May 1, 2020

COVID-19: Update from the US Dept. of Health & Human Services

COVID-19: Update from the US Dept. of Health & Human Services

Yesterday, the Administration made numerous announcements focused on protecting Older Americans – a population we know is particularly vulnerable to COVID-19.

This afternoon, the President, Secretary Azar, and other senior Administration officials hosted a call with organizations representing seniors. As part of the designation of May as Older Americans Month, the White House announced actions taken and new initiatives to keep America’s seniors safe, including actions related to expansions of telehealth, nursing home reporting, and protecting seniors from fraud and abuse. The Administration will also be establishing the Coronavirus Commission for Safety and Quality in Nursing Homes. Read below for more details on the flexibilities and new actions the Department is taking to ensure that the nation’s senior citizens are protected.

The Trump Administration announcements included:

Reopening Guidance: CDC released new webpages with reopening information and resources for:

Advice for Organizations Reopening: FEMA released a document with Planning Considerations for Organizations in Reconstituting Operations During the COVID-19 Pandemic.

Guidance on Returning to Work for Exposed Healthcare Personnel: CDC updated their guidance on Criteria for Return to Work for Healthcare Personnel with Confirmed or Suspected COVID-19. To align with this guidance, CDC also updated information on strategies to mitigate healthcare personnel staffing shortages.

CDC Staffing Resources: CDC has released information and resources on available CDC staff to assist with opening up America. This initiative will help health departments with the staffing resources they need for their programs to get and keep America open.

Testing and Treatment:

  • CDC updated their clinical care guidance for healthcare professionals. The guidance includes information about therapeutic options, clinical tips to know, underlying conditions, telephone response guide, and additional information and resources on home care and care by patient type.
  • The FDA issued an Emergency Use Authorization (EUA) for SARS-CoV-2 Antibody Tests that have been evaluated in an independent validation study performed at the National Institutes of Health’s (NIH) National Cancer Institute (NCI), or by another government agency designated by FDA, and are confirmed by FDA to meet the criteria set forth in the Scope of Authorization.
  • FDA issued a guidance highlighting flexibility under the Drug Supply Chain Security Act (DSCSA) for trading partners responding to the COVID-19 public health emergency.
  • CMS released a memo on Laboratory Testing Comparisons for state survey agency directors.
  • FDA updated their general FAQ document to include a question on the use of disinfectants to prevent or treat COVID-19. Their answer reiterates that disinfectants are to be used on hard, non-porous surfaces and to not use disinfectant sprays or wipes on your skin because they may cause skin and eye irritation. FDA also advises that a person should not inject, inhale, or ingest disinfectant sprays or household cleaners; doing so is dangerous and may cause serious harm or death. If ingested, call poison control or a medical professional immediately.
  • The FDA recently posted FAQs on Ventilators, including questions and answers related to the Enforcement Policy on Ventilators and Ventilators added to the “Umbrella” EUA, which added to the existing FAQs on Public Availability (Open Sourcing) of Ventilator Software and Design.
  • FDA included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19.
  • The FDA granted accelerated approval to a new dosing regimen for cancer therapy, to allow patients with certain cancers to continue treatment with fewer in-person visits.
  • The FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, the FDA has issued 53 individual emergency use authorizations for test kit manufacturers and laboratories.
  • With support from the FDA’s Office of Criminal Investigations and Office of the Chief Counsel, the U.S. Department of Justice announced today that a federal court in Utah has entered an injunction halting the sale of various silver products, promoted as treatments for COVID-19.

CMS Updates

  • Information on Medicare Fee-for-Service Billing: CMS updated their FAQ document on Medicare FFS billing. The FAQs cover a wide range of billing questions for all settings and the updated question relates to Accountable Care Organizations and the Merit-based Incentive Payment program.
  • More Information for Hospitals on EMTALA: CMS issued FAQs on Emergency Medical Treatment and Labor Act (EMTALA) that clarify requirements and considerations for hospitals and other providers during the COVID-19 pandemic.

FAQs on COVID-19 and Pets: The FDA issued a Consumer Update, Helpful Questions, and Answers about Coronavirus (COVID-19) and Your Pets, that provides answers to frequently asked questions. Based on the limited information available to date, the risk of pets spreading the virus that causes COVID-19 to people is considered to low.