News

The Centers for Medicare and Medicaid Services (CMS) issued an emergency regulation on November 4, 2021, requiring COVID-19 vaccination for health care workers (Mandate). The regulation applies to more than 17 million health care workers across the country.

Following are questions and answers about the Mandate:

Q: What types of facilities Are covered by the Mandate?

A: Covered by the Mandate are the following facilities directly regulated by CMS:

• Ambulatory surgical centers,
• Hospices,
• Programs of all-inclusive care for the elderly,
• Hospitals and critical access hospitals,
• Long-term care facilities (nursing homes and skilled nursing facilities),
• Psychiatric residential treatment facilities,
• Intermediate care facilities for individuals with intellectual disabilities,
• Home health agencies,
• Comprehensive outpatient rehabilitation facilities,
•  Clinics (rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services),
• Community mental health centers,
• Home infusion therapy suppliers,
• Rural health clinics and federally qualified health centers, and
• End-stage renal disease facilities.

Q: Are private physician offices covered by the Mandate?

A: No. The Mandate does not apply to other health care entities not listed above, such as physician offices. However, other mandates issued at the state level may apply. Additionally, the Occupational Safety and Health Administration (OSHA)  issued a separate vaccination requirement that applies to companies across all industries that have at least 100 workers.

Q: Does the Mandate apply to assisted living facilities, group homes or other congregate living settings?

A: No. Those entities are not regulated directly by CMS and are not covered by the Mandate. However, other mandates issued at the state level may apply. Additionally, OSHA issued a separate vaccination requirement that applies to companies across all industries that have at least 100 workers.

Q: Which staff members are covered by the CMS Mandate?

A: The Mandate applies to all staff working at a covered facility regardless of clinical responsibility or patient contact. This includes facility employees; licensed practitioners; individuals who provide care, treatment or other services for the facility and/or its patients under contract or other arrangements; students; trainees and volunteers. The Mandate also extends to off-site staff who interact with other staff, patients, residents, clients or program participants in any location beyond the formal clinical setting (such as homes, clinics, other sites of care, administrative offices and off-site meetings.)

Q: Does the Mandate apply to “one-off” vendors that enter a health care facility?

A: No. The Mandate does not apply to outside parties that enter a facility for a limited, one-off purpose, such as delivery or repair personnel, though CMS encourages facilities to require vaccination for these individuals where possible. However, the Mandate does apply to individuals working on an ongoing construction project on-site if they use common facilities with staff or patients, such as restrooms or cafeteria, or interact routinely with other facility staff.

Q: If a staff member works remotely does this mandate still apply?

A: No. Individuals who provide services 100% remotely and who do not have any direct contact with patients and other staff, such as fully remote telehealth or payroll services, are not subject to the Mandate.

Q: What are the vaccination deadlines?

A: All covered facilities must establish a policy ensuring all eligible staff have received their first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine prior to providing any care, treatment or other services by December 5, 2021. All eligible staff must be fully vaccinated by January 4, 2022, which means staff have completed the primary series for the vaccine, having either received a one-dose shot or the second dose of a two-dose shot even if they have not yet completed the 14-day waiting period required for full vaccination.

Q: Are there any exemptions to the Mandate?

A: Yes. The Mandate allows for exemptions based on recognized medical conditions or religious beliefs. Each facility will need to develop a plan for permitting exemptions in alignment with federal law and document each exemption.

Q: What types of medical exemptions are anticipated?

A: Though each facility will develop its own policy, the policy must require documentation confirming recognized clinical contraindications to COVID-19 vaccinations 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.

Q: Are there exemptions for staff who show they have COVID-19 antibodies?

A: No. Staff who have previously had COVID-19 are not exempt from the Mandate.

Q: Does the Mandate require booster shots?

A: No. While the Food and Drug Administration (FDA) and the CDC have recommended boosters for certain groups, the Mandate does not require boosters.

Q: Does the Mandate offer a testing requirement or option for unvaccinated staff?

A: No. All eligible staff must be vaccinated by the deadlines in the Mandate. There is no option for staff, without an applicable religious or medical exemption, to choose to be tested rather than receive the vaccination. However, facilities must develop policies, which may include routine testing along with other precautions, for staff who qualify for a religious or medical exemption.

Q: What will happen if a facility fails to comply with the emergency regulation?

A: For nursing homes, home health agencies and hospice beginning in 2022, enforcement may include civil monetary penalties, denial of payment and even termination from the Medicare and Medicaid program as a final measure. The remedy for noncompliance among hospitals and certain other acute and continuing care providers is termination; however, CMS’ 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.

Q: Which rule is a health care facility expected to follow? The CMS Mandate or the new OSHA Emergency Temporary Standard (ETS)?

A: The facilities listed above should adhere to the requirements of this Mandate. On the same day CMS announced the Mandate, OSHA issued a vaccination requirement for companies with more than 100 employees with slightly different requirements. However, the OSHA policy does not apply to facilities covered by the Mandate. Other health care providers not covered by the Mandate may be subject to other state or federal vaccination requirements, including the OSHA requirement. Note, however, that the prior OSHA ETS issued in June 2021, which addresses mitigating COVID-19-related hazards to workers in health care settings, including training on COVID-19 transmission, increased cleaning standards and providing paid leave for employees to get vaccinated, still remain in effect even for entities covered by the Mandate.

Q: Is there an opportunity to provide feedback to CMS?

A: Yes. While the Mandate was issued as an emergency regulation and is effective as of November 5, 2021, stakeholders will still have 60 days to submit formal comment. However, the vaccination deadlines will occur prior to the comment period closing on January 4, 2022, so employers should not wait to begin implementing vaccination policies as it is unlikely that CMS will make any drastic changes to the Mandate.

Q: Will there be legal challenges to the Mandate?

A: Yes. It is anticipated that some facilities or individuals will file suit to try to prevent CMS from implementing or enforcing the Mandate. However, CMS has broad authority to issue requirements for the facilities it administers, so these facilities should not wait to begin developing and implementing the required policies while legal challenges unfold.

If you have any questions or comments about the Mandate, contact Alexandria K. Montanio.

For additional information on the impact of the coronavirus, visit our information hub for a list of up-to-date content.

Alexandria K. Montanio
410-576-4278 • amontanio@gfrlaw.com