On March 10, 2020, the Quality, Safety & Oversight Group at CMS issued a memorandum entitled “Guidance for use of Certain Industrial Respirators by Health Care Personnel”  (“QSO Memo”) that announced health care workers will have an expansive range of options to protect themselves and patients from COVID-19 and other respiratory illnesses.

The QSO Memo clarifies the application of CMS policies in light of recent CDC and Food and Drug Administration guidance expanding the types of facemasks health care workers may use in situations involving COVID-19 and other respiratory infections.

The QSO Memo is effective for all Medicare and Medicaid provider and certified supplier types including:

  1. Hospitals;
  2. Religious Nonmedical Health Care Institutions;
  3. Ambulatory Surgical Centers;
  4. Hospices;
  5. Psychiatric Residential Treatment Facilities;
  6. Program of All-Inclusive Care for the Elderly;
  7. Transplant Centers;
  8. Skilled Nursing Facilities and Nursing Facilities;
  9. Intermediate Care Facilities for Individuals with Intellectual Disabilities- ICF/IID;
  10. Home Health Agencies;
  11. Comprehensive Outpatient Rehabilitation Facilities;
  12. Critical Access Hospitals;
  13. Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services;
  14. Community Mental Health Centers;
  15. Organ Procurement Organizations;
  16. Rural Health Clinics and Federally Qualified Health Centers; and
  17. End-Stage Renal Disease Facilities.

Personal Protective Equipment

The CDC has updated its Personal Protective Equipment (“PPE”) recommendations for health care personnel caring for patients with suspected cases of COVID-19 or other respiratory illnesses. Based on these recommendations:

  1. Facemasks are an acceptable temporary alternative for respirators when they are low in supply. Available respirators should be used for procedures that are likely to generate respiratory aerosols.
  2. Any National Institute for Occupational Safety and Health approved respirators that are not currently regulated by the FDA, can be used in all health care settings and by health care personnel during the COVID-19 outbreak to maximize the number of respirators available to meet the needs of the U.S. health care system.
  1. When the normal supply of respirators is restored, all health care facilities who treat patients suspected of COVID-19 and other respiratory illnesses should return back to the normal use of respirators. A health care facility that does not currently implement a respiratory protection program should do soon as soon as possible.
  2. Eye protection, gloves and medical gowns are to be used as normal; however, if there are shortages of medical gowns, they should be prioritized for aerosol-generating procedures.
  3. Patients with known or suspected COVID-19 should be cared for in a single person room with the door closed. Keep airborne infection isolation rooms available for patients undergoing aerosol-generating procedures.
  4. Health care personnel and providers should increase emphasis on early identification and implementation of source control. If a patient enters a health care facility with respiratory illness symptoms, a facemask should be provided to the patients as soon as possible.
  5. Additional information on the CDC’s recommendations above can be found here.

On March 17, 2020, the CDC released strategies for health care facilities to optimize the supply of facemasks when supply is limited based on surge capacity. Conventional, contingency and crisis capacities require the implementation of different strategies to ensure patients, health care personnel (“HCP”) and visitors reduce the risk of exposure and transmission of COVID-19. Health care facilities and HCP should implement the following strategies based on their capacity:

  • Conventional Capacity
    • Use facemasks as normal according to the product labeling and in accordance with applicable local, state and federal regulations. Facemasks that have not been cleared by the FDA may not be used as protection from sprays and splashes in health care settings.
  • Contingency Capacity
    • Selectively cancel elective and non-urgent procedures where facemasks are used by HCP.
    • Remove facemasks in public areas for visitors.
    • Extend the use of facemasks for HCP when used in close encounters with several patients without the removal between patient encounters. However, if HCP touches their facemask or if it is soiled or damaged, the facemask must be removed outside of the patient room and replaced.
    • Use facemasks for HCP who encounter patients with respiratory illness symptoms, not for patients as source control. Patients can use a tissue or other forms of a barrier to cover their mouth and nose.
  • Crisis Capacity
    • Cancel all elective and non-urgent procedures where facemasks are used by HCP.
    • Use facemasks beyond the manufacturer’s designated shelf life, as long as the facemasks do not display any degraded materials, tears or other concerns.
    • Implement limited reuse of facemasks for HCP when used in close encounters with several patients without the removal between patient encounters. However, if HCP touches their facemask, or if it is soiled or damaged, the facemask must be removed outside of the patient room and replaced. Facemasks should be carefully folded so that the outer surface is held inward and against itself to reduce contact with the outer surface during storage. The folded mask can be stored between uses in a clean sealable paper bag or breathable container.
      • Not all facemasks can be reused. Facemasks with elastic ear hooks may be more suitable for reuse. Facemasks that fasten to the HCP via ties may not be able to be undone without tearing and should be considered only for extended use, not for reuse.
    • Prioritize the facemasks that are available for selected activities such as:
      • Essential surgeries and procedures.
      • During care where sprays and splashes are anticipated.
      • During activities where face-to-face or close contact with potentially infected patients is unavoidable.
      • For aerosol-generating procedures if, respirators are not available.
    • In cases where facemasks are not available, consider the following:
      • Exclude HCP that are at higher risk of suffering complications from COVID-19.
      • Allow HCP who are recovering or have recovered from COVID-19 to treat patients who also suffer from the disease.
      • Use a face shield that covers the entire face of HCP.
      • Use isolation rooms to reduce the risk of exposure. These rooms should have a high-ventilation-rate, negative pressure, and an inner isolation zone that sits within a “clean” larger ventilated zone.
      • Use ventilated headboards for patients suspected of suffering from COVID-19.
      • Use homemade facemasks as a last resort. These masks are not considered PPE and their capabilities are unknown.
    • To read more on the CDC’s strategies to optimize the supply of facemasks click here.

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