On November 5, 2021, the Centers for Medicare & Medicaid Services (CMS), a division of the Department of Health and Human Services, published its Omnibus COVID-19 Health Care Staff Vaccination requirements that most Medicare- and Medicaid-certified providers and suppliers must meet in order to participate in the Medicare and Medicaid programs (the “CMS Rule”). This emergency regulation is effective as of November 5, 2021 and will cover approximately 17 million workers at about 76,000 healthcare facilities across the country. CMS explained that it issued the rule as an emergency regulation because any delay in implementation would result in additional deaths and serious illness among healthcare staff and patients, further worsening the ongoing strain on healthcare providers. Healthcare industry stakeholders are concerned that the mandate will further strain staffing shortages in the field. 

Applicability

The CMS Rule requires staff to be vaccinated and applies to the following Medicare and Medicaid-certified providers and suppliers: Ambulatory Surgery Centers, Community Mental Health Centers, Comprehensive Outpatient Rehabilitation Facilities, Critical Access Hospitals, End-Stage Renal 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 (“Covered Facilities” or “CMS Certified Providers”).

The vaccination requirement applies to all eligible staff of CMS Certified Providers, regardless of clinical responsibility or patient contact. Eligible staff includes all current staff as well as any new staff who provide any care, treatment, or other services for the facility and/or its patients. The regulation applies to facility employees, licensed practitioners, students, trainees, and volunteers.[1] Additionally, it applies to individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements. Finally, the regulation applies to physicians who have admitting privileges or are treating patients in-person within such facilities.

These requirements are not limited to those staff who perform their duties solely within a formal clinical setting, as many healthcare staff routinely care for patients and clients outside of such facilities (e.g. home health, home infusion therapy, etc.). 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.[2]

As the CMS Rule only applies to Medicare- and Medicaid-certified facilities, and as CMS does not have regulatory authority over care settings such as Assisted Living Facilities or Group Homes, these requirements do not apply to ALFs or Group Homes. The CMS Rule also does not apply to physician’s offices because they are also not subject to CMS health and safety regulations.

Requirements

Covered Facilities must  establish a process or policy to fulfill the staff vaccination requirements over two phases. For Phase 1, within 30 days (i.e. by December 6, 2021), staff at all Covered Facilities must have received, at a minimum, the first dose of a primary series (Pfizer or Moderna) or a single dose (Johnson & Johnson) COVID-19 vaccine prior to staff providing any care, treatment, or other services for the facility or its patients. For Phase 2, within 60 days (i.e., by January 4, 2022), staff at all Covered Facilities must complete the primary vaccination series (except for those staff who have been granted exemptions from the COVID-19 vaccine or for whom COVID-19 vaccination must be temporarily delayed, as recommended by CDC). As such, staff must be “fully vaccinated”[3] by January 4, 2022 in order to meet the requirements of the CMS Rule.[4]

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: CDC COVID-19 vaccination record card (or legible photo of the card); documentation of vaccination from a healthcare provider or electronic health record; or state immunization information system record. This vaccine documentation must be kept confidential and stored separately from an employer’s personnel files.

Exemptions for Medical or Religious Reasons, Accommodations

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)[5]. Covered Facilities should establish exceptions as a part of their policies and procedures, consistent with federal law. CMS indicated 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 (under the ADA or Title VII of the Civil Rights Act of 1964) or who requests an exemption solely to evade vaccination.  

The CMS Rule also addresses situations for certain individuals for whom a vaccination should be temporarily delayed (e.g., because of a recent COVID-19 diagnosis due to clinical precautions and considerations, as recommended by CDC). However, the regulation does not exempt staff who have previously had COVID-19 and attendant antibodies, explaining that available evidence indicates that COVID-19 vaccines offer better protection than natural immunity alone and that vaccines, even after prior infection, help prevent reinfections. CDC recommends that all people be vaccinated, regardless of their history of symptomatic or asymptomatic SARS-CoV-2 infection.

Covered Facilities have the flexibility to establish their own processes that permit staff to request a medical exemption from the COVID-19 vaccination requirements. 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, who is not the individual requesting the exemption and is acting within their respective scope of practice based on applicable state and local laws. This documentation must contain all information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. Additionally, a statement by the authenticating practitioner recommending that the staff member be exempted from the facility’s COVID-19 vaccination requirements is also expected.

CMS requires that facilities develop a process for implementing additional precautions for any staff who are not vaccinated in order to mitigate the transmission and spread of COVID-19. Under federal law, including the ADA and Title VII of the Civil Rights Act of 1964, individuals who cannot be vaccinated because of medical conditions or sincerely held religious beliefs, practice, or observance may be entitled to an accommodation. CMS encourages facilities to review the Equal Employment Opportunity Commission’s website for additional information about situations that may warrant accommodations. In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID-19 to at-risk individuals, in keeping with their obligation to protect the health and safety of patients.

Enforcement and Penalties

CMS will work directly with the 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:

• State survey agencies will assess all facilities for these requirements during the standard recertification survey.

• 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.

Medicare- and Medicaid-certified 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; however, 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.

CMS is not planning to use the new COVID-19 Vaccination Coverage among Health Care Personnel (HCP) quality measure to monitor compliance for providers participating in the Inpatient, PPS-Exempt Cancer Hospital, Long Term Care Hospital, Inpatient Psychiatric, and Inpatient Rehabilitation Quality Reporting Programs. These facilities are expected to report on the new COVID-19 Vaccination Coverage among Health Care Personnel quality measure from October 1, 2021 to December 31, 2021 as established in the various Fiscal Year 2022 payment rules. While this quality measure will provide valuable insight into the number of staff vaccinated over the course of a three-month period, CMS will continue to ensure compliance with the new staff vaccination requirement through the established survey process. As data become available, CMS will continue to evaluate opportunities to inform the survey process.

Alignment with OSHA Emergency Temporary Standard for Healthcare Employers

On June 21, 2021, the Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) to protect healthcare and healthcare support service workers from occupational exposure to COVID-19. Under OSHA regulations at 29 CFR Subpart U (86 FR 32376), covered healthcare employers must develop and implement a COVID-19 plan to identify and control COVID-19 hazards in the workplace and implement requirements to reduce transmission of COVID-19 in the workplace related to the following: patient screening and management, standard and transmission-based precautions, personal protective equipment (facemasks, respirators), controls for aerosol-generating procedures, physical distancing of at least six feet when feasible, physical barriers, cleaning and disinfection, ventilation, health screening and medical management, training, anti-retaliation, recordkeeping, and reporting. The OSHA ETS encourages vaccination by requiring employers to provide reasonable time and paid leave for employee vaccinations and any side effects. The OSHA ETS exempts certain settings including, but limited to (1) non-hospital ambulatory care settings where all non-employees are screened prior to entry and people with suspected or confirmed COVID-19 are prohibited from entry, (2) well-defined hospital ambulatory care settings where all employees are fully vaccinated and individuals with possible COVID-19 are prohibited from entry, and (3) home healthcare settings where all employees are fully vaccinated and there is no reasonable expectation that individuals with COVID-19 will be present.

On November 5, 2021, OSHA issued a second emergency temporary standard requiring worker vaccinations for any employers with 100 or more employees or weekly testing for those who remain unvaccinated without an eligible exemption. CMS worked closely with OSHA to ensure that both regulations were complementary, ensured maximum coverage of staff/workers across a multitude of settings, and were not overly duplicative.

However, unlike the New OSHA Emergency Temporary Standard (for Employers with 100+ employees), also effective as of November 5, 2021, the CMS Rule did not include a testing requirement/alternative for unvaccinated staff; the regulation requires staff vaccination or a valid exemption.[6]

Interaction with State Law and Other Vaccine Mandates

In anticipation of state legal challenges or legislative prohibitions on vaccine mandates,  CMS asserts that a Covered Facility is required to follow the regulation because, under the Supremacy Clause of the U.S. Constitution, it pre-empts any state law to the contrary. U.S. Const. art. VI § 2.

In assessing the various vaccination mandates, including the CMS Omnibus Staff Vaccination Rule, the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, the OSHA COVID-19 Healthcare Emergency Temporary Standard, or the new OSHA Emergency Temporary Standard (100+ employees), CMS states that if a Medicare- or Medicaid-certified provider or supplier falls under the requirements of the CMS Rule, it should look to those requirements first. Healthcare facilities are generally subject to new federal vaccination requirements based on primacy. If facilities participate in and are certified under the Medicare and Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation, then they are expected to abide by the requirements established in the CMS Rule. This rule takes priority above other federal vaccination requirements. CMS’s oversight and enforcement will exclusively monitor and address compliance for the provisions outlined in the CMS Rule, while also continuing to monitor for proper infection control procedures as established under previous regulations.

There are rare situations where the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or the OSHA COVID-19 Healthcare Emergency Temporary Standard may also apply to staff who are not subject to the vaccination requirements outlined in the CMS Rule. Facilities should review these regulations and comply with any other federal requirements as necessary.  If facilities are not certified under the Medicare and Medicaid programs and therefore not regulated by the CoPs, then the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors or OSHA COVID-19 Healthcare Emergency Temporary Standard apply. The OSHA COVID-19 Employer Emergency Temporary Standard (for facilities with greater than 100 employees) applies to employers that are not subject to the preceding two regulations. Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements.  

[1] CMS has also indicated that the vaccination requirements may under the circumstances apply to non-hospital employees when considering the frequency of presence, services provided, and proximity to patients and staff. For example, a construction crew working on a project at a facility and whose members share facilities used by staff, patients, and visitors would be subject to these requirements as well.

[2] Individuals who provide services 100 % remotely and who do not have any direct contact with patients or other staff, such as fully remote telehealth or payroll services, are not subject to the vaccination requirements.  The regulation also does not apply to Religious Nonmedical Health Care Institutions (RNHCIs), Organ Procurement Organizations (OPOs), and Portable X-Ray Suppliers.  In addition, the regulation does not apply to Medicaid home care services, such as Home and Community-based Services (HCBS) since these providers receive Medicaid funding but are not regulated as certified facilities.  CMS’s health and safety regulations do not cover providers of Home and Community-based Services.

[3] For purposes of this regulation, CMS currently considers staff fully vaccinated if it has been two weeks or more since they completed a primary vaccination series for COVID-19. However, staff who have who have completed the primary series for the vaccine received by the Phase 2 implementation date are considered to have met these requirements, even if they have not yet completed the 14-day waiting period required for full vaccination. The completion of a primary vaccination series for COVID-19 is defined in the rule as the administration of a single-dose vaccine (such as the Johnson & Johnson COVID-19 Vaccine), or the administration of all required doses of a multi-dose vaccine (such as the Pfizer-BioNTech COVID-19 Vaccine (interchangeable with the licensed Comirnaty Vaccine) or the Moderna COVID-19 Vaccine). Additionally, staff who receive vaccines listed by the World Health Organization (WHO) for emergency use that are not approved or authorized by the FDA or as a part of a clinical trial are also considered to have completed the vaccination series in accordance with CDC guidelines.

[4] Because the science and clinical recommendations around additional doses and boosters are evolving rapidly, CMS refers individuals to CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States for additional details. To improve immune response for those individuals with moderately or severely compromised immune systems who received either the Pfizer-BioNTech COVID-19 Vaccine or Moderna COVID-19 Vaccine, CDC advises an additional (third) dose after completing the primary vaccination series. Additionally, and for the purposes of this rule, documented receipt of additional or booster doses is not needed for staff who have completed a COVID-19 primary vaccination series authorized or licensed by the FDA, or listed by the WHO for emergency use. Staff who have not received all manufacturer recommended doses of a vaccine listed for emergency use by the WHO may receive an FDA licensed or authorized COVID-19 vaccination series.

[5] CMS encourages facilities to review the Equal Employment Opportunity Commission’s Compliance Manual on Religious Discrimination for more information on religious exemptions.  Facilities have the flexibility to establish their own processes that permit staff to request a religious exemption from the COVID-19 vaccination requirements. CMS requires 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.

[6] While CMS considered requiring daily or weekly testing of unvaccinated individuals, scientific evidence on testing found that vaccination is a more effective infection control measure. CMS will continue to review the evidence and stakeholder feedback on this issue, however facilities may voluntarily institute testing alongside other infection prevention measures such as physical distancing and source control. Of note, CMS published an emergency regulation in September 2020 that established new requirements for Long Term Care facilities (nursing homes) to test facility residents and staff for COVID-19. CMS expects continue compliance with this requirement. Additionally, CMS encourages facilities not covered under this regulation to review the OSHA Emergency Temporary Standard for separate vaccination and testing requirements.