CMS’ Mandatory COVID-19 Vaccination Requirement Reinstated for Louisiana’s Healthcare Facilities

Hospitals and other healthcare facilities that participate in Medicare and Medicaid (collectively Healthcare Facilities) are once again required to comply with the Centers for Medicare and Medicaid Services’ (CMS) COVID-19 vaccine mandate. On Jan. 13, 2022, the U.S. Supreme Court considered both the Occupational Safety and Health Administration (OSHA) vaccine mandate for private employers and the CMS vaccine mandate for healthcare facilities. While the Court struck down the enforceability of the OSHA vaccine mandate, the Court ruled that CMS had the authority to enforce its mandatory vaccination rule for Healthcare Facilities.
As a result of the Supreme Court’s decision, the deadlines by which Healthcare Facilities are required to comply with CMS’ COVID-19 vaccine mandate are now based upon the location of the Healthcare Facility. For ease of explanation, we have broken down the timeline by groups:

• Group 1: Applies to Healthcare Facilities located within the 25-states that did not file legal challenges to CMS’ mandate (Group 1).
• Group 2: Applies to Healthcare Facilities located within the 24-states, including Louisiana, where CMS’ mandate was temporarily enjoined (Group 2).
• Group 3: Applies to Healthcare Facilities in Texas, which were subject to a separate injunction that was lifted on Jan. 19, 2022 (Group 3).

CMS Vaccine Requirements and Applicable Deadlines:

Under the CMS vaccine requirements, Healthcare Facilities must develop and implement policies and procedures requiring all facility personnel to receive the required dosage of an approved COVID-19 vaccine or apply for and receive a medical or religious exemption by the CMS imposed deadlines for Phase 1 and Phase 2. Starting on Feb. 14, 2022, accreditation organizations and CMS-contracted surveyors will begin surveying Healthcare Facilities for compliance with the CMS vaccination requirements as part of any initial certification, standard recertification or reaccreditation, and complaint surveys. Healthcare Facilities with vaccination rates under 100% (excluding Facility Personnel granted an exemption or temporary delay) will be considered non-compliant with CMS’ vaccination requirements.

Specifically:

• Phase 1:
  • Requirement: 100% of Facility Personnel must either (a) receive the first dose of an approved
    two-dose vaccine, (b) receive the single dose of an approved one-dose vaccine, (c) submit a completed application for a medical or religious exemption or (d) qualify for a temporary delay consistent with CDC recommendations.
  • Original Deadline: Dec. 5, 2021;
  • Revised Deadline: Group 1: Jan. 27, 2022;
  • Revised Deadline: Group 2 (which includes Louisiana): Feb. 14, 2022.
  • Revised Deadline: Group 3: Feb. 22, 2022
  • Enforcement: If the Facility has anything less than 100% compliance with the above requirements by the Phase 1 deadline, the facility will receive notice of its non-compliance.
    • A facility that is above 80% and has a written plan to achieve 100% staff compliance within 60 days would not be subject to additional enforcement action.
    • Facilities that do not meet these parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility (e.g., plans of correction, denial of payment, termination, etc.).
• Phase 2:
  • Requirement: 100% of Facility Personnel must either (a) receive and provide documentation of the second dose of a two-dose vaccine, (b) receive written approval from the facility’s designated committee of such personnel’s request for a medical or religious exemption, or (c) qualify for a temporary delay consistent with CDC recommendations.
  • Original Deadline: Jan. 4, 2022;
  • Revised Deadline: Group 1: Feb. 28, 2022;
  • Revised Deadline: Group 2 (which includes Louisiana): March 15, 2022.
  • Revised Deadline: Group 3: March 21, 2022
  • Enforcement: If the Facility has anything less than 100% compliance with the above requirements by the Phase 2 deadline, the facility will receive notice of its non-compliance.
    • A facility that is above 90% and has a written plan to achieve 100% staff compliance within 30 days would not be subject to additional enforcement action.
    • Facilities that do not meet these parameters could be subject to additional enforcement actions depending on the severity of the deficiency and the type of facility (e.g., plans of correction, denial of payment, termination, etc.).

Facilities and Personnel need to understand that CMS expects Facilities to achieve and maintain 100% compliance by April 14, 2022 (for facilities in Louisiana and other Group 2 states). The transitional compliance leeway provided under Phase 1 for 60 days and under Phase 2 for 30 days ends on April 14, 2022. From that point forward, facilities with less than 100% compliance will receive a notice of conditional deficiency and be required to achieve 100% compliance within the parameters developed for complying with Conditions of Participation, which can include termination, denial of payment, and civil monetary penalties depending on the type of Healthcare Facility and severity of the non-compliance.

Facility Personnel:

Facility Personnel Includes: The CMS COVID-19 vaccination requirement applies to virtually all current and new staff working at a CMS certified Healthcare Facility regardless of clinical responsibility or patient contact, including:

• Facility employees, administrative staff and leadership, independent contractors, licensed practitioners, medical staff members, housekeeping and food service workers, students, trainees, and volunteers; and
• Individuals who provide care, treatment, therapy, or other services for the facility and/or its patients under contract or other arrangements (including hospice and dialysis staff, physical, occupational and speech therapists, mental health professionals, social workers, portable x-ray suppliers, etc.)

Limited “Exceptions” to Facility Personnel: As we have all experienced over the past two years, it is difficult to mitigate the spread of SARS-CoV-2, particularly the Omicron variant. Consequently, facilities are encouraged to err on the side of caution and strongly encourage and even extend the vaccination requirement beyond just those listed as Facility Personnel. CMS identified in the original interim final rule the following personnel as not being subject to the vaccination requirement:

• Non-Contact: individuals who do not come to the facility or interact with facility staff or patients including persons performing 100% telework or working exclusively off-site (accounting or auditing firms);
• Limited Contact or “One-Off”: individuals who infrequently enter the facility for limited, specific purposes and for a limited amount of time or have with very limited contact with the facility and its staff including annual elevator inspectors, non-healthcare vendors with limited contact, delivery, or repair personnel.

Developing Reasonable Precautions:

Reasonable Precautions for Facility Personnel: The facility’s policy must also ensure any Facility Personnel a) who are not yet fully vaccinated, b) who have been granted an exemption or accommodation as authorized by law, or c) who qualify for a temporary delay, will adhere to additional reasonable precautions intended to mitigate the spread of COVID-19. There are a variety of actions or job modifications a facility can implement to potentially reduce the risk of COVID-19 transmission including, but not limited to:

• Reassigning such Personnel to non-patient care areas, to duties that can be performed remotely (i.e., telework), or to duties which limit exposure to those most at risk (e.g., assign to patients who are not immunocompromised, unvaccinated, etc.);
• Requiring such Personnel to use a NIOSH approved N95, equivalent or higher-level respirator for source control, regardless of whether they are providing direct care to or otherwise interacting with patients and/or patient care staff;
• Requiring such Personnel to follow additional, CDC-recommended precautions, such as adhering to universal source control and physical distancing measures in areas that are restricted from patient access (e.g., staff meeting rooms, kitchen), even if the facility or service site is located in a parish with low to moderate community transmission;
• Requiring such Personnel to be screened upon entering the facility through temperature checks and possible COVID testing on a schedule designed to reflect the present risks of transmission based on reasonable criteria such as possible exposure to COVID positive persons locally or due to travel, the community transmission rates in the parish, etc.

Reasonable and Prudent Precautions for Non-Facility Personnel: The facility’s policy should develop and implement reasonable protections to mitigate the potential spread of COVID from visitors, delivery personnel, and other non-staff persons and to potentially mitigate the operational burdens of complying with the vaccine mandate. Because it remains unclear exactly how the CMS vaccine mandate will be evaluated in practice by the surveyors, (i.e., what will be considered “infrequent” or “limited” contact, etc.), facilities should take reasonable mitigation precautions to reduce potential transmission as well as the likelihood that surveyors will consider limited contact personnel to have sufficient interactions with facility care staff to be subject to the vaccination requirements. These mitigation precautions should be based on the type, level, and ability to avoid or reduce the transmission risk and should be adaptable as conditions change. When assessing potential exposure risks, the facility could consider:

• the necessity of the person-to-person interaction;
• the ability to reduce the number of people involved, frequency and/or duration of the interactions;
• the transmission rates in the local community or the person’s community; and
• the particular individual’s exposure threat based on travel, duties, etc.

For instance, while the facility’s community may have low transmission rates, if a delivery driver lives and delivers products from a high transmission area, the facility may find it reasonable to impose additional requirements by limiting the driver’s contact to a very limited number of identified facility personnel, requiring the driver to wear an N95 mask, and taking the driver’s temperature. If the driver is delivering food service supplies, the facility could have facility personnel take delivery of the supplies outside by meeting the driver at a designated door to the facility that has limited traffic. On the other hand, if the delivery company or the driver voluntarily provide a copy of the driver’s vaccination records, the facility could reasonably determine that an N95 mask is sufficient.

The essential take-away from these examples is that facilities should look through their operations, identify potential exposure risks, and develop reasonable and workable precautions to mitigate that risk. It is also important to develop reasonable precautions that are functional and operational. Precautions that are overly difficult to comply with will likely be ineffective and may create more risks than a more modest precaution. Healthcare Facilities should carefully review CMS’ latest guidelines and consult with experienced legal counsel to establish effective and operational policies and procedures designed to ensure the facility can comply with the CMS vaccine requirements by the applicable deadlines.

“CMS’ Mandatory COVID-19 Vaccination Requirement Reinstated for Louisiana’s Healthcare Facilities.”

Louisiana Hospital Association Impact Law Brief, Vol. 37, No. 1. Jan. 2022

Michael R. Schulze, Co-authored with Matthew Brown and Heather Arrington