Publications

11.05.2021

On November 5, 2021, the Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) published the highly anticipated interim final rule requiring vaccination of Staff members against COVID-19 for various health care providers and suppliers. This interim final rule with comment period (IFC) focuses on implementing vaccination requirements to those providers and suppliers regulated under their respective Conditions of Participation, Conditions for Coverage, or Requirements for Participation (collectively, “Conditions”) under CMS’ authority. Thus, CMS establishes its authority to mandate these requirements due to their authority to impose health and safety requirements for Medicare- and Medicaid-certified providers and suppliers. The rule is broken into two phases, which are discussed in more detail below. This IFC compliments the emergency temporary standard published by the Occupational Safety and Health Administrations on the same day.

Providers and Suppliers Applicability

The IFC applies to the following providers and suppliers which are grouped into four different categories:

1. Residential Congregate Care Facilities: (a) Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs) (i.e., nursing homes); (b) Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID); and (c) Psychiatric residential treatment facilities (PRTFs).
2. Acute Care Settings: (a) hospitals; (b) Critical Access Hospitals (CAHs); and (c) Ambulatory Surgical Centers (ASCs).
3. Outpatient Clinical Care and Services: (a) End-Stage Renal Disease (ESRD) Facilities; (b) Community Mental Health Centers (CMHCs); (c) Comprehensive Outpatient Rehabilitation Facilities (CORFs); (d) Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs); and (e) Clinics, Rehabilitation Agencies, and Public Health Agencies as providers of outpatient physical therapy and speech-language pathology services.
4. Home-Based Care: (a) Home Health Agencies (HHAs); (b) Hospices; (c) Home Infusion Therapy (HIT) Suppliers; and (d) Programs for All-Inclusive Care for the Elderly (PACE).

The providers and suppliers above each fall within the grasp of CMS’ authority through their obligations to meet their respective Conditions. Notably, the IFC does not apply to health care entities such as physician offices. However, employees of physician offices may still come under the scope of the IFC if they provide care, treatment or other services to facilities and/or facility patients when such facility is covered by the IFC.

Facility Staff Applicability

Under Phase 1, providers and suppliers (collectively, facilities) listed above must develop policies and procedures that ensure that all Staff are vaccinated against COVID-19. “Staff” for purposes of the rules encompasses “any individual that performs their duties at any site of care, or has the potential to have contact with anyone at the site of care, including staff or patients[.]”[1] This includes facility employees, licensed practitioners, students, trainees, volunteers, administrative staff, facility leadership, board members, housekeeping and food services, etc.

Individuals who telework but may encounter fellow Staff or enter a facility for their duties irregularly are considered Staff as well; however, if an individual works 100 percent remotely, then such individual is not subject to this IFC. Additionally, individuals who provide care, treatment or other services, under contract or other arrangement, to facilities and/or facility patients are considered part of the facility’s “Staff” for purposes of the IFC.

Individuals who provide ad hoc non-health care services (e.g., annual elevator inspectors, HVAC repair personnel, etc.) and those who perform services exclusively “off-site” are excluded from the rule. It is important to note that “off-site” means not present at either: the site of patient care or adjacent to the site of patient care. Additionally, individuals who visit a facility or site of care infrequently for limited purposes and are not providing services under arrangement or by contract (e.g., delivery and repair personnel) are also excluded from the rule. CMS does, however, give facilities the option to choose whether they extend their policies beyond those individuals who are considered Staff, thus, facilities could apply their policies and procedures to any individual that interacts with the Staff or facility.

Vaccination Requirement and What It Means to be “Fully Vaccinated”

Under the IFC, facilities are required to have their Staff be fully vaccinated against COVID-19. By the effective date of Phase 1 (listed below), Staff must have received their first dose, or only dose if a single-dose vaccine, of a COVID-19 vaccine (or have requested or been granted an exemption) prior to providing any care, treatment or other services for the facility and/or the facility’s patients. By the effective date of Phase 2 (listed below), Staff must be fully vaccinated unless the individual has been granted an exemption or COVID-19 vaccination is temporarily delayed due to clinical precautions and considerations (which is a Centers for Disease Control and Prevention (CDC) determination).

“Fully vaccinated” means two weeks after completion of either a single-dose vaccine or all required doses of a multi-dose vaccine (referred to as a “primary vaccination series”). For purposes of satisfying the Phase 2 effective date, however, CMS provides that Staff who have received their second dose by the Phase 2 effective date are considered fully vaccinated. Providers and suppliers should be aware, however, that waiver of this 2-week time period does not mean that such individuals should be viewed as “fully vaccinated” for purposes of their policies and procedures. Thus, such policies and procedures should address how the facility will monitor those who are not “fully vaccinated” from a definitional view.

On a related note, the IFC does not require booster doses. Furthermore, individuals will be considered compliant with the rule regardless of the combination of vaccine doses they receive as long as the vaccine is authorized by the Food and Drug Administration or is listed on the World Health Organization’s emergency use list and the second dose is received no earlier than seventeen (17) days after the first dose.

Policies and Procedures

The policies and procedures that facilities implement must address certain topics. First, the policies and procedures must address processes for implementing precautions which help mitigate the transmission and spread of COVID-19 for all Staff who are not fully vaccinated. Providers and suppliers can implement such precautions according to their respective infection and disease control requirements of their Conditions.[2]

Second, the policies and procedures must ensure that vaccination requirements are met through proper tracking and securely documenting vaccination status of Staff. This documentation includes those who have delays in vaccination, exemption requests, and exemption determinations and applies to all current and future Staff. Storage of the documents must comply with the Americans with Disabilities Act and the Rehabilitation Act. Furthermore, CMS provides that acceptable forms of proof vaccination include: the CDC COVID-19 vaccination record card or a picture of the card, a health care provider’s documentation of the vaccination or electronic health record, or a state immunization system record.

Third, there must be proper policies and procedures regarding exemptions. The policies and procedures must address how Staff can request an exemption based on applicable Federal law. Exemptions may be granted for religious beliefs, certain allergies, and medical conditions, however, this is not an exhaustive list of exemptions. In addition to addressing how requests are made, the facility must also address how requests are evaluated, collected, and granted. Federal law governs exemptions related to religious beliefs, disabilities, etc.; however, if the exemption is a medical exemption, the facility is required to obtain documentation signed and dated by a licensed practitioner acting within their scope of practice (who is not the individual requesting the exemption) supporting the medical exemption. Furthermore, facilities must make sure their policies and procedures address how accommodations are addressed.

Finally, the policies and procedures must address certain contingency plans. These plans may address scenarios such as emergencies that lead to Staff shortages, how the facility will handle lack of vaccinated Staff, and how the facility will oversee Staff with exemptions.

Enforcement

Because the requirements under the IFC are inserted into the respective provider and supplier Conditions, the same penalties and enforcement methods imposed by CMS for noncompliance with such Conditions apply here. This may include, civil money penalties, denial of payment, or termination of provider agreements. CMS also indicated that they will issue interpretive guidelines addressing enforcement mechanisms which will include survey procedures of facilities to see how they are complying with the IFC.

Effective Dates

Phase 1 is effective Sunday, December 5, 2021, which includes all of the requirements imposed by the rule except completion of a primary vaccination series. Phase 2 is effective Tuesday, January 4, 2022. By January 4, all Staff must have completed a primary vaccination series subject to the exceptions listed above. It is important to note that there is no sunset clause for this rulemaking and the existence of a public health emergency does not affect the applicability of the rule. Thus, this rule is effective for at least three (3) years subject to additional rulemaking by CMS.

Relationship to Other Rules and Analysis

The Federal government has issued many different rulemakings since the beginning of the COVID-19 pandemic. This IFC is being issued at a time when OSHA has released their highly anticipated mandatory vaccine rule for employers with one hundred (100) or more employees (100 Employer Rule).[3] In addition, OSHA’s emergency temporary standard released back in June (June ETS) has already impacted the healthcare industry as it applies to employers who provide healthcare services or healthcare support services.^[4] Finally, the Safer Federal Workforce Task Force recently released guidance regarding federal contractors as well (further discussion of this guidance can be found here). The following is a step-by-step analysis that health care providers can use to determine which rules apply to them.

First, it must be determined whether this IFC applies to the particular provider (applying the above discussion). If the provider is a facility covered under this IFC, then these rules apply.

1. If the provider is a facility or health care provider not covered under this IFC, then the provider should determine whether its employees are engaging in arrangements whereby the employees are providing services to facilities (or to patients of such facilities) covered under this IFC. If so, those employees are subject to the policies and procedures implemented by those facilities which will incorporate the rules implemented by this IFC.

Second, if the provider determines they are not governed by this IFC but they have more than one hundred (100) employees, then the 100 Employer Rule may still apply. The following steps should be reviewed to determine applicability of the 100 Employer Rule.

1. If the provider is subject to and complying with the mandatory mask mandates of the June ETS, the 100 Employer Rule will not apply (so long as the June ETS is in place);
2. If the provider is exempt from the June ETS regulations, then the 100 Employer Rule will apply;
3. If some of the provider’s employees are subject to the June ETS mandatory mask mandate, but others are exempt, the 100 Employer Rule will apply to those employees that are exempt from the June ETS requirements;
4. Note: it is likely the June ETS will expire in December 2021, at which time, the 100 Employer Rule will apply to all health care providers with more than 100 employees.

This IFC is the first of its kind in regards to federal vaccine mandates. It is important for pertinent providers and suppliers to understand their obligations and take swift action to comply. We will continue to monitor and analyze this rule and provide updates and clarifications on our Website as appropriate. If you have any questions regarding this rule, please contact any member of the Koley Jessen Health Law Practice Group.

[1] 86 Fed. Reg. 61555, 61571 (Nov. 5, 2021).

[2] PRTFs, RHCs/FQHCs and HIT suppliers do not have such requirements, therefore, they must follow nationally recognized infection and disease control guidelines.

[3] 86 Fed. Reg. 61402 (Nov. 5, 2021).

[4] See 29 C.F.R. Part 1910 Subpart U.