COVID-19

CMS Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule

 

Basics  

The emergency regulation is effective as of November 5, 2021, and it ensures safety and protection from COVID-19 for anyone seeking care as the utmost priority. This rule is being issued as an Interim Final Rule without going through notice and comment rulemaking because considering the increased presence of COVID-19 and the Delta variant, CMS found good cause to issue an emergency regulation as an Interim Final Rule allowing the agency to take immediate action to protect the health and safety of residents, clients, patients, and staff. Stakeholders will still have an opportunity to comment on the regulation.

Stakeholders will have 60 days to submit formal comments on comments on the emergency regulations. It’s important to note that this is an emergency regulation and that requirements will go into effect immediately and before any additional response is provided on the comments by CMS. The comment period officially closes on January 4, 2022, at which time CMS will consider and respond to comments as a part of potential future rulemaking if needed.

The staff vaccination requirements apply to Medicare and Medicaid-certified provider and supplier types (collectively, “facilities”) that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements. Facilities are required to have a process or policy in place ensuring that all applicable staff is vaccinated against COVID-19.

Conditions of Participation (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation are foundational health and safety standards established by CMS to protect individuals receiving health care services from Medicare and Medicaid-certified facilities. These foundational health and safety standards cover 21 health care provider and supplier types. To participate in the Medicare and Medicaid programs, health care providers and suppliers must abide by these regulations.

Eligibility  

The staff vaccination requirement applies to the following Medicare and Medicaid-certified provider and supplier types:

  • 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
  • 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

This 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. The requirement includes all current staff and any new staff who provide any care, treatment, or other services for the facility and/or its patients.

This includes facility employees, licensed practitioners, students, trainees, and volunteers. Additionally, this also includes individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangements.

These requirements apply to staff who work offsite as well and are not limited to those staff who perform their duties solely within a formal clinical setting. Many health care staff routinely care for patients and clients outside of such facilities (e.g. home health, home infusion therapy, etc.), so 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, these requirements do not apply to individuals who provide fully remote services and who do not have any direct contact with patients and other staff. These roles include fully remote telehealth or payroll services which are not subject to the vaccination requirements outlined in this regulation.

A physician admitting and/or treating patients in-person within a facility subject to the CMS health and safety regulations and included as a part of this requirement must also be vaccinated so that the facility is compliant. This requirement also applies to the Indian Health Service (HIS) as they are regulated under the CoPs, therefore the staff vaccination requirement outlined within this regulation applies. Religious Nonmedical Health Care Institutions (RNHCIs), Organ Procurement Organizations (OPOs), and Portable X-Ray Suppliers are not included in these requirements.

RNHCIs do not furnish, based on religious beliefs, through its personnel or otherwise, medical items and services (including any medical screening, examination, diagnosis, prognosis, treatment, or the administration of drugs) for their patients, but instead furnishes only nonmedical nursing items and services to beneficiaries who choose to rely solely upon a religious method of healing, and for whom the acceptance of medical services would be inconsistent with their religious beliefs.

Note: the religious components of this type of healing services are not covered by CMS under this benefit; only nonmedical items and services are provided exclusively through nonmedical nursing personnel who are experienced in caring for the physical needs of nonmedical patients are covered). We, therefore, do not believe it would be appropriate to CMS.

For OPOs and Portable X-Ray Suppliers, it is important to note that the staff of these entities is indirectly included in the vaccination requirements through their service arrangements with hospitals, LTC facilities, and other providers and suppliers included under this rule. A service arrangement is when these providers have a contract with other providers to furnish services. That contract may require individuals from these organizations to be vaccinated.

Additionally, entities not covered by this rule may still be subject to the other state or federal COVID-19 vaccination requirements, such as those being issued by the Occupational Safety and Health Administration (OSHA).

This regulation only applies to Medicare and Medicaid-certified facilities. CMS does not have regulatory authority over care settings such as Assisted Living Facilities or Group Homes. This regulation will also not apply to physician’s offices because they are not subject to CMS health and safety regulations.

This regulation only applies to those Medicare and Medicaid-certified provider and supplier types that are subject to CMS health and safety regulations. CMS’s health and safety regulations do not cover providers of Home and Community-based Services.

This requirement doesn’t apply to schools receiving Medicaid funding. It only applies to those Medicare and Medicaid-certified provider and supplier types that are regulated under CMS health and safety regulations. CMS does not regulate schools.

CMS is using the authority established by Congress under the Social Security Act to regulate Medicare and Medicaid-certified health facilities. Sections 1102 and 1871 of the Social Security Act (the Act) grant the Secretary of Health and Human Services authority to make and publish such rules and regulations, not inconsistent with the Act, as may be necessary to the efficient administration of the functions with which the Secretary is charged under this Act. Citations to the relevant statutory authorities for each specific type of provider and supplier are set out in the discussion of each provider- and supplier-specific provision of the regulation. This authority does not extend to certain facilities nor independent physicians/clinicians.

Requirements  

To remain compliant with the regulation, healthcare providers must establish a process or policy to fulfill the staff vaccination requirements over two phases:

Phase 1- Within 30 days after the regulation is published, staff at all health care facilities included within the regulation must have received, at a minimum, the first dose of a primary series or a single dose COVID-19 vaccine before staff providing any care, treatment, or other services for the facility and/or its patients.

Phase 2- within 60 days after the regulation is published, staff at all health care provider and supplier types included in the regulation must complete the primary vaccination series (except for those who have been granted exemptions from the COVID-19 vaccine or those staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by CDC).

For 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 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 (Janssen) 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 is not approved or authorized by the FDA or as a part of a clinical trial are also considered to have completed the vaccination series per CDC guidelines.

 The vaccines which count toward the requirement:  

CMS expects that staff will receive a vaccine licensed or authorized for emergency use by the Food and Drug Administration (FDA), which currently includes-

  • Pfizer-BioNTech COVID 19 Vaccine (interchangeable with the licensed Comirnaty vaccine)
  • Moderna COVID-19 Vaccine
  • Janssen (Johnson & Johnson) COVID-19 Vaccine

Facilities will also comply if they allow staff to work who received a vaccine listed by the World Health Organization (WHO) for emergency use that is not approved or authorized by the FDA, or who received a vaccine during their participation in a clinical trial.

CMS expects that vaccine administration will occur within the United States for most staff and that individuals will receive a COVID-19 vaccine authorized for emergency use or licensed by the FDA. However, it is permissible to receive a COVID-19 vaccine outside of the United States. Eligible COVID-19 vaccinations administered to staff outside of the United States include those that are FDA licensed or authorized for emergency use or those that are listed by the WHO for emergency use.

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 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.

To be considered fully vaccinated, staff must complete a primary vaccination series for COVID-19 as defined in the rule as the administration of a single-dose vaccine, such as the Janssen (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. FDA has approved, and CDC has recommended, boosters for certain groups that previously completed a primary vaccination series. Because the science and clinical recommendations around additional doses and boosters are evolving rapidly, we refer individuals to CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States for additional details.

Furthermore, 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, the CDC advises an additional (third) dose after completing the primary vaccination seriesAdditionally, and for 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.

If a member of your staff received a COVID-19 vaccine that is not FDA approved or authorized and is not listed by the WHO for emergency use may receive an FDA licensed or authorized vaccination series.

Per CDC guidelines, staff in this category should wait at least 28 days following the last dose of a non-FDA approved or authorized and non-WHO-listed vaccination to begin a new series. Staff should consult with their doctor or other health care provider if they have questions about their vaccination.

According to the CDC, no additional doses are needed for staff who participated in a clinical trial at a site in the U.S. and received the full series of an “active” vaccine candidate (not placebo) and vaccine efficacy has been independently confirmed (by a data and safety monitoring board). Staff should consult with their doctor or other health care provider if they have questions about their vaccination.

COVID-19 vaccines are not interchangeable. Therefore, individuals should generally avoid using heterologous vaccines—meaning receiving doses of different vaccines—to complete a primary COVID-19 vaccination series. If one of your staff received a mix of vaccines as part of their COVID-19 primary vaccination series, it does not count toward the vaccination requirement.

Nevertheless, CDC does recognize that, in certain exceptional circumstances (e.g., when the vaccine product given for the first dose cannot be determined or is no longer available), a different vaccine may be used to complete the primary COVID-19 vaccination series. Accordingly, staff may be considered compliant with the requirements within this regulation if they have received any combination of two doses of a vaccine licensed or authorized by the FDA or listed on the WHO emergency use list as part of a two-dose series. Of note, the recommended interval between the first and second doses of a vaccine licensed or authorized by FDA, or listed on the WHO emergency use list, varies by vaccine type. To be compliant with this requirement, the second dose in a two-dose mixed vaccine series must have been received no earlier than 28 days after the first dose.  

There will not be different requirements for existing staff versus new staff. Staff at all health care facilities included within the regulation must have received, at a minimum, the first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by the regulatory deadline, or before providing any care, treatment, or other services for the facility and/or its patients.

The regulation does not include testing requirements for unvaccinated staff. This regulation requires staff vaccination only. 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 to 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.

This regulation does not establish new data reporting requirements. However, hospitals and Long-Term Care facilities (nursing homes) are expected to continue complying with their facility-specific data reporting requirements outlined in the emergency regulations issued by CMS in May 2020, August 2020, and May 2021, respectively. Additionally, facilities participating in the Inpatient, PPS-Exempt Cancer, Long Term Care Hospital, Inpatient Rehabilitation, and Inpatient Psychiatric Quality Reporting Programs must collect data on the new COVID-19 Vaccination Coverage among Health Care Professionals measure from October 1, 2021, to December 31, 2021, and quarterly thereafter.

Exemptions 

CMS requires 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). 

Providers and suppliers 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 (under the ADA or Title VII of the Civil Rights Act of 1964) or who requests an exemption solely to evade vaccination.

There is provision for certain individuals for whom a vaccination should be delayed, for example, because of a recent COVID-19 diagnosis. The regulation addresses staff for whom COVID-19 vaccination must be temporarily delayed, as recommended by the CDC, due to clinical precautions and considerations.

The regulation does not include exemptions for staff that show they have COVID-19 antibodies. Staff who have previously had COVID-19 are not exempt from these vaccination requirements. 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. 

Facilities will determine if an individual’s request for a religious exemption is valid by reviewing the Equal Employment Opportunity Commission’s Compliance Manual on Religious Discrimination for more information on religious exemptions as encouraged by CMS.

The process for staff to seek a religious exemption: 

Facilities have the flexibility to establish their 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 following applicable federal law and as a part of a facility’s policies and procedures.

The process for staff to seek a medical exemption:

Like religious exemptions, facilities have the flexibility to establish their 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.

Accommodations for staff members who meet the requirements for an exemption and are not vaccinated:

The regulation requires that facilities develop a process for implementing additional precautions for any staff who are not vaccinated, 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, practices, 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  

CMS works directly with the State Survey Agencies to regularly review compliance with Medicare/Medicaid regulations across multiple health care settings to enforce the new requirement on facilities.

CMS expects state survey agencies to conduct onsite compliance reviews of these requirements in two ways: 

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

Penalties: 

Medicare and Medicaid-certified facilities are expected to comply with all regulatory requirements, and CMS has a variety of established 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 program 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 health care facilities into compliance. Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.

Opportunities that are available to return to compliance for hospitals and other acute and continuing care providers:

CMS surveyors cite hospitals and other facilities based on the severity of the deficiency, classified among three levels, from most to least severe: “Immediate Jeopardy”, “Condition”, and “Standard.” In all cases, health care facilities have an opportunity to return to compliance before termination.

  • “Immediate Jeopardy” citations indicate a serious scope of non-compliance, failure of the provider to address deficiencies, and close interaction with patients of unvaccinated staff. Termination of the provider type will occur within 23-days following the citation if not immediately addressed.
  • “Condition” level citations indicate substantial non-compliance that needs to be addressed to avoid termination.
  • “Standard” level citations indicate minor non-compliance where (concerning this rule) almost all staff are vaccinated, the provider has a reasonable policy in place to educate staff on the vaccinations, and the provider has procedures for tracking and monitoring vaccination rates. CMS generally allows for continued operation subject to the facility’s agreement to a CMS-approved plan of correction.

CMS is not planning to use the new COVID-19 Vaccination Coverage among Health Care Personnel (HCP) quality measure to monitor compliance. Providers participating in the Inpatient, PPS-Exempt Cancer Hospital, Long Term Care Hospital, Inpatient Psychiatric, and Inpatient Rehabilitation Quality Reporting Programs 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 throughout 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

How CMS staff vaccination requirement interacts with OSHA requirements on this issue: 

On June 21, 2021, the Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) to protect health care and health care support service workers from occupational exposure to COVID-19.

Under OSHA regulations at 29 CFR Subpart U (86 FR 32376), covered health care 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 their workplaces 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
  • 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 before 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.

(3) home health care settings where all employees are fully vaccinated and there is no reasonable expectation that individuals with COVID-19 will be present.

In early November, 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.

Interaction with State Law  

If state law prohibits vaccine mandates, under the Supremacy Clause of the U.S. Constitution, this regulation pre-empts any state law to the contrary. U.S. Const. art. VI § 2.

Should a facility follow 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 upcoming (or new) OSHA Emergency Temporary Standard: 

If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s Omnibus Staff Vaccination Rule, it should look to those requirements first. Health care 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 Omnibus Staff Vaccination 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 Omnibus Staff Vaccination 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 Omnibus Staff Vaccination 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 applies.

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.

It’s important to understand that all federal entities, including CMS, OSHA, and others, worked closely together to ensure that all requirements were complementary, ensure maximum coverage of staff across settings, and were not overly duplicative.