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New COVID-19 Standards for SNFs and Nursing Homes

on Wednesday, 2 June 2021 in Health Law Advisory: Andrew D. Kloeckner, Editor

CMS has imposed additional COVID-19-related education, vaccination, documentation and reporting requirements on Medicare SNFs and Medicaid Nursing Homes (collectively “LTCs”). The action comes in the form of an interim final rule with comment period published May 13, 2021, and effective May 21, 2021. The new rule also imposes parallel requirements on intermediate care facilities for individuals with intellectual disabilities (ICFs-IIDs) with minor variances reflecting the difference in their services and structure. This summary focuses on the treatment of LTCs.

CMS starts by citing alarming but familiar statistics, noting that while nursing home residents make up less than one percent of the American population, they have accounted for over one-third of all COVID-19 deaths. Elsewhere, citing statistics reported to the CDC through the CDC’s National Healthcare Safety Network (NHSN) and posted on its website for the week ending April 11, 2021, the Secretary notes a cumulative total of 647,754 LTC resident COVID-19 cases resulting in 131,926 confirmed deaths.

Defining Who is Covered as “Staff”

The rule amends the CoPs related to infection control for LTCs. It mandates development of policies to address the issues of vaccination, education and documentation for both residents and staff. One key issue is, who are covered staff?

In a departure from how CMS identified staff in earlier COVID-19 testing rules, the Secretary’s comments state that CMS considers LTC facility staff to be “those individuals who work in the facility on a regular (that is, at least once a week) basis.” The term covers employees, volunteers, students and individuals who furnish services under contract, if they work in the facility on a regular basis. The reference to contractors would reach contracted medical directors, dialysis providers, hospice workers, therapy providers, contracted hair stylists, etc. who, along with employees, students and volunteers, would make up the LTC’s staff. The term will not reach individuals, such as plumbers (using the example provided in the Secretary’s comments) who might be called to the facility only once or twice per year, but who might be covered under the earlier and broader testing rules.

Policy Requirements

The LTC policy requirements are fourfold.

  1. Offering the Vaccine. The LTC must offer COVID-19 vaccination to residents and staff when vaccine supplies are available. The exception is for residents and staff who have been vaccinated or have medical contraindications. The resident (or his or her representative) and the staff member must have the option to accept or refuse the vaccine and to change their decision at a later date. The offer must remain open for those who change their mind after once declining to receive the vaccine, but subject to availability. If there is an ongoing problem with availability, the comments anticipate the LTC will have documentation of efforts to obtain availability, although this is not spelled out in the rule.

Note that the right to refuse by a staff member as a condition of participation for LTCs may have the practical effect of undermining an LTC employer’s option to condition employment on employees being vaccinated. It is not clear from the Secretary’s comments whether CMS’ position is tied to the fact vaccines are currently only available under emergency use authorizations and will change when vaccines receive full approval, but there is nothing in the comments suggesting that is the case. There is also nothing in the rule or comments tying staff’s right to refuse to specific, recognized grounds, such as prior vaccination, prior adverse reaction or other medical contraindication. In fact, the comments include simple “vaccine hesitancy” in their examples of staff (or resident) refusals.

The comment period runs to July 12, 2021, and LTCs concerned with CMS’ position (or other parts of the rule) or hoping for more specific guidance may wish to submit comments.

  1. Education. Before the vaccine is offered to residents or staff, the LTC must provide education on the benefits, risks and potential side effects of the vaccine. If the vaccine is offered in a multi-dose regimen, the education should include any change in the benefits and risks or side effects if the multi-dose regimen is not completed. In comments that were not carried forward into the rule, the Secretary calls on staff to be more broadly educated on the benefits of vaccination, not only for their own wellbeing but for the wellbeing of residents and the health of the community. Also, LTCs must provide education to all staff including even those who need not be offered the vaccine because of prior vaccination or contraindication.

Many LTCs participated in the Federal Pharmacy Partnership for Long-Term Care Program in which pharmacies provided potential vaccine recipients the EUA fact sheet for the vaccine. The comments indicate the fact sheets “explains the risks and possible side effects and benefits” of the vaccine they were receiving. We interpret the comments as suggesting LTCs may use the fact sheet for the relevant vaccine as a template in staff and resident education.

  1. Documentation. The new rule requires that a resident’s medical record must include documentation that: (i) the resident (or representative) was provided the required education; (ii) lists each dose administered to the resident; or (iii) notes that the resident did not receive the vaccine due to medical contraindications or refusal.

Similarly, with respect to staff, an LTC facility must maintain documentation demonstrating: (i) that the staff member was provided the requisite education; (ii) the staff member was offered the vaccine (subject to availability); and (iii) “the COVID-19 vaccine status” of each staff member and any other information required for reporting to the NHSN. Compliance will require knowing and therefore asking for the vaccination status of all staff, including contracted staff. LTCs will need to determine where to incorporate the requirement of disclosing current vaccination status in contracts and arrangements for students, volunteers and contracted personnel. Finally, LTCs must maintain documentation that education has been provided to all staff.

  1. Reporting. The rules applicable to LTCs already require certain COVID-19 and other infection/vaccination reporting through the NHSN and other channels. The new rule adds to the list and requires reporting through the NHSN on a weekly basis:

“The COVID-19 vaccine status of residents and staff including total numbers of residents and staff, numbers of residents and staff vaccinated, numbers of each dose of COVID-19 vaccine received, and COVID-19 vaccination adverse events; and …therapeutics administered to residents for treatment of COVID-19.”

Reports are of aggregated data and are available for inspection and in some cases routinely published on the CDC website.

Penalties

The new rule fits within the current infection control standard and penalty scheme; no new or unique penalties are added. However, like all other infection control and reporting requirements, violations are potentially subject to CMPs and create a risk to SNFs’ and NFs’ certifications.

Given the effective date of May 21, 2021, LTCs are encouraged to promptly address the new requirements.

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