On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an emergency regulation (the “CMS Rule”) requiring health care workers in certain health care settings to be fully vaccinated for COVID-19 by January 4, 2022.
A. Facilities Subject to the CMS Rule
The facilities subject to the new vaccine requirements are the following Medicare- and Medicaid-certified provider and supplier types regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements for Participation: Ambulatory Surgery Centers, Community Mental Health Centers, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, End-Stage Renal 2 Disease 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, and Long Term Care facilities. It is important to note that the CMS Rule does not directly apply to other health care entities, such as physician offices, assisted living facilities or group homes, or providers of home and community-based services, that are not regulated by CMS.
B. Vaccine Requirement under the CMS Rule
Under the CMS rule, Covered Facilities must establish policies to ensure that all eligible staff receive the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine before providing any care, treatment, or other services by December 5, 2021. By January 4, 2022, all eligible staff must be fully vaccinated. Covered Facilities are required to track and securely document the vaccination of each staff member. As for what constitutes adequate documentation of vaccination, the following are acceptable: (a) a CDC COVID-19 vaccination record card (or legible photo of the card); (b) documentation of vaccination from a healthcare provider or electronic health record; or (c) state immunization information system record. This vaccine documentation must be kept confidential and stored separately from the Covered Facility’s personnel files. It is important to note that the CMS Rule does not exempt staff who have previously had COVID-19 and attendant antibodies.
C. Eligible Staff
The vaccination requirement applies to eligible staff working at a Covered Facility, regardless of clinical responsibility or patient contact, including all current and new staff. This includes facility employees, licensed practitioners, students, trainees, and volunteers. This also includes individuals who provide care, treatment, or other services for the Covered Facility and/or its patients under contract or other arrangements (for example, a physician admitting and/or treating patients in-person within a hospital must be vaccinated so that the facility is compliant) and are not limited to those staff who perform their duties solely within a formal clinical setting, as many health care staff routinely care for patients and clients outside of such facilities (e.g., home health, home infusion therapy, etc.). CMS has made clear that to ensure maximum patient protection, all staff who interact with other staff, patients, residents, clients, or PACE program participants in any location beyond the formal clinical setting (such as homes, clinics, other sites of care, administrative offices, off-site meetings, etc.) must be vaccinated. However, individuals who provide services one hundred percent (100%) percent remotely and who do not have any direct contact with patients and other staff, such as fully remote telehealth or payroll services staff, are not subject to these vaccination requirements.
D. Religious and Medical Exemptions
The CMS Rule requires Covered Facilities to allow for exemptions to staff with recognized medical conditions for which vaccines are contraindicated (as a reasonable accommodation under the Americans with Disabilities Act (ADA)) or religious beliefs, observances, or practices (established under Title VII of the Civil Rights Act of 1964). Covered Facilities should establish exceptions as a part of their policies and procedures and in alignment with Federal law. CMS believes that exemptions could be appropriate in certain limited circumstances, but no exemption should be provided to any staff for whom it is not legally required or who requests an exemption solely to evade vaccination.
With respect to religious exemptions, Covered Facilities have the flexibility to establish their own processes that permit staff to request a religious exemption from COVID-19 vaccination requirements. CMS requires Covered Facilities to ensure that requests for religious exemptions are documented and evaluated in accordance with applicable federal law and as a part of a facility’s policies and procedures.
With respect to medical exemptions, Covered Facilities also have the flexibility to establish their own processes that permit staff to request a medical exemption from COVID-19 vaccination requirements. Covered Facilities must ensure that all documentation confirming recognized clinical contraindications to COVID-19 vaccinations for staff seeking a medical exemption are signed and dated by a licensed practitioner.
In addition to the policies referenced above regarding vaccination and allowable exemptions, Covered Facilities must establish a process to mitigate the transmission and spread of COVID-19, including the implementation of additional precautions for staff who are not fully vaccinated for COVID-19.
In order to participate in the Medicare and Medicaid programs, health care providers and suppliers must abide by these regulations. CMS will work directly with state survey agencies to regularly review compliance with Medicare/Medicaid regulations across multiple healthcare settings. CMS expects state survey agencies to conduct onsite compliance reviews of these requirements in two ways: (1) State survey agencies will assess all facilities for these requirements during the standard recertification survey; and (2) State survey agencies will assess vaccination status of staff on all complaint surveys.
While onsite, surveyors will review the facility’s COVID-19 vaccination policies and procedures, the number of resident and staff COVID-19 cases over the last 4 weeks, and a list of all staff and their vaccination status. This information, in addition to interviews and observations, will be used to determine the compliance of the provider or supplier with these requirements. Additionally, Accrediting Organizations will be required to update their survey processes to assess facilities they accredit for compliance with vaccination regulations.
Covered Facilities are expected to comply with all regulatory requirements, and CMS has established a variety of enforcement remedies. For nursing homes, home health agencies, and hospice (beginning in 2022), this includes civil monetary penalties, denial of payment, and even termination from the Medicare and Medicaid programs as a final measure. The remedy for non-compliance among hospitals and certain other acute and continuing care providers is termination; provided, however, that CMS’s goal is to bring healthcare facilities into compliance. Termination generally occurs only after providing a facility with an opportunity to make corrections and come into compliance.
F. Current Legal Challenges
On November 10, 2021, a group of attorney generals from ten (10) states joined in a challenge of the CMS Rule in the U.S. District Court for the Eastern District of Missouri, claiming, among other things, that the CMS Rule violates the Administrative Procedure Act (APA), in that (a) it is arbitrary, capricious, and an abuse of discretion, especially because, as these states allege, the vaccination requirement will cause healthcare workers to leave their employers at a time when hospitals and other healthcare providers already are struggling with substantial staffing shortages and other laws, (b) its broad scope (covered are employees, as well as volunteers and contractors performing services for the covered provider or supplier) is too removed from the rationale of protecting patient safety, and (c) CMS failed to comply with the APA’s notice and comment requirements. The states further argue that the CMS Rule exceeds the rulemaking power of CMS and violates the U.S. Constitution’s Tenth Amendment by encroaching on a state’s authority to regulate public health. The lawsuit also alleges violations of the Social Security Act, failure to consult with appropriate state agencies under 42 U.S.C. Section 1395z, failure to prepare the requisite regulatory impact analysis, unlawful use of the federal government’s spending power, and unlawfully compelling states to implement this program in violation of the Anti-Commandeering Doctrine.
G. Immediate Steps for Covered Facilities
Absent rulings from the courts, Covered Facilities should proceed to immediately implement rules and procedures that set forth the following:
(1) A process for ensuring that covered staff (except for those who have pending requests for, or who have been granted, exemptions to the vaccination requirement) have timely received their COVID-19 vaccinations by the aforementioned dates;
(2) An application process for exemptions based on federal law and a process documenting the information used in the exemption application, including a process to confirm that medical exemption documentation is from licensed practitioners and contains information specifying which COVID-19 vaccines are clinically inadvisable for the staff member and the recognized clinical reasons for the conclusion, which exemption application process should commence well in advance of the December 5 deadline so as to permit the Covered Facility ample time to review each exemption application;
(3) Documentation of the vaccination status of covered staff for whom COVID-19 must be temporarily delayed (e.g., individuals who received monoclonal antibodies or convalescent plasma for COVID-19 treatment); and
(4) A process to mitigate the transmission and spread of COVID-19 (including the implementation of additional precautions for staff who are not fully vaccinated for COVID-19).
NOTE: This general summary of the law should not be used to solve individual problems since slight changes in the fact situation may require a material variance in the applicable legal advice.