New Rule Requires COVID-19 Vaccine Education, Offering, and Reporting

Regulation | May 28, 2021 | by Jodi Eyigor

An interim final rule with comment period requiring education, offering, and reporting of COVID-19 vaccination data was published to the federal register on May 13.

The interim final rule Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF-IID) Residents, Clients, and Staff was published to the federal register on May 13, 2021. This interim final rule with comment period went into effect May 21, 2021 and requires providers to educate and offer COVID-19 vaccination to residents, clients, and staff. The rule additionally requires long-term care facilities (nursing homes) to report COVID-19 vaccination rates and resident use of therapeutics through the National Healthcare Safety Network (NHSN). Reported data will be shared publicly at data.cms.gov. Compliance with these requirements will be surveyed under existing federal tag F884 Reporting - National Healthcare Safety Network and new tag F887 COVID-19 Immunization. The comment period on this rule closes July 12.

F887 COVID-19 Immunization

Providers are required to provide education on COVID-19 vaccination to all residents/clients and staff. While the rule states that education should be offered to all, including those who have already been vaccinated or those who are ineligible for vaccination due to contraindication, CMS has clarified that they are directing surveyors to focus on education provided to unvaccinated residents/clients and staff.

For the purposes of these requirements, “staff” are any individuals who work in the nursing home or ICF/IID on a regular basis, at least once per week. This includes any individuals who may not be present for a period of time due to illness, disability, or scheduled time off, but are expected to return to work and would normally be scheduled to work on a regular basis. “Staff” also includes any individuals working under contract or arrangement, such as hospice staff, dialysis staff, rehab therapists, mental health professionals, or volunteers who work on a regular basis. Nursing homes and ICF/IIDs are not required to provide education or offer vaccination to individuals who work less frequently.

Education should include the benefits, risks, and potential side effects of COVID-19 vaccination. Typical benefits include reduced risk of COVID-19 illness and related serious outcomes including hospitalization and death, the bolstered protection afforded by completing the full series if a multi-dose vaccine regimen is offered, and other benefits identified as research continues. When educating on side effects, providers should provide information on common side effects as well as more rare side effects, noting the rare likelihood of serious reactions. The Food and Drug Administration (FDA) also requires that the Emergency Use Authorization (EUA) Fact Sheet is provided at the time of vaccine administration.

Providers may additionally choose to provide education to staff on the development of vaccines, how the vaccine works, and information specific to multi-dose vaccines series. Staff should be educated on the importance of vaccination in protecting the residents they serve, their personal health, and community health. Staff should also be informed about ongoing opportunities for vaccination. Additional education for residents must include information that the COVID-19 vaccine is provided to all long-term care residents without copays or out-of-pocket costs. Education must also provide opportunity for follow-up questions and must be provided in a manner that is reasonably understood by residents and representatives.

While education must be provided to all residents/clients and staff, providers are not required to offer vaccine to those who have already been vaccinated or for whom a contraindication to vaccination exists. Vaccinations must be conducted in a safe and sanitary manner consistent with requirements at §483.80. This includes screening for current suspected or confirmed COVID-19, previous allergic reactions, and administration of therapeutic treatments and services. Providers must document offering vaccine in the resident record or applicable staff record and whether the vaccine was accepted. If vaccination is refused, the reason for refusal must be documented, including if the vaccine was refused because the individual has already received vaccination.

Providers may offer vaccination directly or may partner with another entity such as a long-term care pharmacy to vaccinate residents/clients and staff. If the provider is unable to offer vaccination, the provider must educate the resident/client or staff member on how and where vaccine might be accessed, such as local public health departments or community vaccination sites. Providers should also document attempts to obtain vaccine.

CMS has outlined a number of resources that may be useful in memo QSO-21-29-NH. Additionally, LeadingAge has developed this resource to assist with compliance with these requirements.

F884 Reporting – National Healthcare Safety Network

Long-term care providers (nursing homes) are required to report vaccination data for residents and staff. Data to be reported includes vaccination status of residents and staff, total numbers of residents and staff vaccinated, each dose of vaccine offered, and COVID-19 vaccine adverse events.

As above, for the purposes of this reporting, “staff” means any individual who works in the nursing home on a regular basis, at least once per week. This includes individuals who are working under contract or arrangement, such as hospice workers or rehab therapists. Also as above, individuals who regularly work in the nursing home at least once per week should be included in reporting, even if they are not physically present for the week or reporting, such as those who are out sick or on leave.

Vaccine reporting is cumulative, meaning that it includes residents and staff who have ever been vaccinated, not simply those who received a vaccine that week. Residents and staff who were vaccinated during the Long-Term Care Pharmacy Partnership in December 2020 and the early months of 2021 would be included in weekly reports, provided they continue to live/work in the nursing home. Residents who have discharged or staff who no longer work in the nursing home are not included in reporting.

Additionally, this reporting includes residents and staff who were vaccinated somewhere other than the nursing home. For example, a resident who was vaccinated in the community prior to admission or a staff member who was vaccinated at the local public health department or in a different nursing home where they work would be included in this reporting, even if the other nursing home is also reporting on that staff member. The intent is to give a picture of the vaccination status of those living and working in your nursing home at a given time. Nursing home providers are additionally required to report to NHSN therapeutics administered to residents for treatment of COVID-19. Therapeutics, for purposes of NHSN reporting, have been defined as a treatment, therapy, or drug. Monoclonal antibody treatment is one example of therapeutics to be reported.

Data should be reported on a weekly basis to NHSN and the data will be shared publicly on the nursing home site at data.cms.gov. The reporting week for NHSN purposes is Monday – Sunday, but the chosen day of reporting is at the discretion of the provider consistent with other NHSN reporting requirements. Data for the previous week is shared with CMS shortly after midnight on Monday mornings. CMS will begin enforcement on the new requirements for reporting of therapeutics and vaccine data on June 14. This means that nursing homes must begin including therapeutics and vaccine data in NHSN reporting by 11:59pm on June 13.

As with other F884 citations, compliance will be evaluated through an off-site data review. Noncompliance will be cited at scope/severity “F” for each single week of noncompliance and assessed Civil Monetary Penalties (CMPs). Recall that CMPs assessed for noncompliance at F884 follow a progressive pattern. Each episode of noncompliance is assessed a $1,000 CMP with incremental increases of $500 for each subsequent episode of noncompliance. The first week of missed reporting is assessed a $1,000 CMP. The second week is assessed a $1,500 CMP; the third week is assessed a $2,000 CMP and so on. Please note that with the addition of these new requirements at F884, the CMP schedule does not reset. For example, a nursing home that was last assessed a CMP of $2,500 for noncompliance at F884 and that fails to submit data on vaccination by June 13 at 11:59pm will receive a CMP of $3,000 on June 14, even though it is the first episode of failure to report vaccine data.

What This Means for Providers

Nursing homes have long reported resident data on flu and pneumonia vaccination. However, this data is generally reported through submissions of the Minimum Data Set (MDS), and while providers track flu and pneumonia vaccination of staff, reporting has not been required at the federal level. Additionally, while vaccination rates are improving across the country, initial vaccine acceptance by nursing home staff lagged behind that of nursing home residents.The impact of COVID-19 on the nursing home population and the pattern of transmission between staff and residents has likely contributed to the assumed necessity of these requirements for education, offering, and reporting of COVID-19 vaccination. We note that “staff” for the purposes of these requirements is more narrowly defined than for other requirements, such as COVID-19 testing; however, the significant burden of tracking and reporting data remains. CDC has developed training resources and tools to assist with reporting and tracking, available here.

LeadingAge will be submitting comments on this rule to the federal register ahead of the July 12 deadline. We encourage members to submit comments on behalf of their organizations and welcome any feedback you wish to be considered for inclusion in the LeadingAge comments. Please send comments, concerns, or questions to Jodi Eyigor jeyigor@leadingage.org.