As vaccination rates climb and Long-Term Care (LTC) facilities begin to reopen, the beginning of a return to “normal” also brings the extension of a familiar theme for LTC facilities: new rules and new penalties for noncompliance. Effective May 21, 2021 an interim final rule from the Centers for Medicare & Medicaid Services (CMS) establishes and consolidates COVID-19 vaccination education, documentation, and reporting requirements for LTC facilities applicable to residents and staff. For LTC facilities unprepared to meet the reporting requirements, CMS indicated it would begin reviewing for compliance and issuing penalties beginning Monday, June 14, 2021.
The new rules are applicable to LTC facilities and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID). In addition to publishing the interim final rule, CMS has published a related memo (QSO-21-19-NH) with specific guidance and instructions that each LTC facility should review in implementing the requirements.
Education, Vaccination, and Documentation
The Interim Rule requires LTC facilities to develop policies and procedures to educate residents or resident representatives and staff regarding the benefits and potential side effects associated with the COVID-19 vaccine. When available, LTC facilities must offer the vaccine to all residents and staff unless it is medically contraindicated or the resident or staff member has already been immunized. Notably, “staff” includes those individuals who work in the facility on a “regular basis”—specified to mean an individual who works in the facility at least once per week. Thus, LTC facilities should take careful note that the obligation to educate staff extends beyond their own employees and to those individuals under contract or arrangement, such as physical therapists, hospice staff, mental health professionals, volunteers, and other vendors who are in the facility on a regular basis.
The CMS guidance also establishes specific expectations for facilities to maintain documentation that demonstrates compliance with the new requirements. For residents, CMS expects, at a minimum, documentation in each resident’s medical record that the resident or resident representative was provided education regarding the benefits and potential side effects of the COVID-19 vaccine and that the resident or their representative accepted and received it or did not receive it, along with the reason for not receiving it. CMS further indicated that survey teams will expect to review samples of the educational materials used to educate residents.
LTC facilities will also be expected to maintain similar documentation that each staff member was educated. CMS recommends that LTC facilities create a roster of staff who received education, the date of the education, and samples of materials used. Each LTC facility must also document the vaccination status of each staff member. Due to the expansive definition of “staff” described above, LTC facilities will need to pay special attention to create an accurate roster. Although not addressed in the CMS guidance, LTC facilities should also be mindful of Equal Employment Opportunity Commission guidance addressing how employers can request confirmation of vaccination without requesting or documenting medical information and how to address requests for reasonable accommodation.
For residents and staff who receive the vaccine at the facility, CMS guidance requires that each resident or staff member be educated in the specific COVID-19 vaccination they receive, to include being provided with the vaccine-specific fact sheets from the Food and Drug Administration and available on the CDC website. This information must be provided a second time for residents or staff who receive a second required dose of a vaccine.
Under the guidance, surveyors determining compliance with the new education and vaccination requirements will be requesting a list of residents and staff and their vaccination status. Survey teams will also interview a sample of residents and staff to confirm that they were educated and offered the vaccine. Failure to follow the specific requirements of the new rule or specific guidance in the associated memo could result in deficiency citations and penalties
Reporting of Vaccination Status
The interim rule adds a new requirement for LTC facilities to report weekly to the CDC, via the National Healthcare Safety Network (NHSN), the COVID-19 vaccine status of residents and staff, each dose of vaccine received, COVID-19 vaccination adverse events, and therapeutics administered to residents for treatment of COVID-19. The required reporting must be completed through NHSN’s LTCF COVID-19 Module. CMS noted that it intends to post the new information collected on the CMS COVID-19 Nursing Home Data website to assist public health agencies and stakeholders in monitoring the level of vaccinated residents and staff and in the targeting of additional resources.
While the NHSN data made available online may provide valuable data to public health officials, the reporting system will also easily identify for potential enforcement penalties those LTC facilities who fail to report timely or completely in line with the technical requirements of the new rule. CMS warns that facilities who fail to meet the reporting requirements timely will receive a deficiency at a scope and severity level of F, along with a civil money penalty that starts at $1,000 and increases with each subsequent occurrence of noncompliance.
Even for LTC facilities with robust vaccination programs, the interim rule imposes technical administrative, documentation, and reporting requirements that must be carefully reviewed and implemented. The strong focus on future enforcement efforts in related CMS guidance indicates that the risk of penalties for noncompliance is real and imminent. In advance of the June 14, 2021 enforcement date, LTC facilities need to have robust policies, procedures, and internal processes in place to gather the required information. LTC facilities should also assign sufficient staff to become proficient in using with the NHSN reporting system to ensure timely and accurate submissions and to prevent reporting gaps.
If your organization has questions about the implementation of the new interim rule, related enforcement matters, or LTC facility regulatory matters in general, please contact Nathan Mortier with the Sands Anderson Healthcare Team for specific guidance and advice.
 Revisions to 42 C.F.R. §§ 483.80, 483.430, and 483.460. Available at https://www.govinfo.gov/content/pkg/FR-2021-05-13/pdf/2021-10122.pdf