As previously announced by the Biden-Harris Administration on September 9, 2021, the Centers for Medicare & Medicaid Services (CMS) is requiring mandatory COVID-19 vaccinations for all eligible staff working in or employed by federally funded health care facilities. New federal regulations released yesterday (November 4) in CMS’s sixth COVID-related Interim Final Rule with Comment Period (herein “IFC 6”) amend the conditions of participation for the full range of Medicare and Medicaid certified health care facilities, adding a COVID‑19 vaccination requirement for facility staff.

The overarching goal of the new regulations is to ensure the health and safety of facility employees and the patients, residents, clients, and participants to whom they provide care and services. IFC 6 provides important details and clarifying information and outlines the mandatory vaccination requirements in order to be in compliance with the new federal regulations. As further discussed below, non-compliance with the new requirements potentially could result in the loss of Medicare and Medicaid funding.

Facilities Impacted

The COVID-19 vaccination requirements apply to eligible staff employed by or working in the following Medicare and Medicaid participating providers and suppliers:

• Hospitals (acute care, cancer, children’s, long term care, psychiatric and rehabilitation)
• Critical access hospitals (CAH)
• Ambulatory surgery centers (ASC)
• Home health agencies (HHA)
• Home infusion therapy (HIT) suppliers
• Hospices
• Rural health clinics (RHC) and federally qualified health centers (FQHC)
• Clinics (rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services)
• Psychiatric residential treatment facilities (PRTF)
• Community mental health centers (CMHC)
• End-stage renal disease (ESRD) facilities
• Long term care facilities (skilled nursing facilities and nursing homes)
• Programs of all-inclusive care for the elderly (PACE)
• Intermediate care facilities for individuals with intellectual disabilities (ICF-IID)
• Comprehensive outpatient rehabilitation facilities (CORF)

Notably, private physician and practitioner office practices are not included in the above list. Nevertheless, many employees of private practices will be required to be vaccinated based on their relationships and interactions with the facilities and organizations listed above. In addition, the Occupational Safety and Health Administration (OSHA) has also released regulations and guidance on COVID-19 vaccination requirements which apply in all workplace settings. The OSHA guidance is being closely tracked by Dentons' Labor & Employment Group, which published this client alert yesterday discussing the OSHA guidance.

Key Provisions

Health care facilities are required to develop and implement policies and procedures applicable to eligible staff members. As noted in the IFC 6, “Each facility’s COVID–19 vaccination policies and procedures must apply to the following facility staff, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients: Facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement.” Staff who telework exclusively and never interact with other staff, patients, residents or clients — in institutional, community or home-based settings — are exempt from the mandatory vaccination requirements.

By December 5, 2021, employees will be required to have received the first of a two dose vaccine regimen (Moderna or Pfizer) or one dose of the one dose vaccine (Johnson & Johnson). All employees will be required to be fully vaccinated (two doses of Moderna or Pfizer or one dose of Johnson & Johnson) by January 4, 2022.

CMS will assess compliance with the vaccination requirements through their usual survey and enforcement activities. This will be accomplished by surveyors working for both state survey agencies, including contracted staff, and Medicare-approved accrediting organizations. Those facilities identified as being out of compliance with these regulations will be provided opportunity to achieve compliance or face stiffer penalties, including the imposition of civil monetary penalties, denial of payment for new admissions, or termination of the Medicare/Medicaid provider agreement.

IFC 6 includes allowances for exemptions based on medical conditions or religious beliefs, observances, or practices. However, as noted in the Updated COVID-19 Technical Assistance guidance released by the Equal Employment Opportunity Commission (EEOC) on October 25, 2021, political views are not grounds for exemption. Facilities will be required to develop processes for permitting exemptions while staying in compliance with federal law.

Staff vaccinations must be tracked for all eligible employees and staff. Facilities can develop their own internal tracking tools or can use the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) staff vaccination tool, available on this CDC website.

IFC 6 is published in today’s Federal Register (November 5), accessible here.

The Dentons Health Care Group continues to provide timely updates and insights on COVID-19 and other Medicare and Medicaid issues and is available to assist with policy interpretation and implementation.