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Regulatory Alert: CMS COVID-19 Health Care Staff Vaccination Interim Final Rule Overview

November 10, 2021 9:21 AM | WiAHC Office (Administrator)

Yesterday the WI Department of Health Services’ Division of Quality Assurance (DQA) issued the following information to all DQA regulated providers regarding the Centers for Medicare & Medicaid Services (CMS) Interim Final Rule (released on Nov. 4, 2021), which requires COVID-19 vaccination for most healthcare workers at certain healthcare facilities certified by CMS:

On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) announced a new emergency rule related to a COVID-19 vaccination requirements for Medicare and Medicaid-certified health care providers and suppliers. Specifically, it requires all health care providers and suppliers that participate in a federally certified Medicare and Medicaid program under Conditions of Participation (COP) to develop a plan/process to vaccinate all staff with a first dose or single dose of COVID-19 vaccine by December 6, 2021. All eligible staff must be fully vaccinated by January 4, 2022.

The Emergency regulations apply to the following Medicare and Medicaid-certified providers/suppliers:

  • Ambulatory Surgery Centers
  • Community Mental Health Centers
  • Comprehensive Outpatient Rehabilitation Facilities
  • Critical Access Hospitals
  • End-Stage Renal 2 Dialysis Facilities
  • Home Health Agencies
  • Home Infusion Therapy Suppliers
  • Hospices
  • Hospitals
  • Intermediate Care Facilities for Individuals with Intellectual Disabilities
  • Clinics
  • Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
  • Psychiatric Residential Treatment Facilities (PRTFs)
  • Programs for All-Inclusive Care for the Elderly Organizations (PACE)
  • Rural Health Clinics/Federally Qualified Health Centers
  • Long Term Care Facilities

The regulation does not apply to:

  • Assisted Living Facilities; however, the mandate would apply to large assisted living facilities with more than 100 employees under the OSHA mandate.
  • Home and Community-Based Services
  • Physician’s offices

The vaccination requirement applies to eligible staff working at a facility that participates in the Medicare and Medicaid programs, regardless of clinical responsibility or patient contact. This includes:

  • Facility employees
  • Licensed practitioners
  • Students
  • Trainees
  • Volunteers
  • Individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements

CMS has provided additional information about the COVID-19 Health Care Staff Vaccination Interim Final Rule in a FAQ document.

DQA Review:

CMS expects state survey agencies to conduct onsite compliance reviews of these requirements during recertification surveys and complaint surveys. Surveyors will check to determine if a facility has met the three basic requirements:

  • Having a process or plan for vaccinating all eligible staff
  • Having a process or plan for providing exemptions and accommodations for those who are exempt
  • Having a process or plan for tracking and documenting staff vaccinations.
  • Surveyors will review the facility’s vaccine policies, the number of resident and staff COVID-19 cases over the last 4 weeks and list of staff and their vaccination status. This information will be used to determine the compliance of the provider or supplier with these requirements.

CMS will host a second stakeholder call TODAY, November 10, from 2:30 – 3:30 p.m. CST. To register in advance, visit the CMS Webinar Registration. After registering, you will receive a confirmation email containing information about joining the webinar. Please note that CMS can only accommodate 10,000 participants so register early to guarantee your participation.

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