Earlier this month, 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 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.

Numerous states have files lawsuit against CMS and the Biden Administration challenging the COVID-19 vaccine mandate for healthcare workers. However, the Final Interim Rule currently remains in place.