November 17, 2021

At the direction of the Biden Administration, the Centers for Medicare and Medicaid Services (CMS) issued, this month, an interim final rule (IFR) that will require hospital personnel to receive one of the federally approved COVID-19 injections, unless they obtain an approved exemption. The agency issued a lengthy “frequently asked questions” (FAQ) document to help clarify the 73-page rule. This alert will provide our readers with the key components of the IFR that are most pertinent to hospital planners and decision-makers.

Covered Entities

Among the long list of health-related institutions that the mandate covers, “hospitals” are included—but specifically hospitals that participate in the Medicare and Medicaid programs. That pretty much means nearly every acute care hospital in the country. Facilities that participate in these federal health insurance programs are required to meet certain “conditions of participation” (CoPs) in order to keep the federal funds flowing. CMS utilizes approved surveying organizations, such as the Joint Commission or state survey organizations, to determine if participating hospitals are meeting the terms of the CoPs.

Under the IFR, it will now be a condition of participation that your facility meet the provisions of the vaccine mandate. The specific terms of that mandate will be addressed in the following section. The critical item to note for now is that a hospital’s compliance with the IFR will be determined by one of these survey agencies.

Requirements and Deadlines

Relative to each facility covered under the IFR, such as participating hospitals, every staff member—whether clinical or clerical, whether full-time or part-time—must be fully vaccinated within the next few weeks. This includes independent clinicians (e.g., cardiologists, surgeons) who come to the facility to provide services. Providers of telemedicine who do not enter the hospital are not subject to the mandate.

Remember that two of the three currently approved COVID vaccines (Pfizer and Moderna) are administered in a two-dose protocol spread over a number of weeks. For staff members who have not yet received the first of these doses, they will be required to have their first jab by December 6. The second dose must be received by January 4, according to the IFR. For those who take the Johnson and Johnson version of the vaccine (which involves a single-dose protocol), they will be required to have their injection by December 6.

The vaccination mandate applies only to the primary series of COVID shots listed above. In other words, the current iteration of the IFR does not directly address booster shots. According to the FAQs released by CMS, “facilities will also be in compliance if they allow staff to work who received a vaccine listed by the World Health Organization (WHO) for emergency use that is not approved or authorized by the FDA, or who received a vaccine during their participation in a clinical trial.”

Exceptions and Exemptions

The IFR requires facilities to allow for exemptions to the vaccine mandate for staff under two conditions:

Those with recognized medical conditions for which vaccines are contraindicated [as a reasonable accommodation under the Americans with Disabilities Act (ADA)]; or

Those whose religious beliefs, observances, or practices (established under Title VII of the Civil Rights Act of 1964) compel them to avoid receiving the COVID injection(s).
The FAQs, referenced above, clarify that “no exemption should be provided to any staff for whom it is not legally required (under the ADA or Title VII of the Civil Rights Act of 1964) or who requests an exemption solely to evade vaccination.”

The FAQs also state that hospitals have flexibility in establishing their own processes for permitting staff to request a religious exemption. However, CMS requires facilities to document and evaluate such requests “in accordance with applicable federal law and as a part of a facility’s policies and procedures.” The same flexibility is granted in determining the process for evaluating and granting a medical exemption. In the words of the FAQs:

Facilities must ensure that all documentation confirming recognized clinical contraindications to COVID-19 vaccinations for staff seeking a medical exemption are signed and dated by a licensed practitioner, who is not the individual requesting the exemption and is acting within their respective scope of practice based on applicable state and local laws. This documentation must contain all information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications. Additionally, a statement by the authenticating practitioner recommending that the staff member be exempted from the facility’s COVID-19 vaccination requirements is also expected.
Penalty for Noncompliance

CMS works directly with state survey agencies (SSAs) to regularly review compliance with Medicare/Medicaid regulations across multiple healthcare settings. These agencies will be required to assess the vaccination status of staff on all complaint surveys. The surveyors will also review each facility’s COVID vaccination policies and procedures, as well as a list of all staff along with their vaccination status. This information, in addition to interviews and observations, will be used to determine the compliance of the provider or supplier with these requirements.

So, what if the surveying organization determines the hospital is non-compliant in some respect as it concerns the vaccination mandate? According to the FAQs:

Medicare and Medicaid-certified facilities are expected to comply with all regulatory requirements, and CMS has a variety of established enforcement remedies. For nursing homes, home health agencies, and hospice (beginning in 2022), this includes civil monetary penalties, denial of payment, and even termination from the Medicare and Medicaid program as a final measure. The remedy for non-compliance among hospitals and certain other acute and continuing care providers is termination; however, CMS’s goal is to bring health care facilities into compliance. Termination would generally occur only after providing a facility with an opportunity to make corrections and come into compliance.
So, while certain healthcare facilities (e.g., nursing homes) may face any one of an array of potential penalties for non-compliance, there is only one penalty for hospitals: termination from the Medicare and Medicaid programs. That’s pretty severe and leads to the conclusion that the government is serious about imposing its will in this matter.

Implications

Without getting into the wider debate over the efficacy and potential lethality of these injections, hospital executives will have to deal with the possible fallout that this new federal mandate will have on their ability to perform their core mission: the capacity to care for patients. You will need to immediately ensure you (a) have policies and procedures in place to specifically address circumstances in which exemptions will be given, and (b) document and retain this paperwork for surveying organizations. You will then need to determine how many staff members may be lost due to both their refusal to get the injection(s) and their inability to qualify for an exemption. To what extent will their departure impact your operations? How quickly can acceptable replacements be found and trained?

We’re entering a new phase of the American experience with these mandates. The U.S. Fifth Circuit Court of Appeals has, in the last few days, rejected the Biden vaccine mandate on businesses with over 100 employees. It remains to be seen what the final legal status will be for that mandate, as well as for the hospital IFR. To view the IFR FAQs, please go to the following link: CMS Omnibus Staff Vax Requirements – External FAQ (508 Compliant). As always, you can reach us at info@miramedgs.com.