supplies the nation will need to respond to the Coronavirus. Here are some of its recent actions:
FDA has issued an Emergency IND for convalescent plasma collected from patients who have recovered from the Coronavirus to be used on others. FDA explains how doctors can apply for permission to participate in the Emergency IND here.
FDA has issued an Emergency Use Authorization to allow for the emergency use in health care settings of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as “ventilators”), ventilator tubing connectors, and ventilator accessories that the FDA determines meet specified criteria for safety, performance and labeling. More information is available here.
Abbott Laboratories and Cepheid have received emergency authorization to manufacture and market rapid Coronavirus tests, which will be on the market soon and can detect the virus patients in minutes. Read more about it in the WSJ here.
The CARES Act included $80M in funding for FDA in its response to the Coronavirus, and significantly modernized the way over-the-counter drugs are regulated in the US. FDA’s comments on both issues are available here.
Telemedicine/Telehealth
Perhaps the greatest benefactor of the Coronavirus crisis is the telemedicine industry. Telemedicine allows for remote medical consultations, saving patients the time, cost and risk of seeing a doctor in person. This is particularly important while our nation’s healthcare system responds to the Coronavirus, but we expect the expanded use of telemedicine to never go away. Telemedicine, generally, is regulated by CMS (to the extent a federal payor is involved), FDA (to the extent the technologies allowing for remote consultations are medical devices), state laws (practice of medicine, standard of care) and other important sources of authority. Here are some of the ongoing developments in the Telemedicine industry:
CMS is showing unprecedented flexibility in its regulation of the provision of health care in the United States: The increased scope-of-practice flexibility was just one of several regulation relaxations that CMS announced on Monday. “We’re waiving a wide and unprecedented range of regulatory requirements to equip the American healthcare system with maximum flexibility to deal with an influx of cases.”
The CMS Telemedicine Toolkit is available here.
CMS has also added 85 more Medicare services which can now be provided and reimbursed with Medicare Coverage. Lists and codes available here.
From Regenexx.com: Telemedicine in the Time of Corona
From Regenexx.com: How will The Virus Change Healthcare Forever
Litigation
The Eden Roc hotel in Miami Beach has been sued for $2.3M for failing to refund a down payment for a group of 1200 guests who planned an April trip that they now cannot attend. Reporting from the Miami Herald available here.
The Florida Supreme Court has entered numerous orders relating to litigation across the state. The orders are available here.