CMS Relaxes Respirator Rules as WHO Declares Pandemic

By A.J. Plunkett

Until further notice, CMS surveyors have been directed to suspend verifying   fit tests for healthcare workers required to wear respirators that guard against aerosol transmission of infections during the supply shortage caused by the outbreak of COVID-19.

The World Health Organization officially declared that the respiratory disease had reached a pandemic level on March 11.

OSHA and other infection control regulations generally require that workers be tested to ensure that  N95 respirators and similar personal protective equipment (PPE) fit snuggly in order to provide proper respiratory protection.

CMS issued the directive in response to an emergency use authorization (EUA) on March 9 by the CDC and FDA. That EUA offered guidance “expanding the types of facemasks healthcare workers may use in situations involving COVID-19 and other respiratory infections” to include some industrial respirators, according to Quality, Safety & Oversight Group memo QSO-20-17-ALL.

The memo points to the updated guidance and says, “At this time, these recommendations will be considered by CMS surveyors to determine if Medicare and Medicaid providers and suppliers are complying with infection control protocols:

  • Based on local and regional situational analysis of PPE supplies, facemasks are an acceptable temporary alternative when the supply chain of respirators cannot meet the demand. During this time, available respirators should be prioritized for procedures that are likely to generate respiratory aerosols, which would pose the highest exposure risk to Health Care Providers (HCP).

Facemasks protect the wearer from splashes and sprays.

Respirators, which filter inspired air, offer respiratory protection.

  • When the supply chain is restored, facilities with a respiratory protection program should return to use of respirators for patients with known or suspected COVID-19. Facilities that do not currently have a respiratory protection program, but care for patients infected with pathogens for which a respirator is recommended, should implement a respiratory protection
  • Eye protection, medical gown, and gloves continue to be

If there are shortages of medical gowns, they should be prioritized for aerosol- generating procedures, care activities where splashes and sprays are anticipated, and high-contact patient care activities that provide opportunities for transfer of pathogens to the hands and clothing of HCP.

  • Updated recommendations regarding the need for an airborne infection isolation room (AIIR).

Patients with known or suspected COVID-19 should be cared for in a single- person room with the door closed. AIIRs should be reserved for patients undergoing aerosol-generating procedures.

  • Updated information based on currently available information about COVID-19 and the current situation in the United States, which includes reports of cases of community transmission, infections identified in HCP, and shortages of facemasks, N95 filtering facepiece respirators (FFRs) (commonly known as N95 respirators), and
  • Increased emphasis on early identification and implementation of source control (i.e., putting a face mask on patients presenting with symptoms of respiratory infection).”

In addition, CMS says that “any CMS guidance that explicitly, or by reference, indicates N-95 or PPE usage will automatically incorporate any FFRs authorized under this EUA and any guidance issued by the CDC. This memo is effective for all Medicare and Medicaid provider and certified supplier types.”

The memo also includes several links to current CDC and FDA guidance related to management of the current spread of the 2019 novel coronavirus that causes COVID-19.

The memo can be found here.

A.J. Plunkett is editor of Inside Accreditation & Quality, a Simplify Compliance publication.