The Centers for Medicare & Medicaid Services (CMS) on Nov. 4, 2021, issued a long-anticipated Interim Final Rule with comment (IFC) requiring COVID-19 vaccination for most healthcare workers at certain healthcare facilities certified by CMS. CMS also published a press release, fact sheet, slide presentation and frequently asked questions. The IFC took effect Nov. 5, 2021, but stakeholders have 60 days to provide comments due no later than 5 p.m. on Jan. 4, 2022.
The IFC is intended to be "complementary" to an Occupational Safety and Health Administration (OSHA) emergency rule also issued on Nov. 4, 2021, that applies to employers of 100 or more workers. Holland & Knight has provided an analysis of the OSHA large employer rule. Of note, the OSHA rule faced immediate legal challenges and has been temporarily stayed by the U.S. Court of Appeals for the Fifth Circuit.
The CMS requirements could apply even if a court enjoins the OSHA rules. CMS expects facilities certified by the agency to comply with the IFC, citing its authority to regulate healthcare facilities under Sections 1102 and 1871 of the Social Security Act. It remains to be seen whether the CMS rule will also be challenged.
What Are the Requirements?
The IFC requires covered facilities to establish a policy requiring that all eligible staff receive the 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 Dec. 5, 2021. All eligible staff must have received the necessary shots to be fully vaccinated – either two doses of Pfizer or Moderna or one dose of Johnson & Johnson – by Jan. 4, 2022. At this time, the IFC only requires that workers receive the "primary" vaccine doses and does not require staff to obtain booster doses. Of note, there is no testing option for unvaccinated staff under this requirement. However, the regulation allows exemptions, as explained below.
Which Employers Are Covered?
The IFC applies to Medicare- and Medicaid-certified providers and suppliers regulated under CMS standards. Such "facilities" include, but are not limited to:
- Ambulatory Surgical Centers (ASCs)
- Psychiatric residential treatment facilities (PRTFs)
- Programs of All-Inclusive Care for the Elderly (PACE)
- Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long-term care hospitals, children's hospitals, transplant centers, cancer hospitals and rehabilitation hospitals/inpatient rehabilitation facilities)
- Long-Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes
- Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID)
- Home Health Agencies (HHAs)
- Comprehensive Outpatient Rehabilitation Facilities (CORFs)
- Critical Access Hospitals (CAHs)
- Clinics, rehabilitation agencies and public health agencies as providers of outpatient physical therapy and speech-language pathology services
- Community Mental Health Centers (CMHCs)
- Home Infusion Therapy (HIT) suppliers
- Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs)
- End-Stage Renal Disease (ESRD) Facilities
* Note service providers and suppliers that have a contract with a covered facility would be indirectly affected because of the requirement on covered facilities to ensure that contractors meet the vaccine requirement. (For example, a ground ambulance service that has a contract with a nursing home for transports.)
Are There Any Entities Exempted from this Requirement?
The IFC does not directly apply to other healthcare entities that CMS does not regulate. The regulations do not apply to:
- Religious nonmedical healthcare institutions
- Organ procurement organizations (OPOs)
- Portable X-ray suppliers
- Assisted living facilities
- Group homes
- Home and community-based services
- Physician offices
CMS encourages facilities not covered under this regulation to review the OSHA Emergency Temporary Standard (ETS) for separate vaccination and testing requirements. These facilities will also need to consider the impact of the pending litigation targeting the ETS in the Court of Appeals for the Fifth Circuit and Eleventh Circuit.
Which Staff Personnel Must Comply?
The IFC applies to all current and future employees at covered facilities, regardless of whether the employee holds a clinical or non-clinical position. The regulation broadly defines eligible staff as facility employees, licensed practitioners, students, trainees, contractors and others with direct or indirect patient contact – including administrative staff, facility leadership, board members and environmental services staff.
As discussed above, the policy applies to anyone who provides treatment or services to the facility under contract or other arrangements. Employers and administrators must ensure that all contractors servicing the facility are vaccinated to comply with the new mandate. This rule applies to clinical and non-clinical contractors, such as hospice and dialysis staff, physical therapists, occupational therapists, mental health professionals and social workers.
Are There Any Exclusions?
Exclusions from the requirement are permitted for staff (or contractors) who have pending requests for or have been granted, exceptions to the vaccine requirements, or those staff for whom COVID-19 vaccinations must be temporarily delayed, as recommended by the Centers for Disease Control and Prevention (CDC).
The IFC also excludes staff that provide telehealth services outside of the facility setting and that do not have direct contact with patients and staff that provide support services exclusively outside of the facility setting and do not have direct contact with patients.
What Is the Definition of "Fully Vaccinated?"
The IFC defines an individual as fully vaccinated when two weeks or more have passed since the staff completed a primary vaccination series for COVID-19. That can be either the administration of a single-dose vaccine or the administration of all required doses of a multidose vaccine. It does not include booster shots. Note staff members who've completed their vaccination series by the Jan. 4, 2022, deadline will be considered fully vaccinated, even if they have not yet completed the 14-day waiting period.
What Are the Documentation and Tracking Requirements?
The IFC specifies that providers and suppliers must have a process for collecting and evaluating exemption requests, including tracking and securing documentation of information provided by those who have requested the exemption, the facility's decision on the request and any provided accommodation. Requests for exemptions based on applicable federal law must be documented and evaluated in accordance with the applicable federal law and each facility's policies and procedures.
Does the IFC Preempt State Law?
In anticipation of state legal challenges, CMS asserts that a covered facility is required to follow the regulation because, under the Supremacy Clause of the U.S. Constitution, it preempts any state law to the contrary.
How Will the IFC Be Enforced?
CMS will enforce the regulations through the existing onsite compliance review process with state survey agencies. Accreditation organizations will also be required to update their survey processes. If a facility is not in compliance, the existing enforcement remedies will apply, which could include termination from the Medicare program. Termination would only occur after a facility has been given the opportunity to make corrections. The CMS frequently asked questions make a distinction regarding penalties for types of entities, indicating that for nursing homes, home health agencies and hospice (beginning in 2022), enforcement will include civil monetary penalties, denial of payment and then termination from the Medicare and Medicaid programs as a final measure.