CMS Issues Additional Guidances – COVID-19

Mary Madison, RN, RAC-CT, CDP
Clinical Consultant – Briggs Healthcare

On March 10, 2020, CMS issued several additional guidances to healthcare workers as well as to Medicare Advantage Organizations and Part D Sponsors:

QSO-20-17-ALL…Guidance for use of Certain Industrial Respirators by Health Care Personnel

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Further, the FDA approved the CDC request for an emergency use authorization (EUA) to allow health care personnel to use certain industrial respirators during the COVID-19 outbreak in health care 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 health care personnel from airborne exposure, including COVID19, which can cause serious or life-threatening disease, including severe respiratory illness.

This action allows the NIOSH-approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the COVID-19 outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system.

PLEASE NOTE: Due to the updated CDC guidance and current supply demands of these devices (and the discards associated with testing), CMS is directing surveyors not to validate the date of the last FIT test for health care workers in Medicare and Medicaid certified facilities, until further notice.

The FDA Press Release announces FDA and CDC action to increase access to respirators, including N95s, for health care personnel.   This 4-page QSO memorandum contains links to additional references as well.

Therefore, 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:

  • Hospitals
  • Religious Nonmedical Health Care Institutions (RNHCIs)
  • Ambulatory Surgical Centers (ASCs)
  • Hospices
  • Psychiatric Residential Treatment Facilities (PRTFs)
  • Program of All-Inclusive Care for the Elderly (PACE)
  • Transplant Centers
  • Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs)
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities- ICF/IID
  • Home Health Agencies (HHAs)
  • Comprehensive Outpatient Rehabilitation Facilities (CORFs)
  • Critical Access Hospitals (CAHs)
  • Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Community Mental Health Centers (CMHCs)
  • Organ Procurement Organizations (OPOs)
  • Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
  • End-Stage Renal Disease (ESRD) Facilities

 

QSO-20-19-ESRD…Guidance for Infection Control and Prevention of COVID-19 in Dialysis Facilities

This 7-page memorandum provides guidance (and links to additional information) for:

  • What actions should dialysis facilities implement to promote early recognition and management of patients, staff and visitors?
  • How should facilities monitor or restrict dialysis facility staff?
  • Where should dialysis facilities place patients with undiagnosed respiratory symptoms and/or suspected or confirmed COVID 19?
  • What type of Personal Protective Equipment (PPE) should be used when caring for patients with undiagnosed respiratory symptoms?
  • How should facilities ensure appropriate cleaning and disinfection of environmental surfaces, medical devices and equipment?
  • When should the dialysis facility consider transferring a patient to an alternative site for treatment?
  • When should the dialysis facility consider transferring a patient to an alternative site for treatment?
  • Will dialysis facilities be cited for not having the appropriate supplies?

 

Information Related to Coronavirus Disease 2019 was issued to Medicare Advantage Organizations, Medicare-Medicaid Plans and Part D Sponsors to inform them of the obligations and permissible flexibilities related to disasters and emergencies resulting from COVID-19.  Included in this 4-page notification:

  • Special Requirements
  • Permissive Actions
  • Business Continuity Plans
  • Payment
  • Relax “Refill-Too-Soon” Edits and Provide Maximum Extended Day Supply
  • Reimburse Enrollees for Prescriptions Obtained from Out-of-Network Pharmacies
  • Home or Mail Delivery of Part D Drugs
  • Prior Authorization for Part D Drugs
  • Drug Shortages
  • Vaccines