On November 5, 2021, the Centers for Medicare and Medicaid Services will publish in the Federal Register an interim final rule requiring that the following Medicare and Medicaid certified providers and suppliers ensure that all “applicable staff” be vaccinated for COVID-19, including:
- Ambulatory Surgical Centers
- Psychiatric residential treatment facilities
- Programs of all-inclusive care for the elderly (“PACE”)
- Hospitals (including acute care hospitals, psychiatric hospitals, long term care hospitals, children’s hospitals, hospital swing beds, transplant centers, cancer hospitals, and rehabilitation hospitals);
- Long term care facilities, including skilled nursing facilities and nursing facilities, generally referred to as 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; and
- End-stage renal disease facilities.
What Does the Rule Require?
Applicable providers and suppliers must develop and implement policies and procedures under which staff are vaccinated for COVID-19, regardless of clinical responsibility or patient contact and including all current staff as well as any new staff, who provide any care, treatment, or other services for the facility and/or its patients, including facility employees, licensed practitioners, students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement. Effectively, any staff that interact with other staff, patients, residents, clients or PACE program participants in any location would be required to be vaccinated under this rule. For this purpose, staff includes students, trainees and volunteers. The Rule does not apply to individuals who provide services 100 percent remotely, such as fully remote telehealth or payroll services.
Who is Fully Vaccinated?
Fully vaccinated means being 2 weeks or more since completion of a primary vaccination (2 shots for Pfizer and Moderna; 1 shot for Johnson & Johnson).
The rule requires that employers subject to the rule track and document the vaccination status of each staff member, including where there is a delay in vaccination due to the employee’s recent receipt of antibodies or convalescent plasma. This could include:
- CDC vaccination card (or a legible photo of the card);
- State immunization information system record;
- Documentation from a health care provider or electronic health record;
- Reasonable equivalent of any of the following from a non-US source if the individual was vaccinated outside of the US.
Employers subject to this requirement must implement a process by which staff may request an exemption or accommodation from the vaccine requirement based on applicable federal law. State law exemptions are ignored/preempted for this purpose. In granting such exemption or accommodation, employers must 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.
The interim final rule requires that within the period ending December 5, 2021, the policies and procedures will be drafted and all staff, at a minimum, will have received the first dose of the primary series or a single dose of the vaccine. By January 4, 2022, employers must have a fully vaccinated staff, except for those who have been granted an exemption or addressing those who are delayed due to antibodies or plasma issues.
What is the Penalty for Non-Compliance?
CMS will be issuing interpretive guidelines, including survey procedures, following the publication of the rule. Surveyors will be examining compliance with this rule. Employers that are cited for noncompliance will be subject to the enforcement remedies imposed by CMS depending upon the level of non-compliance (penalties can include civil money penalties, denial of payment for new admissions, or termination of provider status).
There are several movements by certain attorneys general and other stakeholders committed to enjoining CMS’s rule and similar rules. It is possible that the rule will be enjoined prior to the December 4, 2021 implementation date. Employers should still strongly consider taking steps to come into compliance as there is no guarantee that the rule will be enjoined. Further, this is only one of several rules to be promulgated on the vaccination subject. Employers subject to the OSHA rule or the federal contractor rule (which alerts may be found here and here) or other state laws may have a different obligation to meet. We recommend consulting with your Michael Best attorney to determine what options are available to your organization.
For additional resources and tools to allow employers to act swiftly in evolving landscape of the COVID-19 vaccine, sample plans and policies, a state-by-state tracker of applicable legal regulations and a broad analysis of laws implicated by the COVID-19 Vaccine and vaccine mandates, consider purchasing Michael Best's Vaccination Policy Toolkit.