Many hospitals and other healthcare organizations started mandating COVID-19 vaccinations for some or all of their workers over the last six months. Now all of the specified Medicare and Medicaid-certified provider and supplier types (referred to as “facilities”) that are regulated under the Medicare health and safety standards known as Conditions of Participation (CoPs), Conditions for Coverage (CfCs), or Requirements, must get all of their workers fully-vaccinated by January 4, 2022, pursuant to the Center for Medicare & Medicaid Services’s Omnibus COVID-19 Health Care Staff Vaccination interim final rule (CMS rule).

Workplace vaccination requirements are nothing new in healthcare settings. For years, hospitals and other healthcare providers have required employees, subject to exceptions, to receive vaccines against ailments like influenza and Hepatitis B. And most recently, and pertaining to the COVID-19 pandemic specifically, the U.S. Occupational Safety and Health Administration (OSHA) issued its COVID-19 healthcare emergency temporary standard (ETS) on June 9, 2021. This new CMS rule presents an extension of prior immunization practices for healthcare facilities.

Effective Date

The CMS interim final rule was published and took effect on November 5, 2021, with a 60-day comment period. The rule does not have a sunset clause or expiration date. CMS indicates it will issue further guidance for implementation soon.

Covered Facilities and Entities Providing Services to Covered Entities

The CMS rule directly applies to the following categories of Medicare- and Medicaid-certified providers and suppliers:

• ambulatory surgical centers
• hospices
• psychiatric residential treatment facilities
• Programs of all-inclusive care for the elderly
• hospitals
• long-term care facilities, including skilled nursing facilities and nursing homes
• intermediate care facilities for individuals with intellectual disabilities
• home health agencies
• comprehensive outpatient rehabilitation facilities
• critical access hospitals
• 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/federally qualified health centers
• end-stage renal disease facilities

CMS excluded assisted living facilities, group homes, home and community-based services, and physicians’ offices from coverage under this rule.

Just because an entity is not identified as directly covered by the rule does not mean that the entity will not need to comply with its requirements. The interim final rule requires individuals contracted to provide services inside a covered entity’s facility to be vaccinated or exempted. Entities that provide in-person services for covered entities may want to start evaluating which of their employees may be covered by this rule and begin planning for compliance.

Preemption and Supremacy

For covered entities, this rule takes priority over other federal vaccination requirements. CMS worked closely with OSHA to ensure that both regulations were complementary to help avoid confusion and duplication during implementation. CMS intends the interim final rule to preempt state laws regarding vaccination requirements and exemptions from vaccination requirements. We can expect litigation challenging this position by CMS and for CMS to vigorously defend its position on preemption.

Covered Staff

The rule 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 new staff who provide any care, treatment, or other services for the facility and/or its patients. The rule is not limited to covered entity employees.

In addition to employees, the vaccine requirement applies to:

• physicians;
• licensed practitioners;
• students;
• trainees;
• volunteers; and
• “individuals who provide care, treatment, or other services for the facility and/or its patients under contract or other arrangement.”

Individuals who provide services 100 percent remotely, away from patients, clients, and other employees, are not subject to the vaccination requirements. For example, the rule does not require fully remote telehealth or payroll services workers to be vaccinated.

Individuals who provide services outside of the covered facility location, but in the presence of patients, clients, or other workers (e.g., home health, home infusion therapy, etc.), are covered by the vaccination requirement in the rule. According to the frequently asked questions on the new rule, “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.”

Three Basic Requirements

According to the new interim final rule, all covered facilities must create and implement a process or plan to:

1. Vaccinate all eligible staff, without a weekly testing option;
2. Provide medical and religious exemptions required by federal law and impose additional safety protocols to 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; and
3. Track vaccination status and maintain a list of all covered staff and their vaccination status for review by onsite surveyors.

Two Phases

The CMS rule provides a timetable divided into two phases:

First phase to be completed by December 5, 2021: the above processes or plans must be in place and all employees must at least have taken their first doses of a vaccine; and

Second phase to be completed by January 4, 2022: all employees must have taken their second doses of a vaccine. Reaching fully-vaccinated status can occur after this deadline as long as the second dose has been received before the deadline.

Medical and Religious Exemptions

According to the interim final rule, employers should offer limited exemptions from the federal vaccination requirement. These include the following scenarios and recommended practices for covered employers:

• Covered facilities should establish an exemption process as a part of its policies and procedures that aligns with federal law, i.e., only individuals who cannot be vaccinated because of true medical contraindications or sincerely held religious beliefs should be allowed accommodation.
• The CMS final rule contemplates that exemptions might be appropriate in only certain limited circumstances, and no exemption should be provided to any staff for whom it is not legally required.
• The interim final rule states that staff who request an exemption solely to evade being vaccinated should be denied an accommodation,
• In addition, staff who have previously had COVID-19 should not receive an exemption from these vaccination requirements.
• Covered facilities must ensure that requests for medical and religious exemptions are documented and evaluated in accordance with applicable federal law.
• The CMS rule encourages facilities to review the Equal Employment Opportunity Commission’s website for additional information about situations that may warrant accommodations.
• In granting exemptions or accommodations, the CMS final rule requires employers to 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.

Tracking and Recordkeeping

The CMS rule sets out specific requirements:

• All staff COVID-19 vaccines must be appropriately documented by covered facilities.
• All medical records, including vaccine documentation, must be kept confidential and stored separately from an employer’s personnel files, pursuant to the Americans with Disabilities Act (ADA) and the Rehabilitation Act.
• Examples of acceptable forms of proof of vaccination include:
  • S. Centers for Disease Control and Prevention (CDC) COVID-19 vaccination record card (or a legible photo of the card),
  • documentation of vaccination from a health care provider, or
  • confirmation from a state immunization information system record.
• Covered facilities have the flexibility to use the appropriate tracking tools of their choice, and CMS refers facilities to the CDC’s tracking tool available on a complimentary basis to the general public.

Enforcement

CMS may use any of the following tools to enforce the interim final rule and achieve compliance:

• civil monetary penalties;
• denial of payment/reimbursement; and
• termination of Medicare and Medicaid certification/participation.

Generally, such sanctions will occur only after a facility is given an opportunity to make corrections and come into compliance. CMS state survey agencies are empowered to and will conduct onsite compliance reviews to assess compliance with the rule and vaccination status of all covered staff.

Key Takeaways

Covered employers may want to implement the following practices as they digest the interim final rule and other relevant guidance and standards.

• Determine which of the federal mandates applies to your organization (in this order of importance):
  • The CMS interim final rule;
  • OSHA’s ETS for healthcare employers;
  • Federal contractor requirements; or
  • OSHA’s ETS for large employers.

• If the CMS rule applies to one or more of facilities, covered employers may want to take the following actions:

• • create and implement a clear plan and process for vaccinating all covered staff by the deadlines; and
  • create and implement a clear and compliant disability and religious belief reasonable accommodation request process that complies with federal law and that exempts staff only if they have a documented valid medical contraindication or a sincerely-held religious belief that precludes taking the vaccination.

• Make and retain appropriate and accurate records regarding the vaccination status of all covered staff.
• Make and retain appropriate and accurate records regarding the exemption and accommodation processes and decisions.
• Minimize the risk of transmission of COVID-19 to at-risk individuals and maximize efforts to protect the health and safety of patients and employees.