CMS Guidance for Use of Certain Industrial Respirators by Health Care Personnel (3/20)

By CMS - March 10, 2020

Guidance expands types of facemasks healthcare workers can use to protect themselves and patients

The Centers for Medicare & Medicaid Services (CMS) took additional action to ensure America’s healthcare workers are prepared to fight the spread of Novel Coronavirus 2019 (COVID-19). Specifically, CMS sent a memorandum to State Survey Agencies (SAs), which are responsible for inspecting nursing homes and other healthcare facilities serving Medicare and Medicaid beneficiaries. The memo clarifies the application of CMS policies in light of recent Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) guidance expanding the types of facemasks healthcare workers may use in situations involving COVID-19 and other respiratory infections. These are proactive steps to take as part of the White House Task Force’s efforts to ensure a maximum supply of facemasks and respirators are available to enable healthcare providers to safely treat patients without exposing themselves or others to COVID-19.

“CMS is working in lockstep with the CDC, FDA, and other Trump Administration partners to protect both patients and the dedicated healthcare workers who are battling the spread of Coronavirus,” said CMS Administrator Seema Verma. “Today we provided practical information to state inspectors and healthcare facilities on the range of facemasks that can be temporarily used. CMS has been rapidly adapting our guidance to strengthen our nation’s defense against Coronavirus, and today’s action is no exception. We’re working to make sure the healthcare system has the equipment it needs to keep patients and healthcare workers safe.”

The memo CMS issued today aligns CMS policy with recent changes to CDC and FDA facemask and respirator guidance in light of COVID-19 and supply demands. To help reduce burden on healthcare facilities at this time, the CMS memo implements CDC guidance by stating that facemasks, which protect the wearer from splashes and sprays, are an acceptable temporary alternative to respirators, which filter the air, for most medical services until demand for respirators lessens.

Due to the updated CDC guidance on allowable facemasks and respirators, CMS is also alerting state surveyors that they are not required – on a temporary basis – to validate the date of a facility’s last annual test of the fit of N95 masks worn by workers in Medicare- and Medicaid-certified facilities. CMS is temporarily suspending surveyor validation of the test to minimize the discarded masks associated with such testing. 

Additionally, the FDA approved a CDC request for an emergency use authorization (EUA) to allow healthcare workers to use certain industrial respirators during the COVID-19 outbreak in healthcare settings. The FDA concluded that respirators approved by the National Institute for Occupational Safety and Health (NIOSH), but not currently meeting the FDA’s requirements, may be effective in preventing healthcare workers from airborne exposure to serious or life-threatening disease, including COVID-19. This FDA approval allows healthcare personnel to use the NIOSH-approved respirators not currently regulated by the FDA. As a result, in addition to N95 respirator masks, healthcare personnel have other masks at their disposal in order to safely treat patients without exposing themselves or others to COVID-19.

The CMS memo on facemask and respirator guidance issued today, and earlier CMS actions in response to the COVID-19 virus, are part of ongoing White House Task Force efforts. To keep up with the important work CMS is doing in response to COVID-19, please visit the Current Emergencies Website